EndoGastric Solutions launches EsophyX Z+ GERD treatment device

EndoGastric Solutions said this week it launched the EsophyX Z+ device designed for use in transoral incisionless fundoplication procedures to reconstruct the gastroesophageal valve to treat patients with severe gastroesophageal reflux disease.

The device is designed to be used with a partial fundoplication technique that secures tissue with dual deployment of SerosaFuse implantable fasteners, the Redmond, Wash.-based company said.

EndoGastric Solutions’ EsophyX Z+ was used in its first TIF 2.0 procedure by Dr. Michael Murray of the Northern Nevada Medical Center and Dr. Kenneth Chang of UC Irvine Health, according to a press release.

“GERD is a chronic condition and proton pump inhibitors do not control symptoms in about one-third of patients. The design of the new EsophyX Z+ device makes performing TIF 2.0 procedures technically easy and produces a consistent and effective fundoplication thus providing an effective alternative to prescription medications and traditional surgical procedures,” Dr. Murray said in a press release.

“The robust collection of clinical data and recent positive policy coverage announcements support the TIF 2.0 procedure as an established treatment option for patients who wish to eliminate or discontinue PPI use and avoid surgery for acid reflux. This newest design iteration allows for maximal visibility using a standard endoscope combined with almost effortless and confident deployment of fasteners. GI endoscopists and surgeons should consider the TIF procedure in patients seeking a less invasive, proven GERD treatment solution,” Dr. Chang said in a prepared statement.

The original version of the EsophyX device was cleared by the FDA in 2007, with the third generation Z model launched in 2015. The new Z+ device allows for a wider selection of endoscopes to be used to treat the anatomical causes of GERD.

“We are excited to launch the EsophyX Z+ device as we believe it will further enhance the physician’s technical experience. At EndoGastric Solutions, we are committed to addressing the unmet needs in gastrointestinal diseases and offering physicians highly effective options that fill the significant treatment gap between medication and more invasive surgery,” prez & CEO Skip Baldino said in a prepared release.

Earlier this month, EndoGastric Solutions said that new Medicare Administrative Contractors Noridian Health Care Solutions and National Government Services were granted reimbursement access for the transoral incisionless fundoplication procedure using its Esophyx device.

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10 companies to check out at BIOMEDevice San Jose

BIOMEDevice San Jose is an opportunity for thousands of medtech engineers and executives to come together and network. The annual event, created by UBM, is an industry showcase that allows various medtech manufacturers and suppliers to tout their expertise. This year’s event takes place at the San Jose Convention Center in San Jose, Calif., Dec. 6 –7.

Here are 10 exhibitors showcasing some of their technologies at BIOMEDevice San Jose.

Next >>

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How product development outsourcing can make your medtech amazing

In today’s medical device market, more and more companies are using outsourcing as a product development strategy. 

Stuart Karten, Karten Design

[Image from Unsplash]

There has been a fundamental shift in the way companies develop medtech products because of advances in digital technology, medical industry economics and public policy – such as the Affordable Care Act’s withholding of 1% of a hospitals’ total Medicare reimbursements, to the tune of hundreds of millions of dollars a year.  Hospitals must earn the money back each year with high patient satisfaction scores. Medtech products play a significant role in patient satisfaction, for example, so product satisfaction—from clinic to home—plays a large role in a medical device company’s success or failure.  In today’s world, creating an incredible medtech device takes a smart and efficient outsourcing strategy.

My design company works with device, as well as other medical and consumer, companies to help them turn their innovative technology into products that people love. Or, in the case of startups, that VCs want to invest in, or larger conglomerates want to take over. We have been working in the medical device field for more than 33 years, and have created iconic, award-winning products, some of which are even featured in museums.  In the last several years, as medical products have become more consumerized – and a new generation of empowered patients expect products that have awesome design –  device companies have been hiring us as an “outsourced” firm.  We work intimately to tie all of the product development together so the end result becomes something of incredible value.

(See Stuart Karten on Dec. 12 at DeviceTalks West in Orange County, where he will be on a panel, “Tools for Succeeding with Outsourced Product Development.”)

But product development outsourcing is not easy.  Everyone struggles with it.

Every project is unique. We realize bringing disparate teams with different expertise, different time frames, and different end goals can be difficult.

As a design firm that has been a leader in enabling product development, we have four guidelines that we always follow as we prepare and go forth on a project.

Get the full story, along with the four guidelines, on our sister site Medical Design & Outsourcing.

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PE firm KKR closes $1.5B healthcare fund

Private equity giant KKR (NYSE:KKR) this week announced the final closing of its $1.45 billion KKR Health Care Strategic Growth Fund, looking to invest the funds in healthcare growth equity investment opportunities in the America’s.

The fund will receive more than $265 million of capital from KKR itself, alongside external investors through KKR’s balance sheet and employee commitments.

“The health care sector has demonstrated strong fundamentals throughout multiple cycles. Significant advances in medical innovation have yielded new products and services for patients, while consolidation and novel approaches to care delivery have the potential to improve clinical outcomes and reduce associated costs. These dynamics have created a significant market opportunity and an unmet need for strategic growth capital. We look forward to working with high-growth companies in the health care space for which KKR can be a unique partner in helping them achieve scale,” KKR health care strategic growth investing head Ali Satvat said in a press release.

KKR touted that the fund had received “strong backing” from new and existing global investors including public pensions, insurance companies, family offices and high value individuals.

“We are pleased that our enthusiasm for the attractive health care growth opportunities that the Fund enables is shared among a diversified group of global investors. This interest in the space, along with our strong team and record in health care, has helped us significantly exceed our initial target for the fundraise,” KKR private market products group head Alisa Wood said in a prepared statement.

The fund is slated to make equity investments of up to $100 million with a focus on themes including clinical and technological innovation, cost containment and consolidation of therapeutic offerings or care providers.

“KKR’s health care investment team has been investing globally across the health care sector for more than 20 years, resulting in extensive industry experience, an established reputation within the space, and a strong track record of scaling health care-related companies. We believe that we can be a valuable partner to management teams running innovative, high-growth companies by leveraging this experience,” KKR healthcare investment team head Jim Momtazee said in prepared remarks.

In September, KKR invested another $235 million into EchoNous, the parent company of Signostics, for the second time in as many years.

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Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017

Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately.

Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing Chris Fair, who will stay on as a board member with the company.

“I am excited by the opportunity to lead our talented team of employees and partners and create an even more vibrant and dynamic Spinal Elements in the years to come. I thank Chris Fair and the other members of our board of directors for their confidence. Going forward, Spinal Elements will continue to be focused on innovation and execution, driven by differentiated technologies and premium customer service, and we will move quickly to scale new ideas and opportunities into this dynamic marketplace,” Blain said in a press release.

