Senseonics touts patient access program for Eversense CGM

SenseonicsSenseonics (NYSE:SENS) said today that it launched the Eversense Bridge Program, which is designed to improve patient access to Senseonics’ Eversense continuous glucose monitoring system.

The company said that the program can help users confirm their insurance benefits and obtain pre-authorization before sensor placement. The Eversense Bridge Program is also meant to help healthcare providers and patients appeal to insurers regarding denied claims.

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

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Senseonics shares dip on Q4 sales miss, lowered guidance

Senseonics

Shares in Senseonics (NYSE:SENS) fell slightly today after the diabetes-focused device maker posted fourth quarter and full year 2018 earnings that beat loss-per-share consensus but missed sales expectations and lowered its guidance for the 2019 fiscal year.

The Germantown, Md.-based company posted losses of $7.3 million, or 4¢ per share, on sales of $7.2 million for the three months ended December 31, seeing losses shrink 55.2% while sales grew 148.3% compared with the same period during the previous year.

Read the whole story on our sister site, Drug Delivery Business News

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HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019

HydroCision CEO Tranchemontagne

HydroCision said early this month that it tapped former Smith & Nephew (NYSE:SNN) exec Alain Tranchemontagne as its new chief executive officer.

Prior to joining Boston-based HydroCision, Tranchemontagne held a position as U.S. business commercial development senior VP at Smith & Nephew. Before joining Smith & Nephew, Tranchemontagne also held positions at Covidien in senior marketing roles in the patient care division.

We are delighted to have Alain spearhead the next growth chapter in HydroCision’s future. The board was impressed with Alain’s proven track record at major medical device companies, his leadership and market development experience, as well as his passion and energy to broaden the use of our patented, proprietary technology,” board chair John Schulte said in a press release.

“I’m incredibly honored to be joining HydroCision, and I look forward to working closely with the dedicated HydroCision employees and the Board to deliver on the enormous opportunity that lies ahead. I’m also eager to quickly accelerate HydroCision’s growth trajectory, particularly leveraging our unique and differentiated technology into new surgical applications,” Tranchemontagne said in a prepared statement.

 Senseonics taps Kaufman as chief medical officer

Senseonics (NYSE:SENS) said this month it named Dr. Francine Kaufman as its new chief medical officer, effective immediately.

Kaufman previously served as a director at the Comprehensive Childhood Diabetes Center and head of the Children’s Hospital of Los Angeles’ Center for Endocrinology, Diabetes and Metabolism, Germantown, Md.-based Senseonics said.

“We are pleased to have Fran join the executive leadership team at Senseonics. As chief medical officer, she will be instrumental in helping drive forward our innovation platform and the clinical value proposition of the Eversense system. Fran is one of the world’s leading endocrinologists and her deep understanding of the global medical, research, and clinical diabetes community coupled with her track record of applying novel technologies to advance diabetes care for patients make her ideally suited for the role. We are confident that with her leadership, we will further transform and elevate the Eversense platform and bolster our US commercialization efforts at this critical point,” prez & CEO Tim Goodnow said in a press release.

“I am very excited to join the Senseonics team, especially at this point where I feel I have an opportunity to help lay the foundation for the first long-term implantable continuous glucose monitoring system. I have spent my career exploring the treatment and management of diabetes to improve outcomes for patients. I believe in the clinical value the Eversense system provides and am eager to help patients and providers realize its benefits,” Kaufman said in a prepared statement.

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 Camber Spine Tech appoints Dickinson as sales & new biz dev VP

Camber Spine Technologies said last week that it appointed Ryan Dickinson as its new sales and new business dev VP.

Prior to joining King of Prussia, Penn.-based Camber Spine, Dickinson has held positions with Verticor Spine and Invictus Medical, which he helped found.

“After leaving corporate America in 2017 and moving to West Palm Beach I vowed never to return to it again. It only took a few interactions with the founders of Camber Spine to see that they had something truly special brewing. Once I saw the efficacy and revolutionary technology of their implants I was hooked. That coupled with the testimonials of my own doctors using their products, I wanted in, I needed to be a part of what they were doing.  There’s a sense of magic in their implants, a magic that is going to catapult them to limitless heights. I am very excited to join the Camber Spine team. I believe the potential for growth is tremendous given the smart and passionate people that I have already met in the company and a very strong brand portfolio including their two very exciting proprietary technology platforms Spira and Enza,” Dickinson said in a prepared statement.

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 Qure.ai taps former GE Health exec Singh as CCO

Qure.ai said last week that it named former GE Healthcare exec Chiranjiv Singh as its new chief commercial officer.

Prior to joining Qure.ai, Singh served in a number of marketing and sales roles with GE Healthcare including X-ray division chief marketing officer, the San Mateo, Calif.-based company said.

