Echo Therapeutics (NSDQ:ECTE) said today that it’s future may be in jeopardy after getting hit with a restrictive injunction related to a whistleblower case alleging securities violations, theft of trade secrets and more.

The company said it is facing a case in the U.S. District Court for the Southern District of New York related to “various violations of the securities laws, theft of trade secrets, breach of contract and breach of fiduciary duty,” in an SEC filing posted today.

Echo received Order to Show Cause related to the case, which temporarily restrains the company from taking “certain actions outside of the ordinary course of business,” prohibiting it from entering into agreements with Medical Technologies Innovation Asia, which it inked a 10 year deal with in 2013.

“The Order temporarily restrains and enjoins the company from taking certain actions outside of the ordinary course of business, including entering into any agreement with MTIA, or selling, transferring and/or licensing any of the company’s assets,” the company wrote in an SEC filing.

A hearing related to the case is scheduled for December 8, which the company said it will vigorously defend itself against.

However, Echo Therapeutics said the cost of defending itself along with the restrictive injunction may dry up its coffers and leave it to an uncertain future.

“The company expects that defense of these actions will drain the company’s remaining limited resources and prevent the consummation of any transaction that might allow the company to continue funding its research and development activities. The company is exploring its alternatives, but if the company is unable to overturn the temporary restraining order or otherwise settle these actions, the company will be unable to continue as a going concern,” Echo Therapeutics wrote in an SEC filing.

The company said the case is being brought against it by former VP of operations and product development Thomas Bishop. Echo Therapeutics claims that Bishop “tendered his resignation after admitting to lying to the company’s officers and directors regarding attending a meeting in Florida with one or more of the Plaintiffs that he was instructed not to attend,” according to SEC documents.

Echo Therapeutics said that another plaintiff, LifeTech Capital investment banking managing director Craig Pierson, was also at the mentioned meeting in Florida with Bishop, and that Pierson “introduced certain of the plaintiffs to the company.”

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B. Braun said this week it inked a collaborative deal with Omnicell to help decrease the time and clinical support necessary to manage IV infusions and IV compounding.

Through the deal, Omnicell will be able to use B. Braun’s DoseTrac infusion management software through a hyperlink in Omnicell’s performance center, the companies said.

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

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BioTelemetry (NSDQ:BEAT) said today it will pay $7 million in cash to pick up Telcare Medical Supply, which it said was the 1st company to receive FDA clearance for a cellular-enabled blood glucose monitoring system.

The deal will include $7 million in cash up front with the potential for an additional $5 million in performance-based earn-outs, Malvern, Penn.-based BioTelemetry said.

“BioTelemetry is one of the few companies to successfully scale a profitable digital health business. We have a tremendous core competency in real-time remote data collection, analysis, storage and distribution. As we detailed on our last earnings call, we see digital population health management as a natural fit to leverage our expertise and existing partnerships to improve outcomes and reduce costs in some of the more widespread chronic conditions. We chose the diabetes market as our 1st major digital population health initiative because of its significant overall burden on the healthcare system, with estimated direct annual costs in the U.S. of over $245 billion,” BioTelemetry CEO Joseph Capper said in a press release.

BioTelemetry said it expects Telcare to bring in over $5 million in revenue annually and should be near breaking even by the end of 2017.

“Having spent a large portion of my career leading companies focused on diabetes, I understand the complexities and challenges for patients, payors and providers of care. I have seen firsthand the positive effect robust care management programs can have on the lives of people living with this condition. Furthermore, by incorporating the latest advancements in remote digital technology, we will provide the “critical missing ingredient” necessary to close the time and distance gaps endemic in traditional care management programs. Given our clear leadership position in the analysis and transmission of complex digital health information, we are uniquely positioned to accelerate the market penetration of Telcare’s digital population health management solution. Telcare, fueled by its wireless BGM system and highly sophisticated, cloud-based population analytics, provides us with a powerful platform from which to build. We are confident this business will provide a meaningful contribution to our growth over time,” BioTelemetry CEO Capper said in prepared remarks.

In August, BioTelemetry said it won CE Mark approval in the European Union for its Holter analysis software.

The company said the device is usable on a stand-alone basis or with any of its digital holter recorders, and that it expects to market the software under its Millenia brand name.

