Fire1 raises $50m in Series C to support novel HF patient monitor

Connected health company Fire1 said yesterday it closed a $49.7 million (EU €40 million) Series C round to support further development of its novel remote monitoring system designed for heart failure patients.

The round was led by newly invested Gilde Healthcare and joined by newly invested Gimv and Seventure. All existing investors, including Medtronic (NYSE:MDT), Lightstone Ventures and New Enterprise associates joined in the round.

As part of the financing, Gilde Healthcare’s Janke Dittmer and Gimv partner Patrick Van Veneden have joined Fire1’s board of directors.

“Improving outcomes for heart failure patients remains one of the most pressing needs in healthcare. We have been impressed by the Fire1 team, their development progress and the support they’ve garnered from leading clinicians for their comprehensive solution to transform heart failure management, ” Glide Healthcare partner Dittmer said in a press release.

Fire1 said the financing will help support development of its novel remote monitoring solution designed to improve outcomes for patients with heart failure, though did not release any further details of its technology.

“This infusion of new capital from these premier investors will enable us to accelerate our progress and deliver on our commitment to help patients with heart failure. Heart failure is a life-threatening disease and a significant burden on patients and healthcare systems.  Managing patients at home with novel digital health-enabled solutions will help intercept the trajectory of the disease and reduce the need for hospitalization,” Fire1 prez & CEO Conor Hanley said in prepared remarks.

In April 2016, Fire1 said its investors, including Medtronic, put up another $7.5 million for its Series B round.

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Elekta inks oncology co-selling deal with IBM Watson Health

Elekta (STO:EKTA B) said today it inked a collaborative sales deal with IBM‘s (NYSE:IBM) Watson Health through which Elekta will offer IBM’s Watson for Oncology with its cancer care solutions.

With the deal, Elekta said it will begin offering the Watson for Oncology early this year as a clinical decision support solution paired with its digital cancer care solutions, including the Mosaiq oncology information systems.

The combined offerings will be made available in markets including the US, Brazil, India, Australia and select European and Asian markets, Elekta said.

“Joining forces with IBM Watson Health positions Elekta as the first radiation therapy company to offer capabilities that combine conventional health information systems with artificial intelligence and cognitive cloud computing. Our goal is to bring cutting edge artificial intelligence technology to the cancer care continuum, including treatment planning, enabling evidence-based treatment recommendations for every patient regardless of where they are treated. We are excited to be working with IBM Watson Health to achieve this shared vision,” Elekta CEO Richard Hausmann said in a press release.

“Oncologists around the world rely on Mosaiq to support the treatment pathway, and we are eager to extend Watson for Oncology to more physicians and patients globally through Elekta’s sophisticated digital oncology solutions. We are proud to bring the evidence based clinical decision support of Watson for Oncology together with Elekta’s extensive expertise in the oncology EHR and radiation therapy field,” IBM Watson Health oncology & life sciences VP Lisa Rometty said in prepared remarks.

Last month, Elekta said it inked an exclusive deal with Brainlab to make it the authorized distributor of Elekta’s stereotactic neurosurgery solutions.

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Antidote looks to leverage AI, travel e-commerce tech to improve clinical trial enrollment

Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report.

Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out.

While open clinical trials are searchable through a government run national registry, navigating the trials can be extremely difficult, according to the report.

“Fundamentally, it’s a question of structuring information, which is something the tech world is great at. I was shocked no one had done it already,” Graiver said, according to the Wired report.

Antidote’s site allows patients to more easily search for possible clinical trials for their conditions, taking into account personal details for exclusion and inclusion that can often limit the size of studies, Wired said.

The site uses similar technology to travel fare aggregators like Orbitz or Kayak, and is entirely free for patients to use, outside of the cost of access to personal data, according to the report.

“It makes it less of a wild goose chase for patients. There’s just so much information for the common man or woman to get through. Technology can really make a patient’s journey easier,” Antidote partner PatientPower COO Esther Schorr said, according to Wired.

Antidote reportedly makes its money by selling limited access to the user database to pharmaceutical and clinical research institutions, though it claims that data is kept safe and that contact with patients on the site is limited to contact directly through the site.

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Long River Ventures rebrands as LRVHealth, launches $100m fund

Venture capital group Long River Ventures said today it is rebranding under the moniker LRVHealth and that it launched an early-stage digital health, medical device and diagnostics venture platform with a backing of $100 million in venture capital from its LRV IV investment fund.

The venture platform is joined by more than 20 “well-known healthcare insiders and thought-leaders,” eight national healthcare systems and the Innovation Institute, LRV Health said.

“LRVHealth has emerged as the premier early-stage healthcare venture capital firm. When the Innovation Institute began looking for a partner to launch a fund with, we evaluated several potential suitors and concluded that LRVHealth was the best fit. Our intent was to be more than a passive limited partner investor, instead actively participating in the fund with a seasoned team. The Innovation Institute infrastructure will assist in vetting investment opportunities, piloting solutions and helping to grow early-stage companies. We believe the Institute’s business model – highly focused on innovation and growth – brings benefits to the LRV IV Fund that other early-stage funds don’t have. This type of for-profit and non-profit collaboration will be a major catalyst to the transformation already underway across the nation’s healthcare industry,” Innovation Institute prez & CEO Joe Randolph said in prepared remarks.

