Cochlear joins $17m round for sleep apnea nueromod dev Nyxoah


Cochlear Ltd. (ASX:COH) has joined a $17.1 million (EU €15 million) funding round for Nyxoah to support the development and commercialization of its hypoglossal nerve stim therapy for treating obstructive sleep apnea.

Australian hearing tech developer Cochlear lead the round, investing $14.7 million (EU €13 million). The round was also joined by several existing Nyxoah shareholders, the Belgian company said. As part of the funding round, a member of Cochlear has joined Nyxoah’s board of directors.

“Cochlear actively monitors the market for novel technologies and implantable devices that over the long term may leverage its core business. Nyxoah’s minimally invasive solution presents an attractive alternative for patients with compliance or intolerance issues in respect of existing therapies. We look forward to working with Nyxoah,” Cochlear chief tech officer Jan Janssen said in a prepared release.

Nyxoah said that it recently completed a clinical study of its hypoglossal nerve stimulation tech that will serve as a milestone as it seeks CE Mark approval in the European Union. Funds from the round will be used to initiate post-CE Mark European market studies and work towards FDA investigational device exemption approval, the company said.

“We are extremely pleased to welcome Cochlear as a new investor. Their board-level participation will accelerate Nyxoah’s vision of becoming a leader in OSA therapy,” Nyxoah board chair Robert Taub said in a prepared statement.

“Patients from the BLAST OSA study show a major improvement in sleep apnea symptoms including a significant reduction Oxygen Desaturation Index and AHI. The Nyxoah therapy was also associated with high patient compliance and improvements in patient Quality of Life. We look forward to publishing the clinical results in a leading medical journal during 2019,” Nyxoah CEO Enrique Vega said in a press release.

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Merit Medical closes $200m Cianna Medical buy

Merit Medical acquires Cianna Medical

Merit Medical (NSDQ:MMSI) said yesterday that it closed its $200 million acquisition of Cianna Medical, making the company a wholly-owned subsidiary.

Aliso Viejo, Calif.-based Cianna makes the Savi Scout wire-free breast tumor localization system, designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures. The device won 510(k) clearance from the FDA in December 2014.

The deal included an up-front cash payment of $135 million, plus $15 million in earn-outs pegged to supply chain and scalability goals and another $50 million in sales milestones, South Jordan, Utah-based Merit Medical said.

“We are delighted to have Cianna Medical join the Merit family. We are looking forward to continuing Cianna’s momentum, expanding internationally, and associating with Cianna Medical’s domestic sales and marketing team,” Meric chair & CEO Fred Lampropoulos said in a press release.

Upon announcing the deal early last month, Lampropoulos said Merit plans to keep “substantially all” of Cianna’s commercial and R&D teams in place, adding logistical and clinical support to enter new markets.

Late last month, Merit Medical put up third-quarter numbers that beat expectations on both sales and earnings and confirmed that it’s on track to hit the midpoint of its guidance for the rest of the year.

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Aegea Medical raises $17m, touts 3-year adaptive vapor ablation pivotal results

Aegea Medical

Aegea Medical said this week it raised $17 million in a new financing round and released three-year follow-up data from the pivotal study of its Adaptive Vapor Ablation technology designed for use in endometrial ablation procedures.

The funding round was led by Solas BioVentures and its affiliates, with funds slated to support the company’s PACE II trial exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures, the Menlo Park, Calif.-based company said.

Funds from the round will also support the 2019 commercial launch of the company’s next-gen Adaptive Vapor Ablation system, Aegea Medical said.

“Aegea’s Adaptive Vapor Ablation technology offers physicians and patients a simple, elegant and safe treatment for treating a complex, underserved condition. The importance of being able to re-access the uterine cavity after endometrial ablation cannot be overstated. Aegea’s unique ablative medium has the potential to preserve less invasive options for patients. We believe we are just beginning to see the technology’s full potential, and we have confidence in its ability to become the new standard of care for treating menorrhagia,” Solas BioVentures co-founder & managing partner Dr. David Adair said in a prepared statement.

“We are fortunate to have found a partner in Solas BioVentures that truly appreciates our mission to provide patients with a natural treatment option that relieves their symptoms and restores their lives. This funding is an important milestone towards the commercialization of our next-generation Adaptive Vapor Ablation system, as well as research into the feasibility of preserving uterine cavity access following treatment,” Aegea Medical prez & CEO Maria Sainz said in a press release.

The company also released three-year results from the pivotal Aegea vapor system study, with results presented at the AAGL Global Conference on Minimally Invasive Gynecologic Surgery in Las Vegas.

Results from the 155-patient study, conducted at 15 sites in the U.S., Canada, Mexico and the Netherlands, indicated that the 120-second endometrial ablation was safe and effective, with 95% of patients reporting normal menstrual bleeding or no menstrual bleeding.

Data also indicated that 92% of patients reported being very satisfied or satisfied with the procedure, and 95% said they would recommend it.

“We are very encouraged by these positive data, as they show that the results of Adaptive Vapor Ablation stand the test of time. These three-year follow-up data should assure physicians and patients that our innovative and natural vapor-based treatment will successfully deliver sustained safe and effective outcomes including improved quality of life,” Sainz said in a prepared statement.

“These results give me great confidence in Aegea’s Adaptive Vapor Ablation procedure. It’s safe and effective, and it delivers the long-term outcomes we are looking for as physicians. I believe Adaptive Vapor Ablation is a valuable new option for treating women with menorrhagia,” Aegea pivotal study principal investigator Dr. Mark Levie of the Albert Einstein College of Medicine said in a press release.

Late last month, Aegea Medical said that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.

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Baxter expands share repurchase program to $3.4B

BaxterBaxter (NYSE:BAX) said yesterday that it expanded its share purchase program to $3.4 billion.

