Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds

Aroa Biosurgery, Tela Bio

Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair.

The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said.

With the clearance, the companies said that they will now offer the OviTex RBS devices in the US in sizes up to 20×40 cm, a 150% surface area increase over its currently available offerings.

“We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases. Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair,” Tela Bio prez & CEO Antony Koblish said in a prepared statement.

“The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence. As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and comprehensive suite of accessible and affordable options that address the current shortcomings in surgical hernia repair solutions,” Aroa Biosurgery CEO Brian Ward said in a press release.

Last May, Tela Bio and Aroa Biosurgery said they won CE Mark approval in the European Union for the OviTex RBS, which Tela Bio commercially launched in the region.

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Former Rotation Medical CEO Shadan joines Miach Ortho | Personnel Moves – January 3, 2019

Miach Orthopaedics CEO Martha ShadanEarly stage medtech firm Miach Orthopaedics said today that it named former Rotation Medical CEO and medtech vet Martha Shadan as its new prez and chief executive officer.

Shadan has held numerous leadership positions at medtech firms, including Zimmer Biomet (NYSE:ZBH), Covidien, Bristol Myers Squibb and Merck, Westborough, Mass.-based Miach said. Prior to joining Miach, Shadan lead rotator cup repair device firm Rotation Medical, which was acquired by Smith & Nephew for $210 million in December 2017.

Shadan has also served as exec chairwoman of Miach’s board of directors since September last year, the company said. She also serves on AdvaMed’s board of directors, and serves as board chair of the Accel Board of Directors and is a founding member of the Leadership Circle for the Women’s Executive Network.

“We are very glad to have Martha Shadan joining the Miach team. Her experience in the medical device space with successful commercialization of medical devices brings in a very valuable skill set, and we are very much looking forward to working with her as the CEO,” founder & chief medical officer Dr. Martha Murray said in a press release.

 NuVasive’s new CEO Barry shuffles the deck

NuVasive (NSDQ:NUVA) said today that its new CEO and former Medtronic (NYSE:MDT) surgical innovations prez Chris Barry has made significant organizational changes to its executive leadership roster as the company looks to improve internal growth and drive innovation.

The San Diego-based company said that its current prez Matt Link will retain his position with expanded responsibilities, including the direct management of its clinical services and global logistics businesses.

Current CFO and exec VP Raj Asarpota will retain their role alongside new responsibilities leading the company’s finance, accounting, internal audit and tax teams, the company said, while GC and corporate secretary Nate Sisitsky will continue in their role, but will also oversee the company’s real estate and facilities.

Chief compliance officer Jim Garrett will assume an expanded role overseeing the company’s business and quality systems functions, which includes GRI, regulatory affairs and quality affairs, information technology and environmental health and safety, NuVasive said.

Former HR VP Lucas Vitale was named chief human resources officer, while internal and external affairs lead Suzanne Hatcher and manufacturing head Dale Wolf will retain their positions, the company said.

The positions of global process transformation and people and culture exec VP, held by Stephen Rozow and Pete Leddy, respevtively, have been eliminated, NuVasive said.

“After assessing the company over the past two months as CEO, it is clear that NuVasive benefits from significant talent across the organization. Our new structure will enable us to better capitalize on this talent by fostering cross-functional collaboration, consolidating complementary functions and increasing accountability. I am confident this leadership team and our new structure, along with disciplined execution, will better position NuVasive to fulfill our commitments to patients, surgeons, employees and shareholders, and drive NuVasive’s success and sustainable growth,” Barry said in a press release.

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 Obalon Therapeutics promotes prez, COO Huang to the corner office

Obalon Therapeutics (NSDQ:OBLN) said yesterday that it promoted former prez & chief operating officer Kelly Huang to the position of chief executive officer, with former CEO Andy Rasdal taking up the position of exec chair.

Prior to joining Obalon, Huang served as GM for Galderma Laboratories’ aesthetic & corrective division. Before taking the position with Galderma, Huang acted as prez of Endo Pharmaceutical’s exec committee, San Diego-based Obalon said.

“More than a year ago, we brought Kelly in as chief operating officer to lead commercial operations. Kelly has continued to demonstrate that he is a strong and capable leader, and we believe he will be effective as CEO of Obalon. I intend to stay actively involved as executive chairman, primarily to serve as a resource to Kelly, and will also focus on several key strategic projects to help build the intragastric balloon market and create sustainable value for Obalon,” Rasdal said in a press release.