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Ureteral medical device company BrightWater Medical said today it won FDA 510(k) clearance for its ConvertX nephroureteral stent system designed for treating ureteral obstructions.

The ConvertX System is designed as a single device intended to replace a series of devices and procedures used to treat severe obstructions of the ureter. Traditional interventions require an implanted nephrostomy catheter to externally drain urine and a second procedure to implant a nephroureteral stent to circumvent blockage.

Mountain View, Calif.-based BrightWater’s system is designed to be implanted once and convert from a nephroureteral catheter into a nephroureteral stent without requiring sedation or local anesthesia.

“Ureteral blockages due to kidney stones, tumors or scarring from previous surgeries must be treated quickly so urine can be voided. The ConvertX System saves the patient the risk and discomfort of an additional second interventional procedure and may reduce healthcare costs, free up the hospital’s angio suite for other procedures and save the IR procedural time that can be devoted to care of other patients,”BrightWater founds & CEO and ConvertX System developer Dr. Bob Smouse said in a press release.

In addition to the clearance, BrightWater said it recently received a medical device manufacturing license from the California Department of Public Health.

The company also said it plans to submit an application for CE Mark approval in the European Union for the device in the future, and that it is in the process of developing additional ConvertX-based products for other procedures in interventional radiology.

“The ConvertX System is the kind of technology advancement that we require to meet the dual goals of improving patient care and reducing the financial burden to the health care system. Interventional radiology enables patients with severe ureteral blockages to be quickly treated, and technologies like the ConvertX platform provide the IR with simpler, more cost-effective solutions,” Dr. James Benenati of the University of South Florida College of Medicine said in prepared remarks.

In May, BrightWater said it closed a $5.2 million Series A round of financing to support its ConvertX Nephroureteral stent system designed for treating severe ureteral obstructions from development to regulatory filing.

The round was led by OSF HealthCare investment arm OSF Ventures, and joined by angel groups and private investors, the company said.

Funds are slated to be used to cover initial cost for product development, intellectual property and regulatory filings for the ConvertX system.

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Shares in Retractable Technologies (NYSE:RVP) lost nearly half their value last week after a federal appeals court overturned its $352 million anti-trust win over Becton Dickinson (NYSE:BDX).

A 3-judge panel of the U.S. Court of Appeals for the 5th Circuit ruled Dec. 2 that RTI’s claim that BD violated a section of the Sherman Antitrust Act was “infirm as a matter of law.”

“First, patent infringement, which operates to increase competition, is not anticompetitive conduct. Second, false advertising is a slim, and here nonexistent, reed for a [Sherman Act] claim. Third, the allegation that BD ‘tainted’ the market for retractable syringes while surreptitiously plotting to offer its own retractable a few years later is unsupported and incoherent,” Judge Edith Jones wrote.

The 5th Circuit also upheld the false advertising claim and sent it back to the U.S. District Court for Eastern Texas, which will decide how much profit BD must disgorge.

The news sent RVP shares down -46.9% to a $1.30-per-share close Dec. 2. BDX shares closed up 0.6% at $165.53 apiece that day. Neither firm nor their lawyers responded to requests for comment.

The case dates back to 2001, when Little Elm, Texas-based RTI sued BD for patent infringement, settling for $100 million in 2004. RTI sued again barely 3 years later, alleging patent infringement and anti-trust violations. The case was split, with the anti-trust portion on hold while the patent infringement claims were litigated. A federal appeals court decided in July 2011 to reverse an earlier jury finding that both the 1m and 3ml sizes of the BD syringe infringed the Retractable patent, ruling that only the smaller size trespassed on the intellectual property.

The anti-trust phase of the proceedings began in 2010; eventually BD was found to have advertised false claims that its Integra, Safety-Lok, SafetyGlide and Eclipse safety syringes boast the “world’s sharpest needle” and about the amount of “waste space” in RTI’s VanishPoint syringe. In September 2013 a jury found for RTI, awarding $113.5 million after finding that BD violated the Lanham Act’s false advertising proscription. Franklin Lakes, N.J.-based BD later lost an initial bid to toss the case, after the Easter Texas court ruled that infringement can constitute anti-competitive behavior. In October that court declined BD’s bid to overturn the verdict and ordered the company in January 2015 to pony up more than $352.2 million in damages, including more than $11.7 million in attorneys’ fees, plus pre- and post-judgment interest and costs.

