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Medtech Company of the Year 2018 Finalists

These companies have risen above the rest in 2018. Which one do you think deserves to wear the crown?

  • 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 2018 medtech company of the year. Check them out, then let us know your choice at the end. We'll announce our pick the week of December 17, 2018.

  • Banyan Biomarkers

    Banyan Biomarkers captured our attention earlier this year when FDA granted it permission to market the first blood test to evaluate mild traumatic brain injury, commonly called a concussion, in adults. The agency reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its breakthrough devices program.

    “The goal standard right now is the CT scan and it’s better than anything else out there,” Henry Nordhoff, chairman and CEO of Banyan Biomarkers, told MD+DI in February. “But the problem with CT is the cost, the time it takes, and the amount of ionizing radiation that’s delivered to the brain. It’s particularly dangerous when it’s a developing brain. You’re getting about 100 times the ionizing radiation in a brain scan that you’re getting in a chest X-ray.”

    The San Diego-based company’s test identifies two brain-specific protein biomarkers (Ubiquitin Carboxy-terminal Hydrolase-L1 or UCH-L1 and Glial Fibrilliary Acidic Protein or GFAP) that rapidly appear in the blood after a brain injury.

  • Beta Bionics

    Diabetes. Artificial Pancreas. Artificial Intelligence. These are some of the hottest terms in medtech right about now. But what happens when you take these elements and combine them all into one? You get Beta Bionics. The Boston, MA-based firm is developing iLet, a bionic pancreas, which incorporates the elements of AI with glucose monitoring.

    In May, the company received an IDE from FDA to begin a clinical trial testing the iLet Bionic Pancreas. The iLet consists of a dual-chamber, autonomous, infusion pump that mimics a biological pancreas. The body-worn device contains a little cartridge with insulin in it. The device is connected to the body through a tube with insulin. There is also a two-hormone version of the technology, so it can be configured to use insulin or glucagon.

    Here’s where the AI component comes in. Embedded in the system are clinically tested mathematical dosing algorithms driven by machine learning to autonomously calculate and dose insulin and/or glucagon as needed, based on data from a continuous glucose monitor. Once initialized, the iLet engages its machine-learning, AI to autonomously control the individual’s blood-glucose levels and to continuously adapt to the individual’s ever-changing insulin needs.

    If the technology can gain approval it could go head-to-head with Medtronic’s MiniMed 670G dubbed the Artificial Pancreas. During a May interview, Beta Bionics founder and CEO Ed Damiano explained a key difference between the two devices.

    “Medtronic’s technology that’s out on the market now automates insulin partially, but not fully,” Damiano said. “That device is much closer to a traditional insulin pump than it is to something like an artificial pancreas. You have to configure [Medtronic’s artificial pancreas] very much like an insulin pump. It requires a lot of clinical supervision to get that system started and to keep it running. Our bionic pancreas requires that you only type in your body weight – that’s it.”

  • Boston Scientific

    When some of your largest competitors merge to become mega-medtech companies, what do you do? To take a page out of Boston Scientific’s book, you conserve cash and when the time comes you start to acquire all those smaller companies you’ve invested in through the years.

    Boston Scientific’s CEO Mike Mahoney made it clear very early on in the year that the company would be aggressive in M&A. In July, he reassured investors that the firm’s M&A appetite was part of a very well laid out plan. To date, the company has announced about 10 acquisitions.

    But it hasn’t been all roses with Boston Scientific. The company delayed its TAVR program until next year due to several issues. However, Boston Scientific has a second TAVR option in the Acurate valve, a technology it gained access to when it closed its $435 million acquisition of Symetis.

  • Conformis

    Conformis has been in the news for years—it won a 2009 Medical Design Excellence Award for its partial knee replacement implants iUni and iDuo implants, it won a 2012 MDEA for its iTotal CR Knee Replacement System, and most recently its iTotal Hip replacement system was cleared in 2017—but 2018 was a banner year for the company.

    A study of the Conformis iTotal CR Knee Replacement System released in February showed that “the new four-year data highlighting the low risk of revision surgery for patients treated with Conformis iTotal implants provides strong clinical evidence reinforcing survivorship of our implant technology,” said Mark Augusti, president and CEO of Conformis, in a news announcement. Also, a study published in May showed how the iTotal CR “achieved better tibial fit and tibial rotational alignment compared to patients treated with three different off-the-shelf (OTS) total knee arthroplasty (TKA) products.”

    This past summer, the first two total hip replacement surgeries using the Conformis Hip System took place at Florida’s Personalized Orthopedics of the Palm Beaches by Gregory Martin, MD. “Due to the accuracy of the personalized pre-operative surgical plan, the 3D printed patient conforming cutting guides and hip implant components, my hope is that with the new Conformis Hip system, surgeons will be able to improve both patient outcomes and operational efficiencies,” Martin said in a news release.

    Also, Conformis finalized a settlement and license agreement with Smith & Nephew in which Smith & Nephew is required to pay $10.5M to Conformis.

    Conformis uses CT scans to capture a patient’s precise bone measurements and then its iFit Image-to-Implant technology to produce customized implants. Single-use instruments tailored to those patient-specific implants are then 3D printed.