“Jason has inspired many of Spinal Elements’ most exciting technologies – past, present and future – while also fostering a team-oriented culture in each position he has held during his career. I look forward to supporting Jason and the company across all future endeavors,” Fair said in a prepared statement.

The company also announced plans to move its global headquarters to its Carlsbad, Calif.-based location and reiterated that the move will have “minimal impact on Spinal Elements’ Marietta, Ga.-based operations and employees.”

“The company remains committed to its Marietta campus and our employees based there,” Blain said in a prepared release.

 Tissue Regenix taps former Sanofi Biosurgery COO Couldwell as CEO

Tissue Regenix (LON:TRX) said earlier this month it tapped former Global Sanofi Biosurgery COO Steve Couldwell as its new chief executive officer, effective immediately.

Prior to joining Sanofi, Couldwell held a number of roles at Smith & Nephew including European orthopedics prez and sales & marketing senior VP of the advanced wound management biz.

“Since being appointed to the board in 2013 I have been impressed with the great commercial potential of our dCELL platform. The recent acquisition of CellRight Technologies has increased the market potential and provided a highly complementary product range in the $1.7 billion. US bone graft and substitute market. I am delighted to be appointed CEO and look forward to leading the Group through the integration of CellRight and expansion of commercial activities as we execute our commercial strategy and grow our market share throughout the US and the rest of the world,” Couldwell said in a prepared statement.

“The board and I are delighted to welcome Steve as the Group’s new CEO. He has an exceptional track record of growing businesses and the Board firmly believes that Steve has the required skillset and experience to guide the Group along the pathway to profitability. Alongside this, Steve has an in-depth knowledge of the Group thanks to his years as a non-executive director making him an ideal candidate for this position,” board chair John Samuel said in a press release.

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 MedLumics taps former VC partner Greene as CEO

Cardiac device developer MedLumics said this week it tapped former venture capital firm Seroba Lifesciences partner James Greene as its new chief executive officer.

Prior to his time at Seroba, Greene helped found and lead cardiovascular device companies in the US and Europe including Verso Technologies, APK Advaned Medical Technologies, APICA Cardiovascular and MitralSolutions. Greene has also held positions at large firms including Medtronic (NYSE:MDT), Guidant and Abbott (NYSE:ABT).

“I am honored to be chosen to lead MedLumics as CEO. MedLumics’ innovative AblaView optically guided ablation technology enables clinicians to finally confirm in real time the creation of transmural scars without relying on a surrogate marker. The gravity of this innovation is the potential to reduce recurrence rates of AF, improve patient care, and provide a more cost-effective solution for the treatment of cardiac arrhythmias in today’s value-based medicine environment. MedLumics has a stellar team of professionals focused on developing innovative product solutions that offer clinicians better options for treating patients who suffer from AF and other arrhythmias,” Greene said in prepared remarks.

MedLumics said that in addition to the new CEO, it added Giovanni Leo to its board of directors.

“There is a growing need for new technologies to further advance the catheter ablation treatment of arrhythmias, and MedLumics has an opportunity to deliver on this with its highly advanced optics technology. I look forward to lending my expertise as the company focuses on raising the bar in this field,” Leo said in a press release.

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 MDIC CEO Murray to step down

The Medical Device Innovation Consortium said this month that its current prez & CEO William Murray will step down from his position on February 2 as he looks to return to the private sector.

The MDIC board said it has initiated a search for an individual to replace Murray as CEO.

“Over the past four years, it has been my honor and privilege to lead MDIC as we have grown from concept to an established part of the ecosystem in accelerating patient access to safe and effective life changing innovation. I am extremely proud of what we have accomplished. The organization is fortunate to be led by a board of senior leaders throughout the medtech ecosystem, supported by an incredible group of member volunteers and dedicated MDIC staff that give me great confidence we will achieve a smooth transition. My decision to return to the private sector has been difficult and emotional; we have built something very unique and rewarding at MDIC. Announcing my intention 3 months prior to leaving was the right decision to allow MDIC to move forward in a planned manner. I want to thank the MDIC board for their support as I worked through this process,” Murray said in a prepared release.

“The board of directors for MDIC would like to thank Bill for his leadership and contribution to advancing regulatory science for patients and expanding into real world data coordination. We wish him well going forward as he returns to the private sector to pursue other opportunities. MDIC is an integral part of the medtech ecosystem, the board is committed to find the next CEO leader that has the vision, passion and commitment to build on MDIC’s success.” MDIC board chair & Abiomed prez & CEO Mike Minogue said in a press release.

“MDIC has made great progress under Bill’s leadership these past four years. The organization has evolved into an integral partner with patients, industry and the FDA in addressing the most challenging regulatory science issues required for faster, safer and more efficient development, assessment and review of life-changing medical technologies. The FDA looks forward to continued collaborations with MDIC and its new leadership,” FDA Center for Devices and Radiological Health director Dr. Jeffrey Shuren said in a prepared statement.

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 Cardiovascular Systems COO Kenny to step down

Cardiovascular Systems (NSDQ:CSII) said this week that its COO Kevin Kenny will step away from the company, effective December 31, 2017.

Kenny has operated as COO at Cardiovascular Systems since February 2015, and served as exec VP of sales & marketing since May 9, 2011

The company said that it plans to enter into a separation agreement with Kenny in the future, and that it will disclose the terms of the separation agreement following execution by all parties.

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• MedTech Europe elects Brennan as board chair
• Lima taps Negri as interim CFO
• Dentsply Sirona hires Michel as exec VP, CFO
• Bovie Medical CCO McCarthy departs
• OneMedNet taps Frake as product dev VP

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Ascensia Diabetes Care highlights women helping to advance diabetes care

In support of World Diabetes Day earlier this month, Ascensia Diabetes Care published 30 portraits of women who are working to advance diabetes care.

The company’s CEO, Michael Kloss, said he was inspired by the theme of this year’s annual event, Women and Diabetes, and turned within the company for nominations of inspiring women.

Get the full story at our sister site, Drug Delivery Business News.

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Myomo prices upcoming $10m offering

Myomo today priced an upcoming offering, looking to raise approximately $10 million to support its myoelectric braces and orthotics designed for individuals with neuromuscular disorders.

In the offering, the Cambridge, Mass.-based company is looking to float approximately 4.2 million shares and warrants to purchase an additional 4.2 million shares at $2.40 per share. Warrants offered in the round will be exercisable immediately at a price of $2.95 per share, set to expire on December 4, 2022.

Read the whole story on our sister site, The Robot Report

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Rotation Medical touts consistent healing, tear mitigation in rotator cuff study

Rotation Medical today released results from a study of its Bioinductive Implant designed for repairing rotator cuff tears, touting the device’s ability to consistently heal such tears and mitigate tear progression.

Results from the 33-patient study were published in the Journal of Shoulder and Elbow Surgery, the Plymouth, Minn.-based company said.

