ITEM 1. BUSINESS.
Business Development.
Andain Inc., a Nevada corporation (“Company”), was incorporated on July 23, 2004. The address for the Company is: 400 South Beverly Drive, Suite 312, Beverly Hills, California 90212, its telephone number is: (310) 286-1777. The Company commercializes novel technologies in the biotechnology and medical fields. The Company’s products include miniature disposable insulin pump, stem cell therapy for muscular injuries and organ-targeted nano-particles for drug delivery via inhalation.
The Company also operates an in-house technological and industrial incubator, supported by its industrial associates and government funding. Through its incubator program, the Company is constantly screening promising new technologies to commercialize. The Company’s focus is on patented technologies that can be commercialized within a period of 12-24 months and, preferably, provide lifesaving attributes.
Business of the Company.
The Company is currently operating eight business units:
Product-based business units:
·Miniature semi-disposable insulin pump (Gaia Med Ltd.)
·Miniature fully disposable insulin pump (Andain Inc)
·Targeted drug delivery nano-particles (TPDS Ltd.)
·Stem cell therapy (OrCell Ltd.)
·Ultasonic catheter for brain cancer therapy (Sonenco Ltd.)
·Peptide booster for anti-wrinkle cosmeceuticals (NBCT Ltd.)
Service-based business units:
·Management consulting and business development (Impact Active Team Ltd.)
·Industrial and technological incubator (Meizam - Advance Enterprise Center Arad Ltd.)
·Financing services (Meizam Arad Investments Ltd.)
1. Miniature Disposable Insulin Pump.
On July 1, 2010, the Company, through its subsidiaries Meizam - Advanced Enterprise Center Ltd., an Israel corporation (“Meizam Arad”), and Meizam Arad Investments Ltd. an Israel corporation (“Meizam Investments”), entered into an initial share purchase agreement with Gaia Med Ltd., an Israel corporation (“Gaia Med”). On March 31, 2011 Gaia Med issued 600,000 shares to Meizam Investments according to the Industrial Incubator Agreement, where Meizam Investments acquired 33% of Gaia Med shares for 2.25 million New Israeli Shekels (“NIS”) (App. $650,000). During 2013, the Company does not expect to receive additional research and development grants for Gaia Med from the Israeli Ministry of Industry, Trade, and Labor’s (“MOITL”) above the specified in the approved program.
On March 31, 2011 the Company transferred all rights commitments, assets and holdings of Gaia Med from Meizam Arad to Meizam Investments.
On September 30, 2011, Gaia Med adjusted the share distribution to match unissued vested shares. After the adjustment, the Company holds 42.6% of its total issued and outstanding shares.
On December 28, 2011, Gaia Med bought back 27% of its share capital from some of its private shareholders. As a result, the Company increased its holding in Gaia Med to 57.6%.
In addition, the Company develops advanced miniature, ultra slim, 'Band-Aid' patch size insulin pump, the Gemini. Our miniaturizing technology enabled the development of a fully disposable, waterproof, fully programmable insulin pump designed to treat Type I and Type II diabetes for a week. The pump holds 6CC of insulin and is 49mm diameter by 7 mm thick 25 in size, making it very comfortable and almost unnoticeable to wear. Moreover, its ultra-low cost makes it an affordable and clinically superior replacement for pen injector products. Smart on-line monitoring provides a real-time alert for occlusions and leakages.
We also developed a plug in universal remote-control unit that provides the patient, clinic, and doctor dynamic control and on going monitoring of the patient’s insulin treatment program. As a stand-alone, the pump is pre-programmed for patient treatments, providing tailored-made safe basal Insulin treatment and allows for the program-controlled delivery of manual bolus insulin dosages. A fail-safe mechanism prevents the administration of multiple bolus insulin dosages and fully controls basal insulin to prevent hypo-glycemia.
The Company’s fully disposable insulin pump product line based on miniaturizing technologies developed and implemented in our insulin pumps. These insulin pumps address two market segments:
·Type-I diabetics, who are usually eligible for reimbursement of insulin pump expenditure from health insurers and, therefore, many of them use insulin pump. The Company’s miniature product may offer more comfortable and unnoticeable product for this market segment.
·Type-II diabetics, who comprise of the majority of diabetic patients, but usually are not eligible for health insurance reimbursement for insulin pump and, therefore, usually use other injection products, e.g. insulin pen injector, which are eligible for reimbursement. Diabetic doctors usually agree that insulin pump offers clinically superior therapy. The Company’s low cost product may offer an affordable yet superior product for this market segment.
(a) Fully-Disposable Nano-Pump.
On February 1, 2011 the Company initiated an aggressive development program to develop a miniature band-aid patch-size waterproof fully disposable insulin pump suitable for Diabetics type I and type II. The Company’s miniature insulin pump's low cost offers an affordable replacement for the pen-injections used by diabetic type II patients, with superior clinical performance.
The nano-pump is based on an innovative, design:
·The pump is miniature in size: 25 grams, 49x7 mm making it almost unnoticeable.
·It is attached to body by an adhesive patch making it very comfortable to wear and no tubing is required like in conventional pumps.
·The pump is fully disposable and suitable for Type-I diabetics as well as Type-II.
·Its low cost offers an affordable replacement to the insulin pen injector.
·The pump provides a real-time alert for occlusions and leakages.
The development and in-vitro test of the nano-pump were successfully completed, and meets the medical and marketing requirement for diabetic type I type II at the planed manufacturing cost.
(b) Semi-Disposable Nano-Pump.
The Company has completed the development, lab and in-vitro tests of the Diamond semi-disposable miniature pump, which has a disposable part and a reusable sophisticated multi-function part, and met the medical and marketing requirement for treating diabetes type-I and type II. The Diamond semi-disposable miniature pump meets all medical regulatory requirements, and provides low-cost solution for diabetics type I and type II patients.
The Company has concluded the initial production batch of the semi-disposable Diamond pump for pre-clinical and clinical studies as required by regulations. The initial pre-clinical results showed promising results enabling the Company’s engineers further miniaturizing the pump and dramatically reducing the production to a, very low cost and very reliable patch size pump.
As a result, the Company is modifying the pre-clinical and clinical trials, as well the related regulatory applications to meet the new design of the fully disposable and semi-disposable pumps. In addition, the Company is preparing a new patent application to secure the newly developed fully disposable technology.
(c) Current Status.
The Company is currently putting significant efforts in manufacturing and regulatory affairs of the fully disposable miniature pump in order to enable us completing the FDA before end of 2013. During 2013, the Company plans to conduct clinical trials of diabetes type II treatment with our insulin pumps for market acceptance purposes. The Company is maintains its new patent application, which is separate from the semi-disposable pump patents and intellectual properties, in order to secure the newly developed technology.
The development and in-vitro tests of the Diamond semi-disposable pump were successfully completed and meet the medical and marketing requirements for diabetic type-I and type-II patients. The Company now intends further miniaturizing the pump and reducing its production cost.
(d) 12 Month Operational Plan.
Production - The Company’s design for production enables it to commence pump production for the clinical trials. The Company develops FDA standards production line of the fully disposable pump will at a GMP production facility certified for the same regulation and quality assurance as the commercial product.
Clinical trials - The Company’s our scheduled clinical trials will take place at the Diabetics Clinic of Diabetic Center, Schneider Medical Center, Petach Tikva. The clinical trials are designed to support 3 groups of 200 patients per group, compared to the general population of diabetes type-II using conventional insulin pen injection:
Type I diabetes - Pumps personally programmed for type I diabetics. The individual in the group is controlled by Soroka Hospital Diabetic Clinic.
Type II diabetes - Pumps personally programmed for type II diabetics. The individual in the group is controlled by Soroka Hospital Diabetic Clinic.
Type II diabetes - Pumps have general basal programming to be used as the reference group
Type II diabetes - Patients use the conventional pen injection as a control group.
(e) The Market for Insulin Pumps.
Diabetes is a global epidemic with over 285,000,000 diabetes patients worldwide and 7,000,000 patients contracting the disease annually (Source: International Diabetes Federation, Diabetes Atlas 2010). Diabetes can be identified as: Type-1, Type-2 and gestational. Type-2 diabetes accounts for more than 90% of all diabetes cases in developed countries (Source: The American Diabetes Association, 2010).
According to the National Center for Chronic Disease Prevention and Health Promotion (CDC), in 2010 there were 18.8 million people diagnosed with diabetes in the U.S., of which 1.9 million were newly diagnosed in 2010; 26% of them were treated in insulin. The estimated direct cost of diabetes in the U.S. is over $170 billion annually. In order to constrain spiraling healthcare costs and limit the progression of full-blown type 2 diabetes and its complications among an aging and increasingly obese population, the development of more affordable and effective diabetes management (self-testing and treatment) products has become a top priority not only in the U.S., but worldwide.
In Type-1 diabetes, the body fails to produce insulin as a result of an autoimmune response in which the immune system does not recognize its own islet cells and destroys them. This type of diabetes generally occurs in people under the age of 40 and is most commonly acquired during childhood. Type 1 diabetes is treated by insulin injections and diet.
Type-2 diabetes is the most common form of diabetes (90-95% of diabetes patients). It presents as high blood glucose levels despite an initial abundance of the hormone insulin. The cells of the body ignore the insulin and do not allow glucose to enter the body’s cells. This insulin resistance leads to high levels of glucose in the bloodstream, and eventually to beta-cell failure, where the beta cells of the pancreas are no longer able to release insulin in response to high blood glucose levels. Patients may require insulin for control of hyperglycaemia, if this is not achieved with diet alone or with oral hypoglycaemic agents.
Lifelong dependence on insulin delivery forces the patient to manually inject insulin with every meal and to constantly monitor their glucose levels using syringes, pens or needle less injectors. The Diabetes Control and Complications Trial (DCCT) demonstrated that intensive insulin therapy - multiple (three or more) daily injections (i.e. shots with syringe or insulin pen) of insulin (MDI) or insulin pump therapy - keeps blood sugar levels in a normal versus elevated (hyperglycemia) range, and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in Type 1 diabetics, at the expense of increased severe hypoglycemia (low blood sugar from too much insulin or too little glucose in the blood). The incidence of severe hypoglycemia in the trial, defined as treatment requiring assistance, was approximately three times higher in the intensive therapy group, and included altered consciousness, episodes of coma/seizure, and hospital/emergency room visits.
(f) Insulin Pumps.
Diabetes management products market, insulin injection devices and insulin pumps, insulin therapies and oral and injectable diabetes drugs-has become one of the largest medical device markets in the U.S. totalling more than $20 billion in 2008. As the population of diabetics continues to increase, the market is expected to continue to grow at a double-digit rate over the next five years, reaching nearly $28 billion by 2013.
The insulin pump market is sizeable and rapidly growing. Global markets sales are estimated to be over $1 billion annually with a 12% compound annual growth rate.
However, insulin pumps are comparatively expensive, with the average price of $3,500-$5,000 at the U.S. market. The disposable infusion sets are $15-20 each (replaceable every 3 days); while insulin reservoirs cost $5 each. As a result, most diabetes patients still do not use insulin pumps as the replacement of the inferior injection administration. Pumps are used by less than 3% of the potential insulin-injecting patients, and nearly all by Type-1 diabetes patients almost none are used for Type 2 diabetics.
Insulin pumps provide an alternative to daily injections and provide some Type 1 diabetics better control of their diabetes and a more flexible lifestyle. The standard insulin pump is about the size of a pager and is worn outside the body. The pump is programmed to deliver insulin continuously (basal rate) and in specific increments (bolus) when needed usually before a meal. Insulin pump users fill up a new insulin cartridge, which is placed inside the pump, every three to seven days (depending on cartridge size patient body mass and daily insulin usage).
An infusion set of thin, flexible plastic tube with sub-dermal injection needle is attached to the pump and delivers the insulin from the pump to the patient. The infusion sets are inserted just beneath the skin, and need to be changed, on average, every three days. The infusion set tubing is uncomfortable and is susceptible for disconnections due to the physical patient movements and various obstacles.
The insulin pump provides superior diabetes treatment with enhanced glycaemic control and reduces the risk of hypoglycaemic events that dramatically improves a patient’s quality of life. According to the American Diabetes Association, some advantages of using an insulin pump instead of insulin injections are:
Eliminates individual insulin injections
·Delivers insulin more accurately than injections
·Improves A1C
·Fewer large swings in blood glucose levels
·Easier diabetes management
·Allows to be flexible about when and what to eat
·Improves quality of life
·Reduces severe low blood glucose episodes
·Eliminates unpredictable effects of intermediate- or long-acting insulin
·Allows to exercise without having to eat large amounts of carbohydrate
(g) Competition.
Medtronic’s MiniMed division (acquired in August 2001) is the insulin pump market leader (Paradigm pump) in the US, while Roche’s Disetronic division (acquired in May 2003) is the market leader outside of the US. Until 2000, the U.S. insulin pump and disposables market was dominated by MiniMed and Disetronic. Animas began shipping its first generation R1000 insulin pump in July 2000, launched its second generation IR 1000 insulin pump in 2002, its third generation IR 1200 insulin pump in April 2004, and fourth generation IR 1250 in February 2005. In 20005 the US, Animas markets its products through both a direct sales force of about 55 sales representatives (paired with about 75 clinical diabetes educators) and distributors. Animas has shipped more than 14,500 pumps worldwide as of March 2004, up to the end of 2005, and does not currently break out unit sales. In June 2003, Roche stopped shipping insulin pumps to the US as a result of regulatory issues with the FDA, but continued to support its current customer base in terms of customer support and shipping of disposables. Roche re-enter the U.S. market with its Accu-Chek Spirit in 2006.
Deltec introduced the Cozmo insulin pump in December 2002, and partnered with Abbott to introduce its new CozMore Insulin Pump System in August 2004, which works with the Abbott (TheraSense) FreeStyle meter. Deltec has sold about 18,000 pumps as of July 2005, most of which were in the U.S. (Dana Diabecare pump) and Nipro (Amigo pump) also manufacture insulin pumps. Insulet was introduced to the diabetes pump market in early 2007 with its OmniPod disposable insulin pump. Anima is launching its next generation IR 1275 and IR 1500 pumps in and disposable insulin pump.
With miniaturizing technology, the insulin pump manufactures drive for a patch-size fully disposable pump. Several patch pumps are in various development stages:
·Finesse (Calibra Medical): delivers bolus insulin or pramlitide.
·V-Go (Valeritas): is a once-daily disposable insulin delivery system for type 2 diabetes.
·Solo (Medingo): has a three-month life, electronically controlled.
·Freehand (MedSolve Technologies): is remote controlled, 80% smaller than OmniPod.
·Insulin NanoPump (ST Microelectronics and Debiotech): has large reservoir, miniaturized system.
·Altea Therapeutics: is developing a 12-hour and 24-hour patch.
·Medtronic: is developing a patch delivery system.
2. Nano-particles Targeted Drug Delivery Technology.
On June 11, 2006, the Company entered into a Technology Purchase Agreement with Pangea Investments GmbH (“Pangea”). Pangea was the owner of the intellectual properties, potential patent rights, know-how and research and development in process, and all related technical information, in connection with technology as described in a U.S. patent application filed on June 7, 2006. In return for acquiring the rights to use the technology covered by this applied patent, the Company paid to Pangea Investments GmbH 4,500,000 restricted shares of common stock. On February 27, 2012, Pangea Investments GmbH sold all of the restricted shares of common stock held in its name and is no longer a shareholder in the Company.
This application covers a pulmonary inhalation drug delivery system for hydrophobic drug molecules for wet and dry inhalation. Hydrophobic refers to the physical property of a molecule that is repelled from a mass of water. Hydrophobic drugs such as these widely vary in levels of toxicity but are very efficient antibiotics and the only solution capable to treat the MDR (multi drug resistance) bacteria that COPD patients suffer from. They cannot mix and dissolve easily in water or in saline without use of additional toxic solvents and if used in a class IV administration form can cause imminent kidney failure, therefore used only in very extreme cases as a last resource.
On August 14, 2006, the Company established TPDS Ltd., an Israel corporation (“TPDS”), as a subsidiary responsible for further development of the acquired technology into a commercially viable product in the field of respiratory care of chronic obstructive pulmonary disease and ventilator-associated pneumonia patients. TPDS has developed organ-targeted drug delivery nano-particles with timely drug release capacity. TPDS is located at Meizam Arad. Currently, the Company holds 93.6% of TPDS’s equity.
On March 31, 2011 The Company transferred all rights commitments assets and holdings of TPDS from Meizam Arad to Meizam Investments.
On March 31, 2011 TPDS issued 9,367,350 shares to the Company to compensate for the over issuance to Dr. Leonid Luria as of the signed agreement with Dr. Luria dated May 16, 2006. In addition TPDS issued 3,876,192 shares to Meizam Investments according to an industrial incubator agreement, where Meizam Investments acquired 25% of TPDS shares for 2.25 million NIS (approximately $650,000).
TPDS (target particle delivery system) is the Company’s product line based on unique nano-particles capable of carrying different drugs to specific organs. Our nano-particle technology is capable of ultra-high drug loading of hydrophobic and hydrophilic drug types. The nano-particle releases the drug on a pre-designed timing, and then decomposes to its natural ingredients and naturally dissolves by the body's functions. Our nano-particle delivery technology improves significantly the effectiveness and efficiency of delivering antibiotics via inhalation, thus providing a potentially better cure for pulmonary diseases.
TPDS lipid-based nano-particles can deliver almost any drug with extremely high load capability. The nano-particles target only the specific designated organ with hardly any residual drug existence in other internal organs.
The nano-particles release the drug in the target organ in a well-timed and controlled manner. Such controlled release enables lower drug dosage while reducing toxicity and harm.
TPDS nano-particles encapsulate the drug molecules until the release-triggering mechanism releases the drug. As soon the drug is released, the nano particles dissolve to their natural ingredients and are absorbed by the surrounding tissue.
The Company’s primary application is COPD (chronic obstructive pulmonary disease), which affects over 16 million patients in the U.S. alone. The initial target application is VAP (Ventilator-Associated Pneumonia), where patients are commonly treated in intensive care units and suffer high mortality rate, and the Company may offer lifesaving therapy.
TPDS nano-particle can also carry a cocktail of drugs, handling persistent bacteria with anti-inflammatory agents, to prevent lung spasm and airway obstruction, in conjunction with the appropriate drugs. The formulation developed, handles the bacteria that flourish in the lungs, causing inflammation and edema, and eventually lung collapse with devastating effects.
The Company completed the initial development and is preparing batch production for pre-clinical trials
(a) Current Status.
Nano-particle accelerated development - The Company has completed development of the nano-particle technology capable to carry and accommodate hydrophobic (repelling water based molecules) as well hydrophilic (attracting water based molecules) medical drug molecules.
The Company has managed to expand significantly its nano-particles capabilities to carry out also the GSK RELENZA (zanamivir) drug for swine flu (H1N1) therapy. About three years ago, the FDA issued a warning letter regarding the use of RELENZA in inhalation since it has not been proven as safe and effective. Zanamivir is an effective drug for the swine flu. The request for this nano-particle application was referred to us by Professor Pitlik formerly Head of Infectious Diseases Dept. at Belinson Medical Center. The Company estimates that the additional development enhancing the product’s capabilities will provide unique and significant technological advantage and will enhance the Company’s business capabilities.
It is the Company’s goal to enter into clinical trials with the modified nano-particle which will be capable of carrying additional drugs such as the zanamivir knowing that the use of its nano-particle may prevent solution foaming and increase the drug delivery effectiveness.
Ethical Committee ("Declaration of Helsinki") - The Company was asked to add one pre-clinical safety test. The Company will complete the regulatory applications for the planned clinical trials with its next investment round.
Clinical trials - with the next investment round the Company will perform the clinical trials at the respiratory intensive care unit at Rambam Medical Center (Haifa, Israel)
GMP production - The production will take place at Rotem Industries GMP facility. In April 2011 Rotem received the Ministry of Health's approval for producing TPDS drug with no cross-contamination risk!