Material from Reuters was used in this report.

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By: Nina L. Hunter, Ph.D., and Robert M. Califf, M.D.

About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were derived from focus group studies with reviewers from FDA’s different Centers and included input from industry. Since then, we have built on foundational policies and processes to address many of the issues identified in the report.

The team has made tremendous progress toward the goal of modernizing the combination products review program by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the Agency as well as with all stakeholders. We are excited to share our progress with you now. The table below summarizes some key achievements from the past year, including publication of draft guidances, a variety of new processes, and a look at future goals.

As technologies advance across multiple fields, the distinctions that previously allowed combination products to be neatly categorized by FDA’s medical product centers are blurring or even vanishing.

Combination products account for a growing proportion of products submitted for review, and FDA will continue to pursue new approaches to collaboration that ensure safe, effective and innovative medical products are made available to patients as quickly as possible. Continued collaboration with you, our stakeholders, will be critical as together we continue to make progress in this important area.

We are still listening and have much more work to do!

This table summarizes key Combination Product Review Program achievements from the past year. Click on table for PDF version.

The PDF version of the table is also located here: combination-products-review-program

Nina L. Hunter, Ph.D., is FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco

Robert M. Califf, M.D., is Commissioner of U.S. Food and Drug Administration

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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GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said last week that they filed a regulatory submission with the European Medicines Agency for the once-daily, triple-combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) for patients with chronic obstructive pulmonary disease. Last month, the companies submitted a new drug application for the inhaled therapy to the FDA for approval in the U.S.

The triple combination therapy is made up of 3 drugs – an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta-adrenergic agonist. The treatment is delivered once a day using GSK’s Ellipta dry powder inhaler. The regulatory submission is backed by clinical data that includes the phase III Fulfil study, which compared once daily FF/UMEC/VI with AstraZeneca‘s (NYSE:AZN) twice daily Symbicort Turbohaler in patients with advanced COPD. The triple combo therapy demonstrated improved lung function and statistically significant reductions in exacerbations.

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

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Israel’s Bonus Biogroup (TLV:BONS) said today that it successfully injected its lab-grown, semi-liquid bone graft into the jaws of 11 people in an early stage clinical trial evaluating bone loss repair. The company is presenting its results at the International Conference on Oral & Maxillofacial Surgery in Spain today.

The material is grown in a lab from a patient’s  own fat cells and then injected into the voids of problematic bones in the jaw. Over the course of a few months, the material hardens and merges with existing bones to fill out the jaw.

The transplant “was 100% successful in all 11 patients,” Ora Burger, the VP of regulation affairs, told Reuters. “Now we are going to conduct a clinical study in the extremities, long bones.”

CEO Shai Meretski previously founded Pluristem Therapeutics, an advanced Israeli biomedical company that works with stem cells.

“For the first time worldwide, reconstruction of deficient or damaged bone tissue is achievable by growing viable human bone graft in a laboratory, and transplanting it back to the patient in a minimally invasive surgery via injection,”Meretski told the news outlet.

The company has raised $14 million and plans to dual list on NSDQ soon.

The post Lab-grown bone shows 100% success rate in small, early study appeared first on MassDevice.

Sunovion Pharmaceuticals said today that it will soon begin enrollment for a Phase IV study of its anti-epileptic drug Aptiom with Empatica‘s Embrace watch. The Marlborough, Mass.-based company touted its study as the 1st to incorporate a wearable seizure device with an anti-epileptic drug into the design of a clinical trial for partial-onset seizures.

The Embrace watch is an investigational device that will be used in the study to detect and record partial-onset seizures as they are identified by patients or caregivers. Aptiom (eslicarbazepine acetate) is approved in the U.S. as a stand-alone or adjunctive therapy for partial-onset seizures.

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

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There is no clear cut-off age to stop breast cancer screening, according to new data from the largest-ever study on mammogram screening outcomes.

Data from the study was presented this week at the Radiological Society of North America’s annual meeting.

Age-based cutoffs for screenings have been a source of controversy for many years in the healthcare field. Results from the massive study, however, support guidelines that support making breast cancer screening decisions based on individual patients and health status over a specific age, according to study researchers.