“Chiranjiv’s track record of delivering growth in diverse geographies combined with his recent experience of leveraging the power of artificial intelligence to deliver improved patient outcomes, is aligned to Qure.ai’s key objectives. Over the last 3 years, we have been on a mission to deploy our solutions in the emerging markets, including a strong focus on Tuberculosis, the leading infectious cause of mortality worldwide. Chiranjiv’s global experience will help us reach new markets and drive adoption globally,” co-founcer & CEO Prashant Warier said in a press release.

“I’m proud to join a team that has recently published its 5th peer reviewed journal publication in the last year, including the first AI publication in The Lancet. The data science teams from Qure.ai have also presented more than 20 scientific abstracts at leading Radiology conferences such as RSNA and ECR. While there are many companies building algorithms, the fact that we are one of the few AI healthcare companies that is backing up the technology with both academic and industry validations is proof of the quality of our solutions. I see a huge opportunity for market creation and growth by understanding clinical needs and embedding Qure.ai solutions into user workflows to deliver maximum impact. I’m excited to be part of this journey to deliver value to patients and our healthcare system,” Singh said in a prepared statement.

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 Aethlon Medical names Boswell as quality systems, regulatory affairs director

Aethlon Medical (NSDQ:AEMD) said last week that it appointed Lisa Boswell as its quality systems and regulatory affairs director.

Prior to joining San Diego-based Aethlon Medical, Boswell held positions in quality assurance and regulatory affairs at Zoll Data Systems as well as positions in quality control at GlobeImmune.

“Lisa’s leadership will be critical as we move the Hemopurifier through the next stages of development.  Given the recent designation of the Hemopurifier as a Breakthrough Device by the FDA, it is extremely important that robust Quality Systems and Manufacturing processes are in place to support ongoing development and planned clinical trials,” interim CEO Dr. Timothy Rodell said in a press release.

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Senseonics inks CGM data deal with Glooko

SenseonicsSenseonics (NYSE:SENS) said today that data from its Eversense continuous glucose monitoring system can be integrated into Glooko‘s diabetes data management tech.

Thanks to the new partnership, Eversense users will be able to view historical glucose trends in Glooko’s mobile and web apps as well as real-time data from the Eversense mobile app, according to Senseonics.

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

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Senseonics partners to provide veterans with Eversense CGM

SenseonicsSenseonics (NYSE:SENS) this week announced that it partnered with Geo-Med to provide access to the Eversense continuous glucose monitor to more than 9 million veterans and U.S. government staff.

The company’s Eversense device is the first CGM system to feature an implantable sensor that can be worn for up to 90 days.

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

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Senseonics extends distribution agreement with Roche Diabetes Care

Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care.

The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 countries including Brazil, Russia, India and China where Roche will have exclusive distribution.

Senseonics officials boast that the company’s Eversense device is the first CGM system with an implantable sensor that someone with diabetes can wear for up to 90 days.

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

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Senseonics wins MRI-safe FDA nod for Eversense CGM

eversense-logoSenseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning.

“Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and CEO of Senseonics, said in a press release. “Now patients using Eversense CGM do not need to worry about an emergency MRI or delay getting a scheduled MRI based on their glucose sensor. All other CGMs currently on the market are required to be removed before an MRI scan, according to their FDA indications. This is a first for the CGM category.”

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

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Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019

Insulet CFO Wayde McMillan

Insulet (NSDQ:PODD) said yesterday that it tapped former Medtronic minimally invasive therapies CFO and finance VP Wayde McMillan as its new chief financial officer, replacing Michael Levitz.

The Acton, Mass.-based diabetes-focused medtech company said that McMillan will join the company in February and that Levitz will continue as an advisor for a period following the succession to ensure a smooth transition. McMillan will officially take the role of CFO on March 1.

Prior to joining Insulet, McMillan held executive roles in finance at Medtronic, having come to the company during its acquisition of Covidien in 2015. After the acquisition, McMillan helped reorganize the new acquisition into the Medtronic Group structure, the company said.

“We are excited to welcome a leader of Wayde’s caliber to Insulet as the company transitions to profitability, expands internationally, and enters its next phase of rapid growth. Wayde has significant expertise scaling large organizations and a thorough understanding of the strategies we are pursuing globally to accelerate growth and build on our strong foundation. We look forward to benefitting from Wayde’s experience as we continue to position the company for long-term success and solidify our leadership in the global management of diabetes. On behalf of the board of directors and the entire company, I want to thank Mike Levitz for his numerous contributions, as well as his support during this transition period. Over the last four years, Mike has helped develop and execute our strategic imperatives, strengthen our infrastructure and capabilities in support of future growth, and generate exceptional value for shareholders. We wish Mike all the best in his future endeavors,” prez & CEO Shacey Petrovic said in a prepared statement.