(b) 12 Month Operational Plan.
GMP production Line - The Company is required to upgrade the production line at Rotem Industries and add a separate high-pressure homogenizer, in order to avoid possible cross contamination with the other production lines at Rotem.
Initial batch Production - The Company plans to produce minimum 2,000 vials to meet the clinical trial needs of 21 days treatment course, 3 times a day per patient (with spare).
Pre-Clinical Trials - The Company plans to perform the pre-clinical trials with large animals in order to meet all needed safety regulatory requirements. Although it was not requested by the regulations, we intend adding pharmacokinetics and pharmacodynamics tests to exhibit our technology superiority comparing to any other relevant available solutions.
Clinical Trials - 2 cycles of patients in the Respiratory Intensive Care Unit at Rambam Medical Canter are planned. The duration of the first cycle will be minimum 6 months, treating the VAP patients with TPDS nano-particles. The lung fluids will be analyzed for bacterial colonies infection after each treatment (min. 3 times a day). The second cycle will receive the same treatment without our nano-particle, using the same procedure analyzing bacterial colonies infection after each treatment (min. 3 times a day), and comparing the results between the 2 groups.
Lab tests and analytics - For each lung fluid test, the Company needs to test the patient blood-work and urine. Those tests will probably continue after the treatment ends in order to analyze the decay of the delivered drug in the patient's body over time. The lung liquids for bacteria colonies have to be analyzed outside the hospital laboratories. This analysis will take place at Beer-Sheva University analytical department.
(c) Market Overview
Pulmonary Diseases.
COPD (Chronic Obstructive Pulmonary Disease).
This is an umbrella term used to describe lung disease associated with airflow obstruction. Most generally, emphysema, chronic bronchitis and chronic asthma either alone or in combinations fall into this category. There is continuing debate as to whether this term also includes Asthma (non chronic), however as a general rule, it is not included as, even though it does have obstructive components to it, it is in part reversible, and is more generally considered a restrictive lung disease.
The symptoms of COPD can range from chronic cough and sputum production to severe debilitating shortness of breath. In some individuals, chronic cough and sputum production are the first signs that they are at risk for developing the airflow obstruction and shortness of breath characteristic of COPD. In others, shortness of breath may be the first indication of the disease.
Chronic Bronchitis.
This is the inflammation and eventual scarring of the lining of the bronchial tubes. When the bronchi are inflamed and/or infected, less air is able to flow to and from the lungs and a heavy mucus or phlegm is coughed up. The condition is defined by the presence of a mucus-producing cough most days of the month, three months of a year for two successive years without other underlying disease to explain the cough. This inflammation eventually leads to scarring of the lining of the bronchial tubes. Once the bronchial tubes have been irritated over a long period of time, excessive mucus is produced constantly, the lining of the bronchial tubes becomes thickened, an irritating cough develops, and airflow may be hampered, the lungs become scarred. The bronchial tubes then make an ideal breeding place for bacterial infections within the airways, which eventually impedes airflow. Symptoms of chronic bronchitis include chronic cough, increased mucus, frequent clearing of the throat and shortness of breathe.
Emphysema.
This disease begins with the destruction of air sacs (alveoli) in the lungs where oxygen from the air is exchanged for carbon dioxide in the blood. The walls of the air sacs are thin and fragile. Damage to the air sacs is irreversible and results in permanent “holes” in the tissues of the lower lungs. As air sacs are destroyed, the lungs are able to transfer less and less oxygen to
the bloodstream, causing shortness of breath. The lungs also lose their elasticity, which is important to keep airways open. The patient experiences great difficulty exhaling. Emphysema does not develop suddenly. It comes on very gradually. Years of exposure to the irritation of cigarette smoke usually precede the development of emphysema. Of the estimated 3.1 million Americans ever diagnosed with emphysema, 95 percent were 45 or older. Symptoms of emphysema include cough, shortness of breath and a limited exercise tolerance. Diagnosis is made by pulmonary function tests, along with the patient’s history, examination and other tests.
Smoking is the primary risk factor for COPD. Smoking causes approximately 80 to 90 percent of COPD deaths. Female smokers are nearly 13 times as likely to die from COPD as women who have never smoked. Male smokers are nearly 12 times as likely to die from COPD as men who have never smoked. Other risk factors of COPD include air pollution, second-hand smoke, history of childhood respiratory infections and heredity. Occupational exposure to certain industrial pollutants also increases the odds for COPD. A recent study found that the fraction of COPD attributed to work was estimated as 19.2% overall and 31.1% among never smokers.
Ventilator-Associated Pneumonia (VAP).
Pseudomonas Aeruginosa.
This is an opportunistic pathogen, meaning that it exploits some break in the host defenses to initiate an infection. It causes urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacterium, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immuno-suppressed. Pseudomonas aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis, and burns. The case fatality rate in these patients is 50%.
Ventilator-Associated Pneumonia (VAP).
This affects up to 28% of patients receiving mechanical ventilation in the intensive care unit. The mortality rate for VAP ranges from 24 to 50% and can reach 76% in some specific settings or when lung infection is caused by high-risk pathogens common in ICU.
TPDS Technology.
TPDS is in the process of developing a proprietary lipid-based target particles technology that is intended to enable:
·Target Delivery to an Organ. TPDS technology is capable of delivering a desired drug to a specific organ without any residual drug existence to other body organs.
·Control Drug Release. TPDS delivery system releases the drug at a timely and controlled manner. Such controlled release enables significantly lower dosage of the drug preventing toxicity and damage.
·Deliver Non-Hydrophobic Drugs. TPDS is a viable solution for non-hydrophobic (cannot dissolve properly in liquid) drugs reformulation especially to respiratory usage.
Market Need.
COPD.
It is estimated that there are currently 16 million people in the United States diagnosed with COPD. It is estimated that an additional 14 million or more are still undiagnosed, as they are in the beginning stages and have few or minimal symptoms and have not sought health care yet. It is predicted that close to 35 million cases could possibly be found just in the United States alone.
COPD is the fourth leading cause of death in America, claiming the lives of 120,000 Americans in 2002. Beginning in 2000, women have exceeded men in the number of deaths attributable to COPD. In 2002, over 61,000 females died compared to 59,000 males.
In 2003, 10.7 million U.S. adults were estimated to have COPD. However, close to 24 million U.S. adults have evidence of impaired lung function, indicating an under diagnosis of COPD. In 2004, the cost to the nation for COPD was approximately $37.2 billion, including healthcare expenditures of $20.9 billion in direct health care expenditures, $7.4 billion in indirect morbidity costs and $8.9 billion in indirect mortality costs.
TPDS nano-particle drug delivery system carrying a cocktail of drugs, such as Colistin and other drugs handling persistence bacteria with anti-inflammatory agents preventing lung spasm and obstruction of the airways, with anti-infection agents. TPDS formulation subscribed to the patients handles the bacteria that flourishes in the sensitive lung causing inflammation and edema, eventually causing collapsing of the lung.
VAP.
Humanity developed in the last decades multi drug resistance (MDR) mainly for antibiotics. MDR is a major cause of life threatening pulmonary diseases. There is no wide range drug treatment available. No efficient drug for pulmonary MDR diseases. Therefore there is massive failure to save intensive care and chronicle respiratory patients.
3. Stem Cell Therapy for Muscular Injuries.
On November 16, 2010, the Company’s subsidiary Meizam Investments signed an initial share purchasing agreement with OrCell Ltd., an Israel corporation (“OrCell”), to acquire 33% of OrCell's intellectual properties and intangible assets for 1.5 million NIS (around $400,000). OrCell has developed an innovative stem cell technology for healing and rehabilitating of severally damaged muscle tissue and initiating strong myogenetic regeneration in injuries such as myocardial infarction (MI), pressure ulcers, and regenerative diseases of muscle. The Orcel project is conducted at Meizam Arad.
The Company’s innovative stem cell therapy technology rehabilitates and heals damaged muscle tissue by initiating regenerative myogenic cells (cardiac muscle), as well as striated muscle cells (skeletal muscle) growth in damaged tissue sites such as the myocardium (cardiac muscle) following an myocardial infarction (heart attack), limb pressure ulcers, and degenerative muscular diseases. The short-term application is directed towards the treatment of patients with peripheral vascular disease, while the long term application is focused on the healing and regeneration of cardiac muscle following acute myocardial infarction or chronic heart failure.
Employing a patient’s own cells (autologic transplantation), the Company’s unique technology and process diverts the patient's own cells into specific targeted myogenic cells, which can then be inserted into the damaged tissue and accelerates the healing process. The administered myogenic or skeletal stem cells work as a network, acting in exactly the same way that the cells of skeletal and heart muscle tissue perform, and actually replenish the existing cells, thus strengthening the intended injured site following the transplantation process. This process can be utilized for different clinical pathologies as mentioned above and can also be utilized for patient using different donor as the source of the stem cells.
Our developed technology and protocols results in a promising safe regenerative therapy, without side effects, tissue rejection or the requirement of suppressive immunological treatment or malignant tumor hazard. Our technology also provides a simple, fast and safe treatment, overcoming technological difficulties associated with using other stem cell therapies sources such as embryonic, placenta, or umbilical cord blood cells that require cryogenic storage.
The product is based on an invention that allows controlled direction of stem cells toward only myogenic cells. This unique process allows the planted myogenic cells to work as a network (similar to the cells of skeletal and heart muscle tissue) suitable for transplantation use.
Apart from this technology, a mass production protocol is currently being developed allowing safe and efficient mass-production direction of human stem cells into myogenic cells for any human transplantation and human tissue engineering without rejection. The protocol currently shows promising safe human therapy without side effects and is integrated into the injured tissue without body rejection or suppressive immunological medical treatment.
(a) Current Status.
The Company has completed successful animal studies with positive results.
Initial animal tests - The Company’s initial development has being focused on limb therapy. The initial animal studies showed promising results.
Development - The Company has developed two pillar technologies with strong intellectual properties: (i) Direct a stem cell to a myogenic (muscle) cell without any spontaneous direction into unhealthy cells such as cancer; and (ii) Mass-produce the directed myogenic cells for patient treatment. As part of the of the development phase we have developed “harvesting” procedure of human fat tissue from the patient as a row material for extracting the stem cells, diverting and directing the stem cells to muscle cells and reproducing these cells for an effective treatment. Currently we are developing the upscale production process for commercial use.
Production - For clinical trials, the Company needs a GMP certified production facility to produce the stem cells for human use. Currently, the Company is in a process of adapting the infrastructure at Rotem Industries.
(b) 12 Month Operational Plan.
Production from human fat - The Company is further developing the production methods of diverted stem cells from patient fat to a commercial scale. The Company intends introducing a working production method and facility by end Q1, 2014.
Pre-Clinical trial - The Company intends commencing clinical trials in Q3 2013, using initial products produced in its production line.
Clinical trials - They will be conducted at the Regenerative Clinic of Sheba (Tel Hashomer) Medical Center. The Company intends commencing clinical trials in Q2, 2015.
Pre-clinical and ethical applications- Currently, the Company is in the process of animal studies and ethical regulatory process and applications.
4. Ultrasonic Catheter for Brain Cancer Therapy.
On April 10, 2011, Meizam Arad entered into initial share purchase agreement with Sonenco Ltd., an Israel corporation (“Sonenco”). As a consideration for this investment, Sonenco issued to Meizam Arad 55% of its total issued and outstanding shares on a fully diluted basis, and, in addition, 5% of its total issued and outstanding shares on a fully diluted basis to Meizam Arad. As of December 31, 2012, the initial share purchase agreement was not closed. During the period April 10, 2011 through December 31, 2012, the Company continued the development and technology enhancements, as a full IP proprietary of the Company. The Company will finalize the initial share purchase agreement if MOITAL will grant the funds and development grants for Sonenco. Soneneco is located at Meizam Arad.
On March 31, 2011 the Company transferred all rights commitments, assets and holdings of Sonenco Ltd. from Meizam Arad to Meizam Investments.
The Company has developed an ultrasonic drug delivery catheter that enables the delivery of medication-coated nano-particles to specific organs and tissues in the body. The initial application that has been developed is for the treatment of brain tumors by a stereotactic procedure.
The blood brain barrier (“BBB”) protects the brain against toxic substances that circulate in the blood stream. While this is a life-supporting protection for the brain, the existence of the blood brain barrier is a severe limitation for the delivery of most drugs to the brain because they cannot cross in sufficient amounts. A large number of potentially useful drugs, such as cytostatics and central nervous system (“CNS”) in-vitro active agents, do not cross the blood brain barrier at all or in insufficient quantities. Sonenco has developed a novel method of delivering those drugs to the brain that are usually blocked from entering by the blood brain barrier.
The technology's promising future application is in cardiac catheterization, where nano-particles offer a significant advantage in drug delivery over cardiac stents that suffer positioning difficulties and limited size. Those heavy mass solid nano carriers containing drug are hundred times smaller than average human cell and thus can penetrate and cross the human cells without causing any damage. Once stuck in their final position the nano carrier will remain there for a very long period, allowing them to release the attached drug. Programming the nano drugs with a slow controlled release profile will enable them to perform an effective and comprehensive drug delivery treatment.
The Company's solution to drug delivery introduces the following advantages:
·Minimal invasive short procedure (few minutes only).
·Ability to cover big drug dispersion volume.
·Continuous drug exposure at the targeted site.
·Sufficient energy-for maximum efficient dispersion is much below medical energy levels restrictions.
·Precise dispersion profile to meet medical demands derived from fine-tuning and adjustment flexibility of all effecting parameters.
The estimated brain cancer market potential for Sonenco’s pioneering drug delivery catheter exceeds $400 million per year in the major Western economies.
Sonenco has completed animal studies that show an outstanding dispersion performance, with no damage to the healthy brain tissue and the animal subject.
5. Peptide Booster for Anti-wrinkle Cosmetics
On October 16, 2010, the Company’s subsidiary Meizam Investments signed an initial share purchasing agreement with NBCT Ltd., an Israel corporation in formation (“NBCT”), to acquire 35% of NBCT shares for 1.5 million NIS (around $400,000). As of December 31, 2012, the initial share purchase agreement was not closed. During the period of October 16, 2010 through December 31, 2012, the Company continued the development and technology enhancements, as a full IP proprietary of the Company. The NBCT project is conducted at Meizam Arad.
NBCT has developed an intra-dermal nano-technology enhancing skin penetration of collagen generating peptides in cosmetic anti-wrinkle products, and is preparing for clinical trials to be conducted in 2012.
The lipid-based nano-particles deliver peptides to the dermis, and provide:
·Efficient transport of peptides through the epidermis without physical or chemical changes in the skin barrier properties for other materials.
·Effective protection of peptides from degradation by skin enzymes.
·Controlled release of the peptides at the dermis.
·The penetration mechanism does not alter the skin properties.
·Particles pass through the epidermis to the dermis, form an active-agent payload deposit in the dermis that act to prevent any amino acids attacking the payload.
·Particles have a controlled release mechanism for the active agent payload deposit directly to the dermis.
6. Meizam - Advance Enterprise Center Arad Ltd. (Technological and Industrial Incubator).
Meizam Arad is the Company’s subsidiary operating an industrial incubator program under the guidance and support of the Office of the Chief Scientist of MOITL. Meizam Arad board of directors decided not to extend the agreement period with MOITAL beyond the initial term. The Company will continue for the next 3 years to maintain all MOITAL guidelines to the projects funded by MOITAL. The industrial incubator program is aimed at young companies with proven technologies or prototypes that are on the verge of commercialization and industrialization. This program is designed to attract novel technologies and attractive new products supported by government funding at the pre-commercialization phase.
The Company established Meizam Arad on October 25, 2006 in the City of Arad, which is located in the south east of Israel, overlooking Massada and the Dead Sea. Meizam Arad was established as a joint venture between the Company and the City of Arad, and the local industries, which are strategic partners at the industrial incubator program. Currently, the Company holds 73.1% of Meizam Arad’s equity, and Arad and the local industries hold the remaining 26.9%.
On July 27, 2008, MOITL announced Meizam Arad as the winner of the national tender for a three-year license to operate an industrial incubator program supported with government funding. The license entitles Meizam Arad to an annual management fee of NIS 1 million (about $280,000). In addition, each project (company) within the incubator program is entitled to an annual research and development grant of up to NIS 500,000 (about $140,000) per year for up to three years (i.e. a total of NIS 1,500,000 - about $420,000). Each project’s funding is subject to the initial approval of the National Industrial Incubator Committee (“NIIC”) and the final approval of MOITL. In January 2011, MOITL issued an updated regulation extending technology-oriented incubator licenses to six years. Meizam Arad does not intend to apply to MOITL for such an extension.
On January 1, 2009, MOITL officially launched Meizam Arad’s industrial incubator program. During 2009, the Company screened dozens of technology and business opportunities, of which six projects were approved by NIIC.
On January 1, 2010, MOITL officially launched the industrial incubator program for TPDS Ltd., which developed a nano-delivery carrier for inhalation drugs.
On July 1, 2010 MOITL officially launched the industrial incubator program for Gaia Med Ltd., which has developed a miniature insulin pump for diabetic patients.
The local industries in the City of Arad that have taken an interest in Meizam Arad include so far the following manufacturers:
·Luxembourg Industries Ltd. - A chemical manufacturer of intermediate products to the pharmaceutical, cosmetics and agro-chemical industries, which operates chemical reactors and other chemical production equipment. In addition, Luxembourg operates a fully equipped chemical laboratory for research and development, and quality control.
·AMS Electronics Ltd. - An electronics manufacturing service provider, which operates SMT (a method for constructing electronic circuits in which the electronic components are mounted directly onto the surface of printed circuit boards using robotic machinery) production lines and provide turnkey services, including component procurement, final testing, packaging and ship-to-customer supply chain. AMS is listed on the Tel Aviv Stock Exchange.
·Danor Technical Molding Ltd. - A plastics manufacturing service provider, which operates injection molding production lines, and provides engineering services including mold design and manufacturing.
·Arad Metal Processing Ltd. - A metal processing service provider, which operates CNC (computer numerical control, which is the programming technology of computerized metal processing machinery) production lines and other special metal processing equipment, and provides engineering services.
·Arad Industrial Development Company Ltd - a real-estate company providing 22,000 square feet of office and laboratory space to accommodate all ongoing projects.
Meizam Arad technological/industrial incubator provides to its member companies a vast industrial infrastructure of its industrial partners, as well as government funds and a top-of-the-line management team. Arad industries support the incubator companies operations, providing manufacturing and engineering services that significantly accelerate the companies’ time-to-market. The incubator's highly skilled management team comprised of Impact Active Team professionals, supported by other The Company subsidiaries' professionals as well as experts from the local industries.
Until on-going sales of the member companies are established, these industrial partners provide the services to the incubator member companies in exchange for Meizam Arad’s common stock instead of cash, at a price of $1.00 per share, or at a higher price as will be established in a private placement. Those provided services are priced at the fair value and are registered as investments in the member companies.
For each dollar funded by the Company to the incubator company, MOITL funded the incubator company with additional two dollars. Therefore, in exchange of its funding the Company received (through its subsidiary Meizam Arad) shares of the incubator member company for the full program funding including the MOITL funds.
7. Meizam Arad Investments Ltd.
The Company established Meizam Investments on February 9, 2011 as a business unit that provides all the required financing to the other Company's subsidiaries operating under the industrial incubator program. Currently, the Company holds 73.1% of Meizam Arad’s equity
Meizam Investments was established to meet MOITL’s requirement to operate Meizam Arad as a management service provider only, and separate the holding and financing of the incubator through a different entity, as structured at other technology incubators in Israel.
On January 31, 2011, the Company provided financing of $200,723 to the industrial incubator program through Meizam Investments. This financing was provided to Meizam Investments in an equity transaction, and Meizam Investment provided this financing to Meizam Arad in an equity transaction.
