Ortho dev Trilliant Surgical raises $5m

Orthopedic device developer Trilliant Surgical has raised $5 million in a new round of equity financing, according to a recently posted SEC filing.

Money in the round came from a single anonymous investor, with the date of the first sale noted on February 27, according to the filing.

The Houston, Texas-based company, founded in 2007, is developing devices for small bone orthopedic corrections including bone and joint elective and trauma procedures for the foot and ankle.

Trilliant is currently offering ten products for the forefoot, mid foot, rear foot and ankle, according to its website.

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

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Hill-Rom to sell 3rd party rental biz to Universal Hospital Services

Hill-Rom Holdings (NYSE:HRC) said today it inked a deal to sell its third-party rental business to Minneapolis, Minn.-based Universal Hospital Services for an undisclosed amount.

Under the deal, which is expected to close during Hill-Rom’s fiscal third quarter, Hill-Rom will transfer certain moveable medical equipment to UHS to be rented to customers.

The third-party rental business generated $35 million in sales during the fiscal 2017 year, and Hill-Rom said it expects to incur after-tax charges of approximately $20 million, most of which will hit during the company’s second fiscal quarter.

“Portfolio optimization remains a key component of our transformational journey. With this divestiture on track to close during our fiscal third quarter, we are well positioned to redirect resources and strategic investments towards innovation, enhanced commercial capabilities, and areas of our business poised to drive accelerated growth and value in the years ahead,” Hill-Rom prez & CEO John Greisch said in a press release.

Earlier this month, Hill-Rom said it launched improved workflow efficiency and security features for its Welch Allyn Connex vital signs monitoring devices enabled by healthcare IT security company Imprivata.

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Invuity prez & CEO Sawyer steps down, Flora in as interim | Personnel Moves – March 13, 2018

Invuity (NSDQ:IVTY) said late last week that its president and chief executive officer Philip Sawyer has resigned and will be replaced by board member Scott Flora on an interim basis.

Flora has served as a member of the board since last November, and has held positions as prez, CEO and director of Omniguide. He has also held executive positions at Smith & Nephew (NYSE:SNN), including prez and GM of the orthopedics reconstruction division, GM of the trauma and clinical therapies division and senior VP of US & Europe.

“Phil is a truly visionary leader who over his eight years as president and CEO launched the company, led the initial public offering, introduced incredibly innovative new products and hired great talent. As the company has moved to its next phase, now is the perfect time to bring in a CEO who will execute on the company’s vision and move forward towards profitability while scaling the organization. On behalf of the board we appreciate the contributions that Phil has made to the company and wish him well in his future endeavors. Scott is uniquely qualified to lead Invuity in an interim capacity.  He brings executive leadership experience and domain expertise from his deep experience in the medical device industry.  Additionally, Scott has a familiarity with Invuity from his prior consulting role with the Company, and his recent appointment to the Board, that will enable him to seamlessly step into the interim President and CEO role,” board chair Gregory Lucier said in a prepared statement.

Board chair Lucier said that the company is currently searching for a permanent CEO.

“I am enthusiastic about deepening my relationship with Invuity. I look forward to building on Phil’s work and leading the organization during this interim period. We have terrific employees and customers that are excited about our technology,” Flora said in a press release.

 Endospan taps ex-Endologix exec Mayberry as CEO

Endovascular device developer Endospan said yesterday it tapped former Endologix exec Kevin Mayberry as its new chief executive officer, replacing Alon Shalev, who will stay on as a director.

Prior to his time with Endospan, Mayberry operated in various R&D and executive positions at Endologix after joining the company in 2004. Most recently, Mayberry acted as Asia-Pacific operations regional sales director, based in Singapore.

“This is a very exciting time to be joining Endospan. We have submitted for European approval of our Nexus Stent Graft System, the first off-the-shelf endovascular approach to treating aortic arch disease including aneurysms and dissections. While minimally invasive techniques are standard of care for treating descending aortic disease and heart disease, unfortunately the bridge between the two in the difficult-to-treat aortic arch anatomy is vastly underserved and remains a very invasive, high-mortality open surgery. More than 120,000 patients suffer thoracic aortic arch disease every year in the US and Europe, but only about 25% are diagnosed or treated. This global market opportunity already is greater than $1.3 billion in a segment with no off-the-shelf endovascular options. Consequently, we fully expect NEXUS will be embraced by cardiologists as well as cardiac and vascular surgeons,” Mayberry said in a press release.