The newly formed LRVHealth platform is designed for identifying, creating and investing in “disruptive, early-stage companies” in fields including healthcare IT, healthcare technology enabled services, devices and diagnostics, according to a press release.

The LRVHealth platform looks to connect healthcare operators and investors with providers, payers, vendors and industry executives. The investment team at LRVHealth is being lead by Will Cowen, Tripp Peake and Keith Figlioli.

“The healthcare sector is traditionally known for being conservative or risk averse, but the rise of healthcare consumerism and the flood of related data is forcing us into a phase of disruption not seen in our lifetimes. Clinicians are rapidly and successfully embracing new care delivery models, administrators are adopting new perspectives on value and risk, CIOs are demanding system interoperability and data sharing, provider networks are revaluating the scope and scale of their operations and boards and CEOs across the sector are focusing on innovation as a top tier issue,” LRVHealth general partner Will Cowen said in a press release.

LRVHealth touted that their roster of executive advisors includes Acelity CEO R. Andrew Eckert, xG Health Solutions chair Dr. Glenn Steele, former Premier Inc senior VP of corp. dev. and strategy Terry Linn and Mass eHealth Collaborative prez & CEO Micky Tripathi.

“Having been on the forefront of many innovation cycles in healthcare and helping to define new markets, it is critical for our healthcare systems to constantly test and build net new innovations within their systems and in collaboration across multiple systems. LRVHealth and its partners are solely focused on driving innovation across digital health to help transform our nation’s healthcare system and improve patient outcomes and care – a mission that directly supports a key focus of my career. It’s an honor to be an advisor and help the team build great companies that can be financially successful and also empower the healthcare ecosystem to better accomplish its mission for people, patients and supporting communities,” xG Health Solutions chair Dr. Glenn Steele said in a prepared statement.

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Nemaura Medical touts clinical trial data for non-invasive glucose monitor

Shares in Nemaura Medical (NSDQ:NMRD) jumped today after the company touted positive data from the European clinical trial program for its non-invasive sugarBeat glucose monitoring system.

The summary results were taken from a 25-patient group in the three-stage trial, made up of 80% Type I diabetics and 20% Type II diabetics. Each patient continuously wore the sugarBeat device for 14 hours across seven consecutive days.

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

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Arkray inks licensing deal with Mellitus Health for insulin titration software

Arkray‘s U.S. business has inked a licensing deal with Mellitus Healthfor its insulin titration software, Insulin Insights.

Mellitus Health, formerly known as Insulin Algorithms, developed the clinical decision-support tool to help doctors keep their patients’ blood sugar levels in control with optimized insulin therapy. The software is compatible with any blood glucose monitoring system and with all brands of insulin.

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

 

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Finland’s BBS-Bioactive Bone Substitute plans $10m IPO

BBS-Bioactive Bone Substitutes said today that’s its planning for an initial public offering later this year it hopes will bring in some $10 million.

Oulu, Finland-based BBS said it plans to list 1.5 million shares at €5.50 apiece beginning Feb. 5 for gross proceeds of €7.7 million, or roughly $9.6 million. The shares, due to trade on the First North Finland and NASDAQ First North Sweden exchanges, would represent about 23.9% of BBS’s total shares if the flotation is fully subscribed.

Based on proteins extracted from reindeer bone, BBS’s Artebone is designed to be injected to the site of a bone fracture or defect to promote natural healing, the company said. Proceeds from the IPO are slated for completion of the application processes for both CE Mark in the European Union and FDA approval, BBS said, plus product development and commercialization.

“Orthopedic diseases are the second most common cause for disability and user of health care resources worldwide, and they increase with the aging population. An improved standard of living means that there is a desire and capability to treat even difficult bone defects, as long as effective yet safe, reasonably priced and easy-to-use methods exist,” CEO Pekka Jalovaara said in prepared remarks. “The product we have developed has features similar to a person’s own bone graft. The clinical trial ended in late 2017, and the product received good marks for functionality and safety. I believe that Artebone has great potential to succeed in the growing market for orthobiological products both in Europe and elsewhere.”

($1 = €0.804908)

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New Zealand’s Medsafe regulatory body removes pelvic mesh products from market

New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today.

The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and one mini-sling product designed to treat stress urinary incontinence.

Medsafe said that last December it requested safety information from four surgical mesh suppliers in New Zealand, following action taken by Australia’s TGA as it looked to review meshes used for urogynaecological use.

The earlier TGA’s investigation ended in regulatory actions to remove the devices from the market, MedSafe said, and similarly resulted in their removal from New Zealand’s market.

“All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” Medsafe group manager Chris James said in a press release.

The regulatory action only relates to the use of surgical mesh in pelvic organ prolapse via transvaginal implantation and a single product designed for stress urinary incontinence, and does not affect supply of surgical meshes for other uses, including hernia repair or stress urinary incontinence, according to the release.

Medsafe said it will continue to work with the companies to make sure appropriate changes, including warnings in instructions for use, are made in New Zealand as soon as possible.