Data in the study came from over 5.6 million mammogram screenings performed over 7 years between January 2008 and December 2014 and across 150 facilities in 31 U.S. states. Patient demographic data, mammography and biopsy results were considered in the analysis, with over 2.5 million women over 40 in the study.

A total of 4 standard performance metrics were used to evaluate the data at each age group, including cancer detection rate, recall rate, positive predictive value for biopsies and biopsies performed.

The mean rate of cancer detection was clocked at 3.74 per 1,000 patients, with a recall rate of 10%, positive predictive value of recommended biopsies at 20% and for biopsies performed at 29%. In considering age between 40 and 80 years, metrics showed a gradualte upward trend in terms of cancer detection rate and biopsy prediction rate, but a downward trend in recall rate.

“All prior randomized, controlled trials excluded women older than 75, limiting available data to small observational studies. There has been a lot of controversy, debate and conversation regarding the different breast cancer screening guidelines, even among major national organizations, over the past few years,” Dr. Cindy Lee of the University of California, San Francisco said in a prepared statement.

Study researchers indicated that the results supported the argument that individual personal health history and preferences should be used to inform whether or not to stop screenings.

“The continuing increase of cancer detection rate and positive predictive values in women between the ages of 75 and 90 does not provide evidence for age-based mammography cessation,” Dr. Lee said. “We know that the risk of breast cancer increases with age,. With the uncertainty and controversy about what age to stop breast cancer screening, we want to address this gap in knowledge using a large national database.”

• Samsung showcases FDA-cleared GM85 mobile digital radiography system
• GE Healthcare showcases industry-first technologies and digital solutions, focused on improving outcomes
• GE Healthcare unveils Freelium MRI technology
• Siemens Healthcare debuts robot-supported ARTIS pheno angiography system
• Toshiba Medical introduces premium ultrasound systems to enhance the clinical application of ultrasound
• Toshiba Medical’s new 3T MR speeds up neuro exams
• Toshiba Medical launches Aquilion One/Genesis edition
• Toshiba Medical’s fully integrated model-based iterative CT reconstruction wins FDA clearance
• Toshiba Medical launches MR system for efficient, standardized cardiac exams
• Toshiba Medical introduces new compact solution for advanced ultrasound imaging
• Toshiba Medical launches Xario 100 Platinum Series ultrasound tech for healthcare providers of all sizes
• NTT DATA Services announces partnership with AnatomyWorks for brain mapping algorithms
• NTT DATA Services announces partnership with Imbio for lung analytic algorithms for UCA imaging platform
• Doctors in Japan begin treating patients with Elekta’s Leksell Gamma Knife Icon
• BK Ultrasound, powered by Analogic, introduces bkFusion
• SyntheticMR introduces REMyDI, automatic measurement of myelin volume 
• Hologic to showcase breast screening and interventional solutions
• Clarius introduces pocket ultrasound
• Civco to introduce next-gen ultrasound guide
• Varian to showcase imaging components and software solutions
• Philips announces commercial availability of IntelliSpace unverisal data manager for healthcare enterprises
• Philips introduces new data-driven intelligent solutions connecting patients, practitioners & processes
• IBM unveils Watson-powered imaging solutions for healthcare providers
• Ziehm Imaging sets new standards for clinical benefits
• ProMedica to incorporate cardiology in its Sectra enterprise imaging solution
• Konica Minolta Healthcare introduces AeroDR HD high-res digital radiography detector
• Konica Minolta Healthcare introduces AeroRemote active monitoring capability
• iCAD to showcase use of artificial intelligence in medical imaging

The post Data points to no age-related cutoff for mammogram screenings | RSNA 2016 Roundup appeared first on MassDevice.

InGeneron said today that it landed a collaboration with the German Accelerator Life Sciences program, establishing an additional U.S. presence in Cambridge, Mass. The initiative is supported by the German Federal Ministry for Economic Affairs & Energy.

The GALS program will provide InGeneron with a group of mentors to help leverage its network within the industry and support the company’s U.S. presence and development in Europe. GALS will continue to support InGeneron as the company launches clinical development in the U.S. and expands its distribution network, the program said.