The Deerfield, Ill.-based company approved a $2 billion increase in authorization for the company’s existing share repurchase plan.

Baxter also declared a quarterly cash dividend of 19¢ per share of common stock to stockholders as of Dec 3, payable on Jan. 2, of 2019. The company’s indicated annual dividend rate is 76¢ per share of common stock.

“Baxter’s strong balance sheet allows us to serve our shareholders by investing in growth as well as returning value through dividends and share repurchases,” CFO Jay Saccaro said in prepared remarks.

Last month, Baxter shares fell after the healthcare company missed estimates on Wall Street with its third-quarter sales results and cut its revenue outlook for the rest of the year.

Baxter posted profits of $544 million, or $1.00 per share, on sales of $2.77 billion for the three months ended Sept. 30, for a bottom-line gain of 116.7% on sales growth of 2.2% compared with Q3 2017.

The company raised the low end of its earnings outlook, saying it now expects to report adjusted EPS of $2.98 to $3.00, compared with $2.94 to $3 previously, but cut its sales growth guidance to 5%, down from 6% previously.

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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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NeoChord raises $21m


NeoChord has raised $20.6 million in a new round of equity financing, according to a recently posted SEC filing.

The St. Louis Park, Minn.-based company offered Series D preferred stock in the round, with the first sale noted on October 31, according to the filing.

A total of 27 anonymous investors have joined in the offering, according to the filing. NeoChord is looking for an additional $8.8 million before closing the round, bringing the total raised up to a hoped for $29.4 million.

The company has not yet stated how it plans to spend funds in the round.

Earlier this month, NeoChord said that it closed a $25 million Series D equity financing round to help support its mitral valve repair system intended to treat mitral valve regurgitation.

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Ziehm Imaging wins $135m DoD contract for radiology systems

Ziehm Imaging

Ziehm Imaging has won a $135 million contract with the U.S. Department of Defense to supply them with radiology systems, accessories and training, according to a DoD release.

The deal comes through a five-year base contract with an additional single five-year option period, according to the release. A total of 50 responses for the competitive acquisition were received.

Radiology systems, accessories and training will be supplied to the Army, Navy, Air Force, Marine Corps and federal civilian agencies, according to the release, with the location of performance noted as Florida.

Orlando, Fla.-based Ziehm Imaging has not yet commented on the round.

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Report: Quanttus alums land at Apple, Amazon, Alphabet, other major players


Former employees of closed health monitor developer Quanttus have found themselves in critical positions with industry leaders include Apple (NSDQ:AAPL), Amazon (NSDQ:AMZN), Alphabet (NSDQ:GOOGL), Johnson & Johnson (NYSE:JNJ) and other major players, according to a CNBC report.

Originally spun-out of MIT in 2012, Quanttus aimed to develop a wearable vital signs monitor to measure blood pressure, heart rate and respiration. The device they created was designed to capture more than 500,000 vital sign data points each day in hopes of reducing the burden of issues like uncontrolled high blood pressure.

Despite hiring promising engineers and innovators from MIT, Nike, Mass. General Hospital and Apple, the company closed its doors in 2016 after data from early clinical trials of the device didn’t pan out, according to the report.

But employees didn’t go down with the ship – a number of vital personnel, including co-founder David He and CEO Yoky Matsouka, found themselves in important positions at major companies.

Co-founder He went on to join Alphabet’s Verily as a technical lead, while former CEO Matsouka spent a short stint with Apple’s health team before joining Alphabet’s home automation division Nest as chief tech officer, according to CNBC.

Quanttus hardware manager Jordan Rice is now a senior hardware leader at Nike and resident cardiologist and Quanttus study lead Maulik Majmudar joined Amazon, according to the report. Former interim CEO and board member Euan Thompson spent time as digital health head at Samsung and is now at J&J.

A good number of the companies the employees have joined have their own blood pressure monitor projects, CNBC reports.

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Report: Veritas, Elliott join in $5.5B Athenahealth buy

Athenahealth, Veritas Capital, Elliott

Healthcare software developer Athenahealth is set to be acquired by private equity firm Veritas Capital and hedge fund Elliott Management in a deal worth approximately $5.5 billion in cash, according to a new report from Reuters.

The acquisition would price the medical software developer at approximately $135 per share and will be officially announced on Monday, according to the report.

Athenahealth has been under pressure to sell itself from Elliott, which owns an approximate 9% stake in the company, according to Reuters, which cites people familiar with the matter.

Elliott had previously made an unsolicited bid to pick up the company for approximately $160 per share in May, which led to Athenahealth exploring such an acquisition with other firms.

The deal would be the largest such to date for Elliott’s PE arm, called Evergreen and based in Menlo Park, Calif, according to the report.

The company and the buyers in the deal have not yet officially commented on the rumored acquisition.

Athenahealth, which launched a major restructuring effort this year, has seen a number of changes to its executive roster, adding former CEO Jeff Immelt as its board chairman and seeing former CEO Jonathan Bush depart following allegations that he assaulted a former wife, according to Reuters.

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Minnesota’s medtech industry raised $90M in Q3 2018

 Investments in Medical Alley medtech companies, which had dipped in recent years, have made a comeback, according to the Minnesota trade association.

Device companies raised $90 million in the third quarter, pushing the year-to-date total to nearly $200 million raised by 33 companies. Q3’s largest raises in medtech included Urotronic ($26 million, including $20M in Series B funds), 4C Medical ($17 million), and Cardialen ($17 million), continuing a growth trend that began in 2009, Medical Alley said in a statement. Biotech companies broke $100 million in capital raised in a year for the first time in the association’s history. Investment in digital health companies reached $32 million raised in the third quarter for a year-to-date total of $116 million.

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

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