  • DexCom

    For the past two years there have been analyst reports, articles, and think pieces that have said the mounting competition in the continuous glucose monitoring market was enough to spell the end for Dexcom. When Abbott Laboratories received FDA approval in 2017 for its FreeStyle Libre Flash, a glucose monitoring system that can be used as a replacement for blood monitoring, no other competitor was impacted more than Dexcom.  Shares of the San Diego-based company crashed more than 36% upon news of the FreeStyle Libre's approval.

    Yet, despite this development, Dexcom’s performance in 2018 tells the story of a company that is able to get past the competition to effectively communicate its message to doctors and patients.

    Dexcom continued to hold steady in earnings reports throughout the year and even surpassed expectations a few times. The company also got on the M&A train with the acquisition of TypeZero, a firm that has designed a system to provide personalized diabetes management solutions including technology to automatically adjust and regulate insulin delivery.

    So, while the pressures have increased, Dexcom has stepped its game up and continues to perform.

  • Glaukos

    The minimally invasive glaucoma surgical space heated up in 2018, driven largely by Glaukos winning FDA approval for its next-generation iStent inject trabecular micro-bypass system. The San Clemente, CA-based said the iStent inject is designed to optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal.

    It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point in a straightforward click-and-release motion. Each iStent inject stent is about 0.23 mm x 0.36 mm, or about one-third the size of the company's first-generation iStent.

    The company benefited from a competitor's misfortune in late August. Alcon, a division of Novartis, decided to remove all versions of its Cypass Micro-Stent from the global market based on an analysis of five-year post-surgery data. But Glaukos also faces stiff competition from Ivantis, which won FDA approval in August for its Hydrus Microstent.

  • JenaValve

    JenaValve made a lot of headlines this year, particularly in early December when it gained permission from FDA to expand enrollment in an investigational device exemption (IDE) study of its transcatheter aortic valve replacement (TAVR) system. The agency gave the Irvine, CA-based company the okay to expand eligible enrollment from 20 patients to 80 patients who are considered to be at high or extreme surgical risk for open valve surgery.

    The IDE study is part of a larger ongoing CE mark clinical program investigating the JenaValve Pericardial TAVR System for the same indications at centers in Europe and New Zealand.

  • Roche Diagnostics

    Ingrid Maes, director, pharma, life sciences & healthcare, for PricewaterhouseCooper, believes that personalized healthcare is part of the science that will "revolutionize the whole healthcare system." In a video posted to Roche’s site, Maes says that pharma companies will have to collaborate with diagnostics companies to bring together combined solutions to market.

    Roche is already ahead of most in the game. “With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalised healthcare,” the company reports. “Two-thirds of our Research and Development projects are being developed with companion diagnostics.”

    Roche CEO Severin Schwan points to the benefits of having pharma and diagnostics under the same roof. “We can leverage capabilities across the two divisions and with a better understanding of disease heterogeneity in areas like cancer for example. . . and by the means of modern diagnostics . . . we can codevelop medicines and companion diagnostics for more targeted treatments,” he says in a video. He is also enthusiastic about the future “digitization of healthcare data,” which he expects to enable the aggregation and analysis of treatment and outcomes data to recognize correlations that could lead to the development of individual treatments for smaller patient groups.

    This year Roche took 100% ownership of Foundation Medicine, whose liquid biopsy test for solid tumors, FoundationOneLiquid, is now commercially available in the United States. “With the commercial launch of FoundationOne Liquid, we are further expanding access to important genomic information that has the potential to match more patients to targeted therapies,” said Tom Civik, Chief Commercial Officer at Foundation Medicine, in a news statement.

    Earlier this year, the FoundationOne CDx genomic profiling (CGP) assay for all solid tumors was also made available in the United States. Said Vincent Miller, M.D., chief medical officer at Foundation Medicine, in a news statement: "By integrating FoundationOne CDx early into routine clinical care, oncologists can create treatment efficiencies and expand access to biomarker-driven medicines for patients, with the potential to improve treatment outcomes."

    Roche also won FDA approval for its cobas Human Papillomavirus (HPV) Test as a first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid.

  • Senseonics

    Senseonics might have single-handedly changed the continuous glucose monitoring (CGM) game in 2018. The Germantown, MD-based company received a PMA for its Eversense CGM to be used for up to 90 days. The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days.

    In November, the company received an additional approval from FDA to make its Eversense system more accessible to patients. The technology has the potential to give it a significant advantage in the CGM market and place it ahead of its rival, Dexcom.

  • Stryker

    Like Boston Scientific, Stryker also made headlines this year for being active on the M&A trail. The Kalamazoo, MI-based company acquired K2M, a specialist in complex spine and minimally invasive, for about $1.4 billion.

    Stryker also announced its acquisition of Invuity for about $190 million. Invuity is known for its Intelligent Photonics devices used to evenly light surgical cavities. Placed at the site of surgery, the illuminators provide cool lighting that allows surgeons to see into dark surgical cavities.

    In June there was speculation based on a Wall Street Journal report that Stryker was in discussions with Boston Scientific regarding a potential merger, but the orthopedic device maker quickly struck that rumor out

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Beta Bionics
Senseonics, revolutionizing continuous glucose monitoring!
I cast my vote for Beta Bionics . Type 1 is such a hard thing for children to have to live with. Most people have no idea what all is affected by it and how every minute of every day is a constant balancing of blood glucose levels and food consumption. Counting every carb and waiting to eat. Never a normal meal or activity.
Sensionics has my vote.
Senseonics gets my vote!
Definitely Senseonics!!