MassDevice

Cadence announced today plans to enhance cleanroom capabilities in its Plymouth, Mass., and Santo Domingo, Dominican Republic-based facilities to expand support for medical device and life science customers.

Plans include:

The addition of a Class 8 cleanroom in Plymouth, Mass.
The expansion of the existing Class 8 cleanroom in Santo Domingo, Dominican Republic

“We bought our first injection molding machine in 1965. Since that time, we have focused on ‘mission critical’ plastic products, including parts that helped enable man to walk on the moon in 1969,” vice president & GM Jeff Kelly said in prepared remarks. “We are excited to expand this legacy to better support medical applications.”

Cleanroom injection molding using engineered resins will be available on presses ranging from 17 tons to 165 tons in size. The expansion efforts, with expected completion in early May, also creates dedicated space for cleanroom assembly and automation.

“Our commitment to ‘mission critical’ plastic products for medical devices is driving our current expansion efforts. This investment is the direct result of the talent, hard work, and commitment of our employees making us a better company every day,” added Omar Ferretti, vice president of manufacturing for the Bay State and Dominican Republic facilities.

For more information, visit us in booth #302 at BIOMEDevice Boston on April 13-14, 2016 or visit our website at www.cadenceinc.com/plastics.

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Eximo Medical said a 20-patient pivotal trial in Europe, aimed at winning CE Mark approval there for its hybrid peripheral catheter, met its safety and efficacy endpoints.

Rehovot, Israel-based Eximo’s device is designed to combine laser ablation with a blunt, bladed tip to clear partial or full peripheral blockages. The company said it’s pursuing the CE Mark and “will be looking to receive FDA approval in 2017.”

The primary safety endpoints in the trial are freedom from major adverse events at 30 days and freedom from device/procedure-related adverse events until discharge, expected to be 2 days. The efficacy endpoint is technical success rate, or the ability of the catheter to cross the lesion, according to ClinicalTrials.gov.

“We are pleased to announce the successful completion of a 1st-in-human study with a PAD application, which constitutes a significant milestone that will enable the receipt of CE marketing approval in Europe. We are proud that thanks to the unique technology developed by our company, we were able to alleviate patients’ suffering and prevent complicated, unnecessary surgeries, which could, in extreme cases, even have led to amputation of the leg. The completion of the trial represents an additional significant step toward a multi-participant FDA trial in the United States – a potential market of billions of dollars,” CEO Yoel Zabar said in prepared remarks.

“We are proud to be the 1st medical center in the world to have treated patients with the Eximo system. The treatment of all 14 patients by us was highly successful, without any complications. All of the patients have experienced significant pain relief in the treated limb and significant improvement in quality of life,” added Dr. Waclaw Kuczmik of the Medical University of Silesia in Katowice, Poland.

Eximo was founded by Accelmed, which led a $1.6 million Series A round last year for the company, with participation from the Alfred Mann Institute at the Technion, the Technion R&D Foundation and a private investor.

The post Eximo Medical’s hybrid catheter clears pivotal trial appeared first on MassDevice.

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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. Sterigenics acquires Nelson Labs

Sterigenics said it picked up microbiology testing service provider Nelson Laboratories for an undisclosed amount.

Salt Lake City, Utah-based Nelson Labs provides microbiology testing services for the medical device, pharmaceutical and tissue industries and employs 570 individuals, including 300 scientists and 60 registered specialist microbiologists. Read more

4. Study: Proteus Discover boosts compliance, lowers BP & LDL | ACC 2016

Proteus Digital Health yesterday presented interim results from a study of its Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes, claiming use of the system raised patient compliance, lowered blood pressure and reduced low-density lipoprotein-cholesterol.

The Chicago-based company’s Proteus discover operates through the use of an ingestible sensor, the size of a grain of sand, which is activated when it reaches the stomach and communicates with a wearable sensor patch which records time of ingestion and personalized data such as heart rate, physical activity and rest. The data can be seen by a patient through a mobile app, which can be shared with healthcare professionals to optimize patient treatment. Read more

3. SurModics launches 1st-in-human trial for SurVeil drug-coated balloon

SurModics said it enrolled the 1st patient in an early feasibility trial of its SurVeil drug-coated balloon for treating peripheral artery disease, as it looks to metamorphose from device coating provider to medical device maker.