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

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Sorrento Therapeutics (NSDQ:SRNE) subsidiary Scilex Pharmaceuticals said today that its lidocaine patch, ZTlido, met primary and secondary endpoints in a pivotal study comparing the patch to Endo Pharmaceutical‘s Lidoderm patch. The data will be used to resubmit a new drug application to the FDA in mid-2017, the Malvern, Pa.-based company said.

The clinical trial evaluated Scilex’s 1.8% lidocaine patch to the 5.0% Lidoderm patch. The primary endpoint established comparative pharmacokinetics, while the secondary endpoint demonstrated bioequivalence between the 2 patches. ZTlido’s anhydrous patch contains only 36 mg of lidocaine, while Lidoderm holds 700 mg per patch.

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

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Transcatheter tricuspid heart valve repair device developer 4Tech said today it tapped former Thoratec interventional products GM Dr. Michael Ennen as its new prez & CEO, taking over for Carine Schorochoff who will stay on as an advisor and board observer.

Dr. Ennen worked with with Thoratec to take the company’s 1st catheter-based product through CE Mark approval in the European Union and commercialization in the region, as well as helping initiate an investigational device exemption trial for the device in the U.S.

“I’m delighted to welcome Mike to 4Tech as President and CEO. His track record of rapidly advancing breakthrough technologies, combined with his commercial experience, make him an ideal fit for the company. Mike brings deep cardiovascular expertise to the role, as well as tremendous leadership, insight and passion, which we are confident will help drive the success of the TriCinch System and the broader company. I also want to thank Carine for leading 4Tech into the strong clinical-stage position the company is in today and look forward to working with her as an advisor and a board observer,” board chair Bill Hawkins said in prepared remarks.

Prior to his time with Thoratec, Dr. Ennen served as chief scientific officer and held VP roles at ev3/Covidien and FoxHollow Technologies, 4Tech said.

“I am honored to be joining 4Tech, which I believe is positioned to create the category-defining percutaneous solution for tricuspid valve disease. 4Tech has advanced an innovative repair technology, and I am excited to build on that foundation and to accelerate our development efforts. Tricuspid regurgitation remains a significant unmet need, and I’m confident that the TriCinch System will meaningfully advance the portfolio of structural heart products and help patients worldwide,” Dr. Ennen said in a press release.

“This is the perfect time in the evolution of 4Tech for Mike to become its next President and CEO. Mike has consistently demonstrated a superior ability to amplify the commercial viability of medical technology. The 4Tech Team is looking forward to continuing to deliver on 4Tech’s mission under Mike’s leadership and is keen to welcome him and his family to Galway,” former-CEO Schorochoff said in a prepared statement.

Integra LifeSciences (NSDQ:IART) today announced a number of new appointments, lifting Robert Davis Jr. as orthopedics & tissue tech prez and corporate VP, tapping Dan Reuvers as corp VP and SSS prez and announcing that Glen Coleman will assume oversight of its international biz.

“These key leadership appointments reflect the depth and strength of our management team, enabling us to promote executives from within the company. Bob, Dan and Glenn are proven leaders who have demonstrated exemplary management capabilities over the years and a track record of accomplishments that have contributed to our strong business performance,” Peter Arduini said in a prepared statement.

SuperSonic Imagine said late last month it tapped Michèle Lesieur as its new prez & CEO, replacing Bernard Doorenbos. Lesieur previously held various positions at Royal Philips (NYSE:PHG), including Philips France prez.

“SuperSonic Imagine’s supervisory board is enthusiastic about Michèle Lesieur becoming the company’s President and CEO. Her expertise, her leadership and her significant experience in international healthcare companies made her the best candidate to run SuperSonic Imagine, thus replacing Bernard Doorenbos, who was interim President and CEO. Indeed, we would like to thank Bernard for his contribution. Under Michèle’s experienced leadership, the company will continue to implement its strategic plan, which consists in moving forward on its various markets by capitalizing on the highly-innovative nature of its Aixplorer ultrasound platform, launching new innovative features and products and developing new fruitful partnerships. Along with our dedicated employees and a strong leadership team now headed by Michèle Lesieur, the Supervisory Board is confident that the scene is set for resuming a strong development track going forward,” board chair Michael Brock said in a press release.

Skyline Medical said last week it tapped former exec chair Dr. Carl Schwartz as its new chief executive officer.

