An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.

The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device,  a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.

Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with drug therapy in patients with recurrent cryptogenic stroke and PFO. The Respect study showed that 9 patients in the Amplatzer arm suffered non-fatal strokes, compared with 16 in the drug treatment cohort, a non-statistically significant reduction of 50.8%.

St. Jude said at the time that a quirk in the study’s design meant that 3 of the Amplatzer patients were never actually implanted iwth the device. Excluding those patients, and patients in the drug treatment cohort who dropped drug therapy, and the risk of stroke in the Amplatzer arm fell to 63%. And later analyses showed a “magnification” of benefits when 24 non-implanted patients were taken out of the Amplatzer arm and fewer and smaller strokes than patients who received drug therapy alone.

Little Canada, Minn.-based St. Jude bought its Amplatzer technology, along with AGA Medical, for $1.03 billion in 2010.

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A clinical study of the next-generation Sapien 3 implantable heart valve made by Edwards Lifesciences (NYSE:EW) showed a higher rate of pacemaker implantation than with an earlier version of the device.

The study, published online in the journal JACC: Cardiovascular Interventions, compared the 1st 206 patients treated using the Sapien 3 with 371 patients treated with the Sapien XT transcatheter aortic valve replacement, excluding any patients previously implanted with a pacemaker or implantable cardioverter defibrillator.

The study showed that the Sapien 3 group’s rate of pacemaker implantation was significantly higher that for the Sapien XT group, at 19.1% and 12.2%, respectively.

Importantly, implantation height seemed to play a big role; a change in the technique used to deploy the Sapien 3 device cut the rate of pacer implantation from 25.9% to 12.3% – equivalent to the rate for Sapien XT.

“The [pacemaker implantation rate] after TAVR is higher with the S3 than with the XT and is independently associated with the implantation height. This increase in the PMIR may be avoided by intending an aortic stent extension >70%,” according to the study’s authors.

Earlier this month Irvine, Calif.-based Edwards presented results from the Partner II trial from 1,077 intermediate-risk patients at the American College of Cardiology’s annual meeting, showing that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints. The news pushed EW shares to an all-time high April 5.

The Sapien 3 device won a nod from the FDA in June 2015 for high-risk patients.

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Patients with Type II diabetes fared better with Medtronic‘s (NYSE:MDT)MiniMed Paradigm Veo insulin pumps that with multiple daily injections, according to a Medtronic-backed study published in the journal Diabetes, Obesity & Metabolism.

Fridley, Minn.-based Medtronic said the 331-patient Opt2mise clinical trial compared the MDI cohort with the MiniMed-treated group; after 6 months, the MDI cohort was moved to the MiniMed arm; at 12 months, the group that moved to the insulin pump arm doubled the A1C measurement for glucose control and used 19% less insulin.

The group treated with MiniMed for the entire 12 months showed a further 0.1% AC1 reduction to a full-year value of 7.8%, Medtronic said.

“The demonstration in a randomized controlled trial of the durability of the glycemic control obtained with pump therapy should be emphasized. Earlier randomized controlled trials were too brief to offer insights into durability of response, although observational studies have consistently shown a durable response lasting up to 1 year and more. Three large French observational surveys of patients with poorly controlled Type II diabetes each showed a significant improvement in [A1C] (1.2–1.7%), which was subsequently maintained during long-term follow-up. The Opt2mise study complements and extends these findings by showing the sustained superiority of pump therapy over MDI treatment in a similar patient population,” the researchers wrote in the DOM journal.

“At Medtronic Diabetes, we are looking at how we can deliver greater freedom and better health for all people with diabetes, including those living with Type II,” vice president Dr. Francine Kaufman said in prepared remarks. “The results of the Opt2mise trial, which is the largest study of its kind, will help us expand access to insulin pump therapy as a standard of care treatment for the growing number of insulin-takingType II diabetes patients so they can enjoy improved clinical outcomes.”