The FDA granted investigational device exemption for the trial late last year, the Eden Prairie, Minn.-based company said. The 1st-in-human study is slated to enroll 15 patients to examine the safety & usability of the SurVeil device before the design is finalized, SurModics said. Read more

2. Bracco wins FDA nod for liver cancer microspheres

Bracco Diagnostics said yesterday it won FDA premarket approval for its Lumason ultrasound imaging agent, now indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients.

Marketed in other countries as SonoVue, Lumason is a contrast agent made up of gas-filled microbubbles, or microspheres, that reflect sound waves to enhance the image. Lumason was previously approved for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and improve cardiac imaging. Read more

1. Medtronic still unfazed by new inversion rules

Medtronic remains unfazed by the U.S. Treasury Dept.’s push to rein in so-called “inversion” mergers, which allow American companies to re-organized under foreign jurisdictions, after the agency issued new rules on the deals this week.

The U.S. government has grappled with a wave of inversions in recent years, including last year’s $50 billion union of Medtronic and Covidien, which was domiciled in Ireland. Reincorporating overseas allows American companies to slash their tax bills even though their core operations and management stay here. Several U.S. presidential candidates, including Republican Donald Trump and Democrat Hillary Clinton, have seized on the issue in their campaigns. President Barack Obama, a Democrat, has called repeatedly for action by the Republican-controlled U.S. Congress on inversions, but lawmakers have done little. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 6, 2016 appeared first on MassDevice.

PathMaker Neurosystems said today it paired with the Feinstein Institute and Northwell Health to launch an IRB-approved clinical trial of its MyoRegulator device designed to treat muscle spasticity.

The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.

“Initiating our company’s 1st formal human clinical trial represents a significant milestone in our strategy to rapidly and efficiently bring to market an entirely new, non-invasive approach to treating spasticity. We are delighted to be working with Northwell Health and The Feinstein Institute for Medical Research, leaders in the emerging field of bioelectronic medicine,” PathMaker CEO Dr. Nader Yaghoubi said in prepared remarks.

PathMaker said it received confirmation from the FDA that clinical trials of the MyoRegulator constitute non-significant risk device studies, which allows the studies to proceed without an Investigational Device Exemption application. Such trials are assessed by the FDA and not considered to present a potential for serious risk to the health, safety or the welfare of subjects.

“We are thrilled to partner with PathMaker and begin studying a new treatment that could provide relief for patients who suffer from spasticity – a serious condition that can often inhibit patients from participating in everyday activities. I see patients who can no longer open doors or feed themselves as a result of suffering from spasticity. It is my hope that at the conclusion of this trial, we will see that MyoRegulator is a safe and effective treatment option,” study lead investigator Dr. Bruce Volpe of the Feinstein Institute said in a prepared statement.

The company said the MyoRegulator was one of the 1st products given an Expedited Access Pathway designation from the FDA, which it won last October.

In June PathMaker inked a deal with Proven Process to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. The MyoRegulator device aims to treat muscle spasticity in patients with stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury and other neurological conditions, the company said.

The post PathMaker and Feinstein Inst launch MyoRegulator spasticity trial appeared first on MassDevice.

InVivo Therapeutics (NSDQ:NVIV) is continuing to add sites to the Inspire study of its NeuroSpinal Scaffold, announcing today that it added a new site at the Charlottesville’s University of Virginia Health System.

The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

“Spinal cord injury is a devastating condition with severe personal and societal costs. We are excited to participate in this innovative study that has the potential to improve the outcomes in patients with the worst spinal cord injuries,” principal investigator Dr. Chris Shaffrey said in prepared remarks.

The new addition brings the total number of sites for the trial up to 19, the company said.

“We look forward to having Dr. Shaffrey and his team be a part of the Inspire study. The University of Virginia’s geographical reach and experience with spinal cord injury trials will be an asset as we seek to enroll additional Inspire subjects,” CEO Mark Perrin said in a press release.

