Profound Medical said today it won CE Mark approval in the European Union for its Tulsa-Pro ablation device designed to treat prostate cancer.

The Toronto-based company’s system allows for a minimally invasive, whole-gland ablation of the prostate, guided by magnetic resonance imaging machines, the company said.

“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of Tulsa-Pro in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with Tulsa-Pro,” CEO Steve Plymale said in a press release.

The Tulsa-Pro device uses MRI imaging and transurethral robotically-driven ultrasound and closed-loop thermal feedback control to provide highly precise treatment tailed to a patient’s anatomy and pathology, the company said.

“MRI-guided Tulsa-Pro is excellent for planning, guiding and monitoring focal prostate cancer treatment in order to maximize the therapeutic effect and avoid adverse effects. Obtaining a CE Mark for Tulsa-Pro is an important step forward to broaden the therapeutic offering for localized prostate cancer,” Phase I clinical trial lead researcher Dr. Boris Hadaschik said in a prepared statement.

Last July, Royal Philips (NYSE:PHG) said it signed a deal with Profound Medical to use Profound’s proprietary transurethral ultrasound ablation technology to treat prostate cancer patients in conjunction with Philips’ Ingenia and Achieva 3 tesla MRI systems.

The treatment requires only a single session and has comparable outcomes to the best alternative treatment options, the companies said.

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San Francisco-based tissue-integrated sensor maker Profusa said today it won a $1.75 million grant from the National Institutes of Health’s Small Business Innovation Research program.

Funding is slated to help support the company’s fast-tracked Phase I and Phase II studies of its Lumee tissue-integrated biosensors designed for continuous oxygen monitoring to improve outcomes in patients with peripheral artery disease.

“This NIH award is further validation of the potential of our biosensor technology for having a significant impact in transforming clinical outcomes for patients with PAD. These studies will be crucial in advancing our technology and products towards regulatory approvals and commercialization,” CEO Ben Hwang said in a press release.

Phase I of the grant will fund safety studies of Lumee, Profusa said, and Phase II is slated to fund a clinical study of the company’s tech at the University of California San Francisco. Profusa said the grant is the 2nd fast-track small business grant it has received from the NHLBI to develop its tissue-integrated oxygen biosensor for PAD patients.

“Our goal is to further demonstrate the functionality of Profusa’s novel Lumee oxygen biosensor technology in patients with PAD, and to determine its ability to predict surgical outcomes and to guide additional therapies to avoid amputation,” CTO and study co-principal investigator Natalie Wisniewski said in a prepared statement.

The Phase I trial of the program aims to verify the biocompatibility of the biosensors which the company said has been shown to be functional for more than 2 years within the body. Phase II will include a 50-patient clinical trial, Profusa said.

Profusa is developing next-gen tissue-integrated sensors to allow for the monitoring of body chemistry to allow for more personalized health and disease management.

“Profusa’s oxygen-sensing technology may allow doctors for the first time to know the tissue oxygen levels in the ischemic limb before, during, and after treatment. We’ll be able to more accurately select patients who will need a revascularization procedure to heal their wounds, and we will be able to monitor the change in tissue oxygen during and after the procedure in order to guide our treatment and know when it is complete. The upside for our patients will be less pain and disability, improved function, and fewer amputations,” co-principal investigator Dr. Christopher Owens said in prepared remarks.

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Nephros (OTC:NEPH) said last week it received a notice from the FDA closing out a warning letter the company received last May concerning issues with the manufacturing of a variety of its filtration systems.

The warning from the federal watchdog to River Edge, N.J.-based Nephros included warnings on a failure to document and evaluate potential suppliers and a failure to include required information in records and complaint investigations.

Nephros responded to the initial warning letter and received a response from the FDA in August outlining what corrective actions would be required.

The company said the FDA indicated it would verify Nephros’ implementation of corrective measures on its next inspection.

Nephros noted that the initial warning letter and subsequent letter did not restrict its ability to manufacture, produce or ship its products, and did not require any recalls.

After a follow-up inspection in February this year, the FDA was able to clear the company, according to an SEC filing.