On June 3, 2011, the Company provided financing of $104,970 to the industrial incubator program through Meizam Investments. This financing was provided to Meizam Investments in an equity transaction, and Meizam Investment provided this financing to Meizam Arad in a loan transaction.
8. Impact Active Team Ltd. (Management Consulting).
On July 3, 2006, the Company entered into a Share Purchase Agreement with Pangea. Under this agreement, the Company purchased from Pangea all of the outstanding common stock of Impact Active Team Ltd., an Israeli corporation (“Impact”). In return for acquiring these shares, the Company paid to Pangea 2,500,000 restricted shares of common stock. On February 27, 2012, Pangea Investments GmbH sold all of the restricted shares of common stock held in its name and is no longer a shareholder in the Company. Currently, the Company holds 100% of Impact’s equity.
Impact is a management consulting firm specializing in strategic planning and management services: Executive management, strategic business planning, market research, planning and management, sales management, financial planning, strategic alliances, investor and public relations.
The main benefits that Impact provides to the Company are consulting assignments that may present new business opportunities in the medical and biotech fields, and the capability to evaluate these opportunities.
Impact has an affiliation agreement with P.O.C. Hi-Tech (1992) Ltd., a leading management consulting firm in Israel.
Impact does not employ its consultants on a payroll basis. Consulting assignments are performed by Mr. Mar-Chaim and Mr. Elimelech, who are officers of the Company, as well as by various consultants and experts employed by Impact on a contractual basis.
Advisory Board
The Company has an advisory board of experienced professionals in the academy and industry, who support our current new development and operations as well as screening novel technologies and products.
Professor Itay Benhar, Ph.D.
Head of Biotech
Full Professor and chairman of the Department of Molecular Microbiology and Biotechnology at Tel-Aviv University, Israel. He is also a member of the Department of Biomedical Engineering & Neufeld Cardiac Research Institute, Tel-Aviv University, Israel. Professor Benhar received in 1992 a PhD in Molecular Biology from the Hebrew University, Hadassah Medical School Jerusalem, Israel, where he studied control of bacterial gene expression. Professor Benhar did his postdoctoral fellowship at the National Cancer Institute, NIH, working with Dr. Ira Pastan on recombinant immunotoxins.
In 1995, Professor Benhar joined the Department of Molecular Microbiology and Biotechnology of the George S. Wise Faculty of Life Sciences as a tenure-track assistant professor. Professor Benhar received tenure at 2002, and became an associate professor in 2005 and a full professor in 2008. In 2007, Professor Benhar was appointed as Department Chairman.
Professor Benhar’s is an expert and opinion leader in the field of antibody engineering. Over the 18 years of being active in that field, he prepared several phage display libraries from which antibodies against numerous targets were isolated. Professor Benhar publishes 68 research papers, wrote 10 book chapters and submitted 8 patent applications. Research in Professor Benhar’s group if currently focused on three major topics: (1) evaluation of novel formats of antibody-toxin fusion proteins as potential anti-cancer agents. (2) Evaluation of death switches that are activated by viral proteases for potential eradication of virus-infected cells. (3) Application of filamentous phages as targeted drug-carrying nanomedicines. Research in Professor Benhar’s lab is currently funded with grants from the Israeli Health ministry, the Israel Cancer Association and the Israel Science Foundation.
Professor Benhar spent 2 years at the National Institute of Health during his post-doc fellowship program, Bethesda, MD, and 2 additional years in Washington Hospital Center, Washington DC during his sabbatical from Tel-Aviv University.
Previously, Professor Benhar was a Committee Member of the Israeli Ministry of Health: Healthy People 2020 Initiative; Member of the National Council for Health Promotion, Israel Ministry of Health; Member of the National Council for the Prevention and Treatment of Cardiovascular Diseases, Israel Ministry of Health; Chairman of The Israeli Group for Heart Research, Subsection of the International Society for Heart Research.
Professor Mickey Scheinowitz, Ph.D., F.A.C.S.M.
Head of Regenerative Therapy
Professor Scheinowitz is head of Regenerative Therapy Department of Biomedical Engineering and Neufeld Cardiac Research Institute, Tel-Aviv University, Israel. He spent two years at the National Institute of Health during his post-doctoral fellowship program, Bethesda, Maryland, and two additional years in Washington Hospital Center, Washington DC during his sabbatical from Tel-Aviv University.
Previously, Professor Scheinowitz was a committee member of the Israeli Ministry of Health: Healthy People 2020 Initiative; member of the National Council for Health Promotion, Israel Ministry of Health; member of the National Council for the Prevention and Treatment of Cardiovascular Diseases, Israel Ministry of Health; and chairman of The Israeli Group for Heart Research, Subsection of the International Society for Heart Research.
Professor Scheinowitz has published more than 60 manuscripts in peered professional and scientific journals, presented over 100 abstracts in different meetings worldwide, and he was invited to dozens of conferences as invited speaker. During his academic career he had supervised over 50 graduate and doctorate students. Professor Scheinowitz also has vast experience with the industry specifically with the medical device companies.
Dr. Orna Yosef, Ph.D.
Head of Stem Cell Technologies
Researcher, Lecturer and director of the cells and tissue engineering laboratory in the Department of Biomedical Engineering at Tel Aviv University, Israel. Dr. Yosef was one of the founders of a new lab, took a significant part in its design and the purchase of some of most advanced equipment of its kind in the country. Responsible for the lab curriculum including lectures and workshop, as well as the lab projects in the field of cell cultures and cell engineering. Dr. Yosef Specializes in stem cells research, gene therapy, tissue cultures, molecular biology and in small animal studies models.
Dr. Yosef received dual Post-Doctorate Degrees from Tel-Aviv University in Gene Therapy and Molecular virology as well as in Prostate pathology. Doctorate from Bar-Ilan University in molecular biology and physiology of skeletal muscle.
Dr. Yosef is a researcher at the Weizmann Institute in the field of signal transduction. Senior researcher in stem cells and cardiovascular research at the “Neufeld Cardiac Research Institute” in Sheba Medical Center, Tel Hashomer, Israel. Supervising undergraduate, graduate and M.D. degree students in clinical applied research.
Dr. Yosef is a reviewer for the journal Cardiovascular Research on the topic of mesenchymal stem cells and Cardiovascular Research.
Dr. Gilead Asseo, M.D.
Head of Medical Affairs
Dr. Asseo is a founder, and currently acting as Director at Vaica Medical Ltd., a high tech company that has patented computerized medication dispensers and reminders, remotely connected to manned and Internet based call centers. He also serves as a medical consultant in the field of life science and medical devices to high tech companies and investor organizations.
Following film and television studies at Tel Aviv University, Faculty of Art, Dr. Asseo worked as a TV cameraman, documenter and reporter for the Israel national TV, Vis News Association, and ABC News for 5 years, and was nominated for cameraman of the year 1980 by Vis News for the Royal Film Society in the UK.
Dr. Asseo finished his medical training at Ben Gurion University in 1987, graduated as General Surgeon in 1996 at the Rabin Medical Center, and acted as Surgical Chief at the Safed Hospital ER.
Dr. Asseo entered the high tech industry, first as a Medical Director for Odin Technologies, and then founded his own company - MDG Medical in 2001, writing the patents, and acting as director and CEO. MDG Medical designed and is marketing a complex computerized medication delivery system for hospital wards, is currently invested at close to $50M, and is present in more than 250 hospitals in the USA, Europe and Israel.
Dr. Asseo founded and ran the first hospital based telemedicine center in Israel at Safed Hospital, and served as lecturer at Safed Nursing School covering surgery and basic science. He also acted as medical reporter with a personal column for NRG - Maariv’s Internet portal.
Ronen Smooha
Head of Software
Mr. Smooha is a former Microsoft executive and veteran of the Israeli software industry. After joining Microsoft Israel in 2001, he went on to lead the subsidiary’s ISV business development services and Developer Evangelism. In this capacity, Mr. Smooha was responsible for .NET platform adoption across the market, growing revenue and impact worldwide, while forming long term relations with the ISV eco-system. He formed RDS Business Development in 2009, which provides business development support for seasoned start-ups and IT companies and business and technical due diligence for International companies, angel investors and Israeli software incubation centers. Mr. Smooha is on the board of E4D solutions LTD, advisory board of SkilliQ, and on the investment committee of Meizam.org, an industrial incubation center.
Forward Looking Business Development.
In addition to the above business activities, the Company will continue to search for business opportunities, particularly toward small and medium-sized enterprises. The Company does not propose to restrict its search to any particular geographical area or industry, and may, therefore, engage in essentially any business, to the extent of its limited resources. This includes industries such as service, manufacturing, high technology, product development, medical, communications and others. The Company’s discretion in the selection of business opportunities is unrestricted, subject to the availability of such opportunities, economic conditions, and other factors. No assurance can be given that the Company will be successful in finding or acquiring a desirable business opportunity, and no assurance can be given that any acquisition, which does occur, will be on terms that are favorable to the Company or to its stockholders. Business
opportunities may come to the Company’s attention from various sources, including professional advisers such as attorneys and accountants, venture capitalists, members of the financial community, and others who may present unsolicited proposals. The Company may pay a finder’s fee in connection with any such transaction.
The Company will not restrict its search to any specific kind of firm, but may acquire a venture which is in its preliminary or development stage, one which is already in operation, or in a more mature stage of its corporate existence. The acquired business may need to seek additional capital, may desire to have its shares publicly traded, or may seek other perceived advantages which the Company may offer. However, the Company does not intend to obtain funds to finance the operation of any acquired business opportunity until such time as the Company has successfully consummated the merger or acquisition transaction.
The analysis of business opportunities will be under the supervision of the Company’s officers and directors with MOITL. In analyzing prospective business opportunities, management will consider such matters as available technical, financial and managerial resources; working capital and other financial requirements; history of operations, if any; prospects for the future; nature of present and expected competition; the quality and experience of management services which may be available and the depth of that management; the potential for further research, development, or exploration; specific risk factors not now foreseeable, but which then may be anticipated to impact the Company’s proposed activities; the potential for growth or expansion; the potential for profit; the perceived public recognition or acceptance of products, services, or trades; name identification; and other relevant factors. In many instances, it is anticipated that the historical operations of a specific business opportunity may not necessarily be indicative of the potential for the future because of a variety of factors, including, but not limited to, the possible need to expand substantially, shift marketing approaches, change product emphasis, change or substantially augment management, raise capital and the like.
Company management intends to meet directly with other key personnel of the target business entity as part of its investigation. To the extent possible, the Company intends to utilize written reports and personal investigation to evaluate the above factors.
Prior to making a decision to participate in a business opportunity, it is the Company’s policy to receive written materials regarding the business opportunity containing as much relevant information as possible, including, but not limited to, such items as a description of products, services and company history; management resumes; financial information; available projections, with related assumptions upon which they are based; an explanation of proprietary products and services; evidence of existing patents, trademarks, or service marks, or rights thereto; present and proposed forms of compensation to management; a description of transactions between such company and its affiliates during the relevant periods; a description of present and required facilities; an analysis of risks and competitive conditions; a financial plan of operation and estimated capital requirements; audited financial statements, or if they are not available at that time, unaudited financial statements, together with reasonable assurance that audited financial statements would be able to be produced within a required period of time; and the like.
The Company will participate in a business opportunity only after the negotiation and execution of appropriate agreements. Although the terms of such agreements cannot be predicted, generally such agreements will require certain representations and warranties of the parties thereto, will specify certain events of default, will detail the terms of closing and the conditions which must be satisfied by the parties prior to and after such closing, outline the manner of bearing costs, including costs associated with the Company’s attorneys and accountants, and will include miscellaneous other terms.
Employees.
The Company has three full time employees and eight part-time service providers who are engaged by the Company’s and its subsidiaries Impact Active Team Ltd and Meizam - Advanced Enterprise Center Arad Ltd.
ITEM 1A.
ITEM 1A. RISK FACTORS.
In addition to the other information contained in this Form 10-K, the following risk factors should be considered carefully in evaluating the Company’s business. The Company’s business, financial condition, and results of operations could be materially adversely affected by any of these risks. Please note that additional risks not presently known to the Company or that it currently deems immaterial may also impair its business and operations.
Risks Relating to the Business.
(a) The Company Has a History of Losses That is Likely to Continue, Requiring Additional Sources of Capital, Which May Result in Curtailing of Operations and Dilution to Existing Stockholders.
The Company has incurred a net loss of $2,504,588 for the year ended December 31, 2012, $1,359,896 for the year ended December 31, 2011, and $6,547,265 for the period of inception (July 23, 2004) through December 31, 2012. The Company cannot provide assurance that it can achieve or sustain profitability or even generate positive cash flow in the future. If revenues grow more slowly than anticipated, or if operating expenses exceed expectations or cannot be adjusted accordingly, the Company will continue to incur losses. The Company will continue to incur losses until it is able to establish reasonable levels of sales. The Company’s possible success is dependent upon the successful development and marketing of its products and services, as to which there is no assurance. Any future success that the Company might enjoy will depend upon many factors, including factors out of its control or which cannot be predicted at this time. These factors may include changes in or increased levels of competition, including the entry of additional competitors and increased success by existing competitors, changes in general economic conditions, increases in operating costs, including costs of supplies, personnel and equipment, reduced margins caused by competitive pressures and other factors. These conditions may have a materially adverse effect upon the Company or may force it to reduce or curtail operations. In addition, the Company will require additional funds to sustain and expand
its sales and marketing activities, particularly if a well-financed competitor emerges. The Company will need to raise up to $10,000,000 in the next 36 months to implement its plan of operation. In the event that the Company needs additional financing, there can be no assurance that financing will be available in amounts or on terms acceptable, if at all. The inability to obtain sufficient funds from operations or external sources would require the Company to curtail or cease operations. Any additional equity financing may involve substantial dilution to then existing stockholders.
(b) The Independent Registered Public Accounting Firm Has Expressed Substantial Doubt About the Company’s ability to Continue as a Going Concern, Which May Hinder the Ability to Obtain Future Financing.
In its report dated May 2, 2013, the Company’s independent auditor stated that the financial statements for the year ended December 31, 2012 were prepared assuming that the Company would continue as a going concern. The Company's ability to continue as a going concern is an issue raised as a result of cash flow constraint, an accumulated deficit, and recurring losses from operations. The Company continues to experience net losses. The Company's ability to continue as a going concern is subject to the ability to execute a business combination and thereafter to generate a profit and/or obtain necessary funding from outside sources, including obtaining additional funding from the sale of the Company's securities, increasing sales or obtaining loans from various financial institutions where possible. The continued net losses and stockholders' deficit increases the difficulty in meeting such goals and there can be no assurances that such methods will prove successful.
(c) The Company May Not Be Able to Accommodate Rapid Growth Which Could Decrease Revenues.
To manage anticipated growth, the Company must continue to implement and improve its operational, financial and management information systems. The Company must also hire, train and retain qualified personnel, continue to expand and upgrade core technologies, and effectively manage its relationships with end users, suppliers and other third parties. The Company’s expansion could place a significant strain on its current services and support operations, sales and administrative personnel, capital and other resources. The Company could also experience difficulties meeting demand for its products and services. The Company cannot guarantee that its systems, procedures or controls will be adequate to support operations, or that management will be capable of fully exploiting the market. The Company’s failure to effectively manage growth could adversely affect the business’s financial position and results of operations.
(d) Protection of Proprietary Rights May Affect the Company’s Success and Ability to Compete.
The Company’s success and ability to compete will be dependent in part on the protection of its patents, trademarks, trade names, service marks and other proprietary rights. The Company intends to rely on trade secret and copyright laws to protect the intellectual property that it plans to develop, but there can be no assurance that such laws will provide sufficient protection, that
others will not develop products that are similar or superior to the Company’s, or that third parties will not copy or otherwise obtain and use its proprietary information without authorization. In addition, certain of the Company’s know-how and proprietary technology may not be patentable.
The Company may rely on certain intellectual property licensed from third parties, and may be required to license additional products or services in the future, for use in the general operations of its business plan. There can be no assurance that these third party licenses will be available or will continue to be available to the Company on acceptable terms or at all. The inability to enter into and maintain any of these licenses could have a material adverse effect on the Company’s business, financial condition or operating results.
There is a risk that some of the Company’s products may infringe the proprietary rights of third parties. In addition, whether or not the Company’s products infringe on proprietary rights of third parties, infringement or invalidity claims may be asserted or prosecuted against it and it could incur significant expense in defending them. If any claims or actions are asserted against the Company, it may be required to modify its products or seek licenses for these intellectual property rights. The Company may not be able to modify the Company’s products or obtain licenses on commercially reasonable terms, in a timely manner or at all. The Company’s failure to do so could have a negative effect on its business and revenues.
(e) The Company’s Dependence on Outside Suppliers and Manufacturers May Affect Its Ability to Conduct Business.
The Company will depend on a number of outside suppliers and manufacturers components for its products. There is an inherent risk that certain components of the Company’s products will be unavailable for prompt delivery or, in some cases, discontinued or only available at substantially higher costs. Due to the current political crisis in the Middle East and corresponding predicted continued increase in taxes, energy costs, the price of production and transportation of goods is likely to dramatically increase, thus increasing supply price. If such supply price increases occur, the Company will either suffer from decrease in margins or be required to raise the Company’s prices, which could compromise demand. The Company has only limited control over any third-party manufacturer as to quality controls, timeliness of production, deliveries and various other factors. Should the availability of certain components be compromised, it could force the Company to develop alternative designs using other components, which could add to the cost of goods sold and compromise delivery commitments. If the Company is unable to obtain components in a timely manner, at an acceptable cost, or at all, it may need to select new suppliers, redesign or reconstruct processes used. In such an instance, the Company would not be able to manufacture any products for a period of time, which could materially adversely affect the Company’s business, results from operations, and financial condition.
(f) The Company Will Face Strong Competition in Its Markets, Which Could Make It Difficult for It to Generate Revenues.
The market for the Company’s products and services will be competitive. The Company’s future success will depend on its ability to adapt to rapidly changing technologies, evolving industry standards, product offerings and evolving demands of the marketplace.
Some of the Company’s competitors have:
·longer operating histories;
·larger customer bases;
·greater name recognition and longer relationships with clients; and
·significantly greater financial, technical, marketing, public relations and managerial resources than the Company.
Competitors may develop or offer services that provide significant technological, creative, performance, price or other advantages over the products offered by the Company. If the Company fails to gain market share or lose existing market share, the Company’s financial condition, operating results and business could be adversely affected and the value of the investment in the Company could be reduced significantly. The Company may not have the financial resources, technical expertise or marketing, distribution or support capabilities to compete successfully.
(g) The Company Could Fail to Develop New Products to Compete in this Industry of Rapidly Changing Technology, Resulting in Decreased Revenues.
The markets in which the Company intends to compete are characterized by rapid technological change, frequent new product introductions, evolving industry standards and changing needs of customers. There can be no assurance that the Company’s products and services will continue to be properly positioned in the market or that the Company will be able to introduce new or enhanced products into the market on a timely basis, or at all.
There is the risk to the Company that there may be delays in initial shipments of new products or services. Further risks inherent in new product introductions include the uncertainty of price-performance relative to products of competitors, competitors’ responses to the introductions and the desire by customers to evaluate new products for longer periods of time.
(h) New Versions of The Company’s Products May Contain Errors or Defects, Which Could Affect Its Ability to Compete.
The Company’s products will be complex and, accordingly, may contain undetected errors or failures when first introduced or as new versions are released. This may result in the loss of, or delay in, market acceptance of the Company’s products. The Company may in the future discover errors and additional scalability limitations in new releases or new products after
the commencement of commercial shipments or be required to compensate customers for such limitations or errors, as a result of which the Company’s business, cash flow, financial condition and results of operations could be materially adversely affected.
(i) The Company’s Ability to Grow is Directly Tied to Its Ability to Attract and Retain Customers, Which Could Result in Reduced Revenue.