“I am very pleased to be assuming the CEO position at this exciting inflection point in Skyline Medical’s strategic plan. We have made a great deal of progress in recent weeks with the Streamway System, including new domestic sales, the approval by Health Canada and the expansion of our global distribution network. We expect to receive CE Mark for Streamway in the coming weeks, and have engaged GLG Pharma for distribution in the U.K. and Central Europe. With the promise of using Streamway for patient diagnostics and a joint venture directed at mobile operating rooms and other U.S. government purchasers, our growth prospects are better than they have been in a very long time. I look forward to executing our business plan with the support of a talented management team and of our board of directors,” Dr. Schwartz said in a prepared statement.

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Biotronik said today it enrolled the 1st patients in the BioInsight clinical study of its BioMonitor 2 heart monitor, which looks to investigate the feasibility implanting the BioMonitor 2 in office settings.

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.

“One of the benefits of BioMonitor 2 is the ease of the insertion procedure, which typically only takes a few minutes. In-office procedures can reduce patient’s and physician’s time, increase access to the device and reduce cost burdens for healthcare systems. Early insertion will likely also reduce the time needed for a conclusive diagnosis,” Dr. Raul Weiss of Ohio State University said in prepared remarks.

The company’s BioInsight study is a multi-center, prospective, non-randomized post-market study in which patients will be implanted with the BioMonitor 2 via an in-office procedure, and will be followed for 90 days to monitor possible adverse events, including infection and bleeding.

“BioMonitor 2 has been rapidly adopted by physicians, becoming a trusted, reliable solution to monitor for cardiac arrhythmias. There is a significant need for BioMonitor 2, and we want to ensure our physicians have the utmost confidence in their ability to deliver efficient patient care. The BioInsight study will assure physicians and patients that performing the insertion procedure in an office setting safely and effectively improves access to this critical diagnostic tool,” prez Marlou Janssen said in a press release.

Biotronik said it hopes to complete the trial in the 3rd quarter of 2017. The company won FDA clearance for the device in April, and won CE Mark approval in the European Union last August.

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NeuroPace today released 7-year follow-up data from a clinical trial of its RNS neurostimulation system designed to prevent epileptic seizures, touting an over-70% reduction in seizure frequency.

The company’s RNS system is a closed-loop brain-responsive neurostim system designed for preventing epileptic seizures, and has been approved by the FDA as adjunctive therapy to treat partial onset epilepsy in patients who are non-responsive to medication.

Data from the study was presented this week at the American Epilepsy Society’s meeting in Houston, the Mountain View, Calif.-based company said.

Follow-up data indicated a median reduction in seizure frequency of 72% at 7 years. At 7-years, 25% of patients reported a seizure reduction of greater than or equal to 93% for any 3 month period in the year, the company said.

A total 29% of patients in the trial reported experiencing 1 or more 6-month period free from seizures, according to a press release.

Clinical trial patients are continuing to be treated in an ongoing long-term treatment study, NeuroPace said, which is an ongoing, multi-center prospective open-label study for participants in either a feasibility or randomized controlled trial of the RNS system.

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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.

Get this in your inbox everyday by subscribing to our newsletters.

5. FDA clears BrightWater Medical’s ConvertX nephroureteral stent

Ureteral medical device company BrightWater Medical said today it won FDA 510(k) clearance for its ConvertX nephroureteral stent system designed for treating ureteral obstructions.

The ConvertX System is designed as a single device intended to replace a series of devices and procedures used to treat severe obstructions of the ureter. Traditional interventions require an implanted nephrostomy catheter to externally drain urine and a second procedure to implant a nephroureteral stent to circumvent blockage. Read more

4. Teleflex puts up $1B for Vascular Solutions

Teleflex said today it will pay approximately $1 billion to acquire Vascular Solutions.

Through the deal, Teleflex will pick up all outstanding shares of Vascular Solutions at $56 per share, in cash. Boards of both companies have approved the deal, which is expected to close during the 1st half of 2017. Read more

3. Echo Therapeutics faces uncertain future in whistleblower case

Echo Therapeutics said today that its future may be in jeopardy after getting hit with a restrictive injunction related to a whistleblower case alleging securities violations, theft of trade secrets and more.

