FDA approves Intact Vascular’s Tack dissection repair device

Intact VascularThe FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018

Google Health CEO David Feinberg

Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report.

The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other candidates include execs from health consulting, hospital management and insurance.

In his new position, Feinberg will work closely with CEO Sundar Pichai, according to CNBC, which references individuals familiar with the search process.

Feinberg will oversee multiple groups at Google interested in healthcare including its core search team, cloud business and Google Brain AI team, according to the report.

The formerly independent Alphabet DeepMind health and AI company will also merge back into Google under the newly formed Google health team, according to a separate CNBC report.

Feinberg will be looking to organize the healthcare efforts at the tech giant, including building a health team within Google’s Nest automated home division, which was also merged back into the Google Home team this year, that could help monitor seniors living independently, according to the report.

No information has emerged as to whether Feinberg will work hand-in-hand with other Alphabet healthcare plays, including Verily.

Google has not yet officially commented on the hiring.

 Owens & Minor names Sledd as interim prez & CEO, begins search for perm replacement

Owens & Minor (NYSE:OMI) said last week that it named board member Robert Sledd as its new board chair and interim prez & CEO, succeeding P. Phipps.

The Richmond, Va.-based company said that it has formed a search committee, which will be assisted by an executive search firm, as it looks for a permanent replacement for the departed Phipps.

Sledd has served as a board member since 2007 and previously spent more than 20 years as chairman and CEO of food distro company Performance Food Group, which he co-founded in 1987. He also recently served as managing partner at Pinnacle Ventures and Sledd Properties, and prior to that served as a Senior Economic Advisor to the former Governor of Virginia.

“The board believes the business will benefit from a change in leadership. We thank Cody for his contributions to Owens & Minor and appreciate Bob Sledd’s willingness to step in on an interim basis as we conduct a search for our next CEO. Bob has a long and successful track record operating a large distribution company. We will benefit from his wealth of management experience as well as his knowledge of our business from his board tenure. Under Bob’s leadership, we will continue to execute on our strategic plan to strengthen and diversify our business as we also focus on operational excellence,” lead director Anne Whittemore said in a prepared statement.

“Owens & Minor is a highly respected company that is well positioned to address the critical supply chain needs of providers and manufacturers across the continuum of care. I look forward to working with our dedicated teammates to provide our customers with services and products that improve healthcare delivery,” Sledd said.

In addition to Sledd taking over as interim CEO, the company said that its current interim CFO Robert Snead will continue in his position.

“Robert is an outstanding teammate and I look forward to working closely with him,” Sledd said.

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 EOS Imaging taps NA prez Lobinsky as CEO

EOS Imaging (EPA:EOSI) said last week that it has picked NA prez Mike Lobinsky as its new CEO, taking over for Marie Meynadier who will step away from the position at the beginning of the new year, but will retain a board seat.

The move comes as the Paris, France-based company looks to strengthen its presence in the US and to expand its shareholder base, EOS Imaging said.

Lobinsky’s election was unanimously decided by the company’s board of directors, EOS Imaging said. He has held leadership positions with Smith & Nephew (NYSE:SNN), Brainlab, Blue Belt Technologies  and Stryker (NYSE:SYK), the company added.

EOS Imaging said that it also added Valérie Worrall as its new CFO. Worrall has previously served as CFO of medical device company Balt.

“I have enjoyed working with Mike for over a year. His leadership and knowledge of the industry, combined with his fine understanding of corporate culture, are excellent assets for EOS imaging and I have complete confidence in his ability to continue and accelerate the development of the company. Our North American market is considerable, and Mike will be able to develop it without denying our European roots, relying on the talented management team present in Paris, particularly Eric Maulavé, chief operating officer, to continue to drive global growth. It was an honor and a great pleasure to serve the company and to develop it since its foundation. I am most grateful to the men and women within our staff, to our directors, shareholders and clinical partners, who contributed to this development over these last years. Our teams can be proud of the work accomplished, and I have full confidence that they will continue to build our success under Mike’s leadership,” Meynadier said in a press release.