“The section 38 review and restrictions are the strongest action possible under current legislation. As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website. Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained,” James said in a prepared statement.

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Eli Lilly beats the Street with Q4 earnings

Shares in Eli Lilly (NYSE:LLY) fell slightly this morning even though the pharmaceutical company beat analysts’ estimates with its fourth quarter and full-year financial results.

The Indianapolis-based company swung to a net loss in the fourth quarter, posting -$1.7 billion, or $1.85 per share, on sales of $6.2 billion for the 3 months ended Dec. 31, for sales growth of 7% compared with the same period last year.

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

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Avinger pulls trigger on 1-for-40 reverse stock split

Avinger (NSDQ:AVGR) said this week it enacted a 1-for-40 reverse stock split of its common stock, effective yesterday, as it looks to satisfy the $1 minimum bid price requirement to be listed on Nasdaq.

In the split, each shareholder in the Redwood City, Calif.-based company received a single share of common stock for every 40 shares they previously held, with cash paid in lieu of fractional shares that were a result of the split.

The split was approved by the company’s shareholders on Monday, and has reduced the outstanding shares in Avinger from approximately 35.1 million to approximately 877,000.

“The reverse stock split is a critical step in our strategy to maintain the company’s Nasdaq listing and is an important component of our broader strategy to strengthen the company’s capital position,” prez & CEO Jeff Soinski said in a press release.

Last month, Avinger said it is seeking FDA approval for its next-generation Pantheris atherectomy device only a day after it said it won CE Mark approval for the platform.

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Halo Neuroscience raises $13m in Series B

Neurostimulation device maker Halo Neuroscience said today it raised $13 million in a Series B round of financing to support its Halo Sport neurostim headset designed to improve muscle memory acquisition from athletic training.

The funding round was led by TPG and joined by existing investors Lux Capital, JAZZ Venture Partners and XFund, the San Francisco-based company said.

“This round of funding is a testament to the proven science behind Halo, and to the enormous potential of the company in the areas of consumer and medical neuromodulation. Halo has pioneered a powerful new means of improving human performance, and we’re proud to stand behind its technology and leadership,” TPG’s Heath Lukatch, who joined Halo’s board, said in a prepared statement.

The company’s flagship device, the Halo Sport, is designed to deliver neurostimulation to the motor cortex in a 20 minute neuropriming session which Halo Neuroscience claims induces a temporary state of hyperplasticity that allows neural pathways from the motor cortex to the muscles to be optimized and strengthened.

“Halo is a leader in unlocking the potential in the brain’s capacity to learn, and stands as one of the most exciting new technologies I’ve seen in recent years. Currently used by elite athletes at the highest level of sport, we anticipate a wider audience to develop among those seeking to improve a broad range of human activity, from sports-specific skills to key cognitive functions,” board exec chair Peter Gotcher said in a prepared statement.

Halo Neuroscience said that the device is currently being used by organizations including the San Francisco Giants, the US Olympic Ski Team and US Special Operations Forces.

“What started in 2013 as a team of neuroscientists who believed in the power of neurostimulation has led to a global movement. We are proud to be the torchbearers in the space and are excited we now have the financial fuel to build and launch two new products that will further unlock human potential,” Halo co-founder Dr. Daniel Chao said in a press release.

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Boston Scientific’s drug-coated balloon goes up against Medtronic’s DCB in first-of-its-kind trial

Top-line results from a head-to-head trial comparing Boston Scientific‘s (NYSE:BSX) Ranger drug-coated balloon and Medtronic‘s (NYSE:MDT) In.Pact Admiral DCB found no statistically significant difference in patency rates between the two drug-device products.

The trial is the first of its kind, according to Boston Scientific’s president of peripheral interventions, Jeff Mirviss.

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

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Judge grants class certification in lawsuit over Medtronic’s Infuse

A federal judge in Minnesota yesterday granted class certification to an investors’ lawsuit brought against Medtronic (NYSE:MDT) over its Infuse bone-growth protein, a little more than a year after an appeals court revived the case.

Approved in 2002 for use in spinal fusion surgery, Infuse at one point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Fridley, Minn.-based Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.

This lawsuit accuses Medtronic of concealing the negative side effects of Infuse. The plaintiffs claim that investors bought Medtronic shares based on the misrepresentations and were subsequently injured when the stock dropped after Infuse’s safety issues came to light.

In December 2016 the U.S. Court of Appeals for the 8th Circuit revived the case, ruling that a lower court judge was wrong to find that the plaintiffs sued too late in waiting more than two years after learning of the alleged intent to defraud. The plaintiffs include institutional investors West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG and Employees’ Retirement System of Hawaii.

The appeals court found that it was not until a Spine Journal issue was published in June 2011 that reasonable shareholders might have inferred that problems with the company’s Infuse studies indicated an intent to defraud.

Yesterday Judge John Tunheim of the U.S. District Court for Minnesota granted certification to anyone who bought MDT shares between Sept. 8, 2010, and June 28, 2011, setting the stage for the case to proceed.

Medtronic agreed to settle another shareholder lawsuit for $85 million in March 2012.