The Company has no way of predicting whether its marketing efforts will be successful in attracting new business and acquiring substantial market share. If the Company’s marketing efforts fail, it may fail to attract new customers and fail to retain existing ones, which would adversely affect the Company’s business and financial results.
(j) If Government Regulation of The Company’s Business Changes, the Company May Need to Change the Manner in Which It Conducts Business, or Incur Greater Operating Expenses.
The adoption or modification of laws or regulations relating to the Company’s business could limit or otherwise adversely affect the manner in which the Company currently conducts its business. If the Company is required to comply with new regulations or legislation or new interpretations of existing regulations or legislation, this compliance could cause the Company to incur additional expenses or alter the Company’s business model.
The manner in which legislation may be enacted and enforced cannot be precisely determined and may subject either the Company or its potential customers to possible liability, which in turn could have an adverse effect on the Company’s business, results of operations and financial condition.
The TPDS products will require approval by the U.S. Food and Drug Administration before sales can be made in this country. This process, which ordinarily requires clinical approvals, may take some time before any approval is given. This process could affect the ability of the Company in its overall marketing of these products, which will, in turn affect the Company’s business and the ability to generate revenues.
(k) Operating Results May Be Adversely Affected by the Uncertain Geopolitical Environment and Unfavorable Factors Affecting Economic and Market Conditions.
Adverse factors affecting economic conditions worldwide have contributed to a general inconsistency in the power industry and may continue to adversely impact the Company’s business. Terrorist and military actions may continue to put pressure on economic conditions. If such an attack should occur or if the economic and market conditions could deteriorate as a result of a terrorist attack, the Company may experience a material adverse impact on its business, operating results, and financial condition as a consequence of the above factors or otherwise.
(l) The Company May Incur Significant Costs to Ensure Compliance with U.S. Corporate Governance and Accounting Requirements.
The Company may incur significant costs associated with its public company reporting requirements, costs associated with newly applicable corporate governance requirements, including requirements under the Sarbanes-Oxley Act of 2002 and other rules implemented by the Securities and Exchange Commission. The Company expects all of these applicable rules and regulations to increase its legal and financial compliance costs and to make some activities more time-consuming and costly. The Company also expects that these applicable rules and regulations may make it more difficult and more expensive for it to obtain director and officer liability insurance and the Company may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for the Company to attract and retain qualified individuals to serve on its board of directors or as executive officers. The Company is currently evaluating and monitoring developments with respect to these newly applicable rules, and it cannot predict or estimate the amount of additional costs the Company may incur or the timing of such costs.
(m) Any Required Expenditures as a Result of Indemnification Will Result in an Increase in Expenses.
The Company’s bylaws include provisions to the effect that it may indemnify any director, officer, or employee. In addition, provisions of Nevada law provide for such indemnification, as well as for a limitation of liability of directors and officers for monetary damages arising from a breach of their fiduciary duties. Any limitation on the liability of any director or officer, or indemnification of any director, officer, or employee, could result in substantial expenditures being made by the Company in covering any liability of such persons or in indemnifying them.
(n) The Company’s Success Is Largely Dependent on the Abilities of Its Personnel.
The Company’s success is largely dependent on the personal efforts and abilities of its senior management. The loss of certain key members of the Company’s senior management, including its president, could have a materially adverse effect on the Company’s business and prospects.
The Company intends to recruit skilled employees who are experts in the biotechnology and medical industry. The failure to recruit these key personnel could have a materially adverse effect on the Company’s business. As a result, the Company may experience increased compensation costs that may not be offset through either improved productivity or higher revenue. There can be no assurances that the Company will be successful in retaining existing personnel or in attracting and recruiting experienced qualified personnel.
Risks Relating to the Common Stock.
(a) The Company’s Common Stock Price May Be Volatile.
The trading price of the Company’s common stock, once a public offering is made, may fluctuate substantially. The price of the common stock may be higher or lower than the price you pay for your shares, depending on many factors, some of which are beyond the Company’s control and may not be directly related to its operating performance. These factors include the following:
·Price and volume fluctuations in the overall stock market from time to time;
·Significant volatility in the market price and trading volume of securities of business development companies or other financial services companies;
·Changes in regulatory policies with respect to business development companies;
·Actual or anticipated changes in earnings or fluctuations in operating results;
·General economic conditions and trends;
·Loss of a major funding source; or
·Departures of key personnel.
Due to the continued potential volatility of the stock price, the Company may be the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from the business.
(b) Absence of Cash Dividends May Affect Investment Value of the Company’s Stock.
The board of directors does not anticipate paying cash dividends on the common stock for the foreseeable future and intends to retain any future earnings to finance the growth of the Company’s business. Payment of dividends, if any, will depend, among other factors, on earnings, capital requirements and the general operating and financial conditions of the Company as well as legal limitations on the payment of dividends out of paid-in capital.
(c) No Assurance of a Public Trading Market and Risk of Low Priced Securities May Affect Market Value of the Company’s Stock.
The Securities and Exchange Commission (“SEC”) has adopted a number of rules to regulate “penny stocks.” Such rules include Rule 3a51-1 and Rules 15g-1 through 15g-9 under the Securities Exchange Act of 1934. Because the Company’s securities may constitute “penny stocks” within the meaning of the rules (as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, largely traded in the Over the Counter Bulletin Board or the Pink Sheets), the rules would apply to the Company and its common stock.
The SEC has adopted Rule 15g-9 which established sales practice requirements for certain low price securities. Unless the transaction is exempt, it shall be unlawful for a broker or dealer to sell a penny stock to, or to effect the purchase of a penny stock by, any person unless prior to the transaction:
·the broker or dealer has approved the person’s account for transactions in penny stock pursuant to this rule; and
·the broker or dealer has received from the person a written agreement to the transaction setting forth the identity and quantity of the penny stock to be purchased.
In order to approve a person’s account for transactions in penny stock, the broker or dealer must:
·obtain from the person information concerning the person’s financial situation, investment experience, and investment objectives;
·reasonably determine that transactions in penny stock are suitable for that person, and that the person has sufficient knowledge and experience in financial matters that the person reasonably may be expected to be capable of evaluating the risks of transactions in penny stock;
·deliver to the person a written statement setting forth the basis on which the broker or dealer made the determination stating in a highlighted format that it is unlawful for the broker or dealer to affect a transaction in penny stock unless the broker or dealer has received, prior to the transaction, a written agreement to the transaction from the person, stating in a highlighted format immediately preceding the customer signature line that the broker or dealer is required to provide the person with the written statement, and the person should not sign and return the written statement to the broker or dealer if it does not accurately reflect the person’s financial situation, investment experience, and investment objectives; and
·receive from the person a manually signed and dated copy of the written statement.
It is also required that disclosure be made as to the risks of investing in penny stock and the commissions payable to the broker-dealer, as well as current price quotations and the remedies and rights available in cases of fraud in penny stock transactions. Statements, on a monthly basis, must be sent to the investor listing recent prices for the penny stock and information on the limited market.
There has been no public market for the Company’s common stock. The Company intends to have a market maker file an application on the Company’s behalf with the Over the Counter Bulletin Board in order to make a market in the Company’s common stock. However, until this happens, if the market maker is successful with such application, and even thereafter, an investor may find it difficult to dispose of, or to obtain accurate quotations as to the market
value of the Company’s securities. The regulations governing penny stocks, as set forth above, sometimes limit the ability of broker-dealers to sell the Company’s common stock and thus, ultimately, the ability of the investors to sell their securities in the secondary market.
Potential stockholders of the Company should also be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns include:
·control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer;
·manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases;
·“boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons;
·excessive and undisclosed bid-ask differential and markups by selling broker-dealers; and
·the wholesale dumping of the same securities by promoters and broker dealers after prices have been manipulated to a desired level, along with the resulting inevitable collapse of those prices and with consequent investor losses.
(d) Failure To Remain Current In Reporting Requirements Could Result in the Company Being Delisting From The Over The Counter Bulletin Board.
Companies that trade on the Over the Counter Bulletin Board (such as the Company) must be reporting issuers under Section 12 of the Securities Exchange Act of 1934, as amended, and must be current in their reports under Section 13, in order to maintain price quotation privileges on the Bulletin Board. When the Company becomes listed on that market, if it fails to remain current in the Company’s reporting requirements, the Company could be delisted from the Over the Counter Bulletin Board.
In addition, the National Association of Securities Dealers, Inc., which operates the Bulletin Board, has adopted a change to its Eligibility Rule. The change makes those Over the Counter Bulletin Board issuers that are cited for filing delinquency in its Form 10-K’s/Form 10-Q’s three times in a 24-month period and those Bulletin Board issuers removed for failure to file such reports two times in a 24-month period ineligible for quotation on the Bulletin Board for a period of one year. Under this rule, a company filing with the extension time set forth in a Notice of Late Filing (Form 12b-25) is not considered late. This rule does not apply to a company’s Current Reports on Form 8-K (but failure to timely file a Form 8-K could have other ramifications for the Company).
As a result of these rules, the market liquidity for the Company’s common stock could be severely adversely affected by limiting the ability of broker-dealers to sell the Company’s securities and the ability of stockholders to sell their securities in the secondary market.
(e) Failure to Maintain Market Makers May Affect Value of the Company’s Stock.
If the Company is unable to maintain National Association of Securities Dealers, Inc. member broker/dealers as market makers, the liquidity of the common stock could be impaired, not only in the number of shares of common stock which could be bought and sold, but also through possible delays in the timing of transactions, and lower prices for the common stock than might otherwise prevail. Furthermore, the lack of market makers could result in persons being unable to buy or sell shares of the common stock on any secondary market. There can be no assurance the Company will be able to maintain such market makers.
(f) Issuance of Common Stock in Exchange for Services or to Repay Debt Would Dilute Proportionate Ownership and Voting Rights, and Could Have a Negative Impact on the Market Price of the Company’s Stock.
The Company’s board of directors may issue shares of common stock to pay for debt or services, without further approval by its stockholders based upon such factors as the board of directors may deem relevant at that time. It is likely that the Company will issue securities to pay for services and reduce debt in the future. It is possible that the Company will issue additional shares of common stock under circumstances it may deem appropriate at the time.
(g) If The Company is Unable to Raise Necessary Additional Capital as Needed, Its Business May Fail or its Operating Results and the Stock Price May Be Materially Adversely Affected.
To secure additional needed financing, the Company may need to borrow money or sell more securities, which may reduce the value of its outstanding common stock. Selling additional stock, either privately or publicly, would dilute the equity interests of the Company’s stockholders. In addition, if the Company raises additional funds by issuing equity securities, the holders of the new equity securities may have rights superior to those of the holders of shares of common stock, which could adversely affect the market price and the voting power of shares of its common stock. If the Company raises additional funds by issuing debt securities, the holders of these debt securities may have some rights senior to those of the holders of shares of common stock, and the terms of these debt securities could impose restrictions on operations and create a significant interest expense for the Company.
(h) Shares Eligible For Future Sale.
All of the shares currently held by management have been issued in reliance on the private placement exemption under the Securities Act of 1933. Such shares will not be available for sale in the open market without separate registration except in reliance upon Rule 144 under the Securities Act of 1933. In general, under Rule 144 a person (or persons whose shares are
aggregated) who has beneficially owned shares acquired in a non-public transaction for at least one year, including persons who may be deemed affiliates of the Company (as that term is defined under that rule) would be entitled to sell within any three-month period a number of shares that does not exceed 1% of the then outstanding shares of common stock, provided that certain current public information is then available. If a substantial number of the shares owned by these stockholders were sold pursuant to Rule 144 or a registered offering, the market price of the common stock at that time could be adversely affected.
ITEM 1B.
ITEM 1B. UNRESOLVED STAFF COMMENTS.
Not Applicable.
ITEM 2.
ITEM 2. PROPERTIES.
The Company does not own any fixed property and has no agreements in place or planned to acquire any properties. The Company currently maintains an office of 1,000 square feet at 400 South Beverly Drive, Suite 312, Beverly Hills, California, 90212. The Company pays an annual rent for use of this office in restricted shares of Company common stock. These offices are currently adequate for the needs of the Company.
All commercialization and research and development operations are performed through the Company’s subsidiaries, Impact Active Team Ltd., Meizam Arad Investments Ltd., TPDS Ltd., Meizam - Advanced Enterprise Center Arad Ltd., and Gaia Med Ltd., and the principal support facilities are located in 36 Hayarkon St. Yavne, Israel. The operation facilities include a biological, chemical, and miniaturizing laboratories.
The Company believes that these facilities are sufficient to support its anticipated operations and any additional needs we may encounter for at least the next five years. The Company also believes that, if it becomes necessary, it will be able to obtain alternative facilities.
ITEM 3.
ITEM 3. LEGAL PROCEEDINGS.
Other than as set forth below, there are no known legal or other proceedings against the Company that could at the time of submitting this report that could have a materially adverse effect on the Company’s financial position or operations.
The Company instituted a claim of NIS 12,000,000 against the City of Arad, Israel in respect of an award by the Israeli government for operating an industrial incubator project that becomes due in 2011. The City of Arad was unable to comply the Company’s payment claims; therefore, the Company intends in the near future to institute legal proceedings in this matter.
ITEM 4.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
PART II.
ITEM 5.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES.
Market Information.
The Company’s common stock began trading on the OTCBB under the symbol “ANDN”. The range of closing prices shown below is as reported by the OTCBB. The quotations shown reflect inter-dealer prices, without retail mark-up, markdown or commission and may not necessarily represent actual transactions.
Per Share Common Stock Bid Prices by Quarter
For the Fiscal Year Ended on December 31, 2012
Per Share Common Stock Bid Prices by Quarter
For the Fiscal Year Ended on December 31, 2011
(1) The Company’s common stock commenced quotation on the OTCBB on June 29, 2011.
Holders of Common Equity.	
As of March 31, 2013, the Company had 66 record holders of its common stock. The number of record holders was determined from the records of the Company’s transfer agent. The number of record holders excludes any estimate of the number of beneficial owners of common shares held in street name.
Dividends.
The Company has not declared or paid a cash dividend to stockholders since it was organized. The Board of Directors presently intends to retain any earnings to finance the Company’s operations and does not expect to authorize cash dividends in the foreseeable future. Any payment of cash dividends in the future will depend upon the Company’s earnings, capital requirements and other factors.
Equity Securities Sold Without Registration.
There were no sales of unregistered (restricted) securities not during the year ended on December 31, 2012 not previously reported by the Company, except as follows:
On June 14, 2012, the Company issued 200,000 restricted shares of common stock to the Company’s transfer agent, Globex Transfer, LLC, for professional services rendered valued at $10,000.
ITEM 6.
ITEM 6. SELECTED FINANCIAL DATA.
Not applicable.
ITEM 7.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following management’s discussion and analysis of financial condition and results of operations is based upon, and should be read in conjunction with, the Company’s audited financial statements and related notes presented in a separate section of this report following Item 15, which have been prepared in accordance with accounting principles generally accepted in the United States of America.
Overview.
(a) General Discussion.
The Company invests in commercialization of its technologies and products. The Company’s main efforts are to optimize development, engineering for production, regulation, pre-clinical and clinical trials and market penetration, respectfully, to each of its products. The Company is constantly working to enhance its products by new synergetic novel technologies keeping each of its products advantageous in its market.
The Company’s technological / industrial accelerating incubator specializes in utilization of the industrial infrastructure of companies that it works with, optimizing each product’s research and development and engineering development to the “best-in-the-market” product.
The Company’s team of experts manages all technological, medical, regulatory and other aspects needed to insure timely development, and market presence within the planed program and budget.
The Company operates five product lines:
·Miniature insulin pump
·Targeted drug delivery nano-particles
·Stem cell therapy
·Ultasonic catheter for brain cancer therapy
·Peptide booster for anti-wrinkle cosmeceuticals
Miniature Disposable Insulin Pump.
The Company is committed to develop a fully disposable miniature insulin pump, suitable for diabetics type I and type II as well, without any MOITAL grant, saving the need to pay future royalties. The Company’s main challenge was to achieve production price capable to compete with the low price of the insulin pen syringe injection for diabetic type II. The Company’s detailed market survey showed a significant advantage of such a product in the market, providing the comfort of a “band aid” patch size product, accurate as the expensive insulin pumps and preventing any hyper or hypo life threatening situations to the patient (stable blood glucose level superior to the syringe use).
The Company’s team successfully developed the technology of the MinIn (Miniature Insulin) fully disposable pump, and lab tested all regulatory aspects of the MinIn pup, ready for the clinical trials initial production batch. During the first quarter of 2012, The Company’s team focused on the technology transfer for GMP/GLP production, and Helsinky approval for clinical trials.
The Company estimates that the Gemini development, regulatory, and manufacturing in order to complete all needed clinical trials, will require an additional $750,000. In addition we estimate that it will require $600,000 to introduce the innovative pump to the market and large distributors
Nano-particles Targeted Drug Delivery Technology.
The Company is also committed to develop its nano-particle technology with the capacity to accommodate hydrophobic (repelling water based molecules), as well hydrophilic (attracting water based molecules) properties. These developments enable the Company to carry out GSK RELENZA (zanamivir) drug for swine flu (H1N1) therapy. The Company’s lab results show very stable nano-particle with over a six months shelf life capable to carry hydrophobic and hydrophilic molecules with a high drug load, providing exceptional drug delivery efficiency. During the first quarter of 2012, the Company’s team mapped all intellectual properties used to develop the multi-task nano-particles and to secure it in a separate its intellectual properties apart from those used by TPDS.
The Company estimates that the additional development, regulatory, and manufacturing in order to complete all needed clinical trials, will require an additional $1,100,000.
Stem Cell Therapy for Muscular Injuries.
The Company has completed successful animal studies with positive results on limb therapy. The initial animal studies showed very promising rehabilitating results. Because of those results, the Company has modified and accelerated its development program with two pillar technologies with strong intellectual properties: (i) Direct a stem cell to a myogenic (muscle) cell without any spontaneous direction into unhealthy cells such as cancer; and (ii) mass produce the directed myogenic cells for patient treatment. As part of the of the development phase, the Company has developed a “harvesting” procedure of human fat tissue from the patient as a row material for extracting the stem cells, diverting and directing the stem cells to muscle cells and reproducing these cells for an effective treatment. Currently, the Company is developing the upscale production process for commercial use.
The Company estimates that the additional development, regulatory, and manufacturing in order to complete all needed pre-clinical trials, will require an additional $650,000.
(b) Operations.
Insulin Pumps.
The Company separates the development in any aspect from the development of the Gaia Med Diamond semi-disposable pump. The Company has successfully managed to develop Gaia-Med’s technology and intellectual properties secured by patents, and develop new, separate intellectual properties for the Gemini pump During 2012 the Company further developed and enhanced the Gemini patents. Those enhancements will be filed in second quarter of 2013. The Company’s development success of new and separate technology that is not based or relates in any aspect on Gaia-Med’s technology precludes the Company and the incubator from any royalties' payment on the Gemini product line. The Company and the incubator also continue to develop the semi-disposable Gaia-Med pump within its original program. Therefore, the Company intends to establish a new company to accommodate all assets and operations of the Gemini pump as soon as this pump is ready for clinical trials batch production.
Nano-Particles.
The Company separates the additional development in any aspect from the development done in TPDS.
The Company has successfully managed to develop new technology and intellectual properties to be secured by new patents, for the multi-tasking nano-particles, to be filed in as with the Company's next investment round. The Company’s development success of new and separate technology that is not based or relates in any aspect on TPDS’s technology precludes the Company and the incubator from any royalties’ payment on this product line. Currently, the
Company and the incubator-halted development of TPDS based technology, and now develop only its new technology. The Company will revisit the original TPDS development program during 2013, according the pre-clinical results of the new technology and product.
With the next investment round the Company intends to establish a new company to accommodate all assets and operations of the new technology and development
Stem Cell Therapy.
The Company intends to establish a new company to accommodate all assets and operations of the new technology and development of the project as soon the clinical trials will commence.
Results of Operations.