In March, InVivo said it added Philadelphia’s Thomas Jefferson University Hospital as a clinical site. A day earlier, InVivo saw shares jump as much as 25% after announcing positive 6-month results for its 5th patient in the Inspire study of its neuro-spinal scaffold.

The company has shown significant momentum with its Inspire trial, announcing the addition of 2 clinical sites, in Greenville, N.C. and Louisville, Ky., as well as reporting that the FDA accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its neuro-spinal scaffold.

InVivo said its HDE modular shell for the Neuro-Spinal Scaffold is composed of 3 modules, including a preclinical study module, manufacturing module and clinical data module. The submission of the final module triggers a 75-day HDE review clock, the company said.

In late February, InVivo said the FDA approved a protocol amendment for its Inspire study examining the benefit of its Neuro-Spinal Scaffold for treating patients with complete thoracic AIS A spinal cord injuries, establishing objective performance criterion for the trial.

The post InVivo adds 19th site at University of Virginia site to Inspire study appeared first on MassDevice.

Sleep and neurological disorder device developer Advanced Brain Monitoring said today it won FDA 510(k) clearance for its Sleep Profiler PSG2 overnight EEG designed for to diagnose sleep apnea.

The Carlsbad, Calif.-based company said the Sleep Profiler PSG2 is designed to allow for objective evaluation of sleep patterns and home assessment of rapid eye movement related to obstructive sleep apnea.

“Sleep Profiler PSG2 meets the requirements for unattended polysomnography, the most accurate method for in-home assessment of sleep-disordered breathing. Clinical study results, required for FDA clearance, showed the Sleep Profiler PSG2 delivers unparalleled accuracy in the automated detection of sleep stage-dependent mild and moderate sleep apnea,” chief medical officer Dr. Philip Westbrook said in prepared remarks.

Advanced Brain Monitoring said a study result from its Sleep Profiler can be used to identify patients with abnormal sleep duration and efficiency, decreased slow wave sleep and increased cortical arousals. These factors are associated with hypertension, obesity, diabetes and memory impairment, the company said.

“Sleep Profiler includes automated sleep staging. Results showed the Sleep Profiler accuracy in detection of REM sleep and slow wave sleep was equivalent to manual scorers from different sleep laboratories,” Advanced Brain Monitoring prez and principal investigator Daniel Levendowski said in a press release.

The post Advanced Brain Monitoring wins FDA nod for Sleep Profiler PSG2 appeared first on MassDevice.

Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker.

The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.

Micra is cleared with indications for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome, according to an FDA release.

“For many years we’ve been hopeful that a transcatheter pacing solution – with a safety and effectiveness profile on par with conventional devices – would become available, and today Micra has achieved this milestone. In the clinical trial, the Micra was successfully implanted in nearly all patients, and met its safety and effectiveness endpoints by wide margins. This gives us great confidence that this miniaturized device will bring patients the most advanced pacing technology, combined with the less-invasive nature of the new technology,” Micra TPS trial principal investigator Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center said in a press release.

The Micra is the 1st miniaturized pacer to win FDA approval, the Fridley, Minn.-based company said.

The device is designed to be attached to the heart with small tines and delivers electrical pulses to pace the heart through an electrode at the end of the device, and does not require a surgical “pocket” under the skin or leads.

“Dating back to the development of the 1st external battery operated pacemaker more than 60 years ago, Medtronic has a long history of collaborating with clinicians to better understand the needs of patients, and then innovating new products to meet those needs. We are thrilled to be the 1st to introduce a transcatheter pacemaker to patients in the U.S., and we’re looking forward to working with physicians and educating implanters to extend the positive results of our global clinical trial experience to even more patients,” Medtronic cardiac rhythm and heart failure biz prez Dr. John Liddicoat said in prepared remarks.

Medtronic said the Micra TPS is the only transcatheter pacing system to be approved for 1.5 and 3 tesla full-body magnetic resonance imaging scans.

“As the 1st leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” FDA Center for Devices and Radiological Health Office of Device Evaluation acting director Dr. William Maisel said in an FDA release.

Last November, Medtronic said its micro-sized leadless pacemaker met its primary safety and effectiveness endpoints with “wide margins.” Results from the trial were presented at the American Heart Association’s scientific sessions meeting this week and published in the New England Journal of Medicine, Medtronic said.