In the trial, researchers investigated the use of the Bioinductive Implant in patients with chronic, degenerative, intermediate to high-grade partial-thickness tears.

Outcomes were assessed using the American Shoulder and Elbow Surgeons and Constant-Murley scores preoperatively and at 3 and 12 months post-procedure. Magnetic resonance imaging was also performed to assess tendon healing and thickness at the original tear site.

“Partial thickness rotator cuff tears do not heal spontaneously and have a high propensity to increase in size and/or develop into full-thickness lesions. This study shows that the Bioinductive Implant not only repairs the tear and increases tendon thickness, but it also prevents tear progression. In addition, because the native tendon footprint remains intact around the location of the defect, the Bioinductive Implant may accelerate rehabilitation and recovery as compared with more conservative postoperative management when partial thickness lesions are taken down and repaired as full thickness tears,” lead investigator Dr. Theodore Schlegel of the Steadman Hawkins Clinic Denver said in a prepared statement.

Results indicated significant improvement in clinical scores and an increase in mean tendon thickness of 2mm, with new tissue indistinguishable from the underlying tendon. A total 94% of patients experienced complete healing or considerable reductions in defect size.

Rotation Medical said that consistent partial to complete fill-in of the original bursal, intrasubstance and articular partial-thickness tear defects were observed as early as 3 months post-operation, with sustained efficacy through 12 months.

A total of 94% of patients agreed or strongly agreed they were satisfied with results of the surgery, and no tears progressed to full-thickness in patients who followed post-op rehabilitation plans. No serious adverse events were reported.

“In addition to further demonstrating that our Bioinductive Implant increases tendon thickness and prevents re-tears, we are pleased that the majority of patients in this study said they were satisfied with the results of their rotator cuff surgeries. As health systems transition to value-based care, data like these are becoming increasingly necessary to demonstrate the effectiveness of medical devices on indicators such as patient satisfaction, in addition to key health economic drivers that we are measuring in our REBUILD Registry Study,” prez & CEO Martha Shadan said in a press release.

In October, Smith & Nephew (NYSE:SNN) said that it agreed to pay as much as $210 million for Rotation Medical and its regenerative shoulder repair treatment.

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FDA clears AliveCor’s KardiaBand ECG for Apple Watch

AliveCor said today that the FDA approved its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.

First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.

AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the correlation between heart activity and physical activity using data from heart rate and activity sensors in the watch. The app prompts users to capture an ECG reading when heart rate and activity are out of whack either with KardiaBand or AliveCor’s portable KardiaMobile device.

“KardiaBand paired with SmartRhythm technology will be life-changing for people who are serious about heart health,” AliveCor CEO Vic Gundotra said in prepared remarks. “These capabilities will allow people to easily and discreetly check their heart rhythms when they may be abnormal, capturing essential information to help doctors identify the issue and inform a clear path of care to help manage afib, a leading cause of stroke, and other serious conditions.”

“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” added Dr. Ronald Karlsberg of Cedars Sinai Heart Institute and UCLA’s School of Medicine UCLA in Los Angeles. “Today, [ECGs] are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke. With an EKG device on the wrist, afib can be detected wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first AliveCor [ECG] device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalized health care.”

The KardiaBand accessory goes for $199 and requires an annual $99 subscription to AliveCor’s Premium service, the company said.

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The Case for Real-World Evidence (RWE) in Medical Device Development

Medical Devices are used in the real world every day, so shouldn’t they be tested in the real world? You would think so. But the FDA hasn’t necessarily been of that mindset — until now.

Per FDA regulations, testing has to be conducted under supervised clinical trials, which have pre-designed protocols. When most think of clinical studies, they think of the structured, randomized clinical studies conducted for drug products; however clinical studies are also required for some high risk medical device applications. When determining if real-world evidence is relevant, one should consider that medical devices work physically, while drugs work chemically or biologically. Therefore, medical devices are tested by the end users or clinical professionals that will use them during the medical device validation process. Some devices are low risk and easy to use, while others are quite complex/high risk medical devices that require professional knowledge and/or detailed instructions for use. It is these high risk devices that require clinical type testing for FDA approval.

Another factor calling for real-world data is that medical devices are invented, so human factors/user error type testing should be conducted during design of the prototype to ensure the devices are not in need of further improvements prior to full scale medical device manufacturing and production. Medical device manufacturers can appreciate that devices may go through various iterations during the medical device development process, and if proper procedures are being followed, then continuous testing is being conducted and documented in the Design History File (DHF) to ensure the product is safe and effective for use. It stands to reason, then, there could be even more to learn once a medical device enters the post market/post production stage, or in layman’s terms, real-world use. Read the full article here…

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Biolase closes $12m rights offering

Biolase (NSDQ:BIOL) said today that it closed a rights offering that will bring in some $12 million for the dental laser maker.

The offering, which expired at 5 pm Eastern yesterday, delivered subscriptions for some 26.3 million shares, Irvine, Calif.-based Biolase said. That’s about 5,000 more than planned, the company said.

Biolase said it hoped to raise at least $8 million when it announced the flotation in September. Affiliates of Oracle Investment Management founder Larry Feinberg and Crabtree Ventures founder Jack Schuler each pledged to at least $3 million apiece, the company said at the time.

The shares and proceeds are slated to be distributed Dec. 4, Biolase said.

In August Biolase posted a 134% increase in second-quarter net losses, which reach -$8.3 million, or -12¢ per share, on a -8.7% sales decline to $12.6 million compared with Q2 2016.

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Cordis, Medinol win FDA nod for Elunir drug-eluting stent

Cordis and Medinol announced today that the FDA approved its EluNir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries.

The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in the U.S., according to the companies.

Get the full story at our sister site, Drug Delivery Business News.

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Lung cancer expert: Smoking stigma still hurting patients, families and research

A number of therapies designed to treat patients with lung cancer have been approved this year, including products from Novartis (NYSE:NVS), Merck (NYSE:MRK) and Bristol-Myers Squibb (NYSE:BMY).  That progress is exciting for Dr. Fred Hirsch, the head of the International Association for the Study of Lung Cancer.

“We do have a lot of good things to tell the public these days – that tremendous progress has happened both in terms of early detection, lung cancer screening and foremost, the treatment of patients with advanced lung cancer,” he told Drug Delivery Business News.

The milestones reached by industry and researchers within the last few years are largely rooted in a better understanding of the biology of lung cancer, according to Hirsch, which has translated into the development of personalized therapies for individual patients

Get the full story at our sister site, Drug Delivery Business News.

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Elekta delays rollout for Unity MR-radiation therapy combo

Elekta (STO:EKTA B) today said it’s delaying the rollout of its Unity device, designed to combine magnetic resonance imaging with a linear accelerator for radiation therapy, saying it needs more time to finalize and validate the linac control system.