(a) Total Revenue.
The Company had total revenue of $181,298 for the year ended December 31, 2012 compared to $325,006 for the year ended December 31, 2011, a decrease of $143,708 or approximately 44%. This decrease in net revenue was the result of no government grants received by the Company’s operating subsidiary, Meizam Arad, from MOITL during 2012 as compared to $312,990 in 2011.
The total revenue for the year ended December 31, 2012 ($181,298) was generated by consulting activities compared to $12,016 for the year ended December 31, 2011, an increase of $169,282 or approximately 1,409%. This was due to the fact that the Company made a strategic decision to allow the OCS agreement to expire and not renew it (the agreement expiration does not prevent the Company to get government grants subject to other regulations).
The Company had total revenue of $1,248,322 for the period of inception (June 23, 2004) through December 31, 2012.	
(b) General and Administrative Expenses.
The Company had general and administrative expenses of $2,870,407 for the year ended December 31, 2012 compared to $1,235,679 for the year ended December 31, 2011, an increase of $1,634,728 or approximately 132%. This increase in general and administrative costs was mainly due to stock based compensation of $1,862,000 to key management in 2012 as compared to no stock based compensation to key management in 2011.
The Company had general and administrative expenses of $7,100,447 for the period of inception (June 23, 2004) through December 31, 2012.
(c) Research and Development Expenses.
The Company had research and development expenses of $55,359 for the year ended December 31, 2012 compared to $223,878 for the year ended December 31, 2011, a decrease of $168,519 or approximately 75%. This decrease in research and development was due to the following reasons:
·The Company stopped employing sub-contractors funded by government grants.
·The Company had no impairment of goodwill expenses for the year ended December 31, 2012 compared to $14,708 for the year ended December 31, 2011.
The Company had research and development expenses of $391,287 for the period of inception (June 23, 2004) through December 31, 2012.
(d) Other Income, Net.
The Company had $236,175 other income for the year ended December 31, 2012 compared to $15,000 for the year ended December 31, 2011 generated by debt forgiveness of service providers.
(e) Net Loss.
The Company had a net loss of $2,504,588 for the year ended December 31, 2012 compared to $1,359,896 for the year ended December 31, 2011, an increase of $1,144,692 or approximately 84%. The increase in net loss is the result primarily from the Company’s accelerated development and engineering for production of our disposable insulin pump.
The Company had a net loss of $6,547,265 for the period of inception (June 23, 2004) through December 31, 2012.
Operating Activities.
The net cash used in operating activities was $343,498 for the year ended December 31, 2012 compared to $275,472 for the year ended December 31, 2011, an increase of $68,026 or approximately 25%. This change is mainly attributed to increase in share-based payments.
Investing Activities.
Net cash used in investing activities was $0 for the year ended December 31, 2012 compared to $20,649 for the year ended December 31, 2011, a decrease of 100% that is attributed to patent and acquisition of a subsidiary during 2011.
Liquidity and Capital Resources.
As of December 31, 2012, the Company had total current assets of $499,250 and total current liabilities of $700,613, resulting in a working capital deficit of $201,363. The cash and cash equivalents was $0 as of December 31, 2012 compared to $872 for the year ended December 31, 2011, a decrease of $872 or 100%. This decrease resulted from negative cash flows from operations.
The net cash provided by financing activities was $342,626 for the year ended December 31, 2012 compared to $259,265 for the year ended December 31, 2011, an increase in cash provided financial activities of $83,361 or approximately 32%. This increase resulted primarily from proceeds from stock issued for cash.
The Company’s current cash and cash equivalents balance will not be sufficient to fund its operations for the next 12 months. The Company’s ability to continue as a going concern on a longer-term basis will be dependent upon its ability to generate sufficient cash flow from operations to meet its obligations on a timely basis, and to obtain additional financing, and ultimately attain profitability. The Company’s continued operations, as well as the implementation of the Company’s business plan will depend upon its ability to raise additional funds through bank borrowings and equity or debt financing.
Whereas the Company has been successful in the past in raising capital, no assurance can be given that these sources of financing will continue to be available to it and/or that demand for the Company’s common stock will be sufficient to meet its capital needs, or that financing will be available on terms favorable to the Company. If funding is insufficient at any time in the future, the Company may not be able to take advantage of business opportunities or respond to competitive pressures, or may be required to reduce the scope of the Company’s planned product development and marketing efforts, any of which could have a negative impact on its business and operating results. In addition, insufficient funding may have a material adverse effect on the Company’s financial condition, which could require it to:
·curtail operations significantly;
·sell significant assets;
·seek arrangements with strategic partners or other parties that may require the Company to relinquish significant rights to products, technologies or markets; or
·explore other strategic alternatives including a merger or sale of the Company.
To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the issuance of such securities may result in dilution to the Company’s existing stockholders. If additional funds are raised through the issuance of debt securities, these securities may have rights, preferences and privileges senior to holders of common stock and the terms of such debt could impose restrictions on the Company’s operations. Regardless of whether the Company’s cash assets prove to be inadequate to meet its
operational needs, the Company may seek to compensate providers of services by issuance of stock in lieu of cash, which may also result in dilution to the Company’s existing stockholders.
Inflation.
The impact of inflation on the Company’s costs and the ability to pass on cost increases to its customers over time is dependent upon market conditions. The Company is not aware of any inflationary pressures that have had any significant impact on its operations over the past quarter and the Company does not anticipate that inflationary factors will have a significant impact on future operations.
Off-Balance Sheet Arrangements.
The Company has entered into numerous purchase agreements with local biotech companies through its subsidiary Meizam Arad under its industrial incubator program. These projects are detailed under Item 1, Business.
Critical Accounting Policies.
The SEC has issued Financial Reporting Release No. 60, “Cautionary Advice Regarding Disclosure About Critical Accounting Policies” (“FRR 60”), suggesting companies provide additional disclosure and commentary on their most critical accounting policies. In FRR 60, the Commission has defined the most critical accounting policies as the ones that are most important to the portrayal of a company’s financial condition and operating results, and require management to make its most difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. Based on this definition, the Company’s most critical accounting policies include: (a) use of estimates; (b) impairment of long-lived assets; (c) share-based compensation; and (d) government grants. The methods, estimates and judgments the Company uses in applying these most critical accounting policies have a significant impact on the results the Company reports in its financial statements.
(a) Use of Estimates.
The preparation of financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates these estimates, including those related to revenue recognition and concentration of credit risk. The Company bases its estimates on historical experience and on various other assumptions that is believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
(b) Impairment Long-Lived Assets.
For purposes of recognition and measurement of an impairment loss, a long-lived asset or assets are grouped with other assets and liabilities at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities. The Company assesses the impairment of long-lived assets (including identifiable intangible assets) annually or whenever events or changes in circumstances indicate that the carrying value may not be recoverable.
When management determines that the carrying value of long-lived assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, we test for any impairment based on a projected undiscounted cash flow method. Projected future operating results and cash flows of the asset or asset group are used to establish the fair value used in evaluating the carrying value of long-lived and intangible assets. The Company estimates the future cash flows of the long-lived assets using current and long-term financial forecasts. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. If this were the case, an impairment loss would be recognized. The impairment loss recognized is the amount by which the carrying amount exceeds the fair value.	
(c) Share-Based Compensation.	
The Company follows ASC Topic 718-10, “Stock Compensation,” which addresses accounting for transactions in which an entity exchanges its equity instruments for goods or services, with a primary focus on transactions in which an entity obtains employee services in share-based payment transactions. Topic 718-10 requires measurement of the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. Upon the adoption of Topic ASC 718-10, the Company maintained its method of valuation for stock option awards using the Black-Scholes valuation model, which has historically been used for the purpose of providing pro-forma financial disclosures in accordance with Topic ASC 718-10.
The use of the Black-Scholes valuation model to estimate the fair value of stock option awards requires the Company to make judgments and assumptions regarding the risk-free interest rate, expected dividend yield, expected term and expected volatility over the expected term of the award. The assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the actual amount of expense could be materially different in the future.
Compensation expense is only recognized on awards that ultimately vest.
(d) Government Grants.
Government grants are not recognized until there is reasonable assurance that the Group will comply with the conditions attaching then and the grants will be received.
Government grants are recognized in profit and loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grants are intended to compensate.
Government grants that are receivable as compensation for expenses or losses already incurred or for the purpose of giving immediate financial support to the Group with no future costs are recognised in profit and loss in the period in which they become receivable.
(e) New Accounting Pronouncements
In July 2012, the Financial Accounting Standards Board issued new accounting guidance intended to simplify the testing of indefinite-lived intangible assets for impairment. Entities will be allowed the option to first perform a qualitative assessment on impairment for indefinite-lived intangible assets to determine whether a quantitative assessment is necessary. This guidance is effective for impairment tests performed in the interim and annual periods for fiscal years beginning after September 15, 2012. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on our Consolidated Financial Statements.
Forward Looking Statements.
Information in this Form 10-K contains “forward looking statements” within the meaning of Rule 175 of the Securities Act of 1933, as amended, and Rule 3b-6 of the Securities Act of 1934, as amended. When used in this Form 10-K, the words “expects,” “anticipates,” “believes,” “plans,” “will” and similar expressions are intended to identify forward-looking statements. These are statements that relate to future periods and include, but are not limited to, statements regarding the adequacy of cash, expectations regarding net losses and cash flow, statements regarding growth, the need for future financing, dependence on personnel, and operating expenses.
Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
ITEM 7A.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not applicable.
ITEM 8.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
Audited financial statements as of and for the years ended December 31, 2012 and 2011, and for the period of inception (July 23, 2004) through December 31, 2012, are presented in a separate section of this report following Item 15.
ITEM 9.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
(a) Effective on January 28, 2013, Crowe Horwath (Israel), the independent registered public accounting firm who was previously engaged as the principal accountant to audit the Company’s financial statements, was terminated by the Company. The decision to change principal accountants was approved by the Company’s Board of Directors.
Crowe Horwath (Israel) did not audit any of the Company’s financial statements.
Crowe Horwath (Israel) completed its review of the Company’s interim financial statements for the periods ended June 30, 2012. No further reviews were provided by Crowe Horwath (Israel) to the Company (a review of the interim financial statements dated September 30, 2012 was conducted by AS Financial Auditors, an independent public accounting firm, using professional standards and procedures for conducting such reviews). During the period from July 15, 2012 (the date of engagement of this firm) through January 28, 2013, there were no disagreements with Crowe Horwath (Israel) on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure. In addition, there were no “reportable events” as described in Item 304(a)(1)(iv)(B)1 through 3 of Regulation S-K that occurred during the period from July 15, 2012 through January 28, 2013.
(b) On February 3, 2013, the Company engaged Yarel + Partners as successor to Crowe Horwath (Israel) as its independent registered public accounting firm to audit the Company’s financial statements. Prior to that date, neither the Company (nor someone on its behalf) consulted the newly engaged accountant regarding any matter.
ITEM 9A.
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures.
The Company maintains disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Securities Exchange Act of 1934 (“Exchange Act”)) that are designed to ensure that information required to be disclosed in its periodic reports filed under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to management, including the principal executive officer and the principal financial officer, to allow timely decisions regarding required disclosure.
The Company’s management, with the participation of the principal executive officer and the principal financial officer, evaluated the effectiveness of its disclosure controls and procedures as of December 31, 2012. Based on that evaluation, the principal executive officer and the principal financial officer concluded that, as of that date, the Company’s disclosure controls and procedures were not effective at the reasonable assurance level because of the identification of material weaknesses in its internal control over financial reporting, which the Company views as an integral part of its disclosure controls and procedures.
Management’s Annual Report on Internal Control over Financial Reporting.
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act, and in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”).
The Company’s management conducted an evaluation, under the supervision and with the participation of the principal executive officer and the principal financial officer, of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2012 based on the criteria established in the report entitled “Internal Control - Integrated Framework” published by the Committee of Sponsoring Organizations (COSO) of the Treadway Commission. Based on this evaluation, management concluded that the Company’s internal control over financial reporting was not effective as of December 31, 2012. Specifically the Company did not maintain an effective control environment based on the criteria established in the COSO framework.
A material weakness is a control deficiency, or combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim consolidated financial statements will not be prevented or detected. The following material weaknesses were identified related to the Company’s control environment:
·the Company did not maintain written accounting policies and procedures and did not maintain adequate controls with respect to the review, supervision and monitoring of its accounting operations.
·the Company did not establish a formal enterprise risk assessment process.
These control environment material weaknesses contributed to the material weaknesses described below:
·the Company did not maintain effective controls over the accounting for acquisitions and divestitures; specifically, effective controls were not designed and in place to ensure that such transactions were completely and accurately accounted for in accordance with general accepted accounting principles (“GAAP”);
·the Company did not maintain effective controls over its accounting for consolidated subsidiaries and equity method investees; specifically, the Company did not maintain effective controls to ensure the completeness and accuracy of its accounting for its subsidiaries either consolidated or accounted for under the equity method in accordance with GAAP;
·the Company did not design and maintain effective controls to ensure that accrued expenses, including accruals and legal and professional fees, were complete and accurate in accordance with GAAP;
·the Company did not design and maintain effective controls to ensure the completeness and accuracy of its translation of financial statement accounts denominated in foreign currencies and translation of foreign currency transaction gains or losses recorded in accordance with GAAP;
·the Company did not design and maintain effective controls to ensure that revenue-recognition policies were recorded in accordance with GAAP; and
·the Company did not design and maintain effective controls to ensure that accounting reconciliations between subsidiaries were prepared in accordance with GAAP.
Additional material weaknesses identified were as follows:
·the need to hire an in-house accountant trained in U.S. generally accepted accounting principles to establish a system of internal financial reporting controls; and
·the need to improve planning and execution of the Company’s Section 404 project to meet the requirements of the Sarbanes-Oxley Act on a timely basis.
(a) Remediation of Material Weaknesses.
The Company has begun remediation efforts with respect to the material weaknesses that have been identified above. The Company plans to continue to review and make necessary changes to the design of its internal control environment, including the roles and responsibilities of each functional group within the organization and reporting structure, and to enhance and document policies and procedures to improve the effectiveness of its internal control over financial reporting.
Because the Company must not only design new controls to remediate these material weaknesses, but also implement and test them in order to ensure that the weaknesses have been remediated, the Company expects that a number of these material weaknesses will not be remediated by December 31, 2013, the next date as of which the Company must assess its internal control over financial reporting. While unremediated, these material weaknesses have
the potential to result in the Company’s failure to prevent or detect misstatements in its consolidated financial statements.
The Company has taken, or will take, the following actions:
·the Company intends to design, implement and maintain an effective control environment over financial reporting based upon the Treadway Commission guidelines;
·the Company has begun creating policies and procedures manuals, including documentation of its accounting policies and methods of applying those policies, and intend to continue to increase the resources devoted to its accounting and finance function;
·the Company has begun upgrading its existing accounting software to a recognized software package to ensure financial reports are available more timely; and
·the Company’s management is implementing enhanced controls to ensure effective communication among the Company’s legal, finance and operations organizations to ensure that important information about its business, including the effects, if any, of all material agreements, is addressed appropriately and on a timely basis in its financial reporting.
(b) Management’s Conclusions on the Remediation Plan.
The Company believes that the remediation measures described above will strengthen its internal control over financial reporting and remediate the material weaknesses that have been identified. However, the Company has not yet implemented all of these measures and/or tested them. The Company is committed to continuing to improve its internal control processes and will continue to diligently review its financial reporting controls and procedures in order to ensure compliance with the requirements of the Sarbanes-Oxley Act and the related rules promulgated by the SEC. As the Company continues to evaluate and work to improve its internal control over financial reporting, the Company may take additional measures to address these control deficiencies.
On September 15, 2010, the SEC, in Release Nos. 33-9142 and 34-62914, adopted amendments to remove the requirement for a non-accelerated filer to include in its annual report an attestation report of the filer’s registered public accounting firm. In addition, the SEC clarified that an auditor of a non-accelerated filer need not include in its audit report an assessment of the issuer’s internal control over financial reporting. Therefore, the Company, as a smaller reporting company, does not include an attestation report of its independent registered public accounting firm regarding internal control over financial reporting in this Form 10-K.
Inherent Limitations of Control Systems.
The Company’s internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.
Management, including the Company’s principal executive officer and the principal financial officer, does not expect that the Company’s internal controls will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of internal controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. Also, any evaluation of the effectiveness of controls in future periods are subject to the risk that those internal controls may become inadequate because of changes in business conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Changes in Internal Control Over Financial Reporting.
There have not been any changes in the Company’s internal control over financial reporting during the fourth quarter of 2012 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
ITEM 9B.
ITEM 9B. OTHER INFORMATION.
Subsequent Event.
Subsequent to December 31, 2012 and through the date these financial statements were issued, 400,000 free trading shares of common stock were issued under the 2011 Stock and Option Plan in connection with the conversion of accounts payables for services provided with the issuance of stock of common shares.
PART III.
ITEM 10.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE.
Directors and Executive Officers.
The names, ages, and respective positions of the directors and executive officers of the Company are set forth below. The directors named below will serve until the next annual meeting of stockholders or until their successors are duly elected and have qualified. Directors are elected for a term until the next annual stockholders’ meeting. Officers will hold their positions at the will of the board of directors, absent any employment agreement, of which none currently exist or are contemplated.
There are no family relationships between any two or more of the directors or executive officers. There are no arrangements or understandings between any two or more of the directors or executive officers. There is no arrangement or understanding between any of the directors or executive officers and any other person pursuant to which any director or officer was or is to be selected as a director or officer, and there is no arrangement, plan or understanding as to whether non-management stockholders will exercise their voting rights to continue to elect the current board of directors. There are also no arrangements, agreements or understandings between non-management stockholders that may directly or indirectly participate in or influence the management of the Company’s affairs. There are no other promoters or control persons of the Company. There are no legal proceedings involving the executive officers or directors of the Company.
(a) Sam Shlomo Elimelech, President/Director.
Mr. Elimelech, age 55, has executive and multidisciplinary technical experience and has founded and led several hi-tech companies in the communication field. During the period of 1982 to 2000, he had extensive executive, management and technical experience in telecommunications. From January 2000 to June 2002, Mr. Elimelech served as a director and CEO of Impact Active Team Ltd., providing executive consulting for that company’s turn-around process up to an IPO. For the period of July 2002 to the present, he has served as an investment manager of Pangea Investments GmbH’s office in Israel, a Swiss-based investment company, and from July 2003 to September 2005, he was an investment manager in Pangea’s subsidiary, Enterprise Capital AG.
(b) Gai Mar-Chaim, Secretary/Treasurer/Director.
Mr. Mar-Chaim, age 50, has over twenty years of experience in strategic planning for more than 300 hi-tech companies. In May 1987 he joined P.O.C. Capital Investments Ltd., a leading management-consulting firm in Israel, an affiliate of Arthur D. Little, and managed its technology & industrial division. In January 2000, Mr. Mar-Chaim joined Fantine Group, a business development and venture capital group, and managed its management consulting practice; in January 2001, he left this firm to resume his consulting activities at P.O.C. In June 2002 he joined Pangea as an investment manager in its Israel office and in July 2003 joined Enterprise Capital as an investment manager, a position he held until September 2005. Mr. Mar-Chaim holds a Masters of Business Administration (finance) degree from Tel Aviv University.
Legal Proceedings.
Legal proceedings involving Mr. Elimelech, and Mr. Mar-Chaim:
(a)	On October 19, 2006, P.O.C., the landlord of Enterprise Capital’s premises in Israel, filed a lawsuit in the Tel-Aviv Court claiming alleged utility debt of Enterprise Capital of about $14,000, plus interest. Impact Active (and not the Company as previously reported), Mr. Elimelech, and Mr. Mar-Chaim are also named as defendants in this action. The defendants have filed answers in this action. On September 24, 2012, the court ruled against Impact Active Team Ltd. and dismissed Mr. Elimelech and Mr. Mr Mar-Chaim from the action.
