Amedica Adds Four Executives

Salt Lake City, Utah-based Amedica Corporation, a spinal and reconstructive medical device manufacturer, has beefed up its executive management in preparation for efforts to shift the standard of care for interbody fusion devices toward proprietary silicon nitride ceramic. As a result, four appointments—senior vice president of market development, vice president of marketing, a senior vice president of sales, and a chief legal and compliance officer—have been added.

Amedica is focused on advancing medical applications of its proprietary silicon nitride ceramic. In November 2007, Amedica secured clearance from the U.S. Food and Drug Administration (FDA) to manufacture and market silicon nitride-based interbody fusion devices. The resulting Valeo product line was launched in 2008. In September last year, FDA granted Amedica expanded biomaterial claims for the Valeo interbody fusion devices. In recent studies published in International Journal of Nanomedicine and Acta Biomaterialia, silicon nitride demonstrated anti-infective properties as well as superior new bone formation and osteointegration in comparison to PEEK (polyetheretherketone) and titanium. Also in September, Amedica received 510(k) clearance from the FDA to market a second-generation family of cervical and lumbar interbody fusion devices.

Vytas Rupinskas joins Amedica as vice president of marketing. Rupinskas brings more than 25 years of marketing experience in the orthopedic, spine, and neuromodulation medical device markets, previously holding senior-level positions at St. Jude Medical Inc., DePuy Orthopaedics Inc., DePuy International and DePuy Spine.

Paul Sendro, formerly senior vice president of sales for Amedica, now will be leading the company’s strategic market development initiatives. Paul has more than 20 years of experience in the orthopedic, trauma, and spinal medical device industries. He has held leadership positions at U.S. Spine, Vertebron, Blackstone Medical Inc., Stryker Corp., and Synthes USA.

Jim Abraham joins Amedica as senior vice president of sales, with more than 25 years of experience in the orthopedic, trauma, spinal, biologics and dental markets. He comes to Amedica from Stryker Orthopedics and previously held a number of executive positions at companies such as IsoTis Orthobiologics Inc., Regeneration Technologies Inc., Encore Orthopedics and Sulzer Medica.

Amedica named Kevin Ontiveros new chief legal and compliance officer. Kevin has more than 20 years of experience serving as in-house and outside corporate counsel for publicly traded and privately held medical device and biotechnology/pharmaceutical companies such as ImaRx Therapeutics Inc. and NPS Pharmaceuticals Inc.

“This is a momentous time for us as we expand our leadership team and gain extensive expertise and insights to further execute on our business strategy,” said Eric K. Olson, president and CEO of Amedica. “Rupinskas, Sendro, Abraham, and Ontiveros bring a wealth of experience to Amedica that will be critical to our ongoing success.”

New R&D VP Appointed at Biomedical Structures to Support Expanded Engineering Center
Biomedical Structures LLC (BMS) is growing. The biomedical textiles company will expand its medical textiles development and manufacturing facility by 10,000 square feet. The added space will support the engineering center for new product development and will increase the number of clean rooms available for textile development, according to the company.

Howe

In preparation for the expansion, BMS has appointed medical device industry veteran Jonathan Howe vice president of research and development. Howe will bring more than 15 years of experience developing solutions for the spinal, sports medicine, and interventional cardiovascular markets to help BMS meet the precise performance requirements of these device textiles.

Prior to joining BMS, Howe was the former director of research and development at Johnson & Johnson’s DePuy Spine division, where he activated, developed and led a global product portfolio designed to grow DePuy Spine’s market share, including the invention of new lumbar spine and cervical interbody devices. He also has served as the director of new product development for DePuy Mitek, a soft tissue repair and sports medicine device company, and as a product development engineer at JNJ’s Cordis, where he specialized in cardiovascular and neurovascular implants. Howe holds numerous patents and has launched dozens of products and product development programs. He received his B.S. in biomedical engineering from Rensselaer Polytechnic Institute in Troy, N.Y., and his M.S. in mechanical engineering and M.B.A. from Massachusetts Institute of Technology in Cambridge, Mass.

“BMS is thrilled to welcome Jonathan Howe to our R&D team,” said CEO Dean Tulumaris. “We are experiencing a tremendous demand for our biomedical textiles for increasingly sophisticated solutions across the orthopedic and cardiovascular markets. Jonathan’s track record of device development and innovative engineering approach are a great fit for our customers’ needs as they continue to evolve.”