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 Physeon names Kullmann as CEO

Vascular medical device developer Physeon said last week it named medtech vet Patrick Kullmann as its new CEO.

Kullmann has previously served in leadership positions at Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT), as well as operating in leadership positions with a number of startups.

“We’re very pleased to have Patrick join the Physeon team at such an exciting time in its evolution. Patrick’s background, experience and accomplishments makes him a perfect leader for the organization,” Physeon parent company Novintum Medical Tech CEO Alan Wilson said in a prepared statement.

“I’m thrilled to join the Physeon team as it continues to move toward the anticipated US clinical trial with its disruptive Veinplicity device for venous access. I am confident that my background in leading highly successful teams will translate into establishing and executing a successful FDA trial strategy for future US approval,” Kullmann said in a press release.

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 Raumedic CEO Bayer moves to N.C.

Raumedic said last week its prez and CEO Martin Bayer is moving his office to North America, looking to lead the company from its Mills River, N.C.-based site which is currently under construction.

Last month, Bayer was tapped as board chair for the company, which is looking to establish itself in the US market. In addition to Bayer’s promotion and move, the company said that COO Martin Schenkel was also tapped as board member for the company.

“I look forward to devoting myself to this task, and being on site will provide me with the best conditions,” Bayer said in a press release.

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 TearLab CFO Brazell to resign, Marquez steps in as interim

TearLab Corp. (OTC:TEAR) said late last month that its chief financial officer Wes Brazell is resigning from the company, effective March 30.

The San Diego, Calif.-based company said that the board of directors has appointed finance senior director Michael Marquez as its interim CFO, also effective March 30.

Prior to his time with TearLab, Marquez held positions with Alcon Laboratories and Price Waterhouse Coopers, the company said.

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Medtech’s existential crisis and how it can survive

The new EY report even includes an equation to show how medtech and other life science companies will need to deliver value: “Future value (FV) is driven by innovation (I) that focuses on outcomes with a high degree of personalization and is fueled
by unlocking the power of data (D.” [Image courtesy of EY]

Executives in medtech and other life sciences companies view digital health startups and high tech giants as an existential threat. To compete, they’re going to have to invest in or acquire customer engagement and personalization skills usually associated with online retailers and social networking sites, according to a new report out today from EY.

The report — Life Sciences 4.0: Securing value through data-driven platforms — quotes Johnson & Johnson CEO Alex Gorsky to indicate where things are going:  “Technology will touch everything that we do, whether it’s the way we use data to better understand the genome … or as it applies to things like minimally invasive surgery, even the way we talk to consumer vis-à-vis social media.”

Technology isn’t the only factor driving the change. Aging populations in the developed world mean that both public and private payers are tackling budgetary constraints and longstanding inefficiencies in healthcare systems.

In the medical device industry, companies are having to decide whether they are products companies selling to health providers or services companies focused on patients as a customer, according to the report’s author, Pamela Spence,  EY Global Life Sciences industry leader.

“I think companies need to decide what they want to be. … It’s hard to do both,” Spence said during an interview with our sister site Medical Design & Outsourcing.

Get the full story on MDO. 

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Unsealed Abiomed whistleblower suit reveals claims of retaliation

Newly unsealed court documents related to an alleged kickback scheme that Abiomed (NSDQ:ABMD) agreed to settle last week for $3 million revealed claims of retaliation against the whistleblower in the case.

The plaintiff-relator in the case, Max Bennett, accused the Danvers, Mass.-based company of firing him in retaliation for speaking out on the allegations that the company wined and dined physicians to encourage them to use its Impella heart pump, according to court documents.

“Shortly after Relator raised questions about Abiomed’s non-compliance with federal law, Abiomed’s management questioned Relator regarding his prior employment with Biotronik Inc. (a pacemaker company) and the reasons why he had left. During the course of these discussions, it became obvious to Relator that Abiomed’s superiors believed that he had been a whistleblower at his previous company, and therefore assumed that he would blow the whistle against Abiomed. Abiomed then retaliated against Relator by firing him on November 14, 2012, in violation of both federal and Massachusetts law,” unsealed court documents read.