The Swedish company said the decision means it’s postponing its bid for CE Mark approval in the European Union until the first half of next year.

“We are convinced that the new technology will revolutionize radiation therapy and create completely new opportunities for physicians and their patients. With the shift in CE Mark and FDA submission, we adjust our target for the first 75 orders accordingly to the first half of calendar year 2020,” CEO Richard Hausmann said in prepared remarks.

Elekta also posted fiscal second-quarter results that topped analysts’ estimates. Profits for the three months ended Oct. 30 were SEK247 million (about $29.5 million), or SEK0.65 per share (8¢), on sales of SEK2.80 billion ($334.7 million). That amounts to profit growth of nearly 350% on sales growth of 15.1% compared with fiscal Q2 last year.

Analysts were looking for EPS of SEK0.52 (6¢) on sales of SEK2.64 billion ($315.4 million).

EKTA B shares were up 0.2% to SEK70.20 ($8.39) apiece today in mid-afternoon trading in Stockholm.

($1 = SEK8.37215)

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Semma Therapeutics closes $114m round to advance cell therapy for Type I diabetes

Semma Therapeutics has closed an oversubscribed $114 million Series B round to help fund the development of its encapsulated stem cell-derived islet therapy for Type I diabetes.

The Cambridge, Mass.-based company reported that it plans to use the newly-acquired funds to bring its cell therapy through clinical proof-of-concept studies, as well as explore other regenerative medicine therapies.

Get the full story at our sister site, Drug Delivery Business News.

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Fractyl raises $44m Series D for Revita DMR tech

Fractyl Laboratories said today that it raised $44 million in a Series D round, led by an undisclosed investor and first-time investors GV, True Ventures and the IDO Fund.

Returning investors included Deerfield Management Company, Bessemer Venture Partners and others. The company said it plans to use the round’s proceeds to fund the continued development of its Revita duodenal mucosal resurfacing procedure for people with Type II diabetes.

Get the full story at our sister site, Drug Delivery Business News.

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Fibralign closes syndicate funding round from AngelMD

Fibralign has recently closed a syndicate funding round coordinated by investment and networking platform AngelMD to support its Nanoweave 3D scaffolding tech and medical devices using the technology.

The Union City, Calif.-based company’s first product is the BioBridge collagen matrix, which is an implantable, biocompatible and biodegradable surgical mesh with 510(k) clearance for use in surgery to “reinforce and repair soft tissue where weakness and deficiencies exist,” the company said.

Fibralign is currently exploring use of the device to treat patients who suffer from secondary lymphedema.

“Secondary lymphedema, which occurs when the lymphatic system is disrupted and unable to transport interstitial fluid, most commonly occurs as a result of cancer treatments in western countries. Conventional therapies are costly, marginally successful, and treat symptoms only. To an area in great need of a new approach, the team at Fibralign has introduced a novel BioBridge Collagen Matrix which acts as a 3D scaffolding to promote the growth of new lymphatic vessels and dramatically improve the quality of life for millions of people,” syndicate leader Dr. Orrin Ailloni-Charas said in a press release.

The company is also exploring follow-on opportunities with the BioBridge, including treatments for ischemia, cell and drug delivery and gene therapy, according to a press release.

“We are honored to have AngelMD join us and support our advancement of a much-needed treatment for lymphedema. AngelMD brings much more than capital with its investment to Fibralign. Engaging their network of physicians has been invaluable in providing feedback for our product pipeline and clinical direction,” Fibralign CEO Greg King said in a prepared statement.

The amount of funding raised in the round was not disclosed.

Last September, Stanford University began enrollment in an investigator-led clinical study of  the BioBridge collagen matrix for treating secondary lymphedema.

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One Drop touts A1c improvements in people using mobile app on iPhone, Apple Watch

One Drop today touted data from a study published in the Journal of Medical Internet Research showing that people with diabetes using the One Drop mobile app on their iPhone and Apple Watch reduce their hemoglobin A1c by 1.4%, on average.

The N.Y.-based company noted that lowering blood sugar levels can help patients lessen their risk for cardiovascular disease and microvascular complications.

Get the full story at our sister site, Drug Delivery Business News.

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Genesis Innovation Group launches $10m Cultivate(MD) medtech venture fund

Genesis Innovation Group said today it formed the Cultivate(MD) Capital Fund, which looks to manage $10 million to invest in early stage healthcare companies with a focus on medical device and orthopedic technologies.

Holland, Mich.-based Genesis said it expects the Cultivate(MD) fund to be fully operational and seeking companies to invest in by early 2018. The company said the fund will continue its focus on investing in early stage medtech companies and expand into mid to later-stage companies and investment opportunitites.

“Health care is a dynamic space, and inventors and entrepreneurs face significant risk during their development stages, cultivate(MD) brings the necessary capital and access to an experienced team that will guide an innovation to market. In addition to financial capital, innovators need a network of intellectual capital that will help convert their ideas and assumptions into marketable innovations. Genesis provides a nurturing environment for health care innovations,” Genesis Innovation Group CEO & Cultivate(MD) fund manager Rob Ball said in a press release. “We derive our success through the intersection of improved outcomes, cost savings, experienced teams and strong brands, Cultivate(MD)’s unique partnership with Genesis Innovation Group provides for a rich and tangible participation, and a capital-efficient process, that delivers true innovation in market.”

The newly formed fund will look to invest in technologies with “demonstrated evidence of effectiveness” and will partner with Genesis Innovation Group to appropriately utilize its team and network with goals of reducting the cost of healthcare while improving outcomes for patients.

“Health care innovations can come from many sources, including surgeon or other practitioner, and Genesis has quickly brought together a network of talented and experienced professionals with a successful track record. Genesis’ deep connectivity with key opinion leaders in the medical device field has given us access to test and drive solutions to successful execution,” R&D VP Don Running said in a prepared statement.

Genesis said that the model it is using with the Cultivate(MD) fund has previously resulted in several high-growth, emerging medical device companies including the Magnesium Development Company, Shoulder Innovations and iMagen Orthopedics.

“For more than three decades, the Genesis team members have created and launched dozens of successful health care technology ventures.  Throughout this process they have developed close relationships with leading experts in the medical community. I have been personally engaged with several of these projects and witnessed their attention to the entrepreneur and advisors, as well as their never ending commitment to patient care,” medical director R. Churchill said in a prepared release.

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Cerebrotech wins expanded CE Mark for brain bioimpedance monitor

Brain monitor dev Cerebrotech Medical Systems said today it won expanded CE Mark approval in the European Union for its portable brain bioimpedance monitor with indications for detecting bioimpedance asymmetry associated with stroke.

The certification expands previously won clearance which indicated the device for use in detecting changes to intracranial fluid in patients at risk for edema, the Pleasanton, Calif.-based company said.

“Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients. Having access to a device that can give us this information rapidly has the potential to significantly change the clinical paradigm for emergency stroke care,” scientific advisory board chair Dr. Wade Smith of the University of California San Francisco said in a prepared statement.

Cerebrotech’s Intracranial Fluids Monitor is a non-invasive bioimpedance spectroscopy device designed to detect changes and distribution of brain fluids, and has been shown to detect fluid asymmetry between the left and right hemispheres induced by ischemic strokes in recent clinical trials.

“European regulatory clearance in this emergency stroke application is a significant milestone for the company, and paves the path to commercialization. We are looking forward to advancing the state of stroke care with our wireless and non-invasive approach to intracranial monitoring,” prez & CEO Mitch Levinson said in a press release.

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VitalConnect closes $20m term loan

Wearable biometric diagnostic patch company VitalConnect has closed a $20 million senior secured term loan with Oxford Finance, according to a press release from the finance firm.

VitalConnect produces the VitalPatch wearable biosensor, as well as its VitalConnect Platform to enable monitoring of the patch’s sensor data.

The company’s devices can return multiple measurements in a single biosensor patch, including single-lead ECG data, heart rate, RR interval, heart rate variability, respiratory rate, skin temperature, body posture, fall detection and activity including steps, according to the company’s website.

“VitalConnect’s technology enables healthcare providers to improve both the quality and efficiency of patient care. Oxford is excited to support VitalConnect in its mission to improve patient outcomes and reduce healthcare costs by providing the healthcare community with a clinical-grade wearable biosensor that enables high-quality and continuous, patient monitoring typically found in acute-care units,” Oxford Finance senior managing director Christopher Herr said in a prepared statement.

Funds from the secured term loan will be used to support further commercialization of its VitalConnect solution system for both hospitals and remote patient monitoring markets.

“VitalConnect is focused on delivering solutions that save lives and improve patient care – providing data and analytics that will improve care decisions when it matters most. The expanded debt facility provided by Oxford Finance in addition to our recent funding raise will allow us to continue to focus on these goals by expanding our commercial footprint and while accelerating our pipeline development,” VitalConnect’s CEO Nersi Nazari said in a press release.

Earlier this month, VitalConnect said it raised $38 million in its fourth and final Series C closing, with funds slated to support the launch of its VitalConnect platform and VitalPatch wearable.

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These 10 medtech companies care a lot about research

Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced?

[Image from Unsplash]

Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in the world, ranked by annual revenue for their medical device operations.

On top of ranking by annual revenue, we also look at R&D spending because companies that spend a large portion of their budgets on research are worth keeping an eye on. Such companies are making a bet that spending on research today will allow them to succeed over the long-term by creating important innovations.

Here are the 10 medical device companies that spent the largest portion of their budgets on research during their most recent fiscal years, along with the devices the R&D has helped create.

Next>>

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Onduo taps Glytec’s insulin therapy software as part of virtual diabetes clinic

Glytec has inked a deal with Onduo to integrate the company’s Glucommander Outpatient insulin management software into Onduo’s virtual diabetes clinic.

Onduo, a joint venture of Sanofi (NYSE:SNY) and Verily, is reportedly working to develop a platform that brings together medical devices, software and support from healthcare experts to help people manage their Type II diabetes.

Get the full story at our sister site, Drug Delivery Business News.

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Electrocore closes $70m Series B

Electrocore said today it closed a $70 million Series B round of financing to support the commercial launch of its gammaCore therapy system into the primary headache market.

The round was led by investment group Core Ventures II and joined by Merck’s Global Health Innovation Fund, Knoll Capital Management affiliate Gakasa, American Investment Holdings and the Vinik Family Foundation.

Proceeds from the round are slated to be used for the commercial launch, as well as further studies, of its gammaCore device with a focus on the primary headache market. Funds will also support continued clinical and scientific development of its non-invasive vagus nerve stimulation therapy, the company said.

“The ongoing support from Core Ventures and Merck’s Global Health Innovation Fund shows continued confidence and enthusiasm for our mission to bring vagus nerve stimulation into the mainstream of medicine. The investments from Jeff Vinik’s and Knoll Capital’s groups are excellent confirmations that we have built a compelling platform for the future,” CEO Francis Amato said in a press release.

Electrocore said it has filed for a 510(k) label expansion for its gammaCore device for the acute treatment of migraines and will continue to partner with research organizations to study the use of its nVNS therapy in other indications.

“ElectroCore is leading the way for the future of medicine through the development of non-invasive, self-administered nVNS therapy. The field of neuromodulation is the next great market in healthcare, but until now it has been limited by the route of administration that has required surgery.  We are thankful for the opportunity to continue supporting electroCore as it expands the applicability of nVNS to give patients access to this safe and effective treatment in a cost effective way that can so positively impact the healthcare system,” co-founder & chief science and strategy officer JP Errico said in a prepared statement.

Electrocore developed and produces the gammaCore non-invasive vagus nerve stimulator. The device won FDA approval in April and was launched in mid-July with indications for treating pain associated with episodic cluster headaches in adult patients.

In June, MassDevice.com spoke to ElectroCore CEO Amato about the gammaCore device and how the device differs from other VNS therapy systems

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Dexcom inks continuous glucose monitoring deal with UnitedHealth

Shares in Dexcom (NSDQ:DXCM) rose 4% today after the company announced a partnership with UnitedHealth (NYSE:UNH) to assess if data from a continuous glucose monitor can help people with Type II diabetes manage their condition in a cost-effective way.

UnitedHealth is slated to use CGM data, as well as diet and exercise activity, in a study of 10,000 people that will launch within the next nine months. If the initial study is successful, UnitedHealth plans to kick off a network-wide initiative, Seeking Alpha reported.

Get the full story at our sister site, Drug Delivery Business News.

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CRO Medpace prepares secondary offering

Contract research organization Medpace (NSDQ:MEDP) yesterday announced an upcoming secondary offering of 4 million shares, which could bring in as much as $137 million given current share price for majority shareholder Cinven Capital.

In addition to the initial 4 million shares, the offering includes a 30-day underwriters option to purchase an additional 600,000 shares, totaling more than $20 million given current share prices, putting the total for the offering just under $160 million for Cinven.

If successful, the round would see Cinven drop from a 56% stake to a 48% stake in Medpace, according to a Law360 report.

Jefferies LLC and Credit Suisse Securities are acting as bookrunners for the offering, according to a press release.

Last August, Cincinnati-based Medpace raised more than $185 million in its initial public offering, including an underwriter’s over-allotment that added more than $24 million to the IPO.

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Biocorp inks safety syringe deal with pharma player

Biocorp (PAR:ALCOR) said today that it inked a deal for its NewGuard safety syringe technology with “a leading global player specializing in pharmaceutical products” that it’s not allowed to name.

