Medtech Company of the Year 2017 Finalists

These companies have risen above the rest in 2017. 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 2017 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 11, 2017.

  • Abbott

    Abbott operated under a cloud of skepticism for much of the year as it faced everything from a FDA investigation at one of its facilities, to negotiating a rather messy acquisition. But the company never strayed from its projections, and scored several key regulatory approvals, including FDA approval of the FreeStyle Libre Flash as a replacement for blood glucose monitoring for adults with diabetes, and launched a total of 20 new products. Perhaps more importantly, Abbott closed its acquisition of Alere.

    “Over the course of the year there was a lot of skepticism on the part of analysts and/or investors on all the things that we had to get accomplished that was backend loaded, a lot of third-quarter and fourth-quarter things,” CEO Miles White said during Abbott’s third-quarter earnings call. “But we stuck to our guns on what our projects were. The third quarter alone has been pretty gratifying in that we basically got every approval we forecasted within 30 days or so of when we forecasted it would happen.”

    White added that Abbott’s recent product launches and other business milestones give the company strong momentum for 2018.

     

    [image courtesy of ABBOTT]

  • Abiomed

    Abiomed acquired the Impella heart pump technology back in 2005, and since then the platform has taken off.

    This year, the company put its PMA submission for the newest iteration, the Impella RP, to FDA much earlier than anticipated and received approval from the agency in September. The device, which joins the Impella 2.5, Impella CP, and Impella 5.0/LD, is indicated for providing temporary right ventricular support for as long as two weeks in patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

    Abiomed avoided initially proposed deep cuts to CMS reimbursement of certain procedures using the Impella devices by working with the agency during the comment period, and the final cuts were much less than anticipated (19% vs. the 35% proposed). The company is also expected to benefit from CMS’s decision to designate reimbursement codes for BiVentricular support, which bodes well for adoption of the Impella RP, according to Leerink Analyst Danielle Antalffy.

    Impella has been a hit in markets outside the United States, too. OUS revenue rose around 58% year over year in the company’s final fiscal quarter of 2017.

     

    [image courtesy of ABIOMED]

  • Baxter

    Baxter has been a great comeback story in 2017 under the leadership of CEO Joe Almeida. The former Covidien CEO took the reins at Baxter following a particularly rough 2015 and has taken the company from what was probably one of the lowest points in its history to one that is consistently showing growth and exceeding expectations. The transformation really started in 2016, but has continued throughout 2017.

    Among the company’s key achievements in 2017 is the acquisition of Claris Injectables Limited, which Baxter added to the pharmaceuticals side of its business in July. During the company’s third-quarter earnings call, Almeida said M&A deals like Claris will continue to play an important role in building Baxter’s product pipeline across key growth categories and adjacencies.

    In September Baxter became the first infusion pump vendor to provide a tagless, end-to-end asset tracking solution for infusion pumps with the launch of its DeviceVue, a product the company is marketing exclusively to hospitals using its Sigma Spectrum infusion system. DeviceVue is designed to enhance clinical and hospital efficiency by helping clinicians and biomedical engineers find an unused pump quickly by viewing the pump’s location and status data from their computer, iPad, or iPhone.

     

     

    [Image courtesy of BAXTER]

     

  • Bigfoot Biomedical

    Founded in 2014, Milpitas, CA-based startup Bigfoot Biomedical is taking on heavyweights such as Medtronic, Tandem Diabetes, and Insulet in the race to develop an artificial pancreas for patients with type 1 diabetes. Its approach involves cobbling together a closed-loop solution using its own algorithms and software combined with other companies’ hardware.

    In mid-2016, the company, whose founders and leaders each have a personal connection to someone living with type 1 diabetes, won IDE approval for and enrolled the first patients in a clinical study of its smartloop automated insulin delivery, and later that year it nabbed $35.5 million in series A funding.

    Bigfoot’s momentum continued in the first half of 2017, with investments from two type 1 diabetes—focused nonprofits and its acquisition of Patients Pending, developer of a Bluetooth-connected insulin pen dose capture technology. In the second half of the year, the company announced a blockbuster partnership to integrate its solution with Abbott’s new FreeStyle Libre glucose sensing technology, followed by another agreement to access a custom version of Ypsomed’s Orbit infusion sets.

    A pivotal trial of Bigfoot’s automated insulin delivery system is expected to begin in 2018.

     

     

    [Image courtesy of BIGFOOT BIOMEDICAL]

  • iCAD Inc.

    Tomosynthesis generates 3-D images of the breast, which could help doctors better interpret dense tissue. “Tomosynthesis reveals sections of the breast that can be hidden by overlapping tissue in a standard mammogram,” FDA wrote in 2014. At the time, FDA experts from its Division of Imaging, Diagnostics, and Software Reliability suggested advances were needed to help practitioners manage the greater number of images generated by tomosynthesis and other emerging technologies.

    This year, FDA approved one such advance: the iCAD PowerLook Tomo Detection Software from iCAD Inc., which calls its system “the first and only FDA-approved” concurrent-read cancer detection solution for digital breast tomosynthesis (DBT). Using what the company calls artificial intelligence (AI), the software employs “a trained algorithm developed through deep learning that automatically analyzes each tomosynthesis plane.”

    At RSNA 2017, iCAD reported growing adoption. “Built on the latest deep learning technology, iCAD’s mammography AI solution is clinically proven to optimize radiologists’ image reading and interpretation by reducing DBT read-time by an average of 29.2 percent,” said Ken Ferry, CEO of iCAD, in a news release. “Since its FDA approval in March, PowerLook Tomo Detection has been implemented by a number of leading breast health provider organizations throughout the U.S.”

    iCAD has help in the fight against cancer. Its subsidiary Xoft offers a high-dose-rate, low-energy radiation technology called the Xoft Axxent Electronic Brachytherapy System, which targets cancer while minimizing exposure to surrounding healthy tissue. As of March this year, the system had already treated more than 3,000 early-stage breast cancer patients with intraoperative radiation therapy, the company reported.