Medtronic said that 99.2% of patients in the trial were successfully implanted with the device. A total 96% of 725 patients experienced no major complications, which Medtronic said is 51% less than is seen in patients with conventional pacing systems.

Cardiac injuries occurred in 1.6% of patients, complications at the groin site in 0.7% and pacing issues in 0.3%. Medtronic said there were no dislodgments, no systemic infections and a 0.4% rate of system revisions.

Last April, Medtronic said it won CE Mark approval in the European Union for the Micra, the company said today, touting it as the world’s smallest pacemaker.

The CE Mark was granted based on 3-month results from the 1st 60 patients enrolled in Medtronic’s Micra TPS trial, the company said.

The post FDA clears Medtronic’s miniature Micra transcatheter pacer appeared first on MassDevice.

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing.

J&J agreed to pay $5 million to settle plaintiff Pamela Wicker’s lawsuit alleging that its Prolift mesh caused her injuries, Bloomberg reported. Wicker’s lawyer, Adam Slater, revealed the $5 million payment in a November 2015 filing seeking Judge Brian Marinotti’s approval for his $1.65 million legal fee, according to the news service.

In January, the New Brunswick, N.J.-based healthcare giant agreed to pay $120 million to settle the 1st 2,000 to 3,000 suits it’s facing. The amount of the Wicker settlement could mean that the cost of settling the cases moves much higher, according to Carl Tobias, a product-liability law expert the University of Richmond in Virginia.

“This settlement is a bad sign because it shows investors it’s going to cost a lot more to deal with this liability than people expected,” Tobias told Bloomberg.

The Wicker case “presented unique circumstances,” J&J told the news service via email. While the estimated cost of the mesh litigation isn’t broken out, “the company appropriately discloses overall litigation expenses.”

“From time to time we have agreed to resolve some cases,” J&J said. “We will not discuss the terms of resolutions, nor discuss our ongoing litigation strategy.”

Last month a New Jersey appeals court upheld an $11.1 million jury award in another Prolift case; in February, a Philadelphia jury docked the company $13.5 million in a suit filed over its Ethicon transvaginal polypropylene tape; J&J is appealing that verdict.

The post Johnson & Johnson’s $5m mesh settlement could push costs higher appeared first on MassDevice.

By Stewart Eisenhart, Emergo Group

The US Federal Trade Commission (FTC) has published an online tool designed to help developers of mobile medical and telehealth apps determine which laws and regulations pertain to their products.

Designed with input from the Food and Drug Administration and other agencies, the Mobile Health Apps Interactive Tool presents a series of questions for developers to see whether they must comply with one or more of the following US laws:

Health Insurance Portability and Accountability Act (HIPAA), enforced by the US Department of Health & Human Services
Food, Drug & Cosmetic Act, enforced by the FDA
Federal Trade Commission Act, enforced by the FTC
Health Breach Notification Rule, enforced by the FTC

Developers whose apps collect or create user data, or that diagnose or treat diseases, should explore the tool if they are unsure which (if any) laws apply to them.

Determining whether a mobile medical app qualifies as a medical device can be a significant challenge for developers unfamiliar with the concepts of FDA registration, Quality System Regulation compliance and related requirements. Additional information on telehealth apps and FDA clearance is available in our article on the topic; for developers seeking to consult with the FDA on whether their apps qualify as medical devices, our whitepaper on early communication with the agency may be useful as well.

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.

The post US regulators launch online tool for mobile medical app developers appeared first on MassDevice.

ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension.

The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial has 2 arms: The Solo cohort is designed to evaluate the essential hypertension patients; the Trio cohort will study the treatment-resistant group, Palo Alto, Calif., and Amsterdam-based ReCor said.

“We are excited to have enrolled the first patient in this very important study,” Dr. Joost Daemen, who enrolled the 1st Trio patient at the Erasmus University Medical Center in Rotterdam, Holland, said in prepared remarks. “We have significant experience using the Paradise System and believe that the Radiance-HTN study is well designed to demonstrate the system’s treatment effect. If Radiance-HTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus.”

