Medtech Company of the Year 2019 Finalists

Each year, MD+DI‘s editors take a long, hard look at the medical device and diagnostics companies that rose above the ranks over the past 12 months. It can be savvy business strategies, breakthrough products, or operational execution that set the best of the best apart. The following are our nominees for the 2019 Medtech Company of the Year. Check them out, then let us know your choice at the end. We’ll announce our pick next week, and the Reader’s Choice the week of December 17, 2019.
Acutus Medical
Acutus Medical certainly made its presence known in the electrophysiology space in 2019. The Carlsbad, CA-based company is building an entire EP product line around its AcQMap system. The technology is designed to enable imaging, visualization, planning, and ablation all in one system.
Acutus turned heads this year with a large financing round in round in June, the publication of data from its UNCOVER-AF trial, not to mention partnerships, the integration of AcQMap with Stereotaxis’ robotic navigation system, and the acquisition of Rhythm Xience.
It’s really no wonder Needham & Co. included Acutus on its list of interesting private medical device companies to watch.
Acutus is building an entire EP product line around its AcQMap system. The technology is designed to enable imaging, visualization, planning, and ablation all in one system.
MD+DI chatted with Acutus Medical President/CEO Vince Burgess in September to learn more about the company. Click here to read the Q&A.
AliveCor
Thanks to a year filled with new FDA clearances and partnerships, AliveCor didn’t seem fazed one bit by Apple’s 2018 ECG announcement.
In March AliveCor shared positive news from three studies. In one, ECGs taken with KardiaMobile after discharge allowed doctors to diagnose 56% percent of patients in 9.5 days on average, a huge improvement over “standard care” in which just 10% were diagnosed in an average of 43 days.
The very next month AliveCor announced two more FDA 510(k)-cleared indications for KardiaMobile. AliveCor technology can now detect bradycardia and tachycardia in addition to detecting atrial fibrillation (AFib) and normal sinus rhythm.
“No other consumer ECG device in the world can tell you more about your heart than KardiaMobile,” said AliveCor Chief Executive Officer, Ira Bahr, in a statement.
The company then reported FDA clearance for KardiaMobile 6L, calling it the world’s first available six-lead personal ECG device. The design (which features two electrodes on top for thumb placement and an additional one on the bottom for placement on the patient’s left knee or ankle) supports the Einthoven Triangle formation that allows cardiologists to view electrical activity in the heart from six perspectives.
Partnerships further extended opportunities for AliveCor in 2019. The company partnered with Omron to combine ECG monitoring with at-home blood pressure monitoring in the new Omron Complete, and both ECG and blood pressure readings can be collected by one smartphone app. AliveCor also announced a collaboration with Huami Corp. on next-generation wearables.
And another partnership is helping AliveCor get the word out through direct-to-consumer campaigns. Olympian and Gold Medalist Mark Spitz partnered with AliveCor to share his experience after an AFib diagnosis. The company has also been running commercials with special holiday pricing.
All these efforts could help patients follow the advice AliveCor Founder and Chief Medical Officer Dave Albert shared leading up to his fireside chat at MD&M Minneapolis 2019: “Take care of your body and it will take care of you.”
Apple
We’re undoubtedly going to get some flack for this choice – however, it can’t be denied that Apple has made tremendous gains in healthcare this year. The tech giant kicked off 2019 by collaborating with Johnson & Johnson in a research study to look at how to help improve atrial fibrillation (AFib) outcomes, including stroke prevention, through the use of wearables. By mid-year the Cuppertino, CA-based company would strike a deal with Dexcom to have a-direct to Apple Watch version of the G6 Continuous Glucose meter. Just last month, Apple 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. Apple continues to innovate in healthcare and can get the word out quicker through branding and its commercial footprint.
Axonics Modulation Technologies
Competitive drama aside, 2019 was a critical year for Axonics as it won FDA approval for two indications of its implantable rechargeable sacral neuromodulation device. The device is now FDA-approved for the treatment of fecal incontinence, overactive bladder, and urinary retention.
The device competes directly with Medtronic’s InterStim II device, which has been the standard of care and used to treat more than 300,000 patients, according to Medtronic.
The Axonics system is the first rechargeable SNM system approved in Europe, Canada, Australia, and now the United States. The incumbent is hot on Axonics’ trail, however, to bring a new rechargeable version of its technology to the market, both in Europe and the United States.
Guardant Health
Guardant Health had a huge 2018. The company went from private to public raising $360 million in an IPO. But that was last year? What about 2019? Well, the Redwood City, CA-based company continues its upward momentum. Earlier this year, the firm tested its M&A acumen and picked up Bellwether Bio for an undisclosed sum. Bellwether Bio has a focus of improving oncology patient care through pioneering research into the epigenomic content of cell free DNA. In August, the companyrevealed results of a study that show the Guardant360 assay can accurately detect microsatellite instability status (MSI) as accurately as tissue biopsy. The company said this is the largest comparison of MSI testing to traditional tissue methods across multiple solid tumor types. And in October, the company initiated the Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter (ECLIPSE) study. The primary objective is to evaluate the performance of the company’s Lunar-2 blood test to detect colorectal cancer in a screen-relevant population. If the study yields successful results, the company could gain FDA approval for this indication.
Livongo
Livongo has set the bar for digital health companies. The Mountain View, CA-based company’s key partnerships and IPO helped define its successful 2019. Back in March, Livongo launched what it calls Applied Health Signals, which is a new category of technologies and capabilities that include data science, behavior change, and the clinical impact that work together to benefit the company’s members. The company raised roughly $335 million in its IPO.  In November, the company posted 3Q19 revenue of $46 million. Up about 148% higher year-over-year.
Medtronic
Medtronic CEO Omar Ishrak was heard many times throughout 2019 saying that the company is enjoying the strongest product pipeline in its history. The company’s flurry of new-product-related news over the past 12 months certainly seems to support that viewpoint:

• FDA approved the low-risk indication of transcatheter aortic valve replacement (TAVR) in August for both Medtronic and competitor Edwards Lifesciences.
• The company launched its Midas Rex MR8 drill system.
• Medtronic presented promising data from its IN.PACT AV Access study showing a 56% reduction in the reintervention rate.
• FDA approved Medtronic’s Evolut PRO+ TAVR System just a few days before TCT, which launched during the conference with the low-risk indication.

In the next 12 months, Medtronic is anticipating additional product approvals and launches, including:

• LINQ 2.0 implantable cardiac monitor
• Micra AV leadless pacing system
• MiniMed 780G hybrid closed-loop diabetes system with Bluetooth
• InterStim Micro Rechargeable implantable pulse generator for sacral neuromodulation in pelvic health. The new device is three cubic centimeters in volume and rechargeable. This is a space Medtronic pioneered two decades ago, but now faces competition from newcomer Axonics.
• In deep brain stimulation (DBS), Weinstein said Medtronic will introduce for the first time a DBS system that has the ability to sense the electrical activity of the brain, putting the company on a pathway for a closed-loop deep DBS system. Medtronic anticipates this system will be a major leap forward in DBS therapy, he said. “We’re going to be doing studies there on new algorithms that will actually work with the current system and perhaps change what those stimulation patterns are so we can keep the patient in the range that they should be functioning at,” added Brett Wall, current president of brain therapies division in Medtronic’s RTG.

Also in the coming 12 months, Medtronic has a number of clinical trial readouts planned, including:

• Off-med data evaluating the company’s Symplicity renal denervation system.
• MiniMed 780G U.S. pivotal trial data supporting the company’s hybrid closed-loop diabetes system, mentioned above.
• DIAMEND-AF U.S. pivotal trial data supporting the DiamendTemp ablation system. This is a closed-loop, temperature-controlled system designed to offer physicians improved feedback and control during an ablation procedure. The device was developed by Epix Therapeutics, which Medtronic acquired earlier this year.