“Biomedical textiles can provide the perfect solution for many medical device engineering challenges,” said Howe. “A cutting-edge medical textile developer like BMS is in the middle of a perfect storm of opportunity as device engineers look to improve performance and move toward more lifelike solutions for patients. I’m excited to join the BMS team with the chance to truly innovate on established designs.”
New ultrasonic and roll-to-roll triple cleaning capabilities are part of the expanded clean room space, which triples BMS’ 2011 total. BMS also has increased weaving capacity with advanced equipment to accommodate demand for vascular grafts, synthetic tendons and orthopedic tissue repair, and other woven textile structures.

BMS offers knitting, braiding, weaving, nonwovens, and composites, and uses biocompatible absorbable and non-absorbable materials in devices, drug delivery and surgical systems for applications such as bifurcated stent grafts, tapered tendon and ligament repair structures, and heart valve solutions.

IMDMC Elects Former Legislator as New Executive Director
Former Indiana state representative Peggy Welch has become the Indiana Medical Device Manufacturers Council (IMDMC) latest executive director. Based in Indianapolis, the IMDMC is an association of medical device manufacturers and other companies that work together to promote the education and the interests of medical manufacturers in Indiana and in Washington, D.C. Welch served a state representative in the Indiana General Assembly from 1998-2012. She also concurrently was—and still is—a part-time oncology nurse at the Indiana University Health Bloomington Hospital.

Welch

As a legislator, she focused on healthcare issues by leading the effort to form the life sciences caucus and serving on numerous committees and study groups, including the House Public Health Committee, the Select Joint Commission on Medicaid Oversight, and the Health Finance Commission.

During her tenure in the legislature, Welch received awards recognizing her work on healthcare issues, including the Indiana State Nurses Association’s Nyland Public Policy Award and the American Heart Association’s Heart of Indiana Award. She also was the inaugural recipient of the Great Lakes American Cancer Society Excalibur Award, and was named the Indiana State Medical Society Legislator of the Year.

“We are thrilled to have a person of Peggy’s ability and experience join IMDMC in this important leadership position,” said Chris Cerone, president of IMDMC. “She has a successful track record in healthcare and in public policy leadership, a rare combination that is a perfect fit with IMDMC’s mission to advocate on behalf of Indiana companies that manufacture a range of innovative medical devices.”

Welch is enthusiastic about working alongside the state’s medical device manufacturers. “Indiana is an international leader in the development of life-changing medical devices, and IMDMC will continue its role in advocating on behalf of these Hoosier companies that are critical to the state’s economy and to the health of patients around the world,” she said.

Welch told Orthopedic Design & Technology that because of redistricting, her career in the state legislature was cut short last year when she lost her re-election effort. With this new opportunity at IMDMC, however, she is uniquely positioned to inform state legislators on issues surrounding medtech in the state, which many lawmakers don’t know much about.

Thus far, Welch said, IMDMC has been focused on internal education. Her new position will allow her to bring that education out to the legislature for greater visibility of medtech.

“It’s unfortunate that [state lawmakers] don’t know much about medical device manufacturing in the state, and how it affects the health of the state—and indeed, how the orthopedic industry in Warsaw and companies like Cook Medical right here in Bloomington [where Welch works as a nurse] affect the health of the nation,” Welch told ODT. “My job is to educate the state.”

Welch said she also would be focusing on taxation and workforce issues in the state’s medical device industry.

NLT Spine Adds to Board
Israeli company NLT Spine, a developer of products for minimally invasive spine surgery and percutaneous procedures, has named Peter Wehrly to its board of directors. With 25 years in the medical device industry, he brings heavyweight experience including having served as president of Medtronic Inc.’s Spinal, Biologics and Navigation Division.

“As we prepare the platform’s introduction in the market, we are happy to have Peter Wehrly on our Board of Directors,” said Didier Toubia, NLT Spine’s CEO. “As a seasoned executive Peter can contribute from his vast knowledge, experience and network to advance our commercialization strategy. I am positive that his contribution will be invaluable to NLT Spine.”

Wehrly is the group president of Covidien plc, a position he has held since July 2011. In this capacity, he is responsible for the company’s respiratory and monitoring solutions and vascular therapy businesses, as well as the Japan, Australia-New Zealand, and Canada businesses. Wehrly also has held several executive-level roles at Medingo, a company that produces insulin patches, and Medtronic. He is a graduate of Ball State University in Muncie, Ind., with a bachelor’s degree in management.

“Joining as a board member at NLT Spine will enable me to work closely with a team of experts in their fields to advance the company’s impressive technology platform, which addresses important surgical problems,” Wehrly commented. “The ingenuity and industrious nature of the development team, characteristic of Israeli life science start-up companies, played a major part in my decision to take part in bringing this technology to the market.”