(b)	On November 23, 2006, Mercantile Bank filed a lawsuit in the Tel-Aviv Court is claiming a debt of $40,000, plus interest, from Enterprise Capital. Impact Active team Ltd, Mr. Elimelech, and Mr. Mar-Chaim are also individually named as defendants in this action, as the guarantors to the loan provided to the Enterprise Capital. The defendants have filed answers in this action.
Compliance with Section 16(a) of the Securities Exchange Act.
Section 16(a) of the Securities Exchange Act of 1934 requires the Company’s directors, certain officers and persons holding 10% or more of the Company’s common stock to file reports regarding their ownership and regarding their acquisitions and dispositions of the Company’s common stock with the SEC. Such persons are required by SEC regulations to furnish the Company with copies of all Section 16(a) forms they file.
Based solely upon a review of Forms 3 and 4 and amendments thereto furnished to the Company under Rule 16a-3(d) during fiscal year 2012, and certain written representations from executive officers and directors, the Company is aware that the following required reports were not timely filed:
(a) Ralph Marthaler: Form 4 to report that Pangea Investments GmbH (controlled by Mr. Marthaler) sold all of the shares held in its name to the following individuals: Sam Elimelech, a Company director and president (2,471,878 shares); Gai Mar-Chaim, a Company director and secretary/treasurer (2,471,878 shares); and Ralph Marthaler, the control person of Pangea (600,000 shares). After the reported transaction, Mr. Marthler held a total of 650,000 shares (600,000 purchased in this transaction and 50,000 already held in his own name).
(b) Gerald Fialkov: Form 4 to report: (a) the sale by 1568934 Ontario Limited of 5,000 shares on June 8, 2012; (b) the acquisition of 600,000 restricted shares of common stock from the Company on September 21, 2012 as payment for office rent for 2012; and (c) the acquisition of an additional 20,000 restricted shares of common stock issued effective on January 1, 2012 in order that the total value of the shares issued for 2011 (80,000 - $0.75 per share) for rent of offices provided by 1568934 Ontario Limited located in Beverly Hills, California equals $60,000 (the Company pays restricted shares of common stock to cover the value of $5,000 each month for rent, electricity, telephones, and other expenses of the office) - on August 8, 2011, the Company issued 60,000 restricted shares of common stock, valued at $45,000.
(c) Sam Elimelech: Form 4 to report the following purchases by Mr. Elimelech: (1) 1,000 shares on January 19, 2012; (2) 2,000 shares on January 26, 2012; (3) 1,000 shares on February 1, 2012; (4) 5,000 shares on February 16, 2012; (5) 2,471,878 shares on February 27, 2012; (6) 5,000 shares on March 8, 2012; and (7) 18,000,000 shares on September 20, 2012. A Form 4 to report the return to the Company’s treasury effective on January 1, 2012 of 2,720,000 shares of common stock from the because of a reclassification of the value of the 4,000,000 shares of common stock issued by the
Company under a Regulation S Stock Purchase Agreement between Mr. Elimelech and the Company, dated January 5, 2011.
(d) Gai Mar-Chaim: Form 4 to report the following purchases by Mr. Mar-Chaim: (1) 2,471,878 shares on February 27, 2012; and (2) 18,000,000 shares on September 20, 2012. A Form 4 to report the return to the Company’s treasury effective on January 1, 2012 of 2,720,000 shares of common stock from the because of a reclassification of the value of the 4,000,000 shares of common stock issued by the Company under a Regulation S Stock Purchase Agreement between Mr. Mar-Chaim and the Company, dated January 5, 2011.
All of these reports have either been prepared and filed with the SEC, or are in the process of being prepared for filing.
Corporate Governance.
The primary function of the Company’s board of directors is oversight of management so that identifying and addressing the risks and vulnerabilities that the Company faces is an important component of the board of directors’ responsibilities, whether monitoring ordinary operations or considering significant plans, strategies, or proposed transactions. The risk management process that the Company has established is overseen by the Audit Committee, which is also responsible for oversight of risk issues associated with our overall financial reporting and disclosure process and with legal compliance as well as reviewing policies on risk control assessment and accounting risk exposure. While the board of directors is ultimately responsible for risk oversight, our management is responsible for day-to-day risk management processes. The Company believes this division of responsibilities is the most effective approach for addressing the risks facing the Company and that its board of directors leadership structure supports this approach.
Code of Ethics.
The Company has not adopted a code of ethics that applies to the Company’s principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. The Company has not adopted such a code of ethics because all of management’s efforts have been directed to building the business of the Company; at a later time, the board of directors may adopt such a code of ethics.
Audit Committee.
The Company’s board of directors functions as audit committee for the Company.
The primary responsibility of the Audit Committee will be to oversee the financial reporting process on behalf of the Company’s board of directors and report the result of their activities to the board. Such responsibilities include, but are not limited to, the selection, and if necessary the replacement, of the Company’s independent registered public accounting firm,
review and discuss with such independent registered public accounting firm: (i) the overall scope and plans for the audit, (ii) the adequacy and effectiveness of the accounting and financial controls, including the Company’s system to monitor and manage business risks, and legal and ethical programs, and (iii) the results of the annual audit, including the financial statements to be included in the annual report on Form 10-K.
The Company’s policy is to pre-approve all audit and permissible non-audit services provided by the independent registered public accounting firm. These services may include audit services, audit-related services, tax services and other services. Pre-approval is generally provided for up to one year and any pre-approval is detailed as to the particular service or category of services and is generally subject to a specific budget. The independent registered public accounting firm and management are required to periodically report to the audit committee regarding the extent of services provided by the independent registered public accounting firm in accordance with this pre-approval, and the fees for the services performed to date. The audit committee may also pre-approve particular services on a case-by-case basis.
Other Committee of the Board of Directors.
The Company presently does not have a nominating committee, an executive committee of the board of directors, stock plan committee or any other committees.
Recommendation of Nominees.
The Company does not have a standing nominating committee or committee performing similar functions. Because of the small size of the Company, the board of directors believes that it is appropriate for the Company not to have such a committee. All the directors participate in the consideration of director nominees.
The board of directors does not have a policy with regard to the consideration of any director candidates recommended by security holders. Because of the small size of the Company, and the limited number of stockholders, the board of directors believes that it is appropriate for the Company not to have such a policy.
When evaluating director nominees, The Company considered the following factors:
·The appropriate size of the board.
·The Company’s needs with respect to the particular talents and experience of company directors.
·Knowledge, skills and experience of prospective nominees, including experience in finance, administration.
·Experience with accounting rules and practices.
·The desire to balance the benefit of continuity with the periodic injection of the fresh perspective provided by new board members.
The Company’s goal is to assemble a board that brings together a variety of perspectives and skills derived from high quality business and professional experience.
ITEM 11.
ITEM 11. EXECUTIVE COMPENSATION.
The following table presents compensation information for the years ended December 31, 2012, 2011, and 2010 for the persons who served as principal executive officer and principal financial officer (and directors)
Name and principal position
(a) Year
(b) Salary
($) (1)
(c) Bonus
($)
(d) Stock Awards
($)
(e)
Option
Award(s)
($) (2)
(f)
Non-Equity Incentive Plan Compensation
($)
(g)
Nonqualified Deferred Compensation Earnings
($)
(h) All Other
Compen-sation
($)
(i)
Total
($)
(j)
Sam Elimelech, President
2011 2010
180,000
180,000
240,000
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
180,000
180,000
240,000
Gai Mar-Chaim, Sec/Treas.
180,000
180,000
240,000
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
180,000
180,000
240,000
(1)	This compensation has been accrued by the Company but not paid.
(2)	On January 15, 2011 the Company granted 1,980,000 stock options to two directors, to purchase common shares. The stock options are exercisable at fair market value as defined by the plan and vest over 3 years at 33% every year. The stock options were accounted for at their fair value, as determined by the Black-Scholes valuation model, of $Nil, using the following assumptions: Expected volatility of 139.6%; expected life of 2.47 years; risk-free interest rate of 1.07%; and dividend yield of $Nil.
Outstanding Equity Awards at Fiscal Year-End Table.
(1)	Exercisable at fair market value as defined under the Employee Stock Option Plan.
(2)	These options vest at the rate of 330,000 per year for each director over a period of three years. The options granted are not exercisable until January 1 of the following year.
Executive Officer Contracts.
(a) On January 1, 2011, the Company entered into an Employment Agreement with Sam Elimelech, the Company’s president. This agreement replaces the former employment agreement with the Company, cancelled on December 31, 2010. Under this agreement, the Company will pay Mr. Elimelech $15,000 per month (reduced from $20,000 per month under the cancelled agreement) commencing on the effective date and terminating on December 31, 2012, and $20,000 per month commencing January 1 2013 and on. During the period of this agreement, at the end of the calendar month which Mr. Elimelech desires, he can convert salary due into restricted shares of Company common stock at the trading price per share at the conversion date. This agreement also provides for certain other benefits.
(b) On January 1, 2011, the Company entered into an Employment Agreement with Gai Mar-Chaim, the Company’s secretary/treasurer. This agreement replaces the former employment agreement with the Company, cancelled on December 31, 2010. Under this agreement, the Company will pay Mr. Mar-Chaim $15,000 per month commencing on the effective date and terminating on December 31, 2012, and $20,000 per month commencing January 1 2013 and on. During the period of this agreement, at the end of the calendar month which Mr. Mar-Chaim desires, he can convert salary due into restricted shares of Company common stock at the trading price per share at the conversion date. This agreement also provides for certain other benefits.
Other Compensation.
There are no plans that provide for the payment of retirement benefits, or benefits that will be paid primarily following retirement, including but not limited to tax-qualified defined benefit plans, supplemental executive retirement plans, tax-qualified defined contribution plans and nonqualified defined contribution plans. In addition, there are no contracts, agreements, plans or arrangements, whether written or unwritten, that provide for payment(s) to a named executive officer at, following, or in connection with the resignation, retirement or other termination of a named executive officer, or a change in control of the Company or a change in the named executive officer’s responsibilities following a change in control, with respect to each named executive officer.
ITEM 12.
ITEM 12. security ownership of certain beneficial owners and management, AND RELATED STOCKHOLDER MATTERS
Beneficial Ownership Table.
The following table sets forth information regarding the beneficial ownership of shares of the Company’s common stock as of March 31, 2013 (57,669,242 issued and outstanding) by (i) all stockholders known to the Company to be beneficial owners of more than 5% of the outstanding common stock; (ii) each director and executive officer; and (iii) all officers and directors of the Company as a group. Each person or entity has sole voting power and sole dispositive power as to all of the shares shown as beneficially owned by that person or entity:
(1)	Except as noted, each person has sole voting power and sole dispositive power as to all of the shares shown as beneficially owned by them.
(2)	In accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended (“1934 Act”), Gerald Fialkov may be deemed a control person of the shares owned by this stockholder. In computing the number of shares beneficially owned by this stockholder and the percentage ownership of that stockholder, shares of common stock subject to options or convertible or exchangeable into such shares of common stock held by that person that are currently exercisable, or exercisable within 60 days, are included. Therefore, 1,000,000 of the total consists of shares of common stock underlying a stock option issued in connection with a Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated January 14, 2011. This option is exercisable at a price that is equal to the public offering price of the Company’s common stock in a future Form S-1 registration statement and is exercisable for a period of 24 months from the Company’s Form 15c2-11 filing with Financial Industry Regulatory Authority (“FINRA”) (which occurred on April 12, 2011). Therefore, after April 11, 2013 this option is no longer exercisable and this stockholder no longer owns the underlying shares.
(3)	In accordance with Rule 13d-3 under the1934 Act, since 50,000 shares of the total are held by a member of Mr. Elimelech’s household, he is considered to be the beneficial owner of these shares also. In computing the number of shares beneficially owned by this stockholder and the percentage ownership of this stockholder, shares of common stock subject to options or convertible or exchangeable into such shares of common stock held by that person that are currently exercisable, or exercisable within 60 days, are included. Therefore, 660,000 of the total consists of shares of common stock underlying the vested and exercisable portion of a stock option for 990,000 shares of common stock granted by the Company in exchange for services rendered to the Company.
(4)	In accordance with Rule 13d-3 under the 1934 Act, since 50,000 shares of the total are held by a member of Mr. Mar-Chaim’s household, he is considered to be the beneficial owner of these shares also. In computing the number of shares beneficially owned by this stockholder and the percentage ownership of this stockholder, shares of common stock subject to options or convertible or exchangeable into such shares of common stock held by that person that are currently exercisable, or exercisable within 60 days, are included. Therefore, 660,000 of the total consists of shares of common stock underlying the vested and exercisable portion of a stock option for 990,000 shares of common stock granted by the Company in exchange for services rendered to the Company.
Securities Authorized for Issuance under Equity Compensation Plans.
The Company has adopted three equity compensation plans that are still in operation (neither of which has been approved by the Company’s stockholders):
(a) 2012 Stock and Option Plan.
The Company’s 2012 Stock and Option Plan, dated August 5, 2012, is intended to allow designated directors, officers, employees, and certain non-employees, including consultants to receive certain options to purchase the Company’s common stock and to receive grants of common stock. This plan covers up to 10,000,000 shares of common stock. These shares were registered under a Form S-8 registration statement filed with the Securities and Exchange Commission on August 5, 2012. Through December 31, 2012, a total of 2,000,000 shares have been issued out of this plan (with 8,000,000 remaining to be issued).
(b) 2011 Stock and Option Plan.
The Company’s 2011 Stock and Option Plan, dated July 26, 2011, is intended to allow designated directors, officers, employees, and certain non-employees, including consultants to receive certain options to purchase the Company’s common stock and to receive grants of common stock. This plan covers up to 2,000,000 shares of common stock. These shares were registered under a Form S-8 registration statement filed with the Securities and Exchange Commission on July 26, 2011. Through December 31, 2012, a total of 830,000 shares have been issued out of this plan (with 1,170,000 remaining to be issued).
(c) Employee Stock Option Plan.
On January 15, 2011, the Company adopted an Employee Stock Option Plan that is intended to attract and retain key employees of the Company and its subsidiaries by the grant of options and stock appreciation rights. This plan covers up to 3,000,000 shares of common stock. On January 20, 2011, the Company granted stock options under this plan covering a total of 1,980,000 restricted shares of common stock to the two directors of the Company (990,000 each) (with options covering 1,320,000 shares remaining to be issued as of December 31, 2012). These options vest at the rate of 330,000 shares per year for each director over a period of three years. The options granted are not exercisable until January 1 of the following year. The options' exercise price shall be the market price per share effective on January 1 each year. One-third of the shares may be purchased at any time following the first anniversary of the date of its grant, an additional one-third of the shares subject to this option may be purchased at any time following the second anniversary of the date of this grant, and the remaining shares subject to this option may be purchased at any time following the third anniversary of the date of this grant.
Equity Compensation Plan Information
December 31, 2012
Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights
(a) Weighted-average exercise price of outstanding options, warrants and rights
(b) Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(c)
Equity compensation plans approved by security holders
Equity compensation plans not approved by security holders
1,980,000
Fair market value
2012 Stock and Option Plan:
8,000,000
2011 Stock and Option Plan: 1,170,000
Employee Stock Option Plan: 1,320,000
Total
1,980,000
Fair market value
2011 Stock and Option Plan: 1,170,000
Employee Stock Option Plan: 1,320,000
ITEM 13.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
During the last two fiscal years other than as set forth below, there have not been any relationships, transactions, or proposed transactions to which the Company was or is to be a party, in which any of the directors, officers, or 5% or greater stockholders (or any immediate family thereof) had or is to have a direct or indirect material interest.
(a)	On January 1, 2011, the Company entered into an Employment Agreement with Sam Elimelech, the Company’s president. This agreement replaces the former employment agreement with the Company, cancelled on December 31, 2010 (the Employment Agreement between Mr. Elimelech and the Company, dated July 3, 2006). See Exhibit 10.12.
(b)	On January 1, 2011, the Company entered into an Employment Agreement with Gai Mar-Chaim, the Company’s secretary/treasurer. This agreement replaces the former employment agreement with the Company, cancelled on December 31, 2010 (the Employment Agreement between Mr. Mar-Chaim and the Company, dated July 3, 2006). See Exhibit 10.13.
(c)	On January 5, 2011, the Company entered into a Regulation S Stock Purchase Agreements with Mr. Elimelech and Mr. Mar-Chaim. Under these agreements, they each purchased from the Company 1,280,000 restricted shares of common stock for a total consideration of $1,920,000. The Company issued 4,000,000 shares each instead of 1,280,000 to each of the directors (which later amount correctly reflects the value of the services provided); the excess shares were returned to the Company and cancelled effective on January 1, 2012. See Exhibits 10.14 and 10.15.
(d)	On January 6, 2011, the Company terminated the consulting agreement entered into with Pangea Investments GmbH on July 3, 2006. Since Pangea did not deliver consulting and management services under this agreement during the period 2006-2010, the firm is not eligible for any management fees as specified under that agreement.
(e)	On January 14, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited, an affiliate of the Company. Under this agreement, the purchaser purchased from the Company 266,667 restricted shares of common stock at $0.75 per share for a total consideration of $200,000. These shares were issued on or about January 14, 2011. See Exhibit 10.16.
In connection with this agreement, the Company issued to the purchaser an option, dated January 14, 2011, to purchase 1,000,000 restricted shares of the Company’s common stock. This option is exercisable for a period of 24 months from the date of filing by the Company of a Form 211 with the Financial Industry Regulatory Authority (“FINRA”) at an exercise price that is equal to the public offering price of the common stock in a future Form S-1 registration statement of the Company. This filing with FINRA occurred on April 12, 2011. See Exhibit 4.1.
(f)	On January 20, 2011, the Company granted an options to Mr. Elimelech and Mr. Mar-Chaim to each purchase 990,000 restricted shares of Company common stock (see Exhibits 4.3 and 4.4). This option is exercisable at fair market value, as defined in the Employee Stock Option Plan (see Exhibit 4.2). This option vests at the rate of 330,000 per year over a period of three years. The options granted are not exercisable until January 1 of the following year. Therefore, only 330,000 shares of this option were exercisable by each as of December 31, 2012. Each vested portion of the option expires two years after vesting. These options were granted in exchange for services provided to the Company.
(g)	On May 24, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 140,000 restricted shares of common stock at $0.75 per share for a total consideration of $105,000. These shares were issued on or about June 14, 2011. See Exhibit 10.19.
(h)	On July 29, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 66,667 restricted shares of common stock at $0.75 per share for a total consideration of $50,000. These shares were issued on or about August 8, 2011. See Exhibit 10.20.
(i)	On January 1, 2011, the Company began using offices provided by 1568934 Ontario Limited located in Beverly Hills, California. This office space is approximately 1,000 square feet. The Company pays restricted shares of common stock to cover the value of $5,000 each month for rent, electricity, telephones, and other expenses of the office. The Company is under a month-to-month lease of these offices. On August 8, 2011, the Company issued 60,000
restricted shares of common stock to 1568934 Ontario Limited under this arrangement as rent for the 2011 calendar year, valued at $45,000 ($0.75 per share). The Company issued an additional 20,000 restricted shares of common stock effective on January 1, 2012, valued at $15,000.
(j)	On December 26, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 2,590,909 restricted shares of common stock at $0.11 per share for a total consideration of $285,000. These shares were issued on or about December 31, 2011. See Exhibit 10.21.
(k)	On January 5, 2012, the Company granted to 1568934 Ontario Limited, in connection with the purchase agreement dated December 26, 2011, an option to purchase two shares of Company common stock for each share purchased under this agreement, for a total of up to 5,181,818 restricted shares of common stock. The exercise price of this option is 67% of the lowest share price of the first one million shares sold by the Company’s underwriter to the public as of the Company public offering as set for in a Form S-1 registration statement to be filed with the Securities and Exchange Commission at a later time. This option will be exercisable commencing the following day the Company’s underwriter completes the sale of the first 1,000,000 shares of the common stock and continuing up to 5:00 p.m. Pacific Standard Time on a date which is 24 months from such date.