Last week, federal prosecutors said that Abiomed agreed to pay $3 million to settle the case.

The U.S. Justice Dept. said that Danvers-based Abiomed agreed to settle the allegations for $3.1 million after a whistleblower’s lawsuit accused the company of buying meals for doctors “at some of the country’s most expensive restaurants, including Menton in Boston, Nobu in Los Angeles, Spago in Beverly Hills, and Eleven Madison Park in New York City.”

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TAE Life Sciences raises $40m for neutron beam cancer treatment

TAE Life Sciences said yesterday it raised $40 million in venture capital to support the development of its neutron beam technology designed as a potential treatment for head and neck, glioblastoma multiforme and other cancers.

The newly launched Foothill Ranch, Calif.-based company, which operates as a subsidiary of fusion energy company TAE Technologies, is developing neutron beam technology intended for Boron Neutron Capture Therapy.

As part of the company’s launch, it announced that it is partnering with Chinese BNCT company Neuboron Medtech, and that its first neutron beam system will be delivered to Neuboron for its first medical use.

I am pleased to be publicly launching TAE Life Sciences, and for the opportunity to provide solutions for aggressive and late-stage cancer with promising new applications of accelerator-based neutron beam technology. BNCT has been investigated as a promising area of treatment for some time, but challenged by the limited radiation options for convenient clinical practice. Now, TAE Life Sciences stands ready to offer a compelling and compassionate application of medical science innovation, increasing accessibility to treatment options for a challenging disease, and improving outcomes for patients around the world,” TAE Life Sciences CEO Bruce Bauer said in a press release.

BNCT is designed to treat multi-centric, sometimes inoperable tumors diffusely embedded in normal tissue intended to provide minimal harm to healthy cells. TAE Life Science’s proprietary BNCT platform includes a tunable neutron beam and compact form factor, the company said.

Funding in the round was led by Artis Ventures, and TAE Life Sciences said it plans to work with clinical research partners to investigate the use of accelerator-based BNCT to hasten development of its proprietary beam systems as it pursues regulatory clearance.

“TAE Life Sciences has a differentiated platform in the world of nuclear medicine and oncology, and is backed by strong, early results. Their seasoned team has already shown they can execute in a short period of time while continuing to garner interest from across the globe. As early lead investors, we look forward to helping TAE Life Sciences in a similar capacity as our work with Stemcentrx. Both companies have striking similarities in their potential to reshape the future of oncology,” Artis Ventures co-founder and prez Stuart Peterson said in a prepared statement.

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TransEnterix shares dip on Q4, 2017 earnings

Shares in TransEnterix (NYSE:TRXC) have fallen today after the medical device maker posted growing losses in its fourth quarter and full year 2017 earnings.

The Research Triangle Park, N.C.-based company posted losses of $76.2 million, or 40¢ per share, on sales of $3.4 million for the three months ended December 31, seeing losses grow 444.3% while sales grew a massive 6311% compared with the same period during the prior year.

Adjusted to exclude one-time items, losses per share were 8¢, just behind the 7¢ consensus on Wall Street where analysts were expecting to see sales of $3.3 million.

For the full year, TransEnterix posted losses of $144.8 million, or 97¢ per share, on sales of $7.1 million, seeing losses grow 20.7% while sales grew 368.1% compared to the previous fiscal year.

After adjusting to exclude one-time items, losses per share were 35¢, ahead of the 48¢ loss-per-share expectations on Wall Street, where analysts expected to see sales of $7.2 million.

“We made incredible progress during 2017, including the receipt of 510(k) clearance for the Senhance, the establishment of a global sales infrastructure, generating commercial momentum, and solidifying our balance sheet. As we look to 2018, our focus is driving the commercial adoption of Senhance globally by leveraging our sales infrastructure, expanding our instrument offerings, broadening Senhance’s indications for use, and obtaining additional regulatory approvals in key geographies,” prez & CEO Todd Pope said in a prepared statement.

Shares in TransEnterix are down 1.5% so far today, at $1.85 as of 10:07 a.m. EST.

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T2 Biosystems tops The Street with Q4, 2017 earnings

T2 Biosystems Inc. (NSDQ:TTOO) today reported fourth quarter and full year 2017 earnings that topped expectations on Wall Street.