The Issoire, France-based company said the deal call for it to integrate and commercialize the NewGuard technology into the pharma partner’s pre-filled heparin syringes, saying the partner is the #2 player in the heparin space.

Get the full story at our sister site, Drug Delivery Business News.

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Philips deals lighting biz stake for $648m

Royal Philips (NYSE:PHG) said yesterday that it agreed to deal 17.1 million shares in Philips Lighting for €32 per share (about $37.90 apiece), for total proceeds of roughly $648 million (€547 million), cutting its holdings in its legacy business from 40.97% to 29.01%.

As part of the deal the Dutch healthcare conglomerate agreed to buy back  and cancel 2.8 million Philips Lighting shares, raising its stake to 29.59%. The offering is slated to close Dec. 1.

Philips, which said it aims to sell its complete holdings in the lighting business over the next few years, no longer controls the operation; that means CEO Frans van Houten is slated to step down from Philips Lighting’s board at the end of the year.

Goldman Sachs, Merrill Lynch, Rabobank in cooperation with Kepler Cheuvreux and UBS acted as joint bookrunners for the deal, with Rothschild acting as financial adviser, the company said.

($1 = €0.844156)

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GE Healthcare launches Drawbridge Health blood collection biz

GE Healthcare (NYSE:GE) today launched Drawbridge Health, a new blood collection business looking to develop technology designed to integrate draw, collection and sample stabilization into a single device.

The under-development technology is being designed to support room temperature shipping and streamlined downstream processing, which the company said will ensure more reliable, accurate results, GE said.

Drawbridge is hopeful its new blood testing hardware will enable better patient-consumer engagement and drive a shift from reacting to tracking of blood health.

“At GE we share technology, markets, structure and knowledge across our varied businesses, which uniquely positions us to tackle many issues, including this one. With Drawbridge Health, we are combining technology from GE Global Research, expertise from GE Healthcare and business models from GE Ventures to offer a simple, safe and more efficient solution that can help save time, money and lives,” GE Ventures new business creation managing director Risa Stack said in a prepared statement.

Former molecular diagnostics company Gensignia Life Sciences CEO Lee McCracken is joining Drawbridge as its CEO, GE Healthcare said.

“At Drawbridge Health, we have a tremendous opportunity to uniquely enable not only effortless access to diagnostic testing, but to also transform how diagnostics companies and healthcare providers interact with their patient-consumers. The current sample testing process is inconvenient and challenging for patients and medical providers, alike. It requires clinical processing equipment, often a technician specifically trained to draw blood, plus a trip to the doctor’s office or hospital. By combining world class GE technology and a talented founding team to address an important market need, Drawbridge Health is well positioned to transform diagnostic testing for healthcare stakeholders, testing laboratories, patients and consumers,” Drawbridge Health CEO McCracken said in a press release.

Blood and plasma supplies business Haemonetics (NYSE:HAE) saw shares drop slightly this morning, down 0.4% at $58.40 as of 9:51 a.m. EST.

Earlier this month, GE Healthcare inked a multi-year, non-exclusive licensing and professional services deal with medical imaging analysis company DiA Imaging Analysis, according to a press release from the company.

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Stryker, Zimmer Biomet settle poaching spat

Stryker (NYSE:SYK) and Zimmer Biomet (NYSE:ZBH) agreed to bury the hatchet in a lawsuit Stryker brought accusing its orthopedics rival of poaching sales reps.

Kalamazoo, Mich.-based Stryker sued Zimmer Biomet in March in the U.S. District Court for Southern Texas, alleging “concerted and deliberate unfair competition, improper use of Stryker’s confidential and trade secret information, and improper solicitations of Stryker’s customers and employees” in the Houston area.

Zimmer Biomet allegedly enticed a pair of Stryker reps, Andrew Ruggles and Carson Combs, to set up a rival foot & ankle business targeting Stryker customers in breach of their non-compete and non-solicitation agreements, according to the lawsuit. The ex-reps “are now moving the business of those Stryker customers to defendants and utilizing Stryker confidential and trade secret information,” Stryker alleged.

Ruggles quit Stryker in November 2016 and allegedly recruited Combs to follow suit just 4 days later, according to the suit, which asked Judge Gray Miller for a temporary restraining order and preliminary injunction barring Zimmer Biomet, Ruggles and Combs from further alleged violations, according to court documents.

Zimmer Biomet in May moved to dismiss the case, arguing that although Stryker’s claims are pegged to Ruggles and Combs, it inexplicably failed to name them as defendants. In a June 7 response, Stryker maintained that no law requires them to name the duo, because it’s going after Zimmer Biomet and not them.

Yesterday Judge Gray Miller dismissed the case without prejudice, giving the companies 60 days to finalize the settlement agreement, according to court documents.

“Having been advised that a settlement has been reached between plaintiff and defendant, the court dismisses this case without prejudice to reinstatement of plaintiff’s claims if any party represents to the court within 60 days from the date of this order that the settlement could not be completely documented. The court retains jurisdiction over any settlement agreements,” Miller wrote.

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Medtronic retools SynchroMed II infusion pump

Medtronic (NYSE:MDT) said this month that it won approval for a change to its problematic SynchroMed II implantable drug infusion pump designed to address motor shaft wear issues.

The Fridley, Minn.-based medical device titan said the change is aimed at improving the long-term rate of non-recoverable motor stall in the SynchroMed II devices, estimating that pump survivability rates at six years for stalled pumps to be 97.3%2 with on-label drugs and 91.1%2 with off-label drugs.

Get the full story at our sister site, Drug Delivery Business News.

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Boston Scientific takes a $3B hit on latest Lotus valve delay

Boston Scientific (NYSE:BSX) saw its market capitalization lose $3 billion after yesterday revealing another delay for its Lotus replacement heart valve.

The Marlborough, Mass.-based company, which recalled the Lotus transcatheter aortic heart valve in February over issues with its locking mechanism, said it no longer expects the ensuing manufacturing and design specification changes to get the valve back on the market in Europe or allow the final filing in its pre-market approval bid with the FDA by January 2018.

“We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients with aortic stenosis,” chairman & CEO Mike Mahoney said in prepared remarks. “While we are disappointed in this delay to our timelines, we are working to carefully analyze and implement necessary modifications to pass our rigorous internal quality standards.”

Boston Scientific said it plans to deliver an update on the Lotus valve’s status during its fourth-quarter earnings call, slated for Feb. 1, 2018. The delay is not expected to affect its finances for the fourth quarter or full year, the company said, but investors reacted by sending BSX shares down some -7.4% yesterday.

The stock closed at $26.39 per share yesterday after Boston Scientific pulled out of its scheduled appearance at the Piper Jaffray healthcare conference in New York City, but rebounded somewhat this morning in pre-market trading, rising 0.7% to $26.58 apiece. The drop yesterday pared its market cap from roughly $39.1 billion to $36.2 billion.