(l)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Eran Elimelech, son of Sam Elimelech (the Company’s president) but not living in the same household. Under this agreement, Eran Elimelech purchased from the Company 2,000,000 restricted shares of common stock at its par value for a total consideration of $2,000 ($0.001 par value per share). Sam Elimelech disclaims any beneficial ownership of these shares. The company recorded stock based compensation valued at $98,000, the difference between the shares market price on July 29, 2012 and the consideration of $2,000. See Exhibit 10.23
(m)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Sam Elimelech, the Company’s President & CEO. Under this agreement, Sam Eliemelech purchased from the Company 18,000,000 restricted shares of common stock at its par value for a total consideration of $18,000 ($0.001 par value per share). The company recorded stock based compensation valued at $882,000, the difference between the shares market price on July 29, 2012 and the consideration of $18,000. See Exhibit 10.24.
(n)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Gai Mar-Chaim, the Company’s secretary/treasurer. Under this agreement, Mr. Mar-Chaim purchased from the Company 18,000,000 restricted shares of common stock at its par value for a total consideration of $18,000 ($0.001 par value per share). The company recorded stock based compensation valued at $882,000, the difference between the shares market price on July 29, 2012 and the consideration of $18,000. See Exhibit 10.25
(o)	On September 21, 2012, the Company issued 600,000 restricted shares of common stock to 1568934 Ontario Limited as rent for the 2012 calendar year under a Corporate Office Services Agreement, dated January 5, 2012. See Exhibit 10.22.
Certain of the Company’s officers and directors are engaged in other businesses, either individually or through partnerships and corporations in which they have an interest, hold an office, or serve on a board of directors. As a result, certain conflicts of interest may arise between the Company and such officers and directors. The Company will attempt to resolve such conflicts of interest in its favor.
The Company defines director independence in accordance with the definition as set forth in Rule 5605(a)(2) of the Rules of the NASDAQ Stock Market.
ITEM 14.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Audit Fees.
The aggregate fees billed for professional services rendered by Dov Weinstein & Co. for the audit of the Company’s financial statements for the 2011 fiscal year (and review of the interim financial statements for 2011): $16,000; and for review of the March 31, 2012 interim financial statements: $2,000.
The aggregate fees billed for professional services rendered by Crowe Horwath (Israel) for review of the June 30, 2012 interim financial statements: $10,000.
The aggregate fees billed for professional services rendered by Yarel + Partners for the audit of the Company’s financial statements for the year ended December 31, 2012: $25,500.
Audit-Related Fees.
The aggregate fees billed in each of the last two fiscal years for assurance and related services by the accounting firms that are reasonably related to the performance of the audit or review of the Company’s financial statements and are not reported under Audit Fees above: $0.
Tax Fees.
The aggregate fees billed in each of the last two fiscal years for professional services rendered by the accounting firms for tax compliance, tax advice, and tax planning: $0.
All Other Fees.
The aggregate fees billed in each of the last two fiscal years for products and services provided by the accounting firms, other than the services reported above: $0.
ITEM 15.
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES.
The following documents are being filed as a part of this report on Form 10-K:
(a)	Audited financial statements as of and for the years ended December 31, 2012 and 2011, and the period of inception (July 23, 2004) through December 31, 2012; and
(b)	Those exhibits required by Item 601 of Regulation S-K (included or incorporated by reference in this document are set forth in the Exhibit Index).
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.	
Andain, Inc.
Dated: May 10, 2013 By: /s/ Sam Shlomo Elimelech
Sam Shlomo Elimelech, President
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Company and in the capacities and on the dates indicated:
Signature Title Date
/s/ Sam Shlomo Elimelech
Sam Shlomo Elimelech
President/Director
(principal executive officer)
May 10, 2012
/s/ Gai Mar-Chaim
Gai Mar-Chaim
Secretary/Treasurer/Director
(principal financial officer)
May 10, 2012
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Andain Inc.
We have audited the accompanying consolidated balance sheets of Andain Inc. (a development stage company) (“Company) and its subsidiaries as of December 31, 2012, and the related statements of operations, changes in stockholders’ deficit and cash flows for the year then ended, and for the period of inception (July 23, 2004) through December 31, 2012. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. The financial statements of the Company as of December 31, 2011 and the related statements of operations, changes in stockholders’ deficit and cash flows for the year then ended, and for the period of inception (July 23, 2004) through December 31, 2011, were audited by other auditors whose report dated April 8, 2012, except for Note 15 as to which the date is May 9, 2013, expressed an unqualified opinion on those statements
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2012, and the results of its operations and cash flows for the year then ended, and for the period of inception (July 23, 2004) through December 31, 2012, in conformity with accounting principles generally accepted in the United States of America. The financial statements of the Company as of December 31, 2011 and the related statements of operations, changes in stockholders’ deficit and cash flows for the year then ended, and for the period of inception (July 23, 2004) through December 31, 2011, were audited by other auditors whose report dated April 8, 2012, except for Note 15 as to which the date is May 9, 2013, expressed an unqualified opinion on those statements.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has suffered recurring losses, has had significant recurring negative cash flows from operations, and has an accumulated deficit that raises substantial doubt over its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from this uncertainty.
/s/ Yarel + Partners, CPA
Tel Aviv, Israel
May 9, 2013
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Andain Inc.
We have audited the accompanying consolidated balance sheets of Andain Inc. (a development stage company) (“Company) and its subsidiaries as of December 31, 2011 and 2010, and the related statements of operations, changes in stockholders’ deficit and cash flows for the years then ended, and for the period of inception (July 23, 2004) through December 31, 2011. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2011 and 2010, and the results of its operations and cash flows for the years then ended, and for the period of inception (July 23, 2004) through December 31, 2011, in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has suffered recurring losses, has had significant recurring negative cash flows from operations, and has an accumulated deficit that raises substantial doubt over its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from this uncertainty.
As described in Note 15 to the financial statements, the Company amended its financial statements for the year ended December 31, 2011 to reflect a correction of an error in the balance of non-controlling interest.
/s/ Dov Weinstein & Co. C.P.A. (Isr)
Jerusalem, Israel
April 8, 2012, except for Note 15 as to which the date is May 9, 2013
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars)
The accompanying notes are an integral part of these consolidated financial statements
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. Dollars)
The accompanying notes are an integral part of these consolidated financial statements
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
(continued)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
(continued)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
(continued)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
(continued)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ DEFICIT
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
(continued)
The accompanying notes are an integral part of these consolidated financial statements
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. Dollars)
ANDAIN, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. Dollars)
(continued)
The accompanying notes are an integral part of these consolidated financial statements
ANDAIN, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS ENDED DECEMBER 31, 2012 AND 2011, AND
PERIOD OF INCEPTION (JULY 23, 2004) THROUGH DECEMBER 31, 2012
(U.S. Dollars)
NOTE 1 - GENERAL INFORMATION
Andain Inc. (“Company”) was established in 2004 in the State of Nevada, U.S.A. Since commencing operations in 2006, the Company has been engaged, both independently and through its consolidated entities (collectively, the “Group”), in the development of medical technology, from early stage development to advanced clinical trials, for a wide range of medical needs.
Proportion of Ownership:
(1)	Impact Active Team Ltd. was acquired for 4,000,000 shares of Company common stock.
(2)	Gaia Med Ltd. was acquired for $140,122.
NOTE 2 - GOING CONCERN
The Company’s consolidated financial statements are prepared using generally accepted accounting principles applicable to a going concern that contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has not established any source of revenue to cover its operating costs. The Company has sustained operating losses and expects such losses to continue for the foreseeable future. The Company will engage in very limited activities without incurring any liabilities that must be satisfied in cash until a source of funding is secured. The Company will offer non-cash consideration as a means of financing its operations. If the Company is unable to obtain revenue-producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may substantially curtail or terminate its operations.
NOTE 3 - SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates.
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. While management believes that such estimates are fair when considered in conjunction with the consolidated financial position and results of operations taken as a whole, actual results could differ from those estimates and such differences may be material to the financial statements.
Functional and Reporting Currency.
The consolidated financial statements are presented in U.S. Dollars, which is the Company’s functional currency and presentation currency. The financial statements of entities that use a functional currency other than the U.S. Dollar are translated into U.S. Dollars. Assets and liabilities are translated using the exchange rate on the respective balance sheet dates. Items in the income statement and cash flow statement are translated into U.S. Dollars using the average rates of exchange for the periods involved. The resulting translation adjustments are recorded as a separate component of other comprehensive income/(loss) within stockholders’ equity.
The functional currency of foreign entities is generally the local currency unless the primary economic environment requires the use of another currency. Gains or losses arising from the translation or settlement of foreign-currency-denominated monetary assets and liabilities into the functional currency are recognized in the income in the period in which they arise. However, currency differences on intercompany loans that have the nature of a permanent investment are accounted for as translation differences as a separate component of other comprehensive income/(loss) within stockholders’ equity.
New Israeli Shekel (“NIS”) amounts as of December 31, 2012 have been translated into U.S. Dollars at the representative rate of exchange on December 31, 2012 (USD 1 = NIS 3.73).
Consolidation Principles.
The consolidated financial statements of the Company include the accounts of the Company, and all entities in which a direct or indirect controlling interest exists through voting rights or qualifying variable interests. All intercompany balances and transactions have been eliminated in the consolidated financial statements.
Cash and Cash Equivalents.	
Cash and cash equivalents comprise cash balances, cash on current accounts with banks, bank deposits and other highly liquid short-term investments with original maturities of less than three months
Accounts Receivable.
The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. The amount of the allowance is determined by analyzing known uncollectible accounts, aged receivables, economic conditions in the customers’ country or industry, historical losses and the customers’ credit-worthiness. Amounts later determined and specifically identified to be uncollectible are charged or written off against this reserve. During 2012 and 2011 there were no allowances recorded for doubtful accounts.
Property and Equipment.	
Property and equipment are carried at cost, less accumulated depreciation and amortization. Property and equipment are assessed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
Depreciation is computed on a straight-line basis over the estimated useful lives of the assets as follows:
Long-Lived Assets.	
For purposes of recognition and measurement of an impairment loss, a long-lived asset or assets are grouped with other assets and liabilities at the lowest level for which identifiable cash flows are largely independent of the cash flows of other assets and liabilities. The Company assesses the impairment of long-lived assets (including identifiable intangible assets) annually or whenever events or changes in circumstances indicate that the carrying value may not be recoverable.
When management determines that the carrying value of long-lived assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, we test for any impairment based on a projected undiscounted cash flow method. Projected future operating results and cash flows of the asset or asset group are used to establish the fair value used in evaluating the carrying value of long-lived and intangible assets. The Company estimates the future cash flows of the long-lived assets using current and long-term financial forecasts. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. If this is the case, an impairment loss would be recognized. The impairment loss recognized is the amount by which the carrying amount exceeds the fair value.		
Goodwill and Intangible Assets.	
Goodwill represents the excess of the cost over the fair value of net tangible and identifiable intangible assets of acquired businesses. Goodwill is assessed for impairment by applying fair value based tests annually or whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
The goodwill impairment test consists of a two-step process. The first step of the goodwill impairment test, used to identify potential impairment, compares the fair value of a reporting unit to its carrying value, including goodwill. The Company uses un-discounted cash flow models to determine the fair value of a reporting unit. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired, and the second step of the impairment test is not required. The second step, if required, compares the implied fair value of the reporting unit goodwill with the carrying amount of that goodwill. The fair value of a reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value of the reporting unit was the price paid to acquire the reporting unit. If the carrying amount of the reporting unit’s goodwill exceeds its implied fair value, an impairment charge is recognized in an amount equal to that excess.
Patents are stated at cost (primarily comprising legal fees) and are considered to have an indefinite useful life, they are not amortised but tested for impairment on an annual basis.
The Company impaired goodwill and intangible assets in the amounts of $(20,649), $(14,708) and $(433,348) in the years ended December 31, 2012, 2011 and the Period of inception (July 23, 2004) through December 31, 2012, respectively.
Accounts Payable and Accrued Expenses.	
Accounts payable and accrued expenses are carried at amortized cost and represent liabilities for goods and services provided to the Group prior to the end of the financial year that are unpaid and arise when the Group becomes obliged to make future payments in respect of the purchase of these goods and services.
Non-Controlling Interests.	
A non-controlling interest in a subsidiary is an ownership interest in a consolidated entity that is reported as equity in the consolidated financial statements and separate from the Company’s equity. In addition, net income/(loss) attributable to non-controlling interests is reported separately from net income attributable to the Company in the consolidated financial statements.
The Company’s consolidated statements present the full amount of assets, liabilities, income and expenses of all of our consolidated subsidiaries, with a partially offsetting amount shown in non-controlling interests for the portion of these assets and liabilities that are not controlled by us.
Revenue Recognition.	
The Company recognizes revenue when all four recognition criteria have been met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, seller’s price to buyer is fixed or determinable and collectability is reasonably assured.
Interest Income. 	
Interest income is recognized in the consolidated statement of income as it is earned.
Government Grants.
Government grants are not recognized until there is reasonable assurance that the Group will comply with the conditions attaching then and the grants will be received.
Government grants are recognized in profit and loss on a systematic basis over the periods in which the Group recognizes as expenses the related costs for which the grants are intended to compensate.
Government grants that are receivable as compensation for expenses or losses already incurred or for the purpose of giving immediate financial support to the Group with no future costs are recognised in profit and loss in the period in which they become receivable.
The Company received grants from the Office of the Chief Scientist ("OCS") during the years 2009 - 2011. In January 2012, the Company’s board of directors decided not to extend the agreement period with the OCS beyond the initial 3 years term. The Company will continue for the next 3 years to maintain all guidelines to the projects funded by the OCS. Therefore the company is not expected to receive additional government grants.
Out of $682,690 grants received by the Company during 2009-2011, there is $417,259 of accounts receivables as of December 31, 2012 not yet paid by the OCS, The OCS has initiated a final examination of the industrial incubator program under the support of the Office of the Chief Scientist, when the examination team will conclude its work, the OCS will pay all due amounts according to the recommendations of the examination team. The Company's management believes the amount receivable will be paid in full. As of the date of these financial statements, no funds were received from the OCS.
The Company is committed to pay royalties to the Government of Israel with respect to the proceeds from sales of products developed in the framework of projects in which the Israeli Government paid a portion of the expenses. The contingent liability to the OCS is limited to the amount of the grants received plus per annum interest at the LIBOR rate. As of December 31, 2012, no royalties had been paid or accrued. The Company has committed to the OCS to keep the know-how and production rights in the framework of the abovementioned projects under the Project’s possession.
Research and Development.		
Internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed.
Income Taxes.	
Income taxes are accounted for in accordance with the Financial Accounting Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) Topic 740, “Income Taxes.” Under the asset and liability method specified by Topic 740, deferred tax assets and liabilities are recognized for the future consequences of differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases (temporary differences). Deferred tax assets and liabilities are measured using tax rates expected to apply to taxable income in the years in which those temporary differences are recovered or settled. Valuation allowances for deferred tax assets are established when it is more likely than not that some portion or all of the deferred tax assets will not be realized. At December 31, 2012 and 2011, deferred tax assets had a 100% valuation allowance.
Earnings Per Share.	
Basic and diluted losses per share are presented in accordance with ASC 260-10 “Earnings per share”. Outstanding stock options and warrants have been excluded from the calculation of the diluted loss per share because all such securities are antidilutive.
Share-Based Compensation.	
ASC Topic 718, “Stock Compensation,” requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company’s consolidated income statements.
The Company recognizes compensation expense for the value of its awards on a straight-line basis over the requisite service period of each of the awards, net of estimated forfeitures. Estimated forfeitures are based on actual historical pre-vesting forfeitures. Topic 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
The Company estimates the fair value of stock options granted using the Black-Scholes option-pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon comparable companies in the industry in the absence of historical data of the Company. The expected term of options granted represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on annual risk free rates yield rates of non-indexed linked U.S. Federal Reserve treasury bonds with
an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends.
The Company applies ASC Topic 505-50, “Equity Based Payments to Non Employees,” with respect to options issued to non-employees.
Fair Value Measurements.
As defined in ASC Topic 820-10, “Fair Value Measurements and Disclosures,” fair value is based on the price that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, Topic 820-10 establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Other inputs that are observable, directly or indirectly, such as quoted prices for similar assets and liabilities or market-corroborated inputs.
Level 3: Unobservable inputs are used when little or no market data is available, which requires the Company to develop its own assumptions about how market participants would value the assets or liabilities. The fair value hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation techniques in its assessment that maximize the use of observable inputs and minimize the use of unobservable inputs.
The following table presents the Company’s financial assets and liabilities that are carried at fair value, classified according to the three categories described above:
Impact of Recently Issued Accounting Standards.
In May 2011, the FASB issued ASU Topic 2011-04, “Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International Financial Reporting Standards (“IFRS”)” Under Topic 2011-04, the guidance amends certain accounting and disclosure requirements related to fair value measurements to ensure that fair value has the same meaning in U.S. GAAP and in IFRS and that their respective fair value measurement and disclosure requirements are the same. Topic 2011-04 is effective for public entities during interim and annual periods beginning after December 15, 2011. The adoption of Topic 2011-04 did not have a material impact on its consolidated results of operation and financial condition.
Effective June 16, 2011, the FASB issued ASU Topic 2011-05, “Comprehensive Income (ASC Topic 220): Presentation of Comprehensive Income,” which amended current comprehensive income guidance. This accounting update eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholder’ deficit. Instead, comprehensive income must be reported in either a single continuous statement of comprehensive income that contains two sections, net income and other comprehensive income, or in two separate but consecutive statements. In December 2011, the FASB deferred the requirement to present components of reclassifications of other comprehensive income on the face of the income statement that had previously been included in the June 2011 amended standard. These amended standards are applied for interim and annual periods beginning after December 15, 2011. The adoption of Topic 2011-04 did not have a material impact on its consolidated results of operation and financial condition.
In December 2011, the FASB issued Topic 2011-11, “Disclosures about Offsetting Assets and Liabilities.” The objective of Topic 2011-11 is to enhance disclosures by requiring improved information about financial instruments and derivative instruments in relation to netting arrangements. Topic 2011-11 is effective for interim and annual periods beginning on or after January 1, 2013. The Company is currently evaluating the impact of this guidance; however, since this update affects disclosures only, it is not expected to have a material impact on the Company's consolidated financial statements.
In July 2012, the FASB issued new accounting guidance intended to simplify the testing of indefinite-lived intangible assets for impairment. Entities will be allowed the option to first perform a qualitative assessment on impairment for indefinite-lived intangible assets to determine whether a quantitative assessment is necessary. This guidance is effective for impairment tests performed in the interim and annual periods for fiscal years beginning after September 15, 2012. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s consolidated financial statements.
On February 5, 2013, the FASB issued ASU Topic 2013-02, “Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income,” which adds additional disclosure requirements relating to the reclassification of items out of accumulated other comprehensive income. This Topic is effective for the first quarter of 2013 and affects disclosures only, it is not expected to have a material impact on the Company’s consolidated results of operation and financial condition.
There were various other updates recently issued. None of the updates are expected to a have a material impact on the Company’s financial position, results of operations or cash flows.
Reclassification.
Certain 2011 amounts have been reclassified to conform to the current year presentation (see Note 15).
NOTE 4 - ACCOUNTS RECEIVABLE
(1)See note 3 - “Governmental Grants.”
NOTE 5 - PROPERTY, PLANT AND EQUIPMENT
NOTE 6 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES
NOTE 7 - LONG-TERM DEBT
NOTE 8 - STOCKHOLDERS’ EQUITY
Common Stock.