“The Solo cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment,” added Dr. Pei-Hsiu Huang, who enrolled the 1st Solo patient at Sacramento’s Sutter Health. “We are excited to be part of this important study and by the possibility that Radiance-HTN could demonstrate the efficacy of renal denervation with the Paradise system, and open a path to new treatment options for our hypertension patients.”

ReCor won an investigation device exemption from the FDA for the trial in February. The company raised a $15 million Series D round back in April 2015 to fund the study of Paradise, which is designed to use ultrasound energy to ablate the nerve endings in the lining of the renal arteries.

ReCor, Boston Scientific (NYSE:BSX), St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) are all back in the renal denervation game, 2 years after Medtronic announced its Symplicity-3 renal denervation device missed its primary endpoint. Boston Scientific delayed its Vessix program in immediate response, and St. Jude Medical (NYSE:STJ) suspended its own trial. Eventual Medtronic acquisition Covidien ceded the field entirely, winding down development of its OneShot renal denervation device, which already had E.U. regulatory approval, and closing its Rapid II trial.

But the same month that ReCor announced its Series D round, Medtronic launched a new RDN trial, aiming to settle the “confounding” issues raised during Symplicity-3. Boston Scientific is running 2 clinical programs for its Vessix device: The Reduce trial, evaluating Vessix in treating hypertension; and the Relieve series, evaluating the technology for other conditions, including end-stage renal disease, heart failure, atrial fibrillation and diabetes. And St. Jude is running trials of its EnligHTN device in hypertension.

The post ReCor Medical launches trial for Paradise renal denervation device appeared first on MassDevice.

Baxter (NYSE:BAX) is reportedly planning to shutter a plant in Englewood, Colo., over the next year.

“Baxter has informed employees in its [Douglas County] … facility of the company’s plans to exit the facility over the next 12 months to enable effective deployment of the company’s product portfolio in order to best meet the needs of patients,” spokesman John O’Malley told the Denver Business Journal. “With this decision, our primary goal is to minimize the disruption to the customers and the patients that we serve, and support our employees through the change. Some employees will work remotely or relocate to other Baxter facilities. Baxter is still evaluating where the manufacturing currently taking place will transition to.”

The plant employs about 400 workers, according to the newspaper.

Last October, Deerfield, Ill.-based Baxter said it planned to cut about 1,400 jobs by the end of the year, or about 5% of its non-manufacturing workforce, with about ⅔ of the job cuts planned for outside the U.S.

In February Baxter reported 4th-quarter profits of $205 million, or 37¢ per share, on sales of $2.60 billion, for a profit decline of -78.5% on a -6.7% top-line decrease compared with Q4 2014. Adjusted to exclude 1-time items, earnings per share were 43¢, more than a dime ahead of Wall Street analysts’ 32¢ consensus.

Full-year profits slid -61.2% to $968 million, or $1.76 per share, on sales of $9.97 billion, for a -7.0% decline in revenues compared with 2014. Adjusted EPS came in at $1.38, a full 12¢ ahead of The Street.

The post Report: Baxter to shutter Colorado plant appeared first on MassDevice.

St. Jude Medical (NYSE:STJ) said today that it launched its Trifecta GT aortic valve replacement in the European Union, hailing the device as its most advanced tissue valve.

The Trifecta GT won CE Mark approval in the EU in February, the St. Paul, Minn.-based company said. The valve’s titanium stent is covered with tissue to improve tissue-to-tissue contact during the leaflets’ motion. St. Jude said the Trifecta GT also features its Linx anticalcification treatment

The Trifecta GT “will help us provide the best care possible for our patients in need of aortic valve replacement and especially those with challenging clinical cases,” Dr. Gebrine El Khoury of St-Luc Hospital in Brussels, who performed the 1st Trifecta GT implantation, said in prepared remarks.

“The excellent hemodynamic performance of the valve improves quality of life by restoring blood flow both at rest and during exercise, making it an outstanding choice for a wide range of patients,” noted Dr. Alain Leguerrier of Centre Hospitalier Universitaire de Rennes, France. “The enhancements to the Trifecta GT tissue valve facilitate improved valve parachuting and seating, which means the valve can gently glide into place.”