In October 2013, Nephros saw shares plummeted nearly 68% after it issued a recall of 3 of its in-line ultrafilters after receiving reports of bacterial contamination that may have led to a patient’s death.

Nephros said it received reports about its SafeSpout and SafeShower point-of-use filters from 1 customer of “high bacterial counts” likely due to “the breakage of fiber in 4 filters” that may have led to the death and to another instance of infection, according to a regulatory filing

The company logged another 29 complaints of high bacterial counts that were not associated with any adverse events, according to the filing.

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Halyard Health (NYSE:HYH) said today it picked up enternal access solutions company Corpak MedSystems for $174 million.

Corpak, a Linden Capital Partners portfolio company, develops, manufactures and markets a range of branded enternal access devices, Halyard Health said.

The acquisition was funded through a combination of Alpharetta, Ga.-based Halyard Health’s on-hand cash and revolving credit facility and is slated to close in the 2nd quarter.

“We are excited to integrate Corpak’s innovative products into our market-leading enteral feeding portfolio enabling us to serve our doctors and their patients more broadly. Corpak’s business aligns well with our existing Medical Devices segment with slightly higher sales growth and similar gross margins.  This 1st acquisition is an important step in achieving our strategic vision of transforming Halyard into a leading medical devices company, and positioning our business for future growth,” Halyard Health CEO Robert Abernathy said in a press release.

Halyard Health said that Corpak’s portfolio of nasogastric tubes compliments the company’s existing enteral feeding products. Last year, Corpak’s sales were approximately $54 million.

“Corpak achieved above-market growth through our focus on innovation, team and culture, and strategic realignment to become the ‘preferred enteral partner. We believe that Corpak is well positioned for continued achievement and long-term success with Halyard, a company that understands our business, supports our goals and embraces our values,” Corpak CEO Frank McCaney said in prepared remarks.

Halyard Health said the transaction is expected to be 5¢ accretive to its fiscal year 2016 ajusted dilutive net earnings per share excluding charges related to the acquisition. The company updated its previous guidance to $1.50 to $1.70, with the transaction expected to be approximately 15¢ accretive.

“Linden is proud to see Corpak find a great home with Halyard. During our seven-year ownership, Linden pursued its value creation plan that included an expanded strategy, an enhanced leadership team, a non-core divestiture, multiple joint ventures and acquisitions, new headquarters, direct international expansion, and intensive research and development for new product launches,” Linden managing partner Brian Miller said in a prepared statement.

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By Josh Rising, The Pew Charitable Trusts

Under federal policies proposed in January, researchers, medical product innovators, and clinicians will gain unprecedented access to Medicare data that the Obama administration says will facilitate “smarter and more informed” health care decisions. The new rules aim to increase the use of insurance claims data by allowing approved organizations to share claims-based analyses with other groups working to improve care.

Unfortunately, one thing is missing from this trove of information: identification of specific medical devices used in patient care. This shortcoming affects tens of millions of Americans who rely on artificial joints, cardiac stents, or other implanted medical devices. It means that regulators and researchers cannot identify the products used in the most common Medicare hospital procedure—hip and knee replacement surgeries, which account for approximately $7 billion in spending for more than 400,000 beneficiaries per year—because claims currently do not record which device is used.

If claims databases contained device-identifying information, researchers could use it in a number of ways. They could compare and contrast which devices work for which patients, analyzing safety and effectiveness to inform medical decisions. They could see whether problematic outcomes were associated with a specific device—something that’s already possible for drugs.

Claims data, though not perfect, contain information not available elsewhere about large numbers of patients across different care settings over months or years. Better yet, the data is submitted to Medicare and other health plans in a standardized way, which makes it easy to aggregate. This bird’s-eye view of the patient experience allows for analyses that would not be possible with data from sources such as electronic health records that are formatted differently from hospital to hospital.

The time is right to facilitate this kind of device analysis. Medicare claims should contain the product’s unique device identifier, which would provide information on the specific implant used. Taking this single step would expand the uses and benefits of claims information for patients, providers, and payers in the increasingly data-driven American health care system.

Dr. Josh Rising is Pew’s director of health care programs, overseeing the medical device initiative and the improving end-of-life care project.