The Lexington, Mass.-based company reported sales of $1.7 million for its fourth quarter, up 87% when compared with the same quarter least year. Costs for the quarter, excluding the cost of product revenue, were $9.8 million, down 16% over the previous years costs and expenses.

Sales expectations for the fourth quarter on Wall Street were $1.3 million, which the company handily topped.

For the full year, T2 Biosystems reported revenue of $4.7 million, up 15% from the previous year. Product revenue grew 100%, posting at $3.4 million for the year, the company said.

Full year revenues also topped expectations on Wall Street, where analysts expected to see the company post sales of $4.3 million.

“2017 was a productive year for T2, and we achieved a number of significant milestones that set the table for what we believe will be an exciting year for the company. We completed the T2Bacteria Panel FDA filing for market clearance in the United States, grew product revenue over 100%, expanded and reshaped our commercial infrastructure, closed two exciting new partnerships – including one with the CDC for the detection of the Candida auris superbug and closed a $20.1 million gross equity financing. Perhaps most importantly, we continued to see real world presentations, publications and stories from our customers that support the significant value our products can bring to patients and the healthcare system,” prez & CEO John McDonough said in a prepared statement.

T2 Biosystems released updated guidance for its first quarter of 2018, saying it expects to post sales of between $1.3 and $1.6 million, and that it expects to close at least six new contracts in the first quarter including 6 new placements of T2Dx instruments.

Shares in T2 Biosystems have dropped 4.7% in after-hours trading, at $5.90 as of 4:53 p.m. EST.

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Digirad settles wage, employee handling lawsuit for $1m

Digirad Corp. (NSDQ:DRAD) said recently it paid $1.3 million to settle a suit brought against it by a former employee claiming the company treated its employees inappropriately.

The class action suit was filed in the Alameda County Superior Court by former employee Shaun Smith on behalf of them and other employees.

The suit claims that Digirad and MD Office Solutions violated California law by failing to provide off-duty meal and rest breaks and to accommodate accurate wage statements, failing to pay all earned wages in a timely manner and failing to pay all wages upon separation from the companies.

In addition to those claims, Smith asserted individual claims for racial discrimination, retaliation and wrongful termination, according to an SEC filing form Digirad.

The company said it engaged in a voluntary mediation and reached a tentative settlement with the plaintiffs, which was approved last September. In December, the deal won court approval and Digirad paid $1.3 million to settle the suit, according to the filing.

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Healthcare AI dev Medial EarlySign raises $30m in Series B

Machine-learning healthcare developer Medial EarlySign said today it raised $30 million in a Series B round of financing to help support further development of the company’s platforms.

Funding in the round was led by the aMoon Fund and joined by Horizons Ventures and Nir Kalkstein, who founded trading firm Final and helped co-found Medial EarlySign.

“All major players in the healthcare ecosystem, including payers, providers and large employers, are realizing the impact big data and focused analytics can have on their bottom lines, as well as on the well-being of their patients. Medial EarlySign is the perfect algorithm powerhouse to deliver that type of impact and save not only tremendous amounts of money, but also lives.  We feel fortunate to be partnering with the world class team at Medial and look forward to contributing to the company’s success,” aMoon managing partner Dr. Yair Schindel said in a press release.

Israel-based Medial EarlySign is developing machine-learning based models to analyze data from electronic health records, including laboratory test results, demographics, medications and diagnostic codes. The company hopes to leverage the AI-based analytics to improve prediction and optimize care for patients.

“There is an incredible volume of meaningful routine healthcare data. Yet, while these data are electronically stored and available, they are still underutilized, and providers can glean much more actionable intelligence from it. This is where Medial EarlySign comes in. Our unparalleled expertise in these data and predictive health technology allows us to provide valuable insights and create improved actionable opportunities for early intervention, improved decision making, more effective care management, and physician and patient empowerment. This funding will allow us to further broaden our suite of solutions, and expand clinical research and global implementations of our clinically-supported technology. The insights we enable could bring added value to almost every interaction with the patient, with the potential to positively impact millions of lives,” founder & CEO Ori Geva said in a prepared statement.

Medial EarlySign said it is engaged in ongoing studies with more than 20 million patients at 14 institutions globally, and that its systems are already seeing clinical use.

Last month, Medial EarlySign touted data from a study of its algorithm designed to identify diabetic patients who have the highest risk of developing renal dysfunction.

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