The company also announced that it promoted its clinical and regulatory affairs VP Amy Vandenberg to the position of chief clinical and regulatory affairs officer. Prior to joining Obalon, she held positions at companies including Dexcom and Cygnus.

“Amy led the clinical and regulatory aspects for FDA approval of Obalon’s original PMA and recent PMA-S approval of the Navigation/Touch system.  She continues to lead across all functions and levels of the organization.  I am pleased to recognize Amy’s contributions to the current business and future pipeline with her promotion to chief clinical & regulatory affairs officer,” CEO Huang said in a separate release.

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 Lightmed lifts founder & exec chair Lee to the corner office

Lightmed said yesterday that it reappointed its founder and exec chair Gary Lee as its new CEO, replacing Shlomo Alkalay who will return to a consultancy position.

In addition to the appointment, the San Clemente, Calif.-based company said that biz dev director Jennifer Lee was appointed to GM of Americas, effective immediately.

“I am proud to say that during my 1.5 years as CEO of Lightmed, the company has successfully accomplished implementation of our turn-around plan. Lightmed is now much better equipped with best-of-breed automated processes, controls and KPIs to face future global challenges and meaningful growth. I’ve completed what I set out to do and feel confident the company is not only in great shape, but I’m leaving it in the strongest hands under the original leadership of the company founder, Gary Lee,” Alkalay said in a prepared statement.

“Shlomo has shown exceptional leadership and has strategically guided Lightmed to a better position. Speaking on behalf of the entire board, we very much appreciate Shlomo’s service to Lightmed and he will be missed. Shlomo joined as CEO just at the right time when I needed to focus my efforts on our venture capital strategy. Now that the company is healthier and running smoothly, I’m looking forward to taking Lightmed to the next level of expanded product innovation and growth. Furthermore, I’m excited that our director of business development, Jennifer Lee, has assumed her new role in managing the USA, Latin America and Canada. Jennifer is an excellent leader and communicator who has shown remarkable capabilities in building new and existing business relationships. I look forward to seeing her grow our western market in 2019,” Lee said in a prepared release.

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 Nobilis Health taps Springfield as CEO

Nobilis Health said late last month that it appointed James Springfield as its new CEO.

Prior to joining Houston-based Nobilis, Springfield held positions with Memorial Hermann Health Care System, and served in leadership positions at a number of different hospitals and health systems.

“I am excited to take on this role and opportunity, as I have followed the Nobilis story in the Texas market and have seen their dramatic shift in-network and how the management team has successfully grown its medical facility infrastructure (including clinics, ambulatory surgery centers, and hospitals) as well its unique direct to consumer marketing platform.  This proprietary marketing technology provides Nobilis with the unique ability to quickly add new products and specialties and in combination with the recent significant increase of the company’s in-network business, makes Nobilis poised for strong and sustainable growth.  The scalability of the marketing platform allows Nobilis to enter new markets with ease and certainty. With the significant expansion of the company’s in-network business, there is now an opportunity to recruit from a much larger base of physicians, especially in the Texas market. The company intends to pursue alignment with physicians in new and existing specialties, while expanding the Nobilis brands to include total joint replacements, ENT and cardiovascular services, among others.  This is a vision and strategy that the management team and the company’s board of directors share. As Nobilis’ CEO, I welcome the responsibility of executing on this vision, and look forward to achieving the results I believe shareholders want to see. Nobilis will be the only in-network healthcare system that can use marketing to address both patient and provider needs.  In the coming months I look forward to sharing a clear plan on maximizing shareholder value for Nobilis investors,” Springfield said in a press release.

“Jim has extensive executive leadership experience with several of the nation’s largest healthcare providers and payors which fits in well with Nobilis’ shift to an in-network system. The addition of Jim Springfield to the Nobilis team as CEO will allow us to execute and achieve the benefits of an in-network model, including faster collection cycle, larger addressable market, certainty in revenue recognition, and greater willingness from physicians to participate in the in-network space, among other key advantages. He has led out of network to in-network conversions and is ideally suited to finalize Nobilis’ migration to being an in-network healthcare provider,” board chair Harry Fleming said in a prepared statement.

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Tela Bio raises more than $2 million

Tela BioRegenerative surgical implants company Tela Bio has brought in more than $2 million in investments, according to a recent U.S. Securities and Exchange Commission filing.

The Malvern, Pa.–based company had sought to raise a total $3 million, according to the SEC Form D filed Dec. 4.

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

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