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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Stryker (NYSE:SYK) continued its acquisition spree yesterday with the purchase of SafeWire’s spine device line for an undisclosed amount.

SafeWire’s Y-Wire guidewire and Tiger Jamshidi needle family are slated to join Stryker Spine’s portfolio of minimally invasive devices, the Kalamazoo, Mich.-based company said.

“We are excited to bring this important complementary technology into the Stryker family,” Stryker Spine president Brad Paddock said in prepared remarks. “This acquisition increases our competitive advantage as we broaden our product line and extend our customer base among teaching facilities, competitive accounts, and existing SafeWire customers.”

Last week Stryker closed the $1.3 billion acquisition of automated external defibrillator maker Physio-Control, just days after putting a bow on its $2.7 billion buyout of Sage Products and the deal for Synergetics‘s (NSDQ:SURG) neurostimulation assets for an undisclosed amount.

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Stealthy Irish medical device startup Fire1 said today that its investors, including Medtronic (NYSE:MDT), put up another $7.5 million for its Series B round.

Dublin-based Fire1, a spinout from medical device incubator The Foundry, also said it tapped former ResMed (NYSE:RMD) executive Conor Hanley to be its president & CEO and added another pair of senior leaders.

Fire1 said it’s developing a “novel” remote monitoring device but provided no other details about its technology. Lightstone Ventures and New Enterprise Assoc. also participated in the Series B round, the company said.

“With the support from these premier investors, the strength of our newly expanded leadership team, and the Irish government aggressively pushing the connected health ecosystem, we are in a very strong position to accelerate the development and commercialization of our first product,” Hanley said in prepared remarks. “This investment underscores global unmet needs in healthcare delivery, especially in predicting the onset of major diseases.”

Fire1 also tapped another ResMed veteran, John Britton, as commercial operations vice president and named Fiachra Sweeney senior director of engineering. Foundry managing director Mark Deem was made chairman, the company said.

Covidien, which Medtronic acquired for $50 billion last year, got in on Fire1’s Series A round in early 2014.

The Menlo Park, Calif.-based Foundry has spun out a raft of medtech firms, including Ardian (acquired for $800 million in 2010 byMedtronic (NYSE:MDT)); Concentric Medical (for which Stryker (NYSE:SYK) paid $135 million in 2010); and Evalve (acquired by Abbott (NYSE:ABT) for $410 million in 2009). Fire1 is the incubator’s 15th spinout.

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It took 11 years, but DJO Global and Zimmer Biomet (NYSE:ZBH) subsidiary EBI finally escaped the civil side of a False Claims Act lawsuit yesterday alleging that they defrauded Medicare with the sale of bone-growth stimulators.

The suit, filed in 2005 by the owner of a Missouri durable medical equipment billing services company named Jeffrey Bierman, alleged that a raft of companies submitted false Medicare claims for the osteogenesis stimulators. The claims for purchasing the devices should have been made for renting them, Bierman alleged; furthermore, the devices were prescribed for much longer periods of time than was medically necessary, he claimed in the lawsuit.

Although they cost $50 to $100 to make, the stimulators retail for $5,000 and Medicare reimburses for $4,000, according to the suit. The allegedly fraudulent claims from 1998 to 2008 brought in more than $400 million for the defendants, the lawsuit claimed, naming Orthofix (NSDQ:OFIX), Reable Therapeutics (which merged with DJO in 2007), Bioelectron (acquired by EBI in 2008) and Smith & Nephew (NYSE:SNN), in addition to DJO and Biomet’s EBI (Biomet paid nearly $6.1 million to settle with the U.S. Justice Dept. in October 2014.)

After Judge Rya Zobel of the U.S. District Court for Massachusetts granted partial summary judgment in July 2015, Bierman’s claim hinged on a single theory: That DJO and EBI coached doctors to recommend inflated treatment times for the stimulators. Yesterday Zobel ruled that Medicare’s reimbursement calls had nothing to do with how long the recommended treatment times were.

