Blog Tag: Medical Device

Abbott Expands Presence in Heart Valve Repair

Illinois-based Abbott Laboratories recently announced two transactions intended to increase Abbott’s presence in mitral valve replacement therapy and bolster its structural heart portfolio.  First, Abbott will acquire Minnesota-based Tendyne Holdings, Inc. for $250 million.  Second, Abbott provided capital and secured an option to purchase California-based Cephea Valve Technologies – financial terms were not disclosed.

According to its website, Tendyne is a private medical device company focused on minimally-invasive mitral valve replacement therapies and does not yet have a commercially available product. However, in April, the Minneapolis Heart Institute Foundation reported the first successful U.S. implant of a Tendyne heart valve.  Tendyne’s Bioprosthetic Mitral Valve System has approval from the U.S. Food and Drug Administration for a feasibility clinical trial to provide data about the device’s safety and effectiveness.  Enrollment in the trial has already begun.  Tendyne also plans to begin a clinical trial in Europe to support a CE Mark.

Cephea Valve Technologies is a private company focused on developing a transcatheter mitral valve replacement therapy. Cephea’s valves are at an early stage of development and have not yet begun clinical trials.

Before Abbott announced these transactions, Abbott’s only structural heart product was MitraClip, an endovascularly-delivered device that has been used to treat more than 25,000 people. The Tendyne and Cephea valve technologies, like MitraClip, are designed to be implanted in a beating heart without the need for open heart surgery. John M. Capek, Ph.D., Executive Vice President of Ventures for Abbott stated:

The Tendyne acquisition and our agreement with Cephea broaden our foundation as one of the leaders in treatments for mitral valve disease, with the goal of bringing promising, less invasive valve treatment technologies to people who need them.

The mitral valve is positioned between the left upper and lower chambers in the heart.  Some analysts believe that transcatheter mitral valves could address an even larger market than transcatheter aortic heart valves.  There may be agreement among industry players: earlier this month, Edwards Lifesciences Corp., which has strong sales growth for its aortic valves, reached a $400 million deal to acquire CardiAQ Valve Technologies, another company focused on developing transcatheter mitral-valve replacement therapies.

 

UW Donation to Morgridge “Fab Lab” For Medical Device Innovations

University of Wisconsin-Madison alums, Dr. James Berbee and Karen Walsh, have agreed to a five-year, $300,000 gift to the Morgridge Institute for Research through their Berbee Walsh Foundation.  According to the press release, their intention is to “create a prototype pathway for clinical devices between University of Wisconsin-Madison clinicians, students and the Morgridge Advanced Fabrication Laboratory, or ‘Fab Lab.'”

According to its website, Morgridge provides research assistance in a number of medical device areas, including regenerative biology, medical engineering, and core computation.  The website states that some projects currently in the works are more effective ways to maintain health of organs prior to transplant, feedback sensors to warn of the possibility of injury when installing breathing tubes, and a multi-source x-ray tube. Berbee and Walsh’s donation provides the ability for students to be full members of the Fab Lab team, instead of one-time participants, thus allowing them to work closely with clinicians throughout the process.

According to Morgridge CEO Brad Schwartz:

“What’s really exciting about this project is its potential to improve patient care by unlocking great ideas from people at the front lines of medical care”

Further, according to Kevin Eliceiri, the interim director of Morgridge Medical Engineering and the Fab Lab: “I expect this program to have a great impact and generate a fair amount of intellectual property.”  For example, participants can tap into the well-established connections with the Wisconsin Alumni Research Foundation for timely IP support.

The press release notes that Dr. Berbee was an engineering graduate who founded the Berbee Information Networks in Madison in 1993, now owned by CDW, and got involved with Morgridge as he received help from the Fab Lab for early prototypes of his new otoscope. Walsh was an assistant dean at the UW-Madison College of Engineering and helped launch the schools first-ever campus innovation prize, the School’s Prize for Creativity.

IEEE Releases Med Device Cybersecurity Guidelines

Amid myriad media reports about potential vulnerabilities in medical device cybersecurity and the FDA’s efforts to strengthen medical device cybersecurity, the IEEE Cybersecurity Initiative released a report entitled “Building Code for Medical Device Software Security.” The report sets forth a set of elements aimed at reducing the vulnerability of medical device software to malicious attackers. The report employs a loose definition of “medical devices,” ranging from wearable devices to electronic health record systems.

The report highlights the most common types of software vulnerabilities that are exploited by malicious attackers.  The bulk of the report proposes standards for five software implementation considerations in ways to (1) avoid, detect, or remove specific vulnerabilities like using memory-safe languages, secure coding standards, and automated thread safety analysis; (2) ensure proper cryptography; (3) improve software integrity; (4) impede attacker analysis or exploitation; and (5) detect malicious attacks. The report further brings up four software design considerations about maintaining service during or restore service after an attack and supporting privacy requirements, but does not propose any standards. Finally, the report notes that the “building code” itself should be consistent in categorizing particular types of attacks and should be maintained over time.