“For years, St. Jude Medical has dedicated significant resources to develop best-in-class heart valve replacement options while refining our devices based on physician feedback and clinical outcomes,” added St. Jude CTO Philip Ebeling. “The improved design of the Trifecta GT tissue valve allows for smoother placement while providing nearly unobstructed blood flow over the life of the valve. The Trifecta GT tissue valve is a true testament to our commitment to the cardiac surgery community and the patients they treat.”

The post St. Jude Medical launches Trifecta GT valve in Europe appeared first on MassDevice.

Dexcom Inc. (NSDQ:DXCM) today released a customer notice warning of possible malfunctions with the audible alarms and alerts from its G4 Platinum and G5 Mobile continuous glucose monitor systems.

San Diego, Calif.-based Dexcom said it received an “increase in complaints related to audible alarms and alerts,” associated with the 2 CGM units.

The company said it will notify all G4 and G5 users of the defect with instructions on how to verify that their speaker is functional. The notification was international, Dexcom wrote in its customer notice, affecting users in all markets.

Dexcom said it publicly announced that it had sent out the notification in late February. New receivers are slated to be delivered to users with receivers that are not working after the users return the non-functioning devices, the company said.

For users with functioning receivers, Dexcom advised that they should regularly test the devices for the error, especially if they get wet or are dropped.

Dexcom said it will ship each new receiver kit with a copy of the notification until a new speaker change is implemented. The company said it will record and maintain all reported issues.

Last month, Dexcom said it launched full support for Apple‘s (NSDQ:AAPL) Apple Watch for its G5 mobile continuous glucose monitor

The updated app will allow users to monitor their glucose data using the smartwatch, as well as viewing readings and trends and receiving notifications and alerts through the watch, which syncs to the app on the user’s iPhone.

The company said it launched a new feature which allows users to check their CGM information without needing to unlock or open the phone through the notifications panel.

The post Dexcom warns on G4, G5 CGMs appeared first on MassDevice.

Edap (NSDQ:EDAP) said today it inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company.

Investors in the round will receive warrants to purchase up to 3.3 million shares at an exercise price of $4.50 per share, exchangeable beginning 6 months from the date issued and for a period of 2 years after, Edap said.

The French company said it expects the offering to close on or around April 14. H.C. Wainwright & Co. acted as the exclusive placement agent for the round, according to an SEC filing.

Yesterday, EDAP said it submitted an application for FDA 510(k) clearance for its next-gen high-intensity focused ultrasound Focal One device designed to treat prostate cancer.

The company said the new submission comes following the FDA 510(k) clearance of its Ablatherm Robotic HIFU designed for the ablation of prostate tissue, which it won last November.

Last November, Edap said the appeal deadline lapsed for a shareholders lawsuit filed after an FDA advisory panel recommended against approval for its its Ablatherm device for treating prostate cancer.

EDAP shares plunged in 2014 after the FDA’s Gastroenterology & Urology Devices panel voted that the device did not appear to be effective or safe. Ablatherm, which won 510(k) clearance from the federal safety watchdog earlier in November, uses ultra high-intensity focused ultrasound to ablate prostate tissue.

Shareholders sued in August 2014, accusing Edap of misleading investors by exaggerating Ablatherm’s safety and efficacy and understating adverse events.

The post Edap looks to raise $11m in direct placement round appeared first on MassDevice.

Sorrento lures ex-Hologic exec Herde

Sorrento Therapeutics (NSDQ:SRNE) said it lured Kevin Herde, the former vice president of global blood screening & alliance management at Hologic (NSDQ:HOLX), to be its new CFO. Read more

The post Sorrento lures ex-Hologic exec Herde | Personnel Moves April 7, 2016 appeared first on MassDevice.

Brazilian medical device and diagnostic company Adavium Medical, formerly known as Advance Medical, said today it picked up Alka Tecnologia and Hemogram Industria e Comercio, raised $21m in a Series C round of financing and added ex-GE Healthcare CEO Claudia Goulart as its COO.