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Insightec closes $150m Series E

Insightec said today it closed a $150 million Series E private equity round of financing with plans to use funds to support marketing, commercialization and further development of its Exablate Neuro platform.

The round was led by Koch Disruptive Technologies subsidiary Koch Industries, who invested a total of $100 million during the round, the Israel-based company said.

The company’s flagship Exablate Neuro device, which won FDA approval last July for treating essential tremor, uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.

Proceeds from the round are slated to support marketing and commercialization for approved indications for its Exablate Neuro as well as continuing research and development exploring new brain indications for the device, including Parkinson’s disease, Alzheimer’s disease and cancer.

“Insightec is committed to driving global adoption of our existing focused ultrasound treatments, while leading ground-breaking research to apply our proprietary technology in novel ways. With this substantial investment, we plan to ultimately leverage our incisionless solutions to positively transform the lives of millions of patients,” CEO & board chair Dr. Maurice Ferré said in a prepared statement.

Earlier this week, Insightec said it is partnering with the Virginia Tech Carilion Research Institute as it looks to develop treatments for brain disorders utilizing the company’s Exablate Neuro system.

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Tax reforms push Stryker to Q4 red

Stryker (NYSE:SYK) swung to red ink during the fourth quarter despite posting a nearly 10% top-line gain, largely due to the impact of the tax reforms passed last year.

The Kalamazoo, Mich.-based medtech giant reported losses of -$249 million, or -66¢ per share, on sales of $3.47 billion for the three months ended Dec. 31, 2017. That compares with profits of $510 million, or $1.34 per share, for Q4 2016. Adjusted to exclude one-time items, earnings per share were $1.96, 2¢ ahead of the consensus on Wall Street, where analysts were looking for sales of $3.39 billion.

Full-year profits were down -38.1% to $1.02 billion, or $2.68 per share, on sales growth of 9.9% to $12.44 billion compared with 2016; adjusted EPS were a penny ahead of The Street, where the consensus sales outlooked called for $12.37 billion.

“As pre-announced, we delivered excellent organic sales growth of over 8% in the fourth quarter, capping off a strong year for Stryker,” chairman & CEO Kevin Lobo said in prepared remarks. “We expect our positive momentum to continue in 2018 with another year of strong organic sales growth and leveraged adjusted earnings gains.”

Stryker said it expects to log adjusted EPS of $1.57 to $1.62 during the first quarter and $7.07 to $7.17 for the full year, with 2018 organic sales growth of 6.0% to 6.5%.

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Dexcom takes on Abbott in head-to-head glucose monitoring trial

Dexcom (NSDQ:DXCM) touted data today from a head-to-head trial comparing its G5 mobile continuous glucose monitoring system with Abbott‘s (NYSE:ABT) recently-approved FreeStyle Libre Flash glucose monitoring system.

The I-Hart study, which enrolled 40 people with Type I diabetes, found that Dexcom’s device reduced patients’ time spent in hypoglycemia by 43 minutes, while Abbott’s system increased patients’ time spent in hypoglycemia by 19 minutes.

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

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Charting the FDA’s course for 2018-2020

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

By: Jeff Shuren, M.D., J.D.

Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition between countries but rather a measure of timely patient access.  Since then our strategic priorities have been laser-focused on achieving this aim, continually building on one another, with measurable goals that we report on to the public.

Today, I’m pleased to report that we achieved our goals and met or exceeded all our individual targets for our three 2016-2017 strategic priorities. Our actions include, but are not limited to the following:

Establish a National Evaluation System for Medical Devices (NEST)

We developed the foundation for the National Evaluation System for health Technology, including giving a $3 million grant to the Medical Device Innovation Consortium in 2016 to establish a NEST Coordinating Center, and developed a framework for the incorporation of real-world evidence into regulatory decision making.

Partner with Patients

We established the Patient Engagement Advisory Committee, had over 96% of our employees participate in patient engagement events with 48 patient groups, increased the use of patient-reported outcomes in device clinical studies, and increased the conduct and use of patient preference studies in our decision making.

Promote a Culture of Quality and Organizational Excellence

More than 900 CDRH staff enrolled in formal quality training; 46 received new auditor certifications, 120 new quality associate certifications, and 18 new lean six sigma certifications. We also launched the Pre-market Approval (PMA) Critical-to-Quality Pilot Program to streamline the pre-market approval process while assuring a company’s quality system includes controls for features and characteristics considered critical to the safety and effectiveness of the device. As a result, FDA will be able to conduct a post-approval inspection rather than a pre-approval inspection where appropriate.

It is important to note that innovation and safety are two sides of the same coin: FDA fosters innovation in order to spur the development of safer, more effective technologies and assure timely patient access. New devices make less-invasive treatments possible and provide new options to patients whose conditions would have been considered untreatable in the past.

Our actions have already produced tangible, meaningful results. For example, between 2009 and 2017 the annual number of devices CDRH has approved has steadily increased almost 4-fold – from 24 to 95 – to reach an all-time high during the user fee era.

Now it’s time to look ahead to the next three years. So today I am announcing the three strategic priorities for 2018-2020, which we have laid out in more detail in our roadmap for this period. The new plan is based on internal input and feedback about goals, targets, and actions, and builds on the actions of our past priorities which we will continue to work on.