“I am honored to join the team at Insulet, a company with a strong mission dedicated to improving the lives of people impacted by diabetes. I look forward to working alongside the Insulet leadership team and contributing to the company’s initiatives to drive growth, profitability and value creation for shareholders,” McMillan said in a press release.

 Senseonics appoints Isaacson as CFO

Senseonics (NYSE:SENS) said yesterday that it named Jon Isaacson as its new chief financial officer, replacing R. Don Elsey.

Elsey will remain on with the Germanton, Md.-based company in an advisory role to support the transition and to assist in preparation of the company’s annual report filings for the previous fiscal year. Elsey is slated to stay on until his planned retirement date of February 28, or a later date if another agreement is made.

Prior to joining Senseonics, Isaacson acted as CFO of Edelman Financial Services from November 2017 to December 2018, and as managing director of private equity firm American Capital, the company said.

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 Livongo names Shapiro as CFO

Livongo said last week that it appointed board member and audit committee chair Lee Shapiro as its new chief financial officer, effective on February 1.

Shapiro currently serves as a member of the board and audit committee for Medidata Solutions and as the audit committee chair of Tivity Health, Mountain View, Calif.-based Livongo said. He also served at Allscripts Healthcare Solutions as president from 2001 to 2012, the company added.

“I couldn’t be more excited about working with Lee. His intimate knowledge of Livongo, his close working relationships with the leadership team, and his connections across the industry, including virtually every analyst in the healthcare and technology space, will allow us to rapidly accelerate our business and better serve our members and clients,” CEO Zane Burke said in a press release.

“Lee’s experience in scaling companies is a perfect fit for Livongo as the company moves to the next level. I speak for the entire team in sharing my enthusiasm in gaining Lee’s experience in building great companies for Livongo,” exec chair Glen Tullman said in prepared remarks.

“I have been impressed with what the Livongo team has accomplished in such a short time. As the company continues its rapid acceleration, my hope is to contribute in both financial and strategic ways to serve Livongo’s mission of empowering more people with chronic conditions to live better and healthier lives,” Shapiro said in a prepared statement.

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 Reva Medical lifts Elkolli to CFO

Reva Medical (ASX:RVA) said last week that it promoted Leigh Elkolli to the office of chief financial officer and corporate secretary, replacing Brandi Roberts who resigned, effective January 4.

Elkolli joined San Diego-based Reva Medical in August 2017 as finance senior director and corporate controller, the company said. Elkolli previously worked with privately held biotech company Avidity Biosciences, serving as finance director.

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 Wright Medical shuffles the exec roster

Wright Medical (NSDQ:WMGI) yesterday announced a number of internal organizational changes, including lifting current prez Kevin Cordell to the position of chief global commercial officer and exec VP and promoting senior VP and CFO Lance Berry to the newly created position of chief financial and operations officer and exec VP.

Cordell joined Wright in 2014, and has helped integrate the U.S. commercial teams of Tornier after the companies merged, Wright said. In conjunction with his promotion, current int’l prez Peter Cooke will assume the role of president of emerging markets, Australia and Japan and current upper extremities marketing VP Steve Wallace was promoted to int’l prez, the company said.

In his new role, Amsterdam-based Wright Medical said that Berry will be responsible for global finance and accounting, operations, quality, regulatory, information technology, strategy and corporate development.

“Wright Medical is quickly becoming a $1 billion high-growth medtech company that is built to win in the fast-growing Extremities and Biologics markets.  As we continue to grow and progress, there is a need to better align our team to support long-term revenue growth, profitability and day-to-day execution.  At the same time, we must stay strategically focused to maintain our technology differentiation and leadership positions.  It is with these goals in mind that I am creating two new executive vice president positions, reporting to me, to advance our global commercial focus and to further transform our global business processes. With significant opportunities ahead, these organizational changes will allow for further alignment of our cross functional organizations with a stronger and sharper focus on long-term growth and profitability, including a greater emphasis on the emerging market opportunity.  I am looking forward to working with Kevin and Lance in their new leadership roles and am confident that these appointments, along with our other organizational changes, will further bolster our ability to capitalize on the growth opportunities in front of us and accelerate our market performance,” prez & CEO Robert Palmisano said in a prepared statement.

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Senseonics touts first U.S. trial implant of 180-day CGM

SenseonicsSenseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA.

The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days.

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

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Senseonics CFO Elsey to retire | Personnel Moves – December 4, 2018

Former Senseonics CFO R. Don Elsey

Senseonics (NYSE:SENS) said yesterday that its CFO R. Elsey is retiring for the company, and that it has begun searching for a permanent replacement.