Adavium said the newly acquired companies are 2 of the “largest clinical diagnostic companies in Brazil,” and that the acquisition will make Adavium the largest medical equipment and diagnostic company in Brazil

“We bring commercial sophistication and scale to 1 of the largest and most complex healthcare markets in the world. We have spent the past several years evaluating and acquiring the best Brazilian companies that, together with our team and capabilities, would create the undisputed commercial and manufacturing leader. We are now the partner of choice for international companies with premium products. We also develop and manufacture proprietary products that bring the benefits of high-end technologies to the very large, but often ignored, value segment of the Brazilian market that requires affordable products. As a result, a number of our product lines lead in market share,” Adavium Medical CEO Dr. Fred Aslan said in a press release.

Adavium said it raised $21 million in a Series C financing round, with funds slated to finance its 2 recent acquisitions as well as others, and to “strengthen strategic capabilities throughout the company.”

The company also announced its addition of ex-GE Healthcare Latin America CEO and Adavium board member Goulart as the company’s COO and diagnostics biz president.

“As a board member, I have witnessed Adavium Medical’s growth from a start-up to the Brazilian leader in medical equipment and diagnostics and I am thrilled to assume a full-time leadership role. We are building an integrated product development and commercial platform able to bring the right portfolio to the largest number of customers in Brazil in a highly professional, ethical and FCPA-compliant manner,” Goulart said in prepared remarks.

The post Adavium buys 2 firms in Brazil, $21m in funding, adds ex-GE HC exec Goulart as COO appeared first on MassDevice.

imarc The relationship between a clinical research monitor and site coordinator can play a major role in ensuring data integrity and compliance with applicable regulations. Positive relationships can foster timely data entry, rapid resolution of queries, and adherence to FDA regulations. On the other hand, strained relationships can delay data entry, prevent resolution of queries and lead to sites being less inclined to follow regulations. The coordinator-monitor relationship is critical to the research process as it serves as a link between sponsors, investigators, and regulatory authorities.

How can we ensure that these relationships are optimized?

Here are 4 ways to improve the relationship between your site’s research coordinator and monitor:

COLLABORATE: Both the research coordinator and the monitor must approach the relationship with a collaborative mindset. It is imperative that both parties work together rather than against each other. The monitor and research coordinator should partner to achieve the mutual goal of ensuring data is accurate and complete, patient safety is upheld, and regulations are followed.
NOT THE POLICE: Both parties must strive to remember that the monitor is not there to punish the sight or the coordinator. On the contrary, the monitor is there to help prepare the site for potential audits and make the site’s hard work look good! This must be kept in mind when conceptualizing the relationship.
RESPECT TIME AND JOBS: Both the research coordinator and monitor should respect each other’s time and job responsibilities. For the research coordinator, this means providing the monitor with the necessary documents, charts, electronic access, investigational product, time, and resources necessary to complete monitoring duties. For the monitor, this means being cognizant of the fact that the research coordinator has other obligations including outside studies and research subjects. In addition, both parties should arrive punctually for all scheduled monitoring visits and meetings.
ADEQUATE PREPARATION: Closely related to being on time, both parties must be adequately prepared for the monitoring visit. The monitor should be familiar with the protocol, site policies, applicable regulations, and any concerns or issues that are present at the site. The research coordinator should ensure data entry is as complete and clean as possible at the time of the visit, should have addressed previous action items, and should be able to provide the monitor with items requested in preparation for the visit.

What ideas do you have for enhancing the monitor-coordinator relationship?

The post Enhancing Relationships between Monitors and Research Coordinators appeared first on MassDevice.

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5. Dexcom warns on G4, G5 CGMs

Dexcom Inc. today released a customer notice warning of possible malfunctions with the audible alarms and alerts from its G4 Platinum and G5 Mobile continuous glucose monitor systems.

San Diego, Calif.-based Dexcom said it received an “increase in complaints related to audible alarms and alerts,” associated with the 2 CGM units. Read more

4. St. Jude Medical launches Trifecta GT valve in Europe

St. Jude Medical said today that it launched its Trifecta GT aortic valve replacement in the European Union, hailing the device as its most advanced tissue valve.

3. ReCor Medical launches trial for Paradise renal denervation device

ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension.