“Marie’s vision, her energy and her remarkable managerial talent have brought EOS imaging to a stage of excellence and a unique international reputation. Marie has given the company access today to an acceleration opportunity in the United States, which is a new step. She has managed to attract a management team capable of taking up this new challenge and ensure a successful succession. It is rare to be able to apprehend the future in such optimism,” board chair Gérard Hascoet said in a prepared statement.

“I am very grateful to Marie and the board members for their trust and pleased to accept the CEO position. Few companies have accomplished what EOS has and these achievements have established a strong foundation for further development. The potential of our entire solution is outstanding, and I am confident in our ability to translate this into growth and value in the short, medium, and long terms,” Lobinsky said in a prepared release.

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 Bovie Medical CFO Ewers to retire

Bovie Medical (NYSE:BVX) said this week that its chief financial officer, treasurer and secretary Jay Ewers intends to retire.

The Clearwater, Fla.-based company said that it has launched a search for a replacement and that Ewers will stay with the company until a successor is found, after which he will aid in the transition process.

“I would like to thank Jay, on behalf of the board and the entire team at Bovie Medical, for his significant contributions since joining the company in 2014. We appreciate his continued commitment to the company and its shareholders as we identify a successor and wish him the very best in his future endeavors,” prez & CEO Charlie Goodwin said in a prepared statement.

“It has been a great pleasure to serve on the executive leadership team at Bovie Medical and I’m proud of our many accomplishments during my tenure. With the proceeds from the recent strategic transaction, Bovie Medical is in a strong financial position to pursue its future growth objectives, and I believe this was the right time to begin my transition to retirement,” Ewers said in a press release.

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 Procept BioRobotics appoints Waters as CFO

Procept BioRobotics said last week it appointed former Accuray (NSDQ:ARAY)  chief financial officer Kevin Waters as its new CFO.

Prior to joining Accuray, Waters held financial leadership positions with a number of medical device companies including Conceptus, Laserscope and Visx. He has also held positions at PricewaterhouseCoopers, the Redwood Shores, Calif.-based company said.

“Kevin’s deep industry knowledge and leadership experience in commercial stage organizations make him a valuable addition to the Procept team, as we drive towards making Aquablation therapy with the Aquabeam robotic system the standard of care for treating BPH. His appointment rounds out the executive team at Procept, well-positioning the company for strong growth ahead,” founder & CEO Nikolai Aljuri said in a press release.

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Intact Vascular raises $20m in Series C

Intact Vascular said today it raised $20 million in a Series C round of financing, with funds slated to support the company’s Tack endovascular system through the FDA pre-market approval process.

The round was joined by major participants New Enterprise Associates, H.I.G. BioVentures and Quaker Partners, the Wayne, Penn.-based company said. The funding is slated to come in two stages or tranches, with the second closing later this year.

Late last week, the company posted an SEC filing showing that it had raised $10 million in a round of mixed financing, and that it was seeking an additional $11.8 million before closing the round, which is likely connected to its Series C.

“We continue to be impressed with the extensive clinical program that Intact Vascular is advancing to illustrate the significant clinical benefits that a better solution for dissections can have on angioplasty for peripheral arterial disease and critical limb ischemia. NEA is proud to partner with the Intact team, the world class group of TOBA trial series investigators, and our other investing partners to advance the Tack through its pivotal trials and launch as a global commercial growth opportunity,” NEA partner and Intact board member Dr. Justin Klein said in a prepared statement.

Intact Vascular is developing the Tack endovascular system, which is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Intact Vascular said.

The company said it is currently engaged in three clinical trials of the Tack system.

“We are at an exciting inflection point in the development of the Tack Endovascular System. With the projected completion of primary endpoint analysis for our pivotal TOBA II trial, and the projected completion of enrollment in both TOBA II BTK and TOBA III, 2018 is a true watershed year for us. We are delighted to partner with NEA, H.I.G., Quaker and several other investors on our journey to improve the treatment of peripheral arterial disease, and we truly appreciate their continued vote of confidence,” Intact Vascular prez & CEO Bruce Shook said in a press release.

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