“The continuation phase of Opt2mise builds on the findings of the initial study period, which showed that insulin pumps helped participants with insulin-requiringType II diabetes safely achieve better glucose control, with lower insulin doses, than MDI,” added lead author Dr. Ronnie Aronson of Toronto’s LMC Diabetes & Endocrinology. “We found that participants who switched from MDI to insulin pumps were able to achieve these same results by the 12-month mark. Given that many patients with type 2 diabetes have difficulty achieving glycemic control, these additional data demonstrate that insulin pumps provide a significant advantage over MDI with a safe and consistent effect.”

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Seventh Sense Biosystems said today it launched a pivotal trial for its Tap100 touch activated blood collection device.

Medford, Mass.-based Seventh Sense said it expects to file for marketing authorization in the U.S. and European Union in the 2nd quarter of 2016, with a hopeful date for CE Mark approval in the European Union and FDA clearance this summer.

“We are excited to begin the registration trial with the company’s lead product, the innovative TAP100 blood collection device. Under the current system, anyone giving blood for diagnostic tests has to undergo a procedure that is inconvenient, scary and painful. While diagnostics, treatments and therapeutics in medicine continue to advance, current blood collection practices ignore trends making healthcare more convenient and accessible,” CEO Howard Weisman said in a prepared release.

The trial is slated to enroll 120 patients at 3 hospitals in the Northeast U.S. and the company expects it to finish in April, with a Premarket notification submission to the FDA by May.

“The start of our pivotal trial moves us closer to delivering this device to patients and physicians, ultimately enabling blood collection to be performed whenever and wherever it is needed, and by anyone. Our goal is to enable clinicians and patients to get vital health and disease status information more quickly,” Weisman said in a press release. “Blood collection for testing with TAP100 is convenient and painless, and its availability is intended to increase patient compliance with necessary test orders, providing doctors with more timely data on which to base diagnoses and treatment decisions. Increasing compliance by removing barriers to blood-based diagnostics will ultimately lead to better health outcomes.”

The development will pit Seventh Sense against a floundering Theranos, who’s main product is the Capillary Tube Nanotainer, 1 of 2 kinds of tiny vials used to collect blood from patients.

The company, which has a valuation of $9 billion, promises to shake up medical testing by conducting a wide range of tests with 1 drop of blood from a finger-stick using its Nanotainers, rather than the large vial typically collected.

Last October, the FDA flagged quality issues Theranos’ manufacturing plant in Newark, Calif., after inspections in August and September.

In a Form 483 issued after the inspections and released today, the FDA said that quality audits had not been performed at the Newark facility and that the company failed to document internal quality audit schedule.

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IsoRay (NYSE:ISR) said yesterday that it’s spiking its GliaSite radiation therapy system for treating brain cancers, after achieving only modest sales since the FDA cleared the device in 2011.

Richland, Wash.-based IsoRay said it’s cancelling its deals with Dr. Reddy’s Laboratories (NYSE:RDY), Hologic (NSDQ:HOLX) and Karlheinz Goehl-Medizintechnik Goehl concerning GliaSite.

“The GliaSite product has resulted in only marginal sales, but it was the first delivery system available to the company to deliver brachytherapy radiation in the treatment of brain cancer. Management believes that application of the Cesium-131 brachytherapy seed in a braided suture and using other delivery systems which are being developed by others utilizing the company’s Cesium-131 brachytherapy seed are showing greater success and acceptance in the treatment of brain cancer,” IsoRay said in a regulatory filing.

The deal with Dr. Reddy’s is slated to end June 30, with IsoRay ponying up $15,000 in owed royalties. The Hologic agreement is due to end July 11; the Karlheinz Goehl-Medizintechnik Goehl deal was halted April 11, IsoRay said.

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AtriCure (NSDQ:ATRC) said yesterday it won FDA 510(k) clearance for its  CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation.

The CryoForm is designed with the ability to remove heat and actively defrost, which allows the operator to safely detach the device while maintaining internal tissue’s frozen state, the West Chester, Ohio-based company said.