The company said it is facing a case in the U.S. District Court for Southern New York related to “various violations of the securities laws, theft of trade secrets, breach of contract and breach of fiduciary duty,” in a regulatory filing posted today. Read more

2. PTAB tosses out Covidien patent in surgical shears spat with J&J’s Ethicon

The Patent Trial and Appeal Board has thrown out Medtronic subsidiary Covidien‘s patent on electrosurgical shears in a spat between the company and Johnson & Johnson‘s Ethicon Endo-Surgery subsidiary, according to court documents released this week.

The patent relates to a bipolar electrosurgical shearing instrument used to seal and cut blood vessels or vascular tissue, designed to use “both mechanical clamping action and electrical energy to coagulate, cauterize and/or seal tissue,” according to court documents. Read more

1. Retractable Technologies plummets after appeals court tosses $352m win over Becton Dickinson

Shares in Retractable Technologies lost nearly half their value last week after a federal appeals court overturned its $352 million anti-trust win over Becton Dickinson.

A 3-judge panel of the U.S. Court of Appeals for the 5th Circuit ruled Dec. 2 that RTI’s claim that BD violated a section of the Sherman Antitrust Act was “infirm as a matter of law.” Read more

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

Implantable medical systems maker Kyocera Medical said today it won FDA 510(k) clearance for its Initia total hip implant system.

The Japanese company’s Initia total hip system includes Bioceram Azul zirconia-toughened alumina ceramic femoral heads, or can be requested with cobalt chrome femoral heads.

The system includes a total 16 tapered-wedge stem sizes, with 12 available in the US, according to a press release.

In late 2013, Amedica Corp. entered into an agreement with Kyocera to manufacture Amedica’s silicon nitride biomaterial at Kyocera’s Vancouver, Wash., facility.

The FDA-cleared silicon nitride has the potential to promote bone growth defend against infection. Devices made from silicon nitride are semi-radiolucent with clearly visible boundaries, enabling an exact view of intra-operative placement and postoperative fusion assessment via common imaging modalities, according to a press release.

The deal is expected to help Amedica meet demand for the technology, including spinal interbody devices. Amedica has sold over 14,000 of these devices worldwide, according to a company statement.

The post FDA clears Kyocera Medical’s Initia hip implant appeared first on MassDevice.

Using the drug misoprostol in combination with a Foley balloon catheter to induce labor can lead to a speedier delivery, with women delivering several hours earlier than either method alone, according to research from the University of Pennsylvania. The team’s work was published in Obstetrics & Gynecology.

Nearly 1 million women who deliver in the U.S. each year undergo labor induction, but the process is still costly and doctors do not agree on 1 common practice.

The research team at UPenn touted its study as the largest-ever clinical trial of labor induction methods, enrolling 500 women who needed to undergo labor induction at the Hospital of the University of Pennsylvania. The participants were randomly split into 4 different treatment arms to induce labor: misoprostol alone, the Foley balloon catheter alone, the 2 methods combined, or the Foley balloon catheter with a synthetic version of oxytocin.

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

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Researchers from the Institute of Materials Science in Juazeiro, Brazil have reported on the antibacterial properties of usnic acid, a strong lichen metabolite, encapsulated in electrospun fibers. The team’s work was published in Recent Patents on Nanotechnology.

Usnic acid has been used in commercial products, such as creams, toothpastes and sunscreen, due to their antiviral, animicrobial and anti-inflammatory properties. To optimize the use of this compound as an alternative to antibiotics, the team of researchers sought to identify a way to encapsulate the compound and release it in a controlled manner at varying levels of acid concentration.

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

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Invendo Medical said today it won CE Mark approval in the European Union for its Invendoscope SC200, which it touts as the world’s 1st sterile, single-use colonoscope.

The German company said its device is designed to eliminate the complex reprocessing of endoscopes that create a serious risk of cross-contamination and the culturing of resistant bacteria.

“Our revolutionary technology uniquely addresses the significant challenges associated with the cleaning and disinfecting of traditional reusable endoscopes by providing an ergonomically advanced endoscope that offers both sterility and single use. The CE Mark is a significant accomplishment for our company, which enables us to provide endoscopists in Europe with a more advanced technology to perform colonoscopies and a system that enhances patient safety over current devices,” CEO Timo Hercegfi said in a press release.

The company said its Invendoscope SC200 won FDA 510(k) clearance earlier this year, and expects a market introduction of the scope in 2017.

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