Presbia delays Flexivue Microlens FDA PMA approval timeline again

Presbia (NSDQ:LENS) has delayed the timeline for approval of its Flexivue Microlens for treating far-sightedness again due to an earlier request for more information from the FDA.

The Irvine, Calif.-based company was told last October that it had 180 days to provide the agency with 36-month data from all subjects enrolled in the staged pivotal clinical trial, as well as additional safety and efficacy information, before it can complete its premarket approval application review, according to an SEC filing.

Presbia submitted its final pre-market approval module to the FDA during the second quarter of last year, including 24-month data for the Flexivue device, saying it expected the PMA bid to go through during the fourth quarter of 2018 before submitting final 36-month data during Q1 2019.

But the agency said on October 5 that it would require the 36-month data before it could finish its review of the PMA, Presbia said in an Oct. 12 SEC filing. The federal watchdog gave the company until April 3, 2019 to respond.

This week, Presbia said that it still needs additional time to submit the data to the FDA, and added that it got a 180-day extension, according to an SEC filing.

The company said that it expects it will complete the submission of the extra information before the September 30 extension date, but added that there is “no assurance” that it will be granted PMA approval, according to the filing.

Shares in Presbia have fallen 1.7% so far today, at 68¢.

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3M names CEO Roman as board chair | Personnel Moves – February 7, 2019

3M CEO Roman

3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire.

The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14.

“Under Inge’s leadership, 3M evolved into a more agile and competitive enterprise while generating tremendous value for customers and shareholders. Today’s decision underscores the Board’s confidence in Mike’s leadership and strong character to lead 3M into the future as both CEO and chairman of the board,” board independent lead director Mike Eskew said in a prepared statement.

“I am proud of 3M, our people, and what we’ve accomplished together. I’ve known and worked very closely with Mike, including since his appointment as CEO. I’m very confident that 3M’s best days are ahead and Mike will do a fantastic job leading 3M into the future,” Thulin said in a press release.

“It’s an honor to be nominated to the additional role of chairman of the board. I thank Inge for his leadership and partnership throughout my career, especially over the past year in his role as executive chairman,” Roman said in prepared remarks.

 VentureMed names former NxThera prez Paulson as CEO

VentureMed said on Tuesday that it named former NxThera prez & CEO J. Robert Paulson, Jr. as its new prez & chief executive, effective January 1.

Paulson will replace Gary Smith, who the Toledo, Ohio-based company said will continue to serve as a member of the leadership team.

Prior to joining VentureMed, Paulson served as prez, CEO and board director of NxThera from 2009 until the company’s acquisition by Boston Scientific (NYSE:BSX) last year.

Before joining NxThera, Paulson also held president and CEO positions with Restore Medical, which was acquired by Medtronic (NYSE:MDT) in 2008.

“Bob brings tremendous knowledge and experience to the VentureMed Group, together with a strong track record of building successful teams and commercializing compelling new medical technologies. We look forward to Bob’s contributions and leadership during this next phase of the company’s growth. On behalf of the board of directors, I would like to thank Gary for his significant contributions, which have created a solid foundation for the future success of the VentureMed Group,” board member and Endeavour Vision partner Alexander Schmitz said in a press release.

“I am thrilled to be working with our team and physician partners to expand adoption of our Flex VP System, to improve the treatment of peripheral arterial disease, and AV fistulas and grafts, in millions of patients around the world,” Paulson said in a prepared statement.

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 Repro-Med Systems lifts prez & CCO Petigrew to the corner office

Repro-Med Systems said on Monday that its reconstituted board of directors promoted prez & CCO Don Petigrew to the position of CEO.

Petigrew will replace interim CEO and chair Dan Goldberger, who is assuming the position of exec board chair, the Chester, N.Y.-based company said.

“As an industry leader in the home infusion market, RMS delivers invaluable medical and lifestyle solutions to patients who rely on our products. My vision as CEO is to innovate and improve our products such as the FREEDOM system, partner with the medical community to identify new patient needs and expand our reach in the US and abroad. Achieving these goals is a win-win for patients, providers and shareholders alike,” prez & CEO Petigrew said in a prepared statement.

“Don’s presence since joining the company has been immediately accretive. His experience in the infusion industry has uniquely positioned him to build upon the company’s successful foundation. I look forward to working with Don and the team at RMS and our newly reconstituted Board of Directors in my role as Executive Chairman to help the company achieve its potential and execute on our strategy,” exec chair Goldberger said in a press release.

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 Myomo taps Henry as CFO

Myomo said yesterday that it named David Henry as its new CFO, taking over for current chief financial officer Ralph Goldwasser, who is retiring effective February 18.

The Cambridge, Mass.-based company said that Goldwasser will stay on to help in the transition for an anticipated three months.

Prior to joining Myomo, Henry served as chief financial officer of Eos Energy Storage, and has also held CFO positions with American Semiconductor Corp and AMI Semiconductor.

“I would like to thank Ralph, who has worked with me at Myomo for the past eight years, first as a consulting CFO and later as our chief financial officer, enabling us to raise growth capital, including leading our June 2017 IPO and listing on the NYSE American exchange and our follow-on equity financing in December of 2017. We wish Ralph the best in his retirement. We are pleased to have David Henry join Myomo’s executive team as chief financial officer. David has extensive experience to support our efforts to grow the company,” chair & CEO Paul Gudonis said in a press release.

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 Amazon, Berkshire Hathaway & JP Morgan venture snags Kutan as CTO

The joint healthcare venture between Amazon (NSDQ:AMZN), Berkshire Hathaway and J.P. Morgan Chase has picked up former tech chief at digital healthcare startup ZocDoc Serkan Kutan as its new chief technology officer, according to a recent CNBC report.

The move was confirmed as official by the new health venture, according to the report.

“I am thrilled to now announced that I am serving as CTO of this new venture,” Kutan wrote in a LinkedIn posting, according to CNBC.

During his time at ZocDoc, Kutan was tasked with building technology allowing consumers to book doctors appoints digitally, according to the report.

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Presbia reaches ISO medical device quality milestone

Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings.

Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance audits for the next two years.

“We are extremely pleased that we achieved recertification under ISO 13485 during the transitional period, and it further demonstrates our commitment to quality in all aspects of our business,” Bob Lundberg, Presbia‘s SVP of regulatory and quality, said in a news release.

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

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