“We are excited to bring this new technology to the U.S. market. Since the launch in Europe, we have received very positive feedback from our customers, and are looking forward to continued growth in our cryoablation platform,” CEO Mike Carrel said in a press release.

The company said the probe allows for increased flexibility and easier manipulation to allow for better conformation in challenging anatomies.

“The flexibility of CryoForm, together with the automatic defrost function of the CryoIce system, made us decide at the Heart Center Leipzig to start using this product for our cryoablation procedures,” Dr. Martin Misfield of the University of Leipzig said in a prepared release.

In February, Atricure said it launched a clinical trial of its AtriClip left atrial appendage closure device, aiming to show whether the device reduces the incidence of post-operative atrial fibrillation after cardiac surgery to repair a structural heart defect.

AtriCure said the 1st patient in the 1-year Atlas trial was enrolled at PinnacleHealth Hospitals in Harrisburg, Pa. The study, which is slated to enroll up to 2,000 patients with a high risk of developing POAF, is designed to compare treatment with AtriClip in conjunction with a heart defect repair procedure to patients who undergo heart defect repair alone. It’s also designed to evaluate healthcare resource utilization between the 2 groups, AtriCure said.

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Patient Ian Burkhart (front) and project electrical engineering lead Nick Annetta (back right). (photo by Battelle)

Researchers at Battelle today published a paper in Nature covering the progress of its NeuroLife system, implanted in quadriplegic patient Ian Burkhart. In 2014, Burkhart became the 1st patient ever to achieve motor control of his paralyzed arms and hands through his own thoughts.

The NeuroLife system restored enough motion for Burkhart to perform tasks such as pouring out bottles, mixing liquids and taking a credit card from his wallet and swiping it. Burkhart, a quadriplegic, was injured in a 2010 diving accident that paralyzed him from the chest down.

The NeuroLife system, which is the culmination of many years of work for the researchers and engineers at Battelle, consists of a brain-implanted microchip, a computer system with custom built algorithms and machine learning, and specially made sleeves designed to stimulate arm muscles – allowing the patient use thoughts to control the limb.

“The project really got under way about 6 years ago, in the development of the system we have today,” electrical engineering task lead Nick Annetta told MassDevice.com yesterday. “A lot of that development and planning was really working to try and be ready for the different type of signals we thought we might see in the brain.”

To develop the system, Annetta and his Battelle team collected as much as a gigabyte of data every minute from the chip implanted in Burkhart’s brain. The diminutive 4mm by 4mm chip, a Utah array with 96 electrodes, is designed to pick up small changes in voltage caused by neurons firing near the electrodes, he explained.

“So, that data goes through a computer that runs our algorithms. It takes that data, compresses it, runs some processing on it and runs it into our machine-learning algorithm. That decodes what [Burkhart]’s thinking about, what motion he’s thinking about. And then we have another method that we use to figure out what pattern is needed to stimulate the forearm to invoke the movement,” Annetta told us.

The computer then decides what pattern to stimulate and transmits control commands to the neuromuscular electrical stimulator attached to Burkhart’s arms. The stimulation sleeve – a feat in and of itself, Annetta said – was designed to generate pulses that are then fed through the forearm cuff to invoke motion.

“There’s nothing on the market like it, so we had to design our own,” he said.

Similar stimulation devices may have as many as 8 channels, Annetta added; the sleeve Battelle developed has 160. And the sleeves hold the potential to do more than help restore motion for paralyzed individuals.

“That sleeve could be used in a lot of applications, not just this particular system. It could be used for stroke rehabilitation without having to have an implant in the brain. That’s just 1 example,” Annetta said.

Researchers on the team spent about a month poring over data from the chip before Burkhart was connected to the stimulation sleeves, and spent a significant amount of time prior to that learning to move a virtual hand on a screen, Annetta told us.

The virtual hand served 2 purposes, Annetta explained. The 1st was to cue Burkhart on what motions he should be thinking about – for example, displaying a particular hand motion, such as opening or closing, or pointing an index finger. Burkhart would then be instructed to concentrate on making that same motion with his hand, entirely in his mind.