(a)	On January 5, 2011, the Company entered into a Regulation S Stock Purchase Agreements with Sam Elimelech, the Company’s president and CEO, and with Gai Mar-Chaim, the Company’s secretary/treasurer. Under these agreements, they each purchased from the Company 1,280,000 restricted shares of common stock for a total consideration of $1,920,000. The Company issued 4,000,000 shares each instead of 1,280,000 to each of the directors (which later amount correctly reflects the value of the services provided); the excess shares were returned to the Company and cancelled effective on January 1, 2012.
(b)	On January 14, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited, an affiliate of the Company. Under this agreement, the purchaser purchased from the Company 266,667 restricted shares of common stock at $0.75 per share for a total consideration of $200,000. These shares were issued on or about January 14, 2011.
In connection with this agreement, the Company issued to the purchaser an option, dated January 14, 2011, to purchase 1,000,000 restricted shares of the Company’s common stock. This option is exercisable for a period of 24 months from the date of filing by the Company of a Form 211 with the Financial Industry Regulatory Authority (“FINRA”) at an exercise price that is equal to the public offering price of the common stock in a future Form S-1 registration statement of the Company. This filing with FINRA occurred on April 12, 2011.
(c)	On May 24, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 140,000 restricted shares of common stock at $0.75 per share for a total consideration of $105,000. These shares were issued on or about June 14, 2011.
(d)	On July 29, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 66,667 restricted shares of common stock at $0.75 per share for a total consideration of $50,000. These shares were issued on or about August 8, 2011.
(e)	On August 1, 2011, the Company issued 707,352 free trading shares of common stock registered under a Form S-8 registration statement for various professional services to the Company valued at $530,514 for services rendered during 2011. The Company issued 830,000 shares instead of 707,352 shares for the services, the excess shares were returned to the Company on January 1, 2012.
(f)	On January 1, 2011, the Company began using offices provided by 1568934 Ontario Limited located in Beverly Hills, California. This office space is approximately 1,000 square feet. The Company pays restricted shares of common stock to cover the value of $5,000 each month for rent, electricity, telephones, and other expenses of the office. The Company is under a month-to-month lease of these offices. On August 8, 2011, the Company issued 60,000 restricted shares of common stock to 1568934 Ontario Limited under this arrangement as rent for the 2011 calendar year, valued at $45,000 ($0.75 per share). The Company issued an additional 20,000 restricted shares of common stock effective on January 1, 2012, valued at $15,000.
(g)	On August 8, 2011, the Company issued 100,000 restricted shares of common stock to the Company’s transfer agent, Globex Transfer, LLC, for professional services. Valued at $10,000. The Company issued 100,000 shares instead of 13,333 shares for the services, the excess shares were returned to the Company on January 1, 2012.
(h)	On December 26, 2011, the Company entered into a Regulation S Stock Purchase Agreement with 1568934 Ontario Limited. Under this agreement, the purchaser purchased from the Company 2,590,909 restricted shares of common stock at $0.11 per share for a total consideration of $285,000. These shares were issued on or about December 31, 2011.
(i)	On January 5, 2012, the Company granted to 1568934 Ontario Limited, in connection with the purchase agreement dated December 26, 2011, an option to purchase two shares of Company common stock for each share purchased under this agreement, for a total of up to 5,181,818 restricted shares of common stock. The exercise price of this option is 67% of the lowest share price of the first one million shares sold by the Company’s underwriter to the public as of the Company public offering as set for in a Form S-1 registration statement to be filed with the Securities and Exchange Commission at a later time. This option will be exercisable commencing the following day the Company’s underwriter completes the sale of the first 1,000,000 shares of the common stock and continuing up to 5:00 p.m. Pacific Standard Time on a date which is 24 months from such date.
(j)	On March 12, 2012, the Company issued a total of 300,000 restricted shares of common stock (150,000 each) to Otzarot Tarshsih Nechasim Vehashkaott Ltd., for consulting work, and Uziel Economic Consultant Ltd., for marketing services, both for a period of four months commencing February 5, 2012, valued at $9,000 each.
(k)	On June 14, 2012, the Company issued 200,000 restricted shares of common stock to the Company’s transfer agent, Globex Transfer, LLC, for professional services rendered valued at $10,000 ($0.05 per share).
(l)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Sam Elimelech, the Company’s President & CEO. Under this agreement, Sam Eliemelech purchased from the Company 18,000,000 restricted shares of common stock at its par value for a total consideration of $18,000 ($0.001 par value per share). The company recorded stock based compensation valued at $882,000, the difference between the shares market price on July 29, 2012 and the consideration of $18,000.
(m)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Gai Mar-Chaim, the Company’s secretary/treasurer. Under this agreement, Mr. Mar-Chaim purchased from the Company 18,000,000 restricted shares of common stock at its par value for a total consideration of $18,000 ($0.001 par value per share). The company recorded stock based compensation valued at $882,000, the difference between the shares market price on July 29, 2012 and the consideration of $18,000.
(n)	On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Eran Elimelech, son of Sam Elimelech (the Company’s president) but not living in the same household. Under this agreement, Eran Elimelech purchased from the Company 2,000,000 restricted shares of common stock at its par value for a total consideration of $2,000 ($0.001 par value per share). Sam Elimelech disclaims any beneficial ownership of these shares. The company recorded stock based compensation valued at $98,000, the difference between the shares market price on July 29, 2012 and the consideration of $2,000.
(o)	On September 20, 2012, the Company issued 720,000 restricted shares of common stock to American Capital Ventures, and 480,000 restricted shares of common stock to Maplehurst Investment Group, both for investor relations services to be rendered for a period of one year commencing September 20, 2012, valued at $60,000. Accordingly, the Company charged to general and administrative expenses during 2012 a total compensation of $16,750.
(p)	On September 20, 2012, the Company issued a total of 3,000,000 restricted shares of common stock (1,500,000 each) to Otzarot Tarshsih Nechasim Vehashkaott Ltd., for consulting work, and Uziel Economic Consultant Ltd., for marketing services. The Company has determined that services were not performed the services as agreed so the Company did not deliver the stock certificates; the Company now intends to cancel these certificates.
(q)	On September 21, 2012, the Company issued 600,000 restricted shares of common stock to 1568934 Ontario Limited as rent for the year ended December 31, 2012 under a Corporate Office Services Agreement, dated January 5, 2012.
(r)	During October and November 2012, the Company received $50,000 from an investor on account of a future allocation of shares. As of the date of these financial statements, the investment agreement had not been signed.
Preferred Stock.
The Company has authorized, but not issued, 10,000,000 shares of preferred stock, par value $0.001 per share. The board of directors has the authority to establish and fix the designation, powers, or preferences of preferred shares without further vote by the stockholders.
NOTE 9 - PROVISION FOR TAXES
The components of the Company’s (loss) income before provision for income taxes by jurisdiction are as follows:
The components of the provision for income taxes are as follows:
The Company has tax attribute carryforwards in its federal, state and foreign jurisdictions. No tax benefit has been reported with respect to these net operating loss carry forwards in the accompanying financial statements because the Company believes that realization is not likely. Therefore, a valuation allowance of $722,622 is recorded.
The components of deferred tax assets and liabilities are only for Net operating loss carry-forwards at the amount of $722,622 .A valuation allowance of $722,622 is recorded
NOTE 10 - BUSINESS COMBINATIONS
Subsidiary Acquired.		
Gaia Med Ltd. is an Israeli company established on June 30, 2008, and situated in Israel in the City of Arad. On December 31, 2011, the Company acquired control through a share buyback from existing shareholders at a price of NIS 1, giving the Company control over 57.6% of the voting equity interests of that company. This subsidiary was acquired for its unique technologies regarding insulin pump research. The acquisition of Gaia Med was achieved in stages, through a share buy-back scheme.
Consideration Transferred.	
Goodwill Arising from the Acquisition.
Goodwill from the acquisition arose as the inclusion of Gaia Med effectively includes amounts in relation to the benefit of expected synergies, revenue growth and future market development of the Company. These benefits are not recognised separately from goodwill as they do not meet the criteria for identifiable intangible assets.	
None of the goodwill arising from this acquisition is expected to be deductible for tax purposes.
Assets Acquired and Liabilities Recognized at Date of Acquisition.
NOTE 11 - FINANCIAL INSTRUMENTS AND RISK MANAGEMENT
Foreign Exchange Risk.
The Group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. Dollar and the New Israeli Shekel. Foreign exchange risk arises from future commercial transactions, recognized assets and liabilities and net investments in foreign operations.
Interest Rate Risk.
The Company is subject to cash flow interest rate risk due to fluctuations in the prevailing levels of market interest rates. The investment manager monitors the Company’s overall interest sensitivity on a monthly basis and the general director on a quarterly basis.
Credit Risk.
Credit risk refers to the risk that counter-party will default on its contractual obligations resulting in financial loss to the Group. The Group has adopted a policy of only dealing with creditworthy counter-parties and obtaining sufficient collateral, where appropriate, as a means of mitigating the risk of financial loss from defaults.
Liquidity and Capital Risk Management.
The Company’s objectives when managing capital are to safeguard the Group’s ability to continue as a going concern in order to provide returns for stockholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital. In order to maintain or adjust the capital structure, the Group may adjust the amount of dividends paid to stockholders, return capital to stockholders, issue new shares or sell assets to reduce debt.
NOTE 12 - RELATED PARTY TRANSATIONS
Balances and transactions between the Company and its subsidiaries, which are related parties of the Company, have been eliminated on consolidation and are not disclosed in this note. Details of transactions between the Group and other related parties are disclosed below.
The following entities have been identified as related parties of the Company as of December 31, 2012:	
The following transactions were carried out with related parties:
(1)	The annual compensation to key management personnel is $360,000 per year. During 2012 the Company recorded forgiveness of loans from key management personnel in the amount of $512,982. The amount was recorded as an equity transaction.
NOTE 13 - SHARE-BASED COMPENSATION	
2011 Stock and Option Plan.
The Company’s 2012 Stock and Option Plan, dated August 5, 2012, is intended to allow designated directors, officers, employees, and certain non-employees, including consultants to receive certain options to purchase the Company’s common stock and to receive grants of common stock. This plan covers up to 10,000,000 shares of common stock. These shares were registered under a Form S-8 registration statement filed with the Securities and Exchange Commission on August 5, 2012. Through December 31, 2012, a total of 2,000,000 shares have been issued out of this plan (with 8,000,000 remaining to be issued).
2011 Stock and Option Plan.
The Company’s 2011 Stock and Option Plan, dated July 26, 2011, is intended to allow designated directors, officers, employees, and certain non-employees, including consultants to receive certain options to purchase the Company’s common stock and to receive grants of common stock. This plan covers up to 2,000,000 shares of common stock. These shares were registered under a Form S-8 registration statement filed with the Securities and Exchange Commission on July 26, 2011. Through December 31, 2012, a total of 830,000 shares have been issued out of this plan (with 1,170,000 remaining to be issued).
Employee Stock Option Plan.
On January 15, 2011, the Company adopted an Employee Stock Option Plan that is intended to attract and retain key employees of the Company and its subsidiaries by the grant of options and stock appreciation rights. This plan covers up to 3,000,000 shares of common stock. On January 20, 2011, the Company granted stock options under this plan covering a total of 1,980,000
restricted shares of common stock to the two directors of the Company (990,000 each) (with options covering 1,320,000 shares remaining to be issued as of December 31, 2012). These options vest at the rate of 330,000 shares per year for each director over a period of three years. The options granted are not exercisable until January 1 of the following year. The options' exercise price shall be the market price per share effective on January 1 each year. One-third of the shares may be purchased at any time following the first anniversary of the date of its grant, an additional one-third of the shares subject to this option may be purchased at any time following the second anniversary of the date of this grant, and the remaining shares subject to this option may be purchased at any time following the third anniversary of the date of this grant.
Stock Purchases.
On July 29, 2012, the Company entered into a Regulation S Stock Purchase Agreement with Sam Elimelech, the Company’s president and CEO, Gai Mar-Chaim, the Company’s secretary/treasurer, and Eran Elimelech, son of Sam Elimelech. Under these agreements, they purchased from the Company 18,000,000, 18,000,000 and 2,000,000, respectively, restricted shares of common stock, respectively, at its par value for a total consideration of $38,000 ($0.001 par value per share). The company recorded stock based compensation of $1,862,000.
NOTE 14 - SUBSEQUENT EVENT
Subsequent to December 31, 2012 and through the date these financial statements were issued, 400,000 free trading shares of common stock were issued under the 2011 Stock and Option Plan in connection with the conversion of accounts payables for services provided with the issuance of stock of common shares.
NOTE 15 - PRIOR PERIOD ADJUSTMENTS
The Company restated its financial statements for the year ended December 31, 2011, to give retrospective effect to the amendments described below:
The Company determined that its non-controlling interest balance and accumulated deficit during the development stage were overstated by $205,965 due to an error in accounting. The Company restated its prior year calculation of non-controlling interest as follows:
EXHIBIT INDEX
NumberDescription
3.1Articles of Incorporation, dated July 14, 2004 (incorporated by reference to Exhibit 3.1 of the Form 10-SB filed on March 24, 2005).
3.2Bylaws, dated August 1, 2004 (incorporated by reference to Exhibit 3.2 of the Form 10-SB filed on March 24, 2005).
4.1Option issued to 1568934 Ontario Limited by the Company, dated January 14, 2011 (incorporated by reference to Exhibit 10.6 of the Form 8-K filed on March 29, 2011).
4.2Employee Stock Option Plan, dated January 15, 2011 (incorporated by reference to Exhibit 4.2 of the Form 10-Q filed on November 21, 2011).
4.3Stock Option Grant to Sam Elimelech, dated January 20, 2011 (incorporated by reference to Exhibit 4.3 of the Form 10-Q filed on November 21, 2011).
4.4Stock Option Grant to Gai Mar-Chaim, dated January 20, 2011 (incorporated by reference to Exhibit 4.4 of the Form 10-Q filed on November 21, 2011).
4.52011 Stock and Option Plan, dated July 26, 2011 (incorporated by reference to Exhibit 4 of the Form S-8 filed on July 26, 2011).
10.1Affiliation Agreement between the Impact Active Team Ltd. and P.O.C. High-Tech (1992) Ltd. Corporation, dated June 23, 2004 (incorporated by reference to Exhibit 10.8 of the Form SB-2 filed on February 13, 2007).
10.2Consulting Agreement between the Company and Dr. Leonid Lurya, dated May 16, 2006 (incorporated by reference to Exhibit 10.2 of the Form 10-K filed on December 30, 2010).
10.3Share Purchase Agreement between the Company and Pangea Investments GmbH, dated June 11, 2006 (not including Schedule 1, Disclosure Schedule) (incorporated by reference to Exhibit 10.1 of the Form 8-K filed on July 5, 2006).
10.4Technology Purchase Agreement between the Company and Pangea Investments GmbH, dated June 11, 2006 (incorporated by reference to Exhibit 10.2 of the Form 8-K filed on July 5, 2006).
10.5Finder’s Fee Agreement between the Company and Pangea Investments GmbH, dated June 11, 2006 (incorporated by reference to Exhibit 10.5 of the Form 8-K filed on July 5, 2006).
10.6Consulting Agreement between the Company and Pangea Investments GmbH, dated July 3, 2006 (incorporated by reference to Exhibit 10.3 of the Form 8-K filed on July 5, 2006).
10.7Business Development Services Agreement between the Company and Pangea Investments GmbH, dated July 3, 2006 (incorporated by reference to Exhibit 10.4 of the Form 8-K filed on July 5, 2006).
10.8Employment Agreement between the Company and Sam Elimelech, dated July 3, 2006 (incorporated by reference to Exhibit 10.6 of the Form 8-K filed on July 5, 2006).
10.9Employment Agreement between the Company and Gai Mar-Chaim, dated July 3, 2006 (incorporated by reference to Exhibit 10.7 of the Form 8-K filed on July 5, 2006).
10.10Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated July 19, 2006 (incorporated by reference to Exhibit 10.11 of the Form 10-K/A filed on February 7, 2011).
10.11Consulting Agreement between the Company and Meizam - Advanced Enterprise Center Arad Ltd., dated October 25, 2006 (incorporated by reference to Exhibit 10.10 of the Form 10-K filed on December 30, 2010).
10.12Employment Agreement between the Company and Sam Elimelech, dated January 1, 2011 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed on March 29, 2011).
10.13Employment Agreement between the Company and Gai Mar-Chaim, dated January 1, 2011 (incorporated by reference to Exhibit 10.2 of the Form 8-K filed on March 29, 2011).
10.14Regulation S Stock Purchase Agreement between the Company and Sam Elimelech, dated January 5, 2011 (incorporated by reference to Exhibit 10.3 of the Form 8-K filed on March 29, 2011).
10.15Regulation S Stock Purchase Agreement between the Company and Gai Mar-Chaim, dated January 5, 2011 (incorporated by reference to Exhibit 10.4 of the Form 8-K filed on March 29, 2011).
10.16Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated January 14, 2011 (incorporated by reference to Exhibit 10.5 of the Form 8-K filed on March 29, 2011).
10.17Stock Purchase Agreement between the Company and Meizam Arad Investments Ltd., dated January 31, 2011 (incorporated by reference to Exhibit 10.7 of the Form 8-K filed on March 29, 2011).
10.18Stock Purchase Agreement between Meizam - Advanced Enterprise Center Arad Ltd and Meizam Arad Investments Ltd., dated January 31, 2011 (incorporated by reference to Exhibit 10.8 of the Form 8-K filed on March 29, 2011).
10.19Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated May 24, 2011 (incorporated by reference to Exhibit 10 of the Form 8-K filed on July 19, 2011) (excluding Schedules 2.4, 2.7, and 2.10).
10.20Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated July 29, 2011 (incorporated by reference to Exhibit 10 of the Form 8-K filed on August 16, 2011) (excluding Schedules 2.4, 2.7, and 2.10).
10.21Regulation S Stock Purchase Agreement between the Company and 1568934 Ontario Limited, dated December 26, 2011 (incorporated by reference to Exhibit 10 of the Form 8-K filed on February 6, 2012) (including Schedule 1.4 (Option to Purchase Shares of Common Stock) and Schedule 2.4 (Litigation); excluding Schedule 2.7).
10.22Corporate Office Services Agreement between the Company and 1568934 Ontario Limited, dated January 5, 2012 (incorporated by reference to Exhibit 10.22 of the Form 10-Q filed on August 29, 2012).
10.23Regulation S Stock Purchase Agreement between the Company and Eran Elimelech, dated July 29, 2012 (incorporated by reference to Exhibit 10.23 of the Form 10-Q filed on August 29, 2012).
10.24Regulation S Stock Purchase Agreement between the Company and Sam Elimelech, dated July 29, 2012 ((incorporated by reference to Exhibit 10.24 of the Form 10-Q filed on November 19, 2012).
10.25Regulation S Stock Purchase Agreement between the Company and Gai Mar-Chaim, dated July 29, 2012 ((incorporated by reference to Exhibit 10.25 of the Form 10-Q filed on November 19, 2012).
16.1Letter on Change in Certifying Accountant (incorporated by reference to Exhibit 16 of the Form 8-K filed on January 5, 2006).
16.2Letter on Change in Certifying Accountant (incorporated by reference to Exhibit 16 of the Form 8-K filed on November 5, 2010).
16.3Letter on Change in Certifying Accountant (incorporated by reference to Exhibit 16 of the Form 8-K filed on July 24, 2012).
21Subsidiaries of the Company (incorporated by reference to Exhibit 21 of the Form 10-K filed on April 16, 2012).
23.1Consent of Dov Weinstein & Co. C.P.A. (Isr) (filed herewith).
23.2Consent of Yarel + Partners, CPA (filed herewith).
31.1Rule 13a-14(a)/15d-14(a) Certification of Sam Shlomo Elimelech (filed herewith).
31.2Rule 13a-14(a)/15d-14(a) Certification of Gai Mar-Chaim (filed herewith).
32Section 1350 Certification of Sam Shlomo Elimelech and Gai Mar-Chaim (filed herewith).