Another big reason 2019 will be remembered as a turning point in the company’s history is its leadership change that’s currently in transition. Medtronic announced in late August that Ishrak will retire as CEO on April 26, 2020. Geoff Martha has been named Ishrak’s successor.
“Geoff has been involved in the strategy of the company and has been core to creating it, so I look forward to continuity but I also look forward to change,” Ishrak said. “Because the company today, and in April of next year, will be in a completely different place from where it was when I first started. A completely different place. It’s bigger. It’s in a growth trajectory. It’s got a full pipeline of products. We’ve got things established globally, other initiatives in value-based healthcare and other things which we’re much more prudent about and sophisticated about than we were eight or nine years ago.”
Last but most definitely not least, Medtronic made headlines this year when it introduced its surgical robotics platform Tuesday along with a real-time demonstration of a cadaver surgical procedure using the robot, plus a surgeon panel discussion.
XACT Robotics
Between FDA clearance in late October and a financing in November, XACT Robotics is hot to trot this year.
The Israel-based company is developing the industry’s first hands-free robotic system combining 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.
The technology is based on research originally conducted at the Technion – Israel Institute of Technology, by Moshe Shoham, founder of Mazor Robotics (now part of Medtronic).
In November, XACT closed a financing round that fetched $36 million, which will support its U.S. launch and continued R&D efforts. To date, the company has raised about $55 million.
The company was founded in 2013 by Harel Gadot, a serial entrepreneur who is deeply rooted in the surgical robotics space.
“The holy grail of surgical robotics is really one thing; it’s to democratize surgical procedures. Meaning that no matter if you are in New York City or Mid-America or South America, you will get the same treatment,” Gadot told MD+DI. “However, since all of the robotic systems to date are – as everybody calls them – robotic-assisted technologies, they all rely heavily on the technical skills of the physician, which still varies considerably, making democratization almost impossible.”
XACT’s mission is to change that.
“We are able to democratize the interventional procedure if the technical aspect of the insertion and steering of the instrument is done by the robot while the physician is still involved in the planning and monitoring of the system,” Gadot said.
In other words, the robot brings the technical skills to the table while the physician brings the “intellectual skills.” The physician chooses the target and the trajectory and once they confirm the trajectory their job is to monitor the procedure while the robot does all the technical work. The physician never even touches the instrument itself during the procedure, thus removing the variability of technical skill.
Although XACT’s 510(k) clearance is limited to CT-guided procedures, the system was designed to work with any imaging modality, Gadot said, be it MRI, ultrasound, fluoroscopy, or cone-beam CT, so some of the recent funding will go toward expanding the imaging modalities that the robot has regulatory clearance for.
Viz.ai
Artificial Intelligence dominated headlines in 2019. There were a large number of companies with AI-based solutions that were highly successful too. But none stand out more than Viz.ai – a company that has developed a solution that identifies suspected large vessel occlusion (LVO) strokes and automatically notifies specialists. The company received de novo clearance for this solution in 2018. However, 2019 is the year the company really took off. Right off the bat, Viz.ai entered into an agreement with one of medtech’s largest players – Medtronic. The agreement could lead patients to get treatment by technologies like Dublin-based Medtronic’s Solitaire revascularization deviceViz.ai closed out the year by raising $50 million in a series B round. The financing would help the company get its AI solution into the hands of more people.
If ever there was a comeback kid of the year in medtech, Zimmer Biomet would be it for 2019.
Things were looking pretty grim for the company two years ago, but along came CEO Bryan Hanson at the tail end of 2017 and it wasn’t long before things began to look up.
“Our team remains focused and engaged in our key priorities and we continue to make progress in each of these critical areas,” Hanson said during the company’s third-quarter earnings call. “Although there is clearly still much to be accomplished, I’m pleased with the team’s momentum thus far.”
On the supply front, Zimmer Biomet has been able to meet customer demand and improve service levels, Hanson said.
The CEO still sees plenty of opportunities for the company to decrease the complexity and increase the efficiency of its supply chain, but he said he’s happy with the progress thus far.
Quality remediation efforts at what is now referred to as Zimmer Biomet’s “Warsaw North Campus” also remain on track, Hanson said.
“We continue to keep the FDA updated on our progress and are highly confident in our path to full remediation. To instill further confidence in our progress, we have engaged independent third parties to conduct comprehensive mocked audits of our remediation work and the feedback has been positive,” he said.
The company also has launched a global “Quality Begins With Me” program designed to support an environment of empowerment and accountability for all of Zimmer Biomet’s manufacturing team members ensuring that every individual feels personal ownership of the quality process, Hanson said.
On the innovation front, Hanson said Zimmer Biomet’s focus his shifted aggressively toward enabling technology such as robotics, mini robotics, informatics, and operating room efficiency.
“Although the implant will always be at the center of what we do, our goal is to provide a complete ecosystem that is both customer- and patient-centric,” Hanson said.
Examples of innovation that aligns with that focus include the company’s Rosa Knee System for robotically-assisted knee replacement surgery; the mymobility app developed in partnership with Apple; the Walter mini robotic platform; the Signature ONE Planner for upper extremities; and other products aimed at improving the efficiency of the pre-surgical planning process.
Relative to mission and culture, Hanson said the company is “relentlessly focused” on driving a winning Zimmer Biomet culture, and he mentioned the recent rollout of the company’s culture of promises.
“These promises of shaping tomorrow, igniting collaboration, and focusing to win are inspiring and actionable,” Hanson said. “Each comprises a set of practices to empower the team at every level in the organization to collaborate and innovate with an emphasis on the future while working with clarity and focus to maximize our impact today and to deliver on our commitments.”
Hanson said he is confident in the company’s ability to consistently and durably deliver 2% to 3% top-line growth through 2020.
“Over time I also see a pathway for acceleration beyond 2% to 3% without the need for M&A,” Hanson said. “This will take time but the pathway is clear to this team.”

Original Article: (https://www.mddionline.com/medtech-company-year-2019-finalists)