“Because Bierman cannot point to any fact in this record to show that estimated lengths of need are material to Medicare’s decision to purchase DJO’s bone-growth devices, Bierman cannot sustain his False Claims Act action under this theory. Since materiality is also a condition of the state and local False Claims Act analogs under which Bierman has sued, Bierman likewise cannot sustain claims under those statutes,” Zobel wrote.

The other defendants in the case have either settled or had it stayed pending a settlement. Orthofix ended its involvement in late 2012 with a $43 settlement that put to rest both the civil and criminal portions of the suit; Smith & Nephew’s case is stayed pending review of a settlement, according to court documents.

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Livongo Health said today that it raised nearly $45 million in a Series C round it plans to use to grow the footprint of its digital diabetes management program.

The Livongo program combines lifestyle coaching with a connected glucose meter, designed to automatically upload readings and provide real-time insights. It’s aimed at self-insured employers, payers and healthcare providers.

Livongo said the $44.5 million round included new investors Merck‘s (NYSE:MRK) Global Health Innovation Fund, Cowen Private Investments, Sapphire Ventures, Blue Cross Blue Shield of Massachusetts’ investment arm Zaffre Investments and Wanxiang America Corp. Existing backers General Catalyst, Kleiner Perkins Caufield & Byers, DFJ and 7wire Ventures also participated, the Mountain View, Calif.-based company said.

Livongo said it plans to use the cash to expand the diabetes program and to move into other chronic health markets.

“We are excited by the demand for our solution, which combines the latest technology, data science, and coaching to empower people with diabetes to live a better life,” CEO Glen Tullman said in prepared remarks. “The most important challenge to address in healthcare today is how we manage chronic disease, and the status quo simply isn’t working. Livongo Health’s platform delivers real-time, personalized support in context, when and where it’s needed.”

“Livongo is leading a new wave of innovation focused on chronic disease management, beginning with diabetes,” added Zaffre Investments managing director Tuoyo Louis. “The company is unique in combining a consumer focus with broad healthcare and technology experience and has demonstrated measurable results in member satisfaction, clinical improvement, and cost savings based on client reported results.”

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Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.

The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.

“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMonitor 2 simplifies the diagnosis of inconsistent and potentially life-threatening arrhythmias for physicians and patients. The easy insertion process and continuous wireless monitoring help ensure patient compliance while providing accurate data for physician diagnosis. This innovative technology further underscores Biotronik’s commitment to delivering cardiac technology that safely and effectively enables patients to live life to the fullest,” Biotronik prez Marlou Janssen said in prepared remarks.

The BioMonitor 2 is designed to be inserted under the skin of the patient, after which it records all cardiac electrical events, and transmits the data directly to a monitoring physician through the company’s Home Monitoring system.

“The clinical and economic burdens of stroke are high and continue to grow. Prevention is necessary, yet more than 35 percent of strokes are cryptogenic and occur with no known cause. The fast and accurate detection of clinically relevant atrial arrhythmias in these patients is critical to administering therapy that minimizes risk of recurrent stroke. New diagnostic technologies, such as those found in the BioMonitor 2, can help manage these high-risk patients more effectively and efficiently,” Dr. Mark Richards of the Promedica Heart & Vascular Institute said in a prepared statement.

Last August, Biotronik said it won CE Mark approval in the European Union for its BioMonitor 2 subcutaneous insertable cardiac monitor and released results of a pilot study of the device. The company launched the devices in the U.K. and Ireland just last week.

The Australian pilot study reported an average insertion time of less than 2 minutes with a 90% success rate in sending transmissions to Biotronik’s home monitoring system, according to Berlin-based Biotronik.

The device is capable of over 60 minutes of electrocardiogram monitoring, according to Biotronik, and can send up to 6 ECG scans daily through the company’s home monitoring system.

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Hospitals may not be ready to handle the Centers for Medicare and Medicaid Services new bundle reimbursement payments for hip and knee replacement procedures, according to a report from Intralign.

In an online survey, Intralign said hopsitals reported an average grade of 55% out of 100% in rating their preparedness for CMS’s new Comprehensive Care for Joint Replacement datasets. 