Last February Boston voluntarily removed all Lotus valve devices, including its Lotus with Depth Guard, from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus Valve to the delivery system.”

At the time the company said it believed the issue to be caused by an excess of tension in the pin mechanism introduced during the manufacturing process, the same issue that caused an earlier suspension of implants of its Lotus Edge valve system device.

In January, Boston Scientific had reportedly found a fix for its Lotus Edge heart valve after the company paused implantations of the device in October last year.

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Philips announces innovations around imaging, pediatrics and more

Philips today announced new imaging products and services, as well as a 10-year, strategic partnership with Children’s Hospital & Medical Center of Omaha, Neb.

The news is latest of a slew of announcements out of Philips during the Radiological Society of North America (RSNA) conference that is taking place this week in Chicago.

Philips yesterday announced three new products and services related to its radiology offerings, including 3D printed models, a new CT scanner and an extension of a partnership with Banner Health.

Get the full story on our sister site Medical Design & Outsourcing.

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BD tacks another extension onto Bard tender offer

Becton Dickinson (NYSE:BDX) today announced yet another extension to its tender offer for up to $1.1 billion in outstanding C. R. Bard (NYSE:BCR) notes, pushing the deadline back from November 28 to December 14.

The $317-per-share deal, announced last April, is expected to close during the fourth quarter. BD won conditional EU approval for the deal last month. BD is offering to buy up roughly $500 million in 4.4% Bard notes due 2021, $500 million in 3% notes and $149.8 million in 6.7% notes, both due 2026.

In the exchange so far, the Becton Dickinson has validly tendered approximately 86.5% of its 4.4% notes due 2021, 91.5% of its 6.7% notes due 2026 and 94% of its 3% notes due 2026, according to a press release.

The Franklin Lakes, N.J.-based company announced an initial extension from June 5 to July 3, and has since extended four more times, now aiming to close the offer in December.

For each of the notes in the offering, BD said it will offer $970 principal amount of equal BD notes as well as between $2.50 and $20 cash, with an early tender premium of $30 principal amount of equal BD notes. The company said it is also soliciting consents to adopt certain proposed amendments to each of the indentures governing Bard notes to eliminate restrictive covenants.

In May, BD announced the exchange offer alongside a registered offering of $2.25 billion in common stock at $1 per share, with an additional $2.25 billion in depository shares, each representing a 1/20th interest in its mandatory convertible preferred stock at $1 per share.

The offering round included an underwriters option to purchase up to an additional $225 million in common stock and $225 million in depository shares. Proceeds from the offering were slated to support its acquisition of Bard.

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Insightec wins FDA nod for Exablate Neuro glioblastoma trial

Insightec said today it won FDA approval to launch a safety and feasibility trial of its Exablate Neuro, testing its ability to disrupt the blood brain barrier in patients with glioblastoma.

The Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

In the trial, a research team will inject commonly used a sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor, after which ultrasound will be used to oscillate the microbubbles to cause temporary disruption of the blood brain barrier.

“Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology. Insightec continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most – patient lives,” CEO & chair Dr. Maurice Ferré said in a press release.

The study is set to enroll up to 15 subjects with suspected glioblastoma who are scheduled to undergo a tumor resection, with Dr. Graeme Woodworth of the University of Maryland School of Medicine acting as principal investigator.

Last month, Insightec said it won FDA approval for a pivotal trial of its Exablate Neuro device in treating refractory Parkinson’s disease.

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Medical device startups: Here are the secrets of success

[Image from Unsplash]

Bill Betten, Betten Systems Solutions

It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry.

The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University. So the cost of failure or even delay is high.

Unlike the consumer world – where an app or prototype can be developed in a garage (or dorm room), then publicized on YouTube and funded via Kickstarter – the regulated medical device development world requires a different level of commitment, process and demonstration of efficacy.

Get the full story on our sister site Medical Design & Outsourcing.

(See Bill Betten discuss innovation and product development at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)

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PE firm Altus Capital to acquire MGC Diagnostics for $50m

Private equity firm Altus Capital Partners has inked a deal to acquire MGC Diagnostics Corp in a $50.3 million deal.

In the deal, Altus will pay $11.03 per share for each share of MGCD, equalling out to approximately $50.3 million, representing a 44% premium on its January 24 closing price of $7.65.

“We look forward to becoming part of the Altus organization. Our strategies for product innovation and growth are nicely aligned and together we believe we can accelerate the delivery of new product offerings to our customers.  Altus’s financial strength provides incremental funding for our product development pipeline initiatives,” MGCD CEO Todd Austin said in a press release.

Under terms of the merger agreement, Altus will begin its tender offer for shares after November 27, with an expected close date in either late 2017 or early 2018, making MGCD a privately held company.

MGCD’s board approved the acquisition agreement unanimously after reviewing strategic alternatives on January 25, and directors and officers of the company representing 8.9% of the outstanding shares have entered into tender support agreements with Altus.

“After a review of strategic alternatives by our board of directors, we are pleased to reach this agreement with Altus, which provides our shareholders with immediate liquidity and substantial certainty of value. We believe this transaction presents a winning proposition for all our stakeholders.  Altus is a strategic-minded and growth-oriented investor in the manufacturing space with a proven track record of partnering with company management,” MGCD chair Mark Sheffert said in a prepared statement.

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Zebra Medical Vision, Change Healthcare ink AI imaging dev deal

Israeli machine-learning radiology firm Zebra Medical Vision said today it inked a deal with Change Healthcare to produce artificial intelligence solutions for complex radiology reporting environments.

Through the partnership, the companies will combine Change’s radiology solutions and Zebra Medical’s algorithms as they look to improve the efficiency and effectiveness of routine tasks in a radiologists’s workflow.

“For artificial intelligence to be truly valuable, it must be integrated into radiologists’ routine, daily readflow. Pragmatic, artificial intelligence solutions such as the All in One offering from Zebra Medical Vision are essential. We see a strategic fit as Change Healthcare pursues solutions that optimize workflow and access to clinical data for our medical imaging customers,” Change Healthcare radiology & infrastructure GM Ashish Sant said in a prepared statement.

Change Healthcare said it will continue to work with its “forum of clinical and academic leaders” to gain integral insights it sees as inherent in imaging and clinical information to help imaging specialists identify critical conditions more hastily.

“Our team at Zebra Medial Vision is excited to be working with Change Healthcare’s experts. We know that Change Healthcare’s industry-leading enterprise imaging solutions and their deep clinical knowledge combined with our growing artificial intelligence solutions will help bring real benefit to radiologists and their reading practice,” Zebra Medical co-founder & CEO Elad Benjamin said in a press release.

Earlier this month, Zebra said it will upload its radiology algorithms to the Google Cloud as part of the AI1 automated imaging analytics tools offering it announced last month.

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One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how

When Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor’s office with a sinking feeling in his chest.