2. Johnson & Johnson’s $5m mesh settlement could push costs higher

Johnson & Johnson subsidiary Ethicon could be facing a steeper-than-expected tab when it comes to settling the more than 46,000 product liability lawsuits brought over its pelvic mesh products, after details about 1 settlement became public in a legal filing.

1. Report: Baxter to shutter Colorado plant

Baxter is reportedly planning to shutter a plant in Englewood, Colo., over the next year.

“Baxter has informed employees in its [Douglas County] … facility of the company’s plans to exit the facility over the next 12 months to enable effective deployment of the company’s product portfolio in order to best meet the needs of patients,” spokesman John O’Malley told the Denver Business Journal. “With this decision, our primary goal is to minimize the disruption to the customers and the patients that we serve, and support our employees through the change. Some employees will work remotely or relocate to other Baxter facilities. Baxter is still evaluating where the manufacturing currently taking place will transition to.” Read more

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Toshiba (TYO:6502) said today it won clearance through an “authorization to operate” with the U.S. Air Force for the company’s Aplio Platinum series of ultrasound systems.

Toshiba’s Aplio 500 platinum and Aplio 300 platinum ultrasound systems won clearance by meeting the Air Force and Defense Health Agency’s Platform Information Technolagy guidelines implemented to protect Patient Health Information against malware, viruses and malicious software.

“We understand that medical imaging safety goes beyond radiation dose and extends to other areas, including cyber threats where medical imaging technology could be targeted. Cyber threats present a significant risk to not only healthcare provider’s data, but to patient safety when personal health and financial information is stolen, and the confirmation of ATO status will help our customers mitigate those risks,” Toshiba marketing and strategic development veep Satrajit Misra said in prepared remarks.

Toshiba said it previously won Air Force ATO for its CT, MR and cardiovascular X-ray portfolios.

In March, Toshiba said that 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. The ¥665.5 billion sale of Toshiba Medical Systems follows the February announcement that Toshiba would sell the entire medical equipment unit rather than just a controlling stake. A bidding war soon developed among a slew of private equity players and rival corporations.

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While the Affordable Care Act could lead to improved partnerships between medtech manufacturers and hospitals, a new survey and report from ZS Associates indicates that hospital execs aren’t convinced that such partnerships will help them meet their needs.

The passing of the ACA has led to a shift in focus in the healthcare industry towards patient outcomes, which means that medtech companies will need to transition from serving merely as suppliers to becoming partners with hospitals, according to the report.

With a shifted focus to outcomes, medtech vendors will need to adopt new value propositions that emphasize outcomes over products to be able to capture their share of the value created with the changes.

But many hospital execs still aren’t convinced that partnering with medtech vendors will help them meet their biggest priorities, according to information from a survey in the report.

“The industry needs to boost hospital executives’ confidence that medtech manufacturers can function as more than suppliers, partnering with the hospitals to improve the total patient experience and helping ensure quality outcomes,” ZS Associates wrote in the report.

The survey of 85 U.S. hospital executives reported that the hospital execs aren’t expecting to see a huge shift away from cost reduction within the next 2-4 years, but that cost reduction efforts have shifted to achieving outcomes and minimizing medicare penalties and away from reducing the cost of medtech goods.

This is due to CMS’s risk-based payment model, which puts hospitals to bear for the costs from hospital-acquired infections and poor outcomes, as well as rating the hospital’s performance against quality metrics to determine its reimbursement rate.

This gives medtech companies an opportunity to change their relationships with customers and “design innovative ways to create value.”

The survey indicated that while more than 50% of departmental stakeholders think medtech firms can help with innovative tech and new procedures and treatment methodology, less are convinced that medtech companies are ready to take on “a more ambitious agenda.” Only 40% believe medtech firms can help with reducing hospital-acquired infections and rehospitalization and only approximately 33% believe medtech can help with priorities such as operational efficiency.

The report suggested that to become valuable partners to hospitals, medical device companies need to rethink their value propositions, identify and refine the key capabilities necessary to deliver value and transform their go-to-market strategy.

No one approach will work for all companies, according to the report, and not all companies, and hospitals, will want partners. And even firms with partners may take time to develop the mindset to create effective partnerships.

But the effort will be worthwhile for the companies, according to the report, as hospitals shift their attention to lowering costs via performance rather than price.

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