Intralign reported that the biggest issues hospitals are facing are underdeveloped post acute care networks, poor internal information systems weak in modeling, tracking and reporting capabilities and undefined performance metrics.

The Centers for Medicare & Medicaid Services said its 5-year “Comprehensive Care for Joint Replacement” program would involve more than 800 hospitals in 75 geographic areas, bundling payments for hip and knee replacements from hospital admission to 90 days after discharge. The payment would cover “all related items and services paid under Medicare Part A and Part B for all Medicare fee-for-service beneficiaries,” the government health insurer said.

But reimbursements will be pegged to outcomes and costs, which allows Medicare to take back payments and reward good performance with additional payments.

The initial CMS CJR dataset will cover the 3-year baseline period from January 1, 2012 to December 31, 2014, and was initially used to model the program.  The data will be available to facilities so they can understand how CMS will view their facility in the program, Intralign said.

Though the initial 3 years will be the only data available initially, CMS will provide rolling data updates to hospitals on a quarterly basis. The data will allow hospitals to verify included episodes and address or contest issues, as well as monitor the status of their episode spend using the data, Intralign said.

The firm said that the data will come in 19 different raw files that require linking, episode mapping, validation and execution for analysis.  Intralign suggested that hospitals look into expanding their in-house analytics competencies in order to manage ongoing data analysis required by CJR.

The new program was announced last July, when Medicare proposed it would be bundling reimbursement payments for hip and knee replacement procedures, saying it wants to “hold hospitals accountable for the quality of care they deliver to Medicare fee-for-service beneficiaries.”

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European venture capital shop Forbion Capital Partners said today that it raised a $208 million fund it plans to use for investments in medical device, drug and diagnostic companies.

The €183 million fund’s limited partners included strategic investors Charles River Laboratories and Knight Therapeutics, plus the European Investment Fund, the Dutch Venture Initiative, Germany’s KfW development bank, other regional investment agencies, pension funds, insurance companies and “leading European family offices,” the VC shop said. Forbion, which is based in Naarden, Holland, and Munich, said it plans to use about 70% of the Forbion Capital Fund III on the Continent, with the rest invested in U.S. and Canadian companies.

Investments have already been made in 7 companies, the company said: Autonomic Technologies, based in Redwood City, Calif., and Munich, which is developing the Pulsante microstimulator to treat cluster headache; Montreal-based gastrointestinal gene therapy company enGene; Rigontec, a Bonn-based company that’s developing RNA therapeutics to target the RIG-I immune receptor; Oxford, England’s oncolytic immunotherapy firm Replimune; Illes Balears, Spain-based biopharma Sanifit; stealthy Staten Biotech; and drug developer Akarna Therapeutics, based in Cambridge, England.

“Raising such a substantial amount is a tribute to Forbion’s reputation as a quality player in life sciences venture capital investment. In Europe especially, it is still a buyer’s market; as a result, we see many highly attractive assets from an increasingly rich deal flow,” managing partner Sander Slootweg said in prepared remarks. “Our new portfolio is already showing great promise. Canadian molecular therapeutics company enGene, inventors of the so-called ‘gene pill’, has closed 2 major pharma collaborations since we led the Series B financing round in 2015. In the U.K., oncolytic immunotherapy company, Replimune secured a substantial and attractively priced $30 million Series A round after we provided the seed capital. As several more companies are currently enjoying strategic interest, this bodes well for the success of FCF III.”

Forbion also said it hired analyst Matthias Falcenberg from the Max-Planck Institute of Biochemistry to help deploy the new fund.

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EOS Imaging (EPA:EOSI) said it won pre-market approval from the FDA for its spineEos 3D planning software for spinal surgeries.

Paris-based Eos won CE Mark approval in the European Union in February for the system, which is designed to use 3D imaging to create optimized treatment plans for pediatric patients with scoliosis and adults with spine conditions.

“We believe that patients’ spines are complex 3D systems that need a personalized 3D planning of the intended surgery. We’re excited about the interest we’ve seen in our spineEOS planning software from surgeons inside and outside of our current installed base, as well as from our industry partners. We look forward to this next important step toward our broader goal of expanding our EOSapps planning software suite to better connect imaging to patient care,” CEO Marie Meynadier said in prepared remarks.

