Medtech Winners of 2019
These companies, people, technologies, and concepts had a great year in 2019.
MD+DI Staff
Medtech accomplished a lot in 2019. Here's a look at the people, companies, and concepts that succeeded in 2019.
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TAVR On The Rise
2019 was perhaps one of the most influential years in recent history for transcatheter aortic valve replacement procedures – also known as TAVR or TAVI. (For simplicities sake we'll just say TAVR.) Late last year, MD+DI editors asked the question if 2019 would be a standout year for TAVR.
Things kicked off into high gear in January when Boston Scientific and Edwards Lifesciences ended a long-standing dispute regarding TAVR patents. To settle the dispute Irvine, CA-based Edwards paid out $180 million to Boston Scientific. The settlement eased tensions and opened up the field for both companies to operate without the threat of future lawsuits.
In April, TAVR went 'mainstream' after Rolling Stones frontman Mick Jagger went through the procedure. At the time, Larry Biegelsen, an analyst with Wells Fargo said that Jagger's experience was drawing attention to the space. Biegelsen wrote at the time, that this will "likely raise awareness of aortic stenosis and potentially lead to more TAVR procedures which should benefit the TAVR manufacturers. When celebrities like Mick Jagger undergo a surgical procedure, it tends to shine a light on the underlying disease and raise awareness of the procedure itself because of the publicity it generates."
The competitive landscape of TAVR changed when Marlborough, MA-based Boston Scientific nabbed FDA approval for the Lotus Edge Valve. The nod was significant because it ended the duopoly that Edwards and Medtronic held in the TAVR market. Up until the Lotus Edge Valve's approval, Medtronic and Edwards were the only companies that both had CE mark and a green light from FDA to market their TAVR devices.
And in August FDA gave an expanded indication to both Medtronic and Edwards's TAVR devices so the technology could be used in patients with low-risk for death or major complications associated with open-heart surgery. One analyst said the conversation will eventually shift toward TAVR being the "preferred treatment method."
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Forest Devices
It may be hard to believe, but not every hospital is equipped to fully treat a stroke victim, according to Matt Kesinger, CEO of Forest Devices. To help such patients get proper treatment when minutes count, Kesinger and his company are developing AlphaStroke, a portable device for rapidly identifying stroke patients in the field so they can be directed to the right hospital.
The company's efforts have earned it attention (as well as funding) in a few competitions this year, but the ultimate winners could be patients. Given AlphaStroke's potential to quickly identify asymmetry in brain oxygen, the device could cut delays in diagnosis and in treatment. Saving time is critical for stroke patients, as brain damage can occur with each passing minute.
2019 brought a couple awards to help further development. At The MedTech Conference in September the startup won the MedTech Innovator 2019 Showcase and received a $350,000 grand prize award.
In November, Andrew Maza, Forest Devices's VP of clinical operations, won the AHA HealthTech Pitch Competition awards for judge's choice and people's choice.
Kesinger told MD+DI this week that Forest Devices is gearing up for pivotal trials in two countries in 2020 and will begin raising its B-round funding.
Innovation, thanks to Breakthrough Device Designations
It's been a breakout year for breakthrough devices, as designated products in FDA's Breakthrough Devices Program continue to multiply. In September at The MedTech Conference, FDA's Jeffrey Shuren, director of CDRH, told attendees that "the number of designations for breakthrough devices has doubled each year for the past few years." Through the beginning of September the agency had 103 designations, he said.
The program aims to expedite reviews of "certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions," FDA outlined on its site. The Breakthrough Devices Program supersedes the Expedited Access Pathway (EAP) and also contains features from the Innovation Pathway.
We've covered more than a few breakthroughs this year:
Active Implants's NUsurface meniscus implant.
ArcherDx's liquid biopsy and tissue specimen diagnostic application.
AWAK Technologies's wearable and ultra-portable peritoneal dialysis device.
B. Braun Intervention Systems's SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis.
BioVentrix's Revivent TC Transcatheter Ventricular Enhancement System for treating heart failure.
BrainBox Solutions's BrainBox traumatic brain injury (TBI) detection test.
Concept Medical's MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure and MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter.