The three priorities are:

Employee Engagement, Opportunity, and Success. The dedication, expertise, and innovative spirit of our people are the bedrock of the Center and of our success. This priority recognizes the connection between taking care of our employees and achieving our vision. When our staff is engaged, they are the most productive, creative, motivated, less likely to leave, and committed to the mission and vision. However, we recognize that engagement requires work-life balance, open dialogue, and opportunities to succeed. We are grateful to our staff for their deep and abiding commitment to ensuring U.S. patients have access to high-quality, safe and effective medical devices and believe that by making this one of our strategic priorities, we are not only making a formal commitment to our staff but also supporting their ability to deliver on their commitment to patients.

Simplicity. Our issues are often complex; this priority acknowledges that our solutions and processes do not necessarily have to be and that this complexity can sometimes serve as an impediment to ensuring that patients have access to the safest and most innovative products. Simplicity means that in everything we do, we continually streamline our policies, processes, programs, and approaches, as appropriate, to more effectively, efficiently, and quickly achieve our mission and vision.

We are already striving to streamline and modernize CDRH into a better aligned Center that enables us to work more efficiently. Our Total Product Life Cycle approach and reorganization, which integrates our pre-market, post-market surveillance and quality-compliance management Offices and functions, is an example of this. By having our teams look at products throughout the entire lifecycle, we’re enhancing their understanding of the products and their impact on patients. Additionally, we are expanding the application of the Least Burdensome principle to reduce unnecessary burdens on industry and leaning our processes to reduce unnecessary burdens on ourselves.

We have one of the most rigorous regulatory standards for protecting public health – reasonable assurance of safety and effectiveness. And simplicity does not in any way mean sacrificing our commitment to these standards. In fact, we believe that applying an approach of simplicity will enhance our decision making and allow us to make better use of our resources to focus more on what matters most to patients.

Collaborative Communities. This priority acknowledges that we serve the American public better and achieve our vision when stakeholders in the medical device ecosystem, including CDRH, proactively work together to solve problems. The hallmark of a Collaborative Community is a continuing forum where public and private sector members proactively work together to solve both shared problems and problems unique to other members in an environment of trust and openness, where participants feel safe and respected to communicate their concerns. The role of CDRH will be to foster a community spirit and responsible choice through the creation of Collaborative Communities with broad and fair representation to solve problems and proactively build for the future. We will enable our customers to take a more active role in the advancement of smart regulation and the rise of Patient Scientists — those scientists, health care professionals, engineers and others who focus on serving the unmet and developing needs of patients and who incorporate their own experiences as or with patients into their work in industry, health care, and government.

Admittedly, these goals take a more holistic approach to improvement than our priorities of the past. They will require holding ourselves accountable for setting our employees up for success, streamlining processes and policies, and fostering collaboration between members of the public and private sectors.

By applying these three approaches more systematically we believe we will arrive at the threshold of achieving our vision in the next three years. Therefore, as a measure of success, we aim to have more than 50 percent of manufacturers of novel technologies for the U.S. market intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020.

I am convinced we can do this with the dedicated work of our excellent staff and the support of our customers – while continuing our ongoing efforts with NEST, our work with patients and our pursuit of quality and organizational excellence.

In addition to our strategic priorities, we will soon unveil our “Medical Device Safety Plan,” which among other objectives helps chart a path to a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety. We look forward to providing more information about this plan in the coming weeks.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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RenovaCare touts data from 44-patient SkinGun burn treatment retrospective analysis

RenovaCare today released results from a retrospective analysis of 44 patients with severe second-degree wide-area burn injuries who were treated with the technology underlying the company’s SkinGun and CellMist system.

Results from the analysis were published in the peer-reviewed journal Burns, the company said.

“Treated patients presented with a variety of burn wound etiologies and a wide range of TBSA (Total Burn Surface Area). Overall clinical results were very satisfying,” study authors wrote in a press release.

The 44 patients in the analysis were treated through a method which involved isolating and spraying the patients’ skin stem cells onto burn wounds, which RenovaCare said uses technology its SkinGun and CellMist system are based off of.

Patients in the analysis were treated for deep partial-thickness burns, including gas and chemical explosions and electrical, gasoline, hot water and tar scalding burns, RenovaCare said.

According to data from the published analysis, use of the technology on such burn wounds “can achieve rapid wound re-epithelialization, particularly in large wounds.” Average days to healing and discharge in the analysis were low, regardless of the severity or size of the wound, the company said.

“This data is especially compelling because patients were successfully treated for a broad spectrum of burn injuries and vast burn surface areas. Importantly, patients had very short hospital stays, which, we believe could deliver a better healing experience for patients and lower costs for hospitals and insurance providers. The clinical outcomes and minimal hospital stays for severe burn patients published in this article supports our conviction to bring our SkinGun technology to market as quickly as possible. Presently, we’re finalizing the requisite documentation for filing with the FDA to demonstrate the safety of our approach for treating wounds using a patient’s own skin cells,” RenovaCare prez & CEO Thomas Bold said in a prepared statement.

Last October, RenovaCare said it raised $2.3 million in a new direct offering to support its SkinGun technology.