The IEEE Center for Secure Design has also released “Avoiding the Top 10 Software Security Design Flaws,” to give advice on ways to address particular issues including data authentication, authorization, and validation; cryptography; sensitive data classification; and integrating external software components.

ConforMIS to Go Public in Upcoming IPO

Bedford, Massachusetts-based orthopedic medical device company ConforMIS has filed a registration statement with the Securities and Exchange Commission (SEC) announcing that the company intends to go public and raise $172.5 Million.  According to the documents filed with the SEC, the company has not priced the range at which the stock will go public.  The stock will be listed as CFMS in the NASDAQ stock exchange.

Founded in 2004, ConforMIS develops and commercializes medical devices for the treatment of osteoarthritis and joint damage.  ConforMIS transforms patient CT data into customized implants with a complete set of patient-specific instrumentation using its proprietary iFIT technology.  According to the company’s website, ConforMIS maintains a portfolio of over 375 patents and patent applications in the areas of image processing, patient-specific implant systems, patient-specific surgical techniques, patient-specific instrumentation, and manufacturing across multiple joints.

In April, ConforMIS settled patent infringement lawsuits against Wright Medical by granting a license to the company.

Shift Labs Continues Trend Toward Consumer Wireless Healthcare Devices

The medical device market is expanding into more private healthcare products in hopes of bringing healthcare directly to the user.  For example, the increase in popularity of wearable diagnostic devices, such as FitBit, and Apple’s recently released ResearchKit, turning iPhones into medical devices, illustrate that users are ready to look after their own health.

Following this trend, Medical device startup Shift Labs is launching this Spring with a lofty goal: to be “the Nest of medical devices.”  Founded by Human Centered Design & Engineering Professor Beth Kolko along with Koji Intlekofer, Shift Labs is looking to provide products to the rapidly expanding market of home healthcare programs, outpatient clinics, and emerging international locales.

According to founder Koji Intlekofer:

The places where healthcare is growing fastest is outside of traditional hospital settings.

Shift Labs aims to pioneer a new “middle class” of medical device offerings, and provide products outside the hospital setting.  According to founder Beth Kolko,

There is no reason why we can’t make products for nurses and medical practitioners that they enjoy using.  But no one is building products for the people who are going to be providing the care.

 

According to its website, Shift Labs’s first product is the DripAssist, a simple, low-cost take on an infusion pump for monitoring IV drips, which runs on a single AA battery.  By contrast to typical infusion pumps, which can cost anywhere from $5,000 to $15,000, this patent-pending pump has a suggested retail price of only $225.  The DripAssist does not pump fluid in the conventional sense.  Instead, it monitors the rate of an IV drip and sounds an alarm if the pace is outside particular threshold values.

The DripAssist is currently being sold in select international markets and for veterinary usage.  Shift Labs is still in the process of securing FDA clearance to sell the DripAssist in the United States.  USA Today reports that Shift Labs’s next projects in the pipeline are an oxygen monitor, a cooling system for vaccines, and a device to pasteurize breast milk.

Shift Labs states that it received initial startup capital from Y Combinator, which provides seed funding and mentorship for early-stage startups.  Other notable companies seeded by Y Combinator include Reddit, Airbnb, Hipmunk, and Dropbox.

Bills to Repeal Medical Device Excise Tax Introduced

Congressman Erik Paulsen (R., Minn.) and Senator Orrin Hatch (R., Utah) recently introduced bills H.R. 160 and S.149, respectively.  Both bills are part of an effort to repeal the 2.3% excise tax on medical device manufacturers and importers imposed by the Affordable Care Act, commonly known as ObamaCare.  Guidance from the IRS on the medical device excise tax can be found here.

Where previous attempts to modify or repeal the medical device excise tax have stalled in the Senate, the Washington Times reports that prospects of the repeal passing both houses of Congress are bolstered by the newly Republican-controlled Senate.  Further, as is reflected on Congress.gov, both bills have significant bipartisan support, and, according to The Hill, efforts to gain more supporters are ongoing.

But, The Hill reports that Republican and Democrat supporters of the repeal disagree on how to offset the revenue that would be lost should the tax be repealed.  Further tempering optimism for repeal of the excise tax is a January 9, 2015 report from the nonpartisan Congressional Research Service, entitled “The Medical Device Excise Tax: Economic Analysis,” which states in its summary that the effect of the tax on the medical device industry will be minor because of the relatively inelastic demand for medical services, the small tax rate, and the numerous exemptions from the tax.  Contrary to industry reports on the tax that predict significant adverse effects on innovation and employment, the Congressional Research Service’s report suggests that “most of the tax will fall on consumer prices, and not on profits of medical device companies.”