C2N Diagnostics's Alzheimer's disease detection test.
Eko's ECG-based algorithm that could serve as a screening test for heart failure.
Fresenius Medical Care's computer-assisted ultrafiltration control software.
Gala Therapeutics's RheOx airway ablation technology.
Grail's next-generation sequencing (NGS) blood test for the early detection of multiple cancer types in individuals 50 or older.
Medtronic's fully implantable left ventricular assist device.
N8 Medical's CeraShield technology for preventing formation of bacterial and fungal biofilms on device surfaces.
Orchestra BioMed's Virtue sirolimus-eluting balloon in the treatment of below-the-knee peripheral artery disease.
Perfuze's Millipede Clot Ingestion System technology.
Procyrion's Aortix circulatory support device for chronic heart failure.
RenalytixAI's KidneyIntelX.
Resolution Bioscience's Resolution HRD in vitro diagnostic.
RightEye's Vision System for detecting Parkinson's disease.
Shockwave Medical's Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter.
SyncThink's Eye-Sync technology.
Thrive's CancerSEEK test.
Vicarious Surgical's robotically assisted surgical device.
V-Wave's Interatrial Shunt for heart failure.
Image by Colin Behrens from Pixabay
The surgical robotics race has been underway for quite sometime, but 2019 saw several milestones and significant competition, even for the market pioneer, Intuitive Surgical.
This year saw the development of the industry's first hands-free surgical robotic system. XACT Robotics technology combines image-based planning and navigation with the insertion and steering of various surgical instruments (everything from biopsy needles to ablation probes) to the desired location during percutaneous procedures, according to our coverage of XACT Robotics as a 2019 Medtech Company of the Year finalist.
There's also word that virtual reality could have an impact in this space, thanks to Vicarious Surgical's Breakthrough Device Designation for its development of virtual reality in a robotically assisted surgical device.
Medtronic's surgical robot announcement generated tremendous excitement this year as the medtech leader said it would draw from its extensive knowledge of surgical procedures for development of its robotic-assisted surgery system. It is working with surgeons and hospital administrators to address user needs.
Robotic achievements positioned Zimmer Biomet, MD+DI's Company of the Year, for an incredible 2019 and beyond, thanks to knee, spine, and brain applications for its Rosa robotic system.
And there are efforts to develop simple solutions in robotic-assisted surgery that would integrate robotics into existing laparoscopy processes.
Surgeons, hospital systems, and ultimately patients could be the ultimate winners in this race, as such progress and competition could increase user comfort and acceptance as well as patient access.
If you are an innovator in this niche, check out the helpful advice experts shared at MD&M West 2019.
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Obalon Therapeutics
Earlier this year, weight-loss specialist Obalon Therapeutics went through some significant changes. In April, the San Diego, CA-based company eliminated all of its direct sales force and some of its headquarters staff in a move that could reduce operating expenses in 2Q19 by about 35%. Then just a few weeks removed from the restructuring announcement, the company retainedCowen & Co. as an independent financial advisor to assist in exploring financial and strategic alternatives. But the uncertainty subsided when Obalon revealed a plan that would increase patient access and utilization of its gastric balloon weight loss system. The company said it intended to own and operate a network of retail centers throughout the U.S. that focus solely on patients wishing to lose weight using the Obalon Balloon System. The move was well-received as ViralNewsPlace is reporting the Obalon's stock is attracting investors with its latest performance.
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Abbott's FreeStyle Libre
Abbott's FreeStyle Libre glucose monitoring system is a unicorn in the medical device world because of its mass-market potential and unprecedented growth. Abbott CEO Miles White has previously estimated that there are more than 80 million people around the world who would benefit from the device, including both Type 1 and Type 2 diabetes patients.
"It's unlike anything seen before in device or diagnostics businesses," White said during an earnings call earlier this year. "To be honest, traditional medical device companies aren't used to having to deal with that kind of scale."
Suffice it to say, the FreeStyle Libre system represents great power for Abbott. And as any Spiderman fan knows, great power comes with great responsibility. In this case, Abbott's responsibility is to keep up with demand, make the product as affordable as possible, and make sure the patients who need the device have access.
