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Significant Unmet Clinical Need:
Chronic sinusitis is a common condition in which the cavities around the nasal passages (sinuses) become inflamed and swollen. Also known as chronic rhinosinusitis (CRS), this condition interferes with normal sinus drainage and causes mucus to build up. CRS sufferers experience difficulty breathing through the nose. Additionally, the area around the eyes and face may feel swollen, and there may also be throbbing facial pain or a headache.
Some 35 million Americans are affected by CRS annually, with 73 million days of restricted activity or lost work per year and $8 billion in direct healthcare costs. In only 2-10% of cases is bacteria the cause of CRS, yet a recent national survey showed that 81% of adults presenting with acute sinusitis were prescribed antibiotics. CRS is now the fifth-leading indication for antimicrobial prescriptions by primary care physicians. Primary care clinicians and pharmacists are challenged to differentiate between viral and bacterial sinusitis, which have nearly identical symptoms.
About 500,000 persons require sinus surgery annually to treat their CRS. Surgical alternatives include FESS (Functional Endoscopic Sinus Surgery), in which surgical instruments are inserted into the nasal passages to cut and cauterize tissue; or balloon dilation sinuplasty (BDS), wherein clogged sinus passages are dilated with gradually inflated balloons.
While BDS has enjoyed widespread acceptance and rapid adoption since being introduced in 2005, the first-generation BDS devices are relatively crude and do not possess the capability of measuring the force being exerted upon the sinus passage walls. Consequently, the bony sinus ostia are often fractured, leading to bleeding and inflammation. Due to these side effects, an unacceptable recurrence (restenosis) rate of 17% has been documented with surgical treatment of CRS.
No Regulatory Hurdles:
The SinuGeniX RegENT System will follow the 510(k) regulatory path. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is "equivalent" to a device already placed into one of the three classification categories. "Class 1" predicate devices from Entellus, Acclarent, Medtronic, and Xomed all have similar products: This means that SinuGeniX expects to be able to quickly gain clearance to market in the United States.
Favorable Medical Economics:
BDS is a recognized and well-reimbursed procedure. SinuGeniX expects the RegENT System to be actively utilized in many of the nearly 10,000 hospitals and clinics across the U.S., as well as in 86,000 treatment facilities worldwide.
The primary customers for the RegENT System will be otorhinolaryngologists (ENTs) who will prescribe its use for their patients – an estimated patient market of over 3 million in the U.S. alone. Referring sources will likely include: family medicine, allergists, internists, pulmonary internists, pediatricians and pulmonary rehabilitation therapists.
Using RegENT, ENTs are expected to accomplish the BDS procedure in a single office visit, in stark contrast to the current need for these BDS procedures to be administered in a surgery suite under anesthesia.
Extensive IP Protection:
SinuGeniX has numerous patents and patents pending for its RegENT System. Specific details are subject to restricted access.
Significant Competitive Advantages:
The surgical technique known as FESS was developed in the 1980s. An alternative to FESS, BDS, was developed in the mid-2000s. Unlike FESS, in which surgical instruments are inserted into the nasal passages to cut and cauterize tissue, balloon procedures simply dilated sinus passages with gradually inflated balloons. The BDS technique has enjoyed widespread acceptance and rapid adoption. However, the first-generation of balloon devices are relatively crude and possess no means to measure the force being exerted upon the passage walls. Consequently, the bony sinus ostia are often fractured, leading to bleeding and inflammation. Due to these side effects, a recurrence rate of up to 17% has been observed.
FDA REGULATORY DISCLOSURE: SinuGeniX is an emerging technology company.These products are investigational medical devices that have not been approved or cleared for use in the United States.
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