H.R. 160 has been referred to the House Ways and Means Committee while S.149 has been referred to the Senate Finance Committee. Check back here for further developments on efforts to repeal the medical device excise tax.

FDA Approves EnteroMedics’ Implantable Obesity Treatment Device

St. Paul, MN-based EnteroMedics Inc. recently announced  that the Food and Drug Administration (FDA) approved the use of its VBLOC vagal blocking therapy, delivered via its Maestro system.  The system is indicated for treatment of obese adults having a Body Mass Index (BMI) of at least 40 to 45 (units of Kilogram per Meter squared), or a BMI of at least 35 to 39.9 with a related health condition such as high blood pressure or high cholesterol levels, and who have already tried to lose weight in a supervised weight management program within the past five years. A news release by the FDA further noted that the Maestro System is the first obesity treatment device to be approved by the FDA since 2007.

According to the Wall Street Journal, the Maestro system disrupts signals between the stomach and brain by blocking electrical signals in the abdominal vagus nerve through the use of high-frequency electrical pulses. The FDA reported that the Maestro System was evaluated in a 233-patient clinical study where the experimental group lost about 8.5% more of its excess weight than the control group in a 12 month period.  The FDA further reported that about half (52.5%) of patients in the experimental group lost at least 20% of their excess weight, and 38.3% of the experimental group lost at least 25%. According to NBCnews,  as part of the approval process, EnteroMedics must conduct a five year post approval study following at least 100 patients to collect additional safety and effectiveness data.

According to its website:

EnteroMedics® is committed to the delivery of safe, effective and sustainable therapies that address the growing global health crises associated with the increased prevalence of obesity and metabolic diseases, including diabetes and hypertension. EnteroMedics is rapidly advancing its novel technology, VBLOC® vagal blocking therapy delivered via the Maestro® Rechargeable System, to broadly benefit patients, health care providers and stakeholders around the world.

Essential Medical, Inc. Successfully Completes First in Man Studies for MANTA Large Bore Vascular Closure Device

Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a device designed to seal 18F large bore femoral punctures.

According to the press release, the MANTA devices were deployed in less than one minute in each of five patients, achieving hemostasis at the large bore puncture site with exceptional clinical, angiographic and hemodynamic success in all patients. The press release also indicated that none of the patients showed evidence of hematoma, and all patients were discharged the next day.

Essential Medical stated that Dr. Gary Roubin, MD, PhD, a leading interventional cardiologist, performed the first two cases. Dr. Roubin remarked:

“In interventional cardiology it’s critical to define the problem that the patient is facing, solve the problem and use the best clinical science available to confirm beneficial outcomes. We’re doing that with MANTA and it promises to be a truly transformative technology for providing percutaneous access for large bore therapeutic devices.”

According to Essential Medical, MANTA seals femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA), employing sealing components similar to the Company’s other closure device, X-Seal, which received CE mark approval last month, and is said to be indicated for smaller punctures for angiography, angioplasty, and stenting.

Essential Medical indicates that large bore femoral access has been associated with bleeding complications, the need for transfusions, increased hospital costs, and patient discomfort and disability. Dr. Lawrence Garcia, Chief of International Cardiology at St. Elizabeth’s Medical Center in Boston, also participated in the study and stated that the device satisfies a “critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels.”

Greg Walters, founder and CEO, states in the announcement that Essential Medical seeks to commence a CE-marketing study of the MANTA device in early 2015.

 

Senate’s Vote to Repeal Medical Device Tax – Form Over Function?

Despite the Senate’s recent vote to repeal the medical device tax by a margin of 79-20, Forbes reports that the vote will have little practical effect on medical device manufacturers, at least in the short term.  In order to abolish the tax, the article states that the loss of potential revenue from the tax, equal to over $10 billion over 10 years, would have to be completely offset by alternative revenues.  The article posits:

Is there a possibility of the medical device tax being removed (or modified) down the road?  Yes there is – but that road is much more potholed and twisted than many medical device manufacturers think.

According to the article, the 2.3% excise tax on the sales price of medical devices, which was passed as part of the Affordable Care Act, currently applies to almost any FDA-registered device intended for human use.  Because the tax can apply to “everything from MRIs to tongue depressors to ultrasounds to condoms,” the article notes the concern that many taxpayers may not realize that the law can directly affect them.  The article discusses a number of other considerations medical device manufacturers will likely face, including whether a particular company is overpaying, the potential to limit tax liability by determining the “price” of the medical device itself (as separate from bundled services), and situations involving contract manufacturers.  The full article is available here.