"And so, we're addressing that by investing very heavily in manufacturing expansion so that we can go after the mass market, not a niche," White said. "I think the sustainability of the growth is driven not only by the innovation but the ability to go after much bigger markets at a much more affordable level."
Libre is a $2 billion product today, but multiple analysts have speculated that the device could easily become a $5 billion product in time.
"I think it's got enormous potential, and it's got potential beyond glucose," White said. "It's got potential as a wearable and in other analytes and other products over time."
The CEO noted that Abbott has R&D programs underway not only for the repeated enhancement improvement and expansion of Libre but also for its potential application beyond diabetes.
Image Credit: Abbott
Unlikely Healthcare Companies
There are a lot of "unlikely" healthcare companies entering the market – fueled by the rise of consumer's interest in their own health. Large retailers and tech giants made a serious mark on the healthcare landscape in 2019.
In addition to Best Buy's usual offerings of laptops, videogames, and household appliances, the retail giant dove into telemedicine. The retail giant – which has outlived many of its competitors, formed a partnership with Tyto Care. Details of the partnership show that Best Buy will sell Israel-based Tyto Care's handheld examination device. TytoHome is a handheld examination device with attachments that can examine the heart, lungs, skin, ears, throat and abdomen, as well as measure body temperature, to enable remote diagnosis of acute care situations like ear infections, sore throats, fever, cold and flu, allergies, stomach aches, upper respiratory infections, coughs, rashes and more.
CVS Health began branching out beyond its usual offerings and most recently launched Transform Oncology Care. The program uses genomic testing results at the point-of-prescribing to help patients start on the best treatment, faster and in addition, matches eligible patients to clinical trials.
Black+Decker, known mostly for its work on producing household appliances, teamed up with Pillo Health to develop the Pria robot assistant. Boston-based Pillo Health developed the proprietary technology platform that powers Pria, and Black+Decker is facilitating its direct launch to consumers. Towson, MD-based Black+Decker has a division called Stanley Healthcare. Pillo Health's technology bringing Pria to life uses facial recognition and AI, enabling adults to maintain safety, independence and wellness in-home while providing peace of mind to those who are deeply involved in their care through a mobile app.
Google took a deeper dive into healthcare through an unlikely source – Fitbit. In November. Google announced it would acquire the wearables giant for about $2.1 billion. The deal would help Google go head-to-head with the Apple Watch -especially on the healthcare front.
However, Fitbit began taking a deeper dive into healthcare way before the deal. In September, the company announced a new collaboration that would allow Fitbit users in Belgium, the Netherlands, Ireland, and the UK to monitor their heart rhythms for irregularities, which include atrial fibrillation. The company is working with FibriCheck, to provide a health screening and monitoring app for the Fitbit smartwatch.
Apple has been shaping itself up to be a powerhouse in healthcare. In 2018, there were clearances and collaborations that helped the Cupertino, CA-based company get its foot into the door. But in 2019, Apple further cemented its position. Over the summer, Apple released preliminary data from the Apple Heart Study, which demonstrates the effectiveness of wearables to detect atrial fibrillation.
The tech giant also announced three health studies its U.S. customers can now enroll in through a new research app. The studies include the Apple Women's Health Study, the Apple Heart and Movement Study, and the Apple Hearing Study. Conducted in partnership with leading academic and research institutions, these multi-year longitudinal studies are available in the new Research app, which can be downloaded from the App Store.
If this were a slideshow about the top medtech rivalries of the year, Axonics and Medtronic's pelvic health business would lead that list without question. But as this slideshow is intended to shine a spotlight on more positive developments of 2019, we'll focus our attention on the real winners of the story: the sacral neuromodulation market as a whole and the patients who stand to benefit from advancements in this space.
For 22 years, Medtronic was the only player in sacral neuromodulation, which addresses urinary problems as well as fecal incontinence. In 2019, FDA approved an implantable rechargeable sacral neuromodulation (r-SNM) device developed by Axonics for fecal incontinence, urinary urge incontinence, urinary urge frequency, underactive bladder, and urinary retention. The Axonics device is the first rechargeable option in the space. Both approvals also cover the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans while the device is implanted.