The Germantown, Md.-based company said that Elsey will stay on until a replacement is appointed, and remain on in an advisory role through to the completion of the company’s 2018 fiscal year.

“Don has been an important part of the growth of Senseonics as our CFO, and we thank him for his service and high level of professionalism throughout his tenure at Senseonics. Over the past several years, we have successfully completed an IPO and subsequent capital raises, enabling us to execute product launches in Europe, continue our pipeline development initiatives and position the company for a successful commercial launch that is underway in the U.S.  Don has contributed much to all of these efforts, and we wish him well in his next pursuits,” prez & CEO Tim Goodnow said in a prepared statement.

“It has been a pleasure working with the dedicated and talented team at Senseonics. I am proud of what we have accomplished and am confident the company is on a solid path toward delivering life changing technology to people with diabetes,” CFO Elsey said in a press release.

 Accuray names Hamamatsu as CFO

Accuray (NSDQ:ARAY) said late last month that it appointed Shig Hamamatsu as its CFO and senior VP, effective immediately.

Prior to joining Sunnyvale, Calif.-based Accuray, Hamamatsu served as corporate controller and VP at molecular diagnostics company Cepheid  before they were bought by Danaher in 2016.

“Shig has a proven track record of more than 15 years building and leading public company global finance organizations that drive results. I look forward to working with Shig as strategic financial partners to execute Accuray’s growth agenda,” prez & CEO Joshua Levine said in a press release.

“I am excited about my role and appreciate the opportunity to serve as Accuray’s chief financial officer during this transformative time in the company’s history. I look forward to working with our entire executive team and leading the company’s finance organization as we execute our growth and earnings expansion initiatives,” Hamamatsu said in a prepared statement.

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 Hill-Rom adds to exec roster

Hill-Rom Holdings (NYSE:HRC) said late last month that it tapped Barbara Bodem as its new CFO and senior VP, succeeding Steven Strobel who announced plans to retire from the position.

Prior to joining Hill-Rom Holdings, Bodem held a senior VP of finance position with Mallinckrodt, Chicago-based Hill-Rom said.

“We are pleased to have an executive of Barbara’s caliber joining the Hill-Rom team. Barbara brings more than two decades of financial experience along with a deep knowledge of our field from her work with large global medical companies. I am confident that she is a great fit for our company, and will play a key role as we continue to build our diversified portfolio to drive sustainable earnings and deliver on our long-term objectives. On behalf of our entire management team, I want to thank Steve for his significant contributions to Hill-Rom. He has built a strong finance organization, contributed significantly to our financial performance, and positioned us to continue to achieve our financial objectives. I’m grateful that he has agreed to work with us for the next several months to ensure a smooth transition,” CEO John Groetalaars said in a prepared statement.

“I am honored to join Hill-Rom, and look forward to working with John and the rest of the leadership team to build on the company’s momentum and deliver strong financial and operational results, while helping to improve outcomes for the patients and caregivers around the world who rely on Hill-Rom’s products,” Bodem said in a press release.

In addition, Hill-Rom said that it appointed current corp dev & strategy senior VP Andreas Frank as its new Front Line Care biz president, replacing Alton Shader, and current investor relations VP Mary Kay Ladone was appointed as corp dev, strategy & investor relations senior VP.

“Andreas and Mary Kay are seasoned professionals who know our business inside and out. We’re thrilled to tap into their talent and expertise for these roles. I am confident they will help Hill-Rom capitalize on our strong momentum and growth prospects,” Groetalaars said in prepared remarks.

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 Former HHS head Price to join Ga. Gov’s transition team

Former Health and Human Services secretary Tom Price, who resigned following a controversy over their use of a private jet, is joining new Georgia Gov.-elect Brian Kemp’s (R) transition team, according to a report from The Hill.

Price is slated to aid in policy planning during the transition, according to the report.

“Obviously he’s got a lot of great experience with healthcare. No one is more experienced with legislative matters than Tom Price and certainly his time in D.C. as well, so he’s a valuable member of our team, but we’re going to continue to work with a lot of different people on healthcare,” Kemp said, according to The Hill.

Price resigned from his position as U.S. HHS Secretary under President Donald Trump in September amidst criticism over using a private jet paid for on the public dime.

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 Baxter controller Karp resigns, Stevens steps up

Baxter (NYSE:BAX) said last month that its controller & senior VP Carloline Karp has resigned from their position to pursue other interests and business activities, and that it added Brian Stevens as its new chief accounting officer, controller and SVP.

Prior to joining Baxter, Stevens served as chief accounting officer with Groupon, the company said. Stevens is slated to hold the position until a successor is elected and qualified, the company said in an SEC filing.

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