In December 2015, Eos reported results from a a clinical study examining the association of sagittal balance measurements and risk of falling in elderly patients, showing a correlation between falling risk and postural balance measured using its sterEos workstation.

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iStar Medical said today that it raised a $11.4 million Series B round for the implants it’s developing to treat glaucoma.

Wavre, Belgium-based iStar said its pipeline, including the 1st-generation StarFlo implant, is based on the Star material it created. The €10 million Series B round will go toward the development and CE Mark trial of its 2nd-generation MiniJect minimally invasive glaucoma surgery device, the company said

Existing backers Capricorn Venture Partners and Walloon Region Investment Fund participated in the round, joined by new shareholders Belgian Federal Investment Fund, Fond Européen des Matériaux, Start-Up and several private investors.

“MiniJect represents a significant achievement in our company’s history. It leverages our clinical experience with the Star biomaterial, combined with the insights of international scientific experts who helped us to develop this micro-invasive solution, and has the potential to become best in class. I would like to thank our existing investors for their continued support and welcome our new investors to the company. This funding is a validation of our vision, technology and management’s ability to successfully execute the strategy,” CEO Michel Vanbrabrant said in prepared remarks.

“This new funding milestone will enable the next major step for iStar to finalize clinical development and commercialization of a next-generation, micro-invasive glaucoma surgery device. MiniJect offers the potential of an efficacious treatment for a disease that is a major cause of blindness globally,” added chairman Michel Lussier.

iStar raised about $5.4 million (€4 million) in a Series A round in November 2013.

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Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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5. Halyard Health picks up Corpak Medsystems

Halyard Health said today it picked up enternal access solutions company Corpak MedSystems for $174 million.

Corpak, a Linden Capital Partners portfolio company, develops, manufactures and markets a range of branded enternal access devices, Halyard Health said. Read more

4. Biotronik wins FDA nod for BioMonitor 2

Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.

The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength. Read more

3. DJO Global, Zimmer-Biomet’s EBI finally escape bone-growth stimulator suit

It took 11 years, but DJO Global and Zimmer Biomet subsidiary EBI finally escaped the civil side of a False Claims Act lawsuit yesterday alleging that they defrauded Medicare with the sale of bone-growth stimulators.

The suit, filed in 2005 by the owner of a Missouri durable medical equipment billing services company named Jeffrey Bierman, alleged that a raft of companies submitted false Medicare claims for the osteogenesis stimulators. The claims for purchasing the devices should have been made for renting them, Bierman alleged; furthermore, the devices were prescribed for much longer periods of time than was medically necessary, he claimed in the lawsuit. Read more

2. Stryker spree continues with SafeWire asset buy

Stryker continued its acquisition spree yesterday with the purchase of SafeWire’s spine device line for an undisclosed amount.

SafeWire’s Y-Wire guidewire and Tiger Jamshidi needle family are slated to join Stryker Spine’s portfolio of minimally invasive devices, the Kalamazoo, Mich.-based company said. Read more

1. Foundry spinout Fire1 raises $7.5m Series B

Stealthy Irish medical device startup Fire1 said today that its investors, including Medtronic, put up another $7.5 million for its Series B round.

Dublin-based Fire1, a spinout from medical device incubator The Foundry, also said it tapped former ResMed executive Conor Hanley to be its president & CEO and added another pair of senior leaders. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 12, 2016 appeared first on MassDevice.

Salt Lake City, Utah-based Predictive Technology Group (OTCMKTS:PRED) said today it closed its buy of ReNovo Biotech and tapped former ReNovo Biotech CEO Eric Olson as the new prez of Predictive Biotech.

Predictive Biotech said the acquisition will allow it access to ReNovo’s cellular, tissue, biomaterial and regenerative medicine products, as well as access to its distribution channels and customers from a recent private label agreement.

Predictive Technology said it will continue its commercialization expansion of therapeutics through internal growth as well as acquisition of complementary companies.