If there's one thing we know for sure it's that competition breeds innovation, and that certainly seems to be the case in sacral neuromodulation. In October, Medtronic filed a pre-market approval supplement with FDA for its InterStim Micro neurostimulator as well as its InterStim SureScan MRI leads. Like Axonics' system, the InterStim Micro is a rechargeable, implantable sacral neuromodulation device. The SureScan leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval, which could come as early as March 2020.
In addition to having more options, increased marketing efforts by both companies is expected to increase awareness of SNM and expand the market. Mike Matson, a medtech analyst at Needham & Co., touched on this in a report he issued on Dec. 3 based on recent management calls with each company.
"Management emphasized its view that SNM market growth is likely to accelerate over the next few years for several reasons," Matson said. "[Axonics] believes that its entry into the SNM market with a much improved product that is smaller and lasts three to five times longer (~15 years vs. three to five years) will result in more women electing to get the procedure. They noted that in addition to having to undergo surgery every three to five years with [Medtronic's] current SNM system, patients also have a significant out-of-pocket cost from co-pays and deductibles from these procedures. Additionally, management noted that SNM is a 'secret' with low levels of patient awareness and many physicians even failing to recommend it as an option."
Matson also noted that, along with Axonics' marketing efforts, Medtronic's launch of the InterStim Micro "should also serve to help increase penetration and expand the market."
Image Credit: Axonics Modulation Technologies
The Collaborative Spirit of Medtech
This year the medical device and diagnostics industry has continued to embrace collaboration, a trend inspired by the shift toward a value-based care system in the United States.
There seems to be new partnerships popping up every day in virtually every corner of the medtech world, but MD+DI editors have noticed that collaboration is playing a particularly large role in digital health, diabetes, and genomic testing. Here are a few examples of partnerships we've seen in these areas this year:
In January, Johnson & Johnson's Janssen Pharmaceuticals teamed up with Apple for a research study to look at how to help improve atrial fibrillation outcomes, including stroke prevention, through the use of wearables. The partnership leverages an app developed by J&J along with the Apple Watch. This large-scale program is limited to the United States, and is designed as a pragmatic randomized controlled research study for individuals age 65 years or older.
Apple also formed a new collaboration this year with One Drop, a digital health company. One Drop agreed to sell its wireless glucose monitor at select Apple Stores in the United States. Purchasers of the system also receive one year of unlimited diabetes coaching via One Drop's award-winning mobile app.
In April, GE Healthcare announced a partnership with the American College of Radiology (ACR) in an effort to capitalize on the rapidly-evolving field of artificial intelligence (AI). GE is working with ACR to integrate GE's Edison platform with the ACR AI-Lab. Edison serves as a "digital thread" for GE Healthcare's existing AI partnerships and products. The partnership extended these services and allowed ACR members and other radiology professionals to more easily develop and seamlessly deploy their algorithms across hospitals and research centers nationally. Edison allows data to be traced during the development of an algorithm, and its clinical data aggregation services enable radiologists to combine multiparametric data sets and clinical information from electronic health records to create more accurate algorithms.
"We all know it's going to take an ecosystem to do what needs to be done in healthcare when it comes AI," said Karley Yoder, director of product management of AI analytics at GE Healthcare. "We know that to really harness the powers of AI it's going to take many players working on these problems together."
In September, Medtronic and Abbott each announced separate collaboration agreements that demonstrate the importance of medical device companies and pharmaceutical companies working together to improve diabetes management. Medtronic is working with Novo Nordisk, and Abbott is working with Sanofi.
In the genomic testing sector, Cellgen Diagnostics and Genomic Testing Cooperative announced a collaboration in April that is expected to provide the pharmaceutical industry with the seamless integration of biomarker discovery, validation, and IVD development.
This space also saw a huge 15-year partnership form between Qiagen and Illumina. That agreement is expected to broaden the availability and use of next-generation sequencing-based in-vitro diagnostic kits, including companion diagnostics, for patient management. Initially, the partnership will focus on commercializing oncology IVD kits to support patient management. In the future, the collaboration could expand to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, as well as inflammatory and autoimmune diseases.