“I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription and a pat on the back – and I was out the door,” he told Drug Delivery Business News. “I was concerned for my family, I was concerned for my kids. I didn’t really know what this was going to mean for me.”

He found himself searching for devices or products to help him manage his diabetes. From counting carbohydrates to calculating insulin doses, diabetes is a data-driven disease.

Get the full story at our sister site, Drug Delivery Business News.

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Pavmed files FDA 510(k) for CarpX carpal tunnel device

Pavmed (NSDQ:PAVM) said today it filed a 510(k) application with the FDA for its CarpX minimally invasive device designed to treat carpal tunnel syndrome.

The CarpX is a percutaneous device designed to allow the operating physician to relieve compression of the median nerve without a surgical incision. The system combines a balloon catheter with bipolar radio-frequency cutting electrodes and is positioned through guidance with ultrasound, the company said.

“I have had the opportunity to use Pavmed’s highly innovative CarpX device in pre-submission testing and am very impressed with its performance. As a busy hand surgeon, I strongly believe that CarpX will be a game-changer in the treatment of carpal tunnel syndrome, providing patients with a much less invasive option and significantly shorter recovery times than traditional open carpal tunnel surgery. I eagerly await CarpX’s regulatory clearance and the opportunity to offer this ground-breaking innovation to my patients suffering from carpal tunnel syndrome,” Dr. David Kelly of Gilbert, Ariz.’s Center for Dermatology and Plastic Surgery said in a press release.

Upon activation, the CarpX device creates a space within the tunnel to confirm the nerve is protected from the cutting electrode and decompresses the median nerve by dividing the transverse carpal ligament.

“We designed CarpX to closely mimic the anatomic results of traditional invasive carpal tunnel surgery but to do so much less invasively, using catheters, balloons, radiofrequency energy and other established tools that have contributed to the percutaneous and minimally invasive revolutions in the treatment of other conditions. Our balloon catheter device is designed to be inserted under the scarred ligament in a minimally invasive fashion, while pushing the nerve and tendons away. When activated, bipolar radiofrequency electrodes precisely cut the ligament from the inside out in a matter of seconds. The device design provides physicians with ongoing feedback to optimize the safety and completeness of the procedure,” Pavmed chief medical officer Dr. Brian deGuzman said in prepared remarks.

Pavmed said it is hopeful that the CarpX device can decrease costs and move procedures out of operating rooms, as well as decreasing postoperative pain and hospital stays before patients can return to their day-to-day lives.

“We are very excited to have reached this most important milestone in Pavmed’s corporate history. CarpX has become the most commercially promising and clinically exciting product in our pipeline and we believe it will revolutionize the treatment of carpal tunnel syndrome, a widely prevalent condition that exacts a significant clinical and economic burden on society in the U.S. and worldwide. Based on epidemiological and market research data we estimate CarpX’s addressable market opportunity to exceed $1 billion,” Pavmed chair & CEO Dr. Lishan Aklog said in a prepared statement. “As with all of our products, CarpX’s development and regulatory testing were performed using our unique business model focused on speed to market and capital efficiency. We are proud to have achieved this milestone within a timeframe and with capital expenditures to date that beat our model’s benchmarks. We believe we have assembled a strong submission and are targeting clearance in the first half of 2018. Upon successful regulatory clearance, we anticipate an aggressive commercialization strategy using well-established independent sales channels targeting the appropriate physician specialties.”

Earlier this month, Pavmed saw shares rise after the medical device maker beat expectations on Wall Street with its third quarter results

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Report: Justice Dept. closes tampering probe in Johnson & Johnson hip case

The U.S. Justice Dept. reportedly closed its probe into alleged witness tampering in a bellwether trial over the Pinnacle metal-on-metal hip implants made by Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics.

In October a federal judge in Texas took the unusual step of asking federal prosecutors and the FBI to probe the possible witness tampering. Mark Lanier, lead attorney for the plaintiffs in one of six cases being tried in the U.S. District Court for Northern Texas bellwether before Judge Ed Kinkeade, raised the tampering issue during an Oct. 16 hearing based on a conversation between a DePuy sales rep and a surgeon who’s a witness in the case.

Dr. David Stein filed an affidavit Oct. 15 documenting a conversation with Glen Swajger held ostensibly to discuss “a procedure requiring [Swajger’s] involvement.”

“Mr. Swajger looked terrible and appeared stressed, so I asked him what was going on,” Stein said in the affidavit. “He said the day before (October 12, 2017), he had been contacted by the DePuy lawyers and that discussion made him anxious. He said the lawyers were ‘on him like crazy.’ They were putting ‘big-time pressure’ on him.”

Swajger then warned Stein of possible “ramifications” to his medical practice “in connection with my upcoming Dallas testimony,” according to the affidavit.

“He indicated the lawyers were ‘peppering him.’ He said the ‘business in Dallas was freaking [him] out.’ He said he had a ‘terrible’ day on Thursday as a result of this and my going to Dallas was driving him crazy. He said ‘I care about you,’” Stein said in the affidavit.

After Lanier raised concerns about possible witness tampering during a hearing, Kinkeade said he would ask the U.S Attorney’s office in his district and FBI agents to interview Swajger and any defense lawyers he spoke with.

DePuy attorneys Jessica Brennan and Michael Zogby denied the allegations in court filings, saying that Brennan’s contact with Swajger was limited to brief phone conversations confirming his availability for a conference call to discuss the case.

“At no time during Ms. Brennan’s aforementioned calls to Mr. Swajger, or on Mr. Swajger’s call to her, did she request that Mr. Swajger do anything other than be available for a conference call with the trial team. She certainly did not tell Mr. Swajger to do anything or to communicate with Dr. Shein. She merely explained that the trial team wanted to visit with him, explained why, and worked through the timing of such call given Mr. Swajger’s busy schedule,” according to the motion.

Johnson & Johnson reportedly said the Northern Texas attorney general’s office has closed its investigation,

“DePuy has always known these allegations to be meritless, and is pleased that the matter has been resolved,” the company said in a statement provided to Law360.

“We’re certainly pleased with the U.S. attorney’s office’s decision and Judge Kinkeade’s prior ruling,” added Bill Mateja, the lawyer representing Brennan and Zogby. “We’ve known all along that there was never any evidence of witness tampering on our part, and are not surprised with either the U.S. attorney’s office’s decision or the court’s prior ruling. The issue has now been put to rest here in Texas, and we’re hopeful plaintiffs’ counsel in other products liability cases who have attempted to exploit these patently false accusations against Drinker Biddle, Brennan and Zogby will cease as the assertions are baseless.”

Earlier this month the jury in the case delivered a $247 million verdict for the plaintiffs, awarding more than $78.7 million in damages, $90 million in punitive damages against J&J and $78 million in punitive damages against DePuy.

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