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Siemens Healthineers taps ex-Abbott Vascular prez Nath to lead lab diag biz | Personnel Moves January 30, 2018

Siemens (NYSE:SI) Healthineers said today it tapped former Abbott (NYSE:ABT) Vascular president Dr. Deepak Nath as its new laboratory diagnostics business president, taking over for Franz Walt who operated as president from 2014 to 2017.

Nath spent 10 years with Abbott, serving most recently as its vascular division president and as an executive officer of the company, and as president of the molecular diagnostics division prior to that.

He also operated as GM of Ibis Biosciences, and has held positions at Amgen (NSDQ:AMGN) and McKinsey.

“Siemens Healthineers seeks to benefit from market opportunities in the diagnostics market through the introduction of Atellica Solution. Deepak Nath’s exceptional leadership experience and deep industry knowledge will greatly benefit us as we look to expand the early success of Atellica Solution and drive wide adoption in the diagnostics market,” Siemens Healthineers COO Michael Reitermann said in a press release

 Hill-Rom prez, CEO Greisch to step down during Q3

Hill-Rom Holdings (NYSE:HRC) said last week its president & CEO John Greisch will be stepping away from his position during the company’s fiscal third quarter.

The Chicago-based company said that its board of directors has initiated a search for a successor, which it hopes will be completed by the company’s fiscal third quarter.

“It has been an honor to lead this great company over the last eight years, and I am extremely proud of the value we have created together for patients, customers and shareholders. I want to thank each of our 10,000 employees around the world for their support and ongoing commitment to helping people get better care inside and outside the hospital. This is the right time for me personally, and for the company, to transition to the next generation of leadership. Hill-Rom is well positioned for future success with a strong team, solid foundation, and exciting growth prospects, and I look forward to working alongside our tremendous leadership team until we’ve successfully transitioned to my successor,” Greisch said in a prepared statement.

“On behalf of the Board, I would like to thank John for his invaluable leadership and significant contributions to Hill-Rom. Under his leadership, Hill-Rom has transformed its business portfolio, expanded globally and enhanced its position as a global medical device leader. John has directed Hill-Rom to record profitability, created significant shareholder value and positioned the company for a great future. Our company and leadership team have never been stronger, and we look forward to a seamless transition,” board chair Rolf Classon said in a press release.

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 Surefire Medical taps Szela as prez, CEO

Surefire Medical said this month it tapped former Novelion Therapeutics chief exec Mary Szela as its new prez and CEO, succeeding founder James Chomas who held the position of prez & CEO since 2009.

Former CEO Chomas will remain on the company’s board of directors and as an active member of the senior management, the Denver-based company said.

“Immune therapies are reshaping the battle against cancer. The innovative application of technology at Surefire positions the company to become a leading medical device provider in the treatment of cancer. Mary brings the leadership capabilities necessary to fulfill the full potential of what Surefire’s technology can do to transform cancer care on a global scale. Her proven commercial track record, coupled with her passion and commitment to patients, aligns with the company’s mission to better deliver quality of life for cancer patients. The brilliance of Jim Chomas is his ability to look at medical problems and solve them by creating technologies that help physicians successfully treat liver cancer. As the founder of Surefire, he built the company to where it is today and will continue to play an active role focused on innovations that overcome unsolved medical challenges. We’re grateful for all Jim does to advance oncology drug delivery and Surefire’s mission,” board chair Mats Wahlström said in a press relese.

Prior to joining Surefire, Szela held the corner office at Novelion Therapeutics where she oversaw a merger with Aegerion Pharma and QLT Therapeutics, the company said. She also acted as CEO at Melinta Therapeutics and held management positions at Abbott, including as president of its US pharmaceuticals business.

“As with millions of other people who have been directly or indirectly affected by cancer, I’m thrilled to be leading a company making a difference in treating the disease. The application of technology at Surefire is already making a difference, and guiding the company to expand its reach to patients is my primary goal. I’m fortunate to partner with Jim as a member of my staff along with the talented team at Surefire to advance technologies that can truly impact patient care,” Szela said in a prepared statement.

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 Cardiovascular Systems hires former MDT heart valve therapies GM Robb as COO

Cardiovascular Systems (Nasdaq: CSII) said last week it has appointed former Medtronic (NYSE:MDT) heart valve therapies GM Rhonda Robb as its new COO, replacing Kevin Kenny who is exiting the position at the end of this month.

During their time at Medtronic, Robb also held positions in the company’s coronary, peripheral and cardiac rhythm businesses.

“I am excited to have the opportunity to join CSI and I look forward to working with the team to improve the health of people with coronary and peripheral artery disease,” Robb said in prepared remarks.

“Rhonda is a dynamic and talented executive with extraordinary experience in driving innovation and growth in medical technology. She has the leadership ability, executional strengths and experience to further build CSI, and achieve our ambitious growth goals, as well as guide the expansion of the company’s peripheral and coronary franchises. As Chief Operating Officer, Kevin has made many contributions to the growth and success of CSI. We are grateful for his commitment to our mission and wish him well in his future endeavors,” prez & CEO Scott Ward said in a press release.