“We are very excited to announce that we have completed our due diligence, and have now been able to finalize our acquisition of ReNovo Biotech. This acquisition is a significant milestone for PRED and is the first step in our strategy to expand our product portfolio of technologies that are companion treatment solutions to our molecular diagnostic tests and pharmaceuticals. It will quickly help bring our company into revenue and cash flow through the existing distribution channels and private label partnerships. This allows us to begin clinical trials on the treatment of debilitating diseases with allogeneic and autologous stem cell products,” Predictive Technology Group CEO Bradley Robinson said in prepared remarks.

As part of the deal, previous ReNovo CEO Olson will also move to Predictive Biotech as its new president, the company said.

“Eric Olson is a proven President and CEO with over 20 years of experience in a broad range of various stage companies. Mr. Olson has established an outstanding record of verifiable success exceeding revenue, profit and business growth objectives in the rapidly changing medical device, biologics, and molecular diagnostic industries. He has experience in taking companies public and commercializing new technologies. Most recently, Mr. Olson was the President and CEO of Skeletal Kinetics in Cupertino, CA, and before that the President and CEO of Amedica Corporation in Salt Lake City, Utah,” Robinson said in a press release.

The companies did not release any financial or other details of the purchase.

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SteadyMed Therapeutics (NASDAQ:STDY) said today it that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office initiated an inter partes review against a United Therapeutics patent.

The patent in question, No. 8,497,393, is related to a process to purify prostacyclin derivatives, such as treprostinil, which is used in United Therapeutics’ Remodulin and SteadyMed’s drug candidate Trevyent, designed to treat pulmonary arterial hypertension.

“The initiation of this IPR by PTAB is a significant decision in favor of SteadyMed. While we have an appreciation for the patent process in the U.S., we believe that the patent in question is invalid. We are pleased that the PTAB, by its action to institute the formal review process, appears to believe that there is sufficient doubt about the validity of certain claims of the ‘393 patent. We look forward to submitting our new drug application for Trevyent, which has been granted orphan designation, later this year. We are eager to see patients benefit from Trevyent, if approved, we have begun early preparation work for commercialization and believe that we will make significant in-roads to the PAH market,” CEO Jonathan Rigby said in a press release.

San Ramon, Calif.-based Steadymed said that IPR reports from 2012-2015 indicated that 74% of reviews were resolved by finding all claims unpatentable, cancelling claims and rendering patents invalid. Only 14% of cases were resolved by finding some claims unpatentable and cancelling those, and 12% were resolved by finding all claims patentable.

Last July, SteadyMed said it inked an exclusive deal with Cardiome for commercialization of its Treyvant product in regions outside the U.S., hinging on its regulatory approval in those regions.

Cardiome will have exclusive rights to the territories of the European Union, Canada and the Middle East, SteadyMed said.

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By Stewart Eisenhart, Emergo Group

The Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to change its import declaration requirements for medical devices and other healthcare products starting May 3, 2016.

The new requirements are meant to cut down on import documents for foreign manufacturers, as well as to drive import permit applicants to Singapore’s TradeNet online customs system.

The key changes include:

• Merging four current competent authorities—the Cosmetic Control Unit, Medical Device Branch, Complementary Health Products and Health Products Regulation Group—into a single competent authority, allowing importers to declare different categories of products within just one TradeNet application.
• Streamlining the number of HSA health product codes required for imported devices and products from seven currently down to five.
• No longer requiring products exempt from HSA licensing and approval to be declared with HSA product codes. (Such products include cosmetics, health supplements and homeopathic medicines.)

Additional information on medical device registration and importation to Singapore can be found in our whitepaper, video overview and regulatory process chart.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

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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Toshiba (TYO:6502) said yesterday it is partnering with the University of California, Irvine to study possible brain damage incurred in high school football players.

The study is the 1st-of-its-kind investigating cerebral microbleeds as a potential precursor to chronic traumatic encephalopathy, and will operate using Toshiba’s Vantage Titan 3T magnetic resonance imager as the main diagnostic tool, the company said.