     

    [Image courtesy of iCAD INC.]

  • Innovative Health Solutions

    Deaths from drug overdoses in the United States climbed 21% from 2016 to 2017, with the largest increase coming from synthetic opioids such as oxycodone and fentanyl, according to the U.S. Centers for Disease Control and Prevention. The U.S. government has declared the opioid crisis a public health emergency, as communities across the country suffer the deadly effects of these drugs.

    Drugs like naloxone can help prevent overdose deaths if delivered in time, and medications such as methadone can be used to help addicts kick the habit. But now those suffering from opioid addiction have a new tool in their arsenal to help them quit. In November, FDA granted a new indication to Versailles, IN-based Innovative Health Solutions’s NSS-2 Bridge device—a product that was originally cleared in 2014 for use in acupuncture.

    The NSS-2 Bridge is a nerve stimulator that can be placed behind the ear and which branches of certain cranial nerves to help ease symptoms of opioid withdrawal. The device was reviewed through the agency’s de novo pathway, and study results showed that patients experienced at least a 31% reduction in withdrawal symptoms within half an hour.

     

    [image courtesy of INNOVATIVE HEALTH SOLUTIONS]

  • Intuitive Surgical

    As new competitors enter the robotic surgical ring to challenge market leader Intuitive Surgical, a common question among investors this year was how the company planned to increase its lead. The answer came in the form of da Vinci X, not to mention a certain air of confidence the company exuded, knowing that it has a vast amount of experience in the field.

    During the company’s third-quarter earnings call, CEO Gary Guthart acknowledged that new surgical robotics systems entering the U.S. market, including the Senhance system from TransEnterix, may cause a ripple in Intuitive’s sales cycle, but he said the company’s experience will ultimately prevail over the incoming competition.

    Intuitive has an IP portfolio built on previous experience of problems the company has overcome along the way, and the solutions it has patented as a result, “so that’s something that’s an asset for the company as we go forward,” Guthart said.

    Intuitive also launched the da Vinci X in Europe and the United States this year. The newest addition of the da Vinci family provides the market with a much-needed lower-priced robot, but also includes the option to upgrade to more advanced features as needed. Cost has been a major adoption barrier in robotic surgery.

    “While robotics competition is coming, Intuitive Surgical is making the necessary investments to expand its total addressable market and remain a premium player in the surgical robotics market,” wrote RBC analyst Brandon Henry in a note to clients this year.

     

    [image courtesy of INTUITIVE SURGICAL]

  • Pentax Medical

    In past years, Pentax Medical, a division of Hoya Group, has been under pressure as one of three manufacturers of a type of duodenoscope linked to outbreaks of superbug infections.

    Although the company’s scopes were not involved in a 2015 case that may have exposed 179 patients at the Ronald Regan UCLA Medical Center in Los Angeles to carbapenem-resistant enterobacteriaceae (CRE), a strain of antibiotic resistant bacteria, it was nonetheless named, along with Fujifilm and Olympus, in an FDA safety communication that year about endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes. The agency said the scopes could be difficult to sterilize do to a “movable ‘elevator’ mechanism” that featured spaces that could harbor the germs. Subsequently, Pentax scopes were singled out in a separate safety communication by the agency.

    The company updated its manual processing instructions for the scopes, but, even better, Pentax also became the first company to market with a potential solution to the problem in the form of a disposable cap. In September, FDA cleared the company’s ED34-i10T model, which features a disposable distal cap that William Maisel, MD, acting director of CDRH’s Office of Device Evaluation called “a major step towards lowering the risk of future infections associated with these devices.”

     

     

    [Image courtesy of PENTAX MEDICAL]

  • ResMed

    Patients may be resting easier these days thanks to ResMed. The sleep apnea device manufacturer has made strides this year in encouraging patient adherence with treatment and easing their ability to track progress.

    The company kicked off 2017 by announcing that one billion nights of sleep data had been downloaded using its remote patient monitoring platform, AirView. At MD&M West 2017, Amy Cook, director of healthcare informatics, shared with conference delegates ResMed’s efforts to provide devices, accessories, and patient applications aimed to improve user experiences. Part of this effort has been myAir, a personalized therapy management application that patients can access on smartphones and tablets. A study published in CHEST reported that patients using ResMed’s AirView and myAir platforms together used positive airway pressure (PAP) therapy an average hour more per night – 5.9 hours a night, compared with 4.9 hours for the remotely monitored-only group. This is in line with other research earlier this year that showed that myAir patients use their device an average 46 minutes longer per night compared with other patients.

    ResMed has made strides to improve comfort, too. This year it launched its AirTouch F20 full face mask with UltraSoft memory foam cushioning that can adapt to the contours of each patient's face. The permeable foam is also designed to reduce skin irritation. The new mask is compatible with ResMed’s other new launch, the AirMini, described as the world's smallest CPAP machine. Weighing less than one pound, the device could be more portable than previous solutions, encouraging patience adherence during travel. The AirMinican also be monitored remotely through AirView and through a self-monitoring app.

    Also in 2017, ResMed formed the joint venture SleepScore Labs with television host Dr. Mehmet Oz and private equity firm Pegasus Capital Advisors, L.P. The venture has yielded a new noncontact system, SleepScore Max, for calculating a nightly SleepScore and providing insights for improving sleep.

     

    [Image courtesy of RESMED]

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