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 Endologix appoints ex-Abbott exec Morrow as chief marketing officer

Endologix (NSDQ:ELGX) said yesterday it tapped former Abbott exec Greg Morrow as its chief marketing officer, effective immediately.

Prior to joining Irvine, Calif.-based Endologix, Morrow held the position of coronary division and marketing function leader for Abbott Vascular. He also held positions with Novartis (NYSE:NVS), Johnson & Johnson (NYSE:JNJ) and Align Technology (NSDQ:ALGN).

“We are very excited to welcome Greg to Endologix’s executive team. He is a proven marketing executive with a strong track record of growing medical device businesses in highly competitive and challenging environments and achieving breakthrough results. His experience will be invaluable in both strengthening our brand value proposition and maximizing the impact of our innovative new product pipeline,” Endologix CEO John McDermott said in a prepared statement.

“I am thrilled to have the opportunity to lead Endologix’s global marketing team. The company has built an impressive new product portfolio, and our marketing team’s goal is to effectively launch these new technologies, strengthen the brand, and provide excellent clinical outcomes for physicians and their patients,” Greg Morrow said in a press release.

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• Neuromod Devices Limited names Lim as chief scientific officer
• Lohmann & Rauscher CCO Sebastian to step away
• Cook Group promotes Giles to federal & int’l gov’t affairs VP
• CHF Solutions taps Ephshteyn as ops & engineering VP
• Invetech names Kneen as cell therapy VP

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Verily, Sanofi and other industry players team up with NIH to advance Parkinson’s therapies

The National Institutes of Health is joining forces with the tech and pharmaceutical industries to speed the development of new drugs for Parkinson’s disease and identify biomarkers for the debilitating condition.

Companies participating in the public-private partnership include Celgene (NSDQ:CELG), GlaxoSmithKline (NYSE:GSK), The Michael J. Fox Foundation for Parkinson’s Research, Pfizer (NYSE:PFE), Sanofi (NYSE:SNY) and Verily. Combined the groups plan to commit $12 million to effort, which the NIH is slated to match.

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

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Ensysce Bioscience wins fast track status for abuse-deterrent oxycodone

Ensysce Biosciences said this week that its extended-release oxycodone prodrug won fast track status from the FDA.

The San Diego, Calif.-based company is developing the abuse-deterrent drug as a pain management therapy for people with moderate to severe chronic pain.

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

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Former S.D. dentist pleads guilty to $17m medtech fraud scheme

A former dentist from South Dakota plead guilty last week to a $16.6 million scheme to defraud consumers through the sale of a sham laser device and associated treatments, promising it would cure more than 200 different conditions, according to a US Department of Justice report.

The plea was the finale to a three-year effort from the DoJ to halt the distribution of the device, known as the “QLaser System”, according to the report.

The defendant, 82-year-old Robert Lytle of Rapid City, S.D., plead guilty to a single count of conspiracy to introduce misbranded medical devices into interstate commerce with the intent to defraud and mislead, and one count of criminal contempt.

The pleas made were part of a plea agreement, according to the DoJ release.

“Victimizing the elderly and those suffering from serious illnesses are among the most detestable of crimes, and to persist with the QLaser fraud even after being ordered to stop by a federal court is even more abhorrent. The Justice Department is committed to protecting Americans from elder abuse and medical frauds,” US DoJ Civil Division Acting Assistant Attorney General Chad Readler said in a prepared statement.

Two co-conspirators in the scheme had previously plead guilty for their parts, while criminal contempt charges against a fourth individual were dropped by the government.

The individuals involved in the scheme reportedly marketed and distributed the QLaser device to consumers, claiming the systems could safely and effectively treat “a panoply of medical conditions,” including cancer, emphysema, diabetes, autism, HIV and heart disease.

Lytle reportedly created fraudulent labeling which suggested that scientific evidence support the claims, while no such published studies supported the use of the device, the DoJ reports.

To extend credibility, Lytle claimed to be a retired dentist and medical laser expert, and did not reveal that his dental license had been revoked for defrauding and materially deceiving consumers, according to the report.

The actors in the scheme pressed forward even after a federal court ordered a stop to sales and demanded refunds for all QLaser purchasers, with Lytle taking steps to smuggle hundreds of devices out of South Dakota into upstate New York to prevent their seizure and continue sales of the device.

Lyle admitted to entering an agreement in 2005 to market medical devices with false and misleading labeling to defraud consumers, and that he continued to do so in violation of a federal court order. He now faces a maximum statutory sentence of five years imprisonment on the conspiracy charge, with sentencing set for April 20.

“Reprehensible scams using ineffective and useless medical implements victimize suffering people who are already burdened with long-term, often crippling ailments and diseases.  The U.S. Postal Inspection Service puts the highest priority on investigating these kinds of crimes and bringing these criminals to justice,” U.S. Postal Inspector in Charge of the Denver Division Dana Carter said in a press release.

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FDA approves Bracco’s contrast agent for pediatric CNS imaging

The FDA has approved a label change to Bracco Diagnostics‘ MultiHance MRI contrast agent. The company’s product can now be used to visualize lesions with abnormal vascularity of the brain and spine in patients younger than two years old.

Data collected in pediatric patients under the age of two showed that a dose of 0.05 mmol/kg is effective at boosting the visualization of lesions in the brain and spine. Older kids and adults, however, need a dose of 0.1 mmol/kg.

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

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BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial

The FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina.

The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory trial.

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

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Health insurance stocks slide on Amazon-Berkshire Hathaway-JPMorgan Chase non-profit self-insurance venture

Shares in major health insurers UnitedHealth and Anthem fell today after online retail giant Amazon (NSDQ:AMZN), major holding company Berkshire Hathaway and JPMorgan Chase announced a collaborative, independent non-profit looking to provide their employees with healthcare.

The three companies said they will look to “bring their scale and complimentary expertise” to the long-term project, which will initially focus on technology solutions to help provide their US employees and families with “high-quality and transparent healthcare at a reasonable cost,” according to a press release.

“The ballooning costs of healthcare act as a hungry tapeworm on the American economy. Our group does not come to this problem with answers. But we also do not accept it as inevitable. Rather, we share the belief that putting our collective resources behind the country’s best talent can, in time, check the rise in health costs while concurrently enhancing patient satisfaction and outcomes,” Berkshire Hathaway chair & CEO Warren Buffett said in a prepared statement.

The project is still in its early planning stages, but will be led for the time being by Berkshire Hathaway investment officer Todd Combs, JPMorgan Chase managing director Marvelle Berchtold and Amazon senior VP Beth Galetti.

The companies stayed quiet on any other details, but said that long-term management, headquarters location and other operational details will be released “in due course.”

“The healthcare system is complex, and we enter into this challenge open-eyed about the degree of difficulty. Hard as it might be, reducing healthcare’s burden on the economy while improving outcomes for employees and their families would be worth the effort. Success is going to require talented experts, a beginner’s mind, and a long-term orientation,” Amazon CEO Jeff Bezos said in prepared remarks.

“Our people want transparency, knowledge and control when it comes to managing their healthcare. The three of our companies have extraordinary resources, and our goal is to create solutions that benefit our U.S. employees, their families and, potentially, all Americans,” JPMorgan Chase chair & CEO Jamie Dimon said in a prepared statement.

Shares in Anthem have fallen approximately 4.8% so far today, at $244.71 as of 11:13 a.m. EST. Shares in UnitedHealth Group have also fallen, down 3.1% at $239.71 as of 11:14 a.m. EST.

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Medtronic, Philips ink LungGPS lung cancer treatment dev deal

Medtronic (NYSE:MDT) said today it is partnering with Philips (NYSE:PHG) to develop and commercialize the LungGPS patient management platform designed to aid in the identification and management of patients with lung nodules.

The LungGPS platform is designed to improve identification and management of patients with incidental pulmonary nodules, and uses natural language processing to analyze medical report data.

The system also uses Philips’ lung cancer screening solution which automates routine administrative tasks and clinical workflows to improve efficiency and patient care, the companies said.

“Early identification and prompt, appropriate management of pulmonary nodule patients has been proven to improve clinical outcomes. Developing technological solutions to enable our customers to do this quickly, efficiently and consistently continues to be our focus and we’re excited about the expanded possibilities through our new collaboration with Medtronic. The combination of our collective capabilities in imaging, informatics and image-guided intervention has the ability to make a meaningful, positive impact on patient care, clinical outcomes and survivorship,” Philips oncology solutions head Brent Berthy said in prepared remarks.

Both Fridley, Minn.-based Medtronic and Amsterdam-based Philips’ early commercialization efforts will look to provide solutions focused on hospital data, patient management and clinical workflows.

“Lung cancer rates haven’t changed much over the past three decades. The current management of incidental lung nodule tracking is a very manual process, one that includes spreadsheets or post-it notes or no active management at all. It’s time we think differently about how we’re going to tackle this disease, and bring lung healthcare into the twenty-first century. No one single company can tackle this alone and through our collaboration with Philips, we have the opportunity to help achieve better outcomes for these patients – using technology to promote integrated care,” Medtronic lung health GM Matt Anderson said in a press release.

Earlier today, Medtronic said it closed the $28 million acquisition of the Chocolate PTA non-drug-coated balloon made by QT Vascular, after taking an option on the device last year.

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Sunovion touts pivotal Ph3 trial for Parkinson’s drug

Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations.

Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that the drug was generally well-tolerated by patients.

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

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Current Regulatory Landscape for EO Residue Levels in Medical Devices

One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and minimize ethylene oxide residuals remaining in devices after sterilization has taken place.

Ethylene oxide gas remains a popular choice for terminal sterilization because of its effectiveness and its suitability for use with plastic and other heat-sensitive device materials.

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Medtronic’s In.Pact Admiral drug-coated balloon succeeds in two-year study, critical limb ischemia analysis

Medtronic (NYSE:MDT) touted data today from a two-year study of its In.Pact Admiral drug-coated balloon in patients with peripheral artery disease in Japan, as well as the results from a critical limb ischemia subgroup analysis from its In.Pact Global trial.

The company’s In.Pact SFA Japan study enrolled 100 patients and randomized them to receive either the drug-coated balloon or plain balloon angioplasty.

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

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