“This study presents an opportunity to determine how Toshiba’s MRI equipment can be used by healthcare providers to safely and effectively diagnose serious brain trauma or CTE earlier than ever before, which could ultimately impact a patient’s quality of life in the future. We are proud to have the researchers using Toshiba’s Vantage Titan 3T MR system to establish these potential markers of CTE, which speaks to Toshiba’s commitment to partnering with healthcare providers to identify the right imaging solutions to complex clinical situations,” Toshiba clinical collaborations director Eugene Mensah said in prepared remarks.

Toshiba said the study will explore the use of non-contrast MRI as a noninvasive method for examining young athletes and other patients for early signs of CTE, which has been documented as a consequence of sub-concussive head injuries.

The study is slated to evaluate local high school student volunteers and enroll up to 100 high school football players and 50 control subjects. Toshiba said it will provide MRI equipment application training to the UCI researchers in the study.

“There have not been extensive studies of CTE in younger populations to date, so we see this as an important opportunity to examine if there are precursors or early signs that can lead to better diagnosis and treatment. Using Toshiba’s Titan 3T MR system, we may have an effective way to examine how playing football is affecting these subjects, and we hope to break new ground in diagnosing and treating head trauma before it can potentially cause problems for these athletes in the future,” study lead researcher Dr. Mark Fisher of UCI said in a press release.

Toshiba said the Vantage Titan 3T MR was chosen because of its ability to perform non-contrast neuro-imaging, including its Pianissimo noise-reduction tech as well as its ability to determine the prevalence of CMB using flow sensitive black blood sequences.

Last month, Toshiba said it inked a deal to sell its medical device business to Canon (NYSE:CAJ) for $5.9 billion, as the U.S. Justice Dept. and the SEC probed the accounting practices in its U.S. businesses, and today said it plans to lay off an additional 3,000 workers.

A week earlier, Toshiba granted Canon exclusive negotiating rights to buy Toshiba Medical after a hotly contested auction

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Senator Al Franken (D-Minn.) is pushing for more details on Medtronic‘s (NYSE:MDT) study of its Infuse Bone Graft, saying that the product may have “potentially skewed the risk profile” for patients and exposed “insufficient vigilance” by the FDA, according to the Minneapolis Star Tribune.

The senator raised these concerns in a letter to both Medtronic CEO Omar Ishrak and newly appointed FDA Commissioner Robert Califf.

Franken’s worries were raised when the Star Tribune published an article Sunday covering the review of some 3,647 patients implanted with its controversial Infuse bone-growth protein, the senator wrote.

The Minneapolis Star Tribune reported that Medtronic employees spent 2 years reviewing the records but failed to report the 1,000 adverse events to the FDA– including about 1,000 adverse event reports and 4 deaths – within 30 days, as the federal safety watchdog requires. The Fridley, Minn.-based company instead shut down the review in 2008; company executives said the adverse events database compiled from the review was misfiled but eventually reported to the FDA in 2013, according to the newspaper.

The 5-year delay failed to draw any flags at the FDA, which redacted the number of adverse events from a public, 3-sentence summary. The data was only released after the Star Tribune filed a Freedom of Information Act request was granted in September 2015.

Doctors who reported the 4 deaths said they were not related to the use of Infuse (including 2 patients with heart conditions, 1 who died from cancer and another from abdominal inflammation). Although Medtronic revealed “a small slice” of the data in a 2008 bid to expand the indication for Infuse, but the FDA would not accept it as evidence, according to the Star Tribune.

“To this day, neither the company nor the FDA has publicly disclosed full details of the study,” the newspaper reported.

Shortly after the article was published, Medtronic responded, disputing the paper’s report, saying the piece made false insinuations and omitted key facts.

Medtronic said it acknowledged that results from its review were not properly archived nor fully assessed for reportability to the FDA, but that once the data was located in 2013 it was promptly reported “to all appropriate regulatory bodies.” The data does not change the safety and efficacy for Infuse, the company said.

“Despite these facts the article suggests Medtronic attempted to conceal information about the [retrospective chart review], including information about adverse events reported in the data. This suggestion is false, and we want to set the record straight by sharing details that were provided to the Star Tribune but omitted from the article,” Medtronic said in a prepared release. “We have fully lived up to our principles of transparency and disclosure.”

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