After they had used the cue hand to collect information from the sensor on what neurons had fired while he was concentrating on the hand, Burkhart was provided with a 2nd, feedback hand, “which basically presents to him what we think he’s thinking about – what we’ve decoded that he’s thinking about,” Annetta explained.

The virtual hand allowed the team to see if the system would work without having to electrically stimulate the forearm – something Annetta said would introduce another major hurdle.

“This was kind of a simplified version of the system. It not only allowed us to check and see if it would work, but it also allowed us to see how many motions we could really control all at once. That’s 1 thing that kind of separates this kind of system from something that might be controlled from EEG,” he said.

The NeuroLife system allows for very precise control, such as flexing the fingers separately or together, a feat Annetta said is much more delicate than an EEG would be able to accomplish.

After mastering the virtual hand, Burkhart was moved to the real thing. Annetta credited Burkhart for remaining optimistic in the face of years of hang-ups and delays as they worked the kinks out of the system.

“He never really showed signs of despair or any real negativity at all, he just seemed to want to keep going. He was always hoping it was going to improve and having faith that everyone was working toward the same goal, and [that] we’d make it work, we’d advance the field so someone could make use of this in the future,” Annetta said.

After months of work once the prototype was ready, Burkhart was able to operate an arm and hand using the system. Eventually, he was able to master many motions, such as gripping a bottle, pouring out the contents, setting it down and grasping a tool to stir what he’d just poured. Burkhart was able to play basic video games, hoist a variety of mugs, lift a phone to his ear and – importantly for Burkhart – take a credit card out of his wallet and swipe it.

“This was an idea he presented to us. We asked him what would be relevant to him in his everyday life. He said that was a motion he had lost that would be significant to him to regain,” Annetta told us.

The restoration of motion to Burkhart’s arms is somewhat bittersweet, he added, as the device is not portable enough to leave the lab.

“This is the type of work that I’ve always wanted to do, and for a very long time I’ve wanted to work on something like this. To see it actually happening is incredible, but at the same time, Ian can’t take the system home with him. So, he leaves it in the clinic [every day],” Annetta said. “Working with Ian is an absolute privilege. There’s no way I personally expected to have a participant anything like Ian. The amount he gives to the program is incredible.”

Battelle is seeking more participants for the NeuroLife program, he said. Much more work is required to develop a commercialized device, Annetta added.

“It’s invigorating, but at the same time, it makes you really want to buckle down and work harder.”

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Torax Medical said today that the 1st U.S. implantation of its Fenix magnetic continence restoration system was performed late last week.

The Fenix system is made up of a series of magnetic titanium beads that are implanted in the anal sphincter to minimize the involuntary opening of the anal canal. The system comes with a tool to size the implant and a tool to guide the implant and sizing tool into position.

The procedure was carried out at Jacksonville, Fla.’s Mayo Clinic by Dr. Paul Pettit, the St. Paul, Minn.-based company said.

“Currently, if patients are not happy with their quality of life after conservative and less invasive therapy, the only surgical option that stands between them and a colostomy is the newly-available Fenix device. Here at the Mayo Clinic, we are excited to be able to offer this new treatment to our patients,” Dr. Pettit said in a prepared statement.

In January, Torax its Fenix system won FDA Humanitarian Device Exemption approval for treating fecal incontinence.

The FDA announced the device had been cleared for marketing in mid-December, with indications for treating fecal incontinence in patients who are not candidates for, or have failed with other options to treat the issue.

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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. Toshiba partners with UCI to study potential brain damage in HS football players

Toshiba 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. Read more

4. Medtronic touts insulin pump study

Patients with Type II diabetes fared better with Medtronic’s MiniMed Paradigm Veo insulin pumps that with multiple daily injections, according to a Medtronic-backed study published in the journal Diabetes, Obesity & Metabolism.

Fridley, Minn.-based Medtronic said the 331-patient Opt2mise clinical trial compared the MDI cohort with the MiniMed-treated group; after 6 months, the MDI cohort was moved to the MiniMed arm; at 12 months, the group that moved to the insulin pump arm doubled the A1C measurement for glucose control and used 19% less insulin. Read more

3. Study: Patients with Edwards Lifesciences Sapien 3 show higher pacemaker implantation rate

A clinical study of the next-generation Sapien 3 implantable heart valve made by Edwards Lifesciences showed a higher rate of pacemaker implantation than with an earlier version of the device.

The study, published online in the journal JACC: Cardiovascular Interventions, compared the 1st 206 patients treated using the Sapien 3 with 371 patients treated with the Sapien XT transcatheter aortic valve replacement, excluding any patients previously implanted with a pacemaker or implantable cardioverter defibrillator. Read more

2. Sen. Franken pushes for review of Medtronic Infuse study

Senator Al Franken (D-Minn.) is pushing for more details on Medtronic’s 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. Read more

1. FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant

An FDA advisory panel is slated to review the clinical data behind St. Jude Medical’s bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale.

The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 13, 2016 appeared first on MassDevice.

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper is it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer. Say hello to your free, ultimate guide, that you can download now.

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(Reuters) – U.S. federal health regulators have proposed banning Theranos Inc founder Elizabeth Holmes from the blood-testing business for at least 2 years after determining that the company failed to fix certain problems at its California laboratory, the Wall Street Journal reported.

The Centers for Medicare and Medicaid (CMS), in its letter dated March 18, said it planned to revoke the lab’s federal license and prohibit Holmes and Theranos’s president, Sunny Balwani, from owning other labs for at least two years, the WSJ said on Wednesday.

The proposed ban would include Theranos’s only other lab, located in Arizona, which along with the California lab generates most of the company’s revenue, the Journal said.

The Journal said CMS gave Theranos about 10 days to provide adequate evidence of why the sanctions should not be imposed. Theranos had responded and the CMS was reviewing the response, the WSJ said, citing a person familiar with the matter.

A Theranos spokeswoman told Reuters that the CMS had not imposed any sanctions on the company as yet.

Theranos had promised to shake up medical testing by conducting a wide range of tests with just one drop of blood in a user-friendly manner with quick results.

The company has been in the spotlight after reports in the WSJ suggested that the blood-testing devices were flawed and had problems with accuracy.

The CMS in January had said that deficient practices at the California lab posed an “immediate jeopardy to patient health and safety”.

Around that time, Walgreens Boots Alliance Inc, the largest U.S. drugstore chain, said it would stop using the services of the lab until all issues raised by the CMS were addressed.

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A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas.

The accusations 1st surfaced in January with the filing of a purported class-action racketeering lawsuit in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.

Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans. Lawyers for Stevens later petitioned the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.

The subpoenas sent by the grand jury in the Mountain State seek documents related to the purchase of the resin, 2 unnamed sources told the Boston Globe.

“Among other things, 1 of the people said, investigators are examining whether the Marlborough medical device company engaged in deceptive trade practices by knowingly receiving substandard resins from China in packaging from a vendor whose materials had been approved by federal regulators, and whether it fraudulently sold defective products to health care providers,” the newspaper reported.

Boston Scientific spokeswoman Kelly Leadem told MassDevice.com in March that the company “does not use counterfeit or adulterated materials in our medical devices.”

“The company rejects the contrary allegations in the petition” filed by Stevens’s lawyers, Leadem told us. Boston Scientific has not received a subpoena but is cooperating with the U.S. Justice Dept., she told the Globe.

In a statement released April 1 after the FDA revealed that it too is investigating the matter, the company said it’s dedicated to patient safety and backs that up with a robust quality system.

“Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system,” Boston Scientific said. “In 2011, we located a new supplier of Marlex resin. Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure that our mesh products manufactured with the newly sourced material met product specifications.

“We have the highest confidence in the safety of our mesh devices. We have shared our test data with the FDA, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests,” the company said.

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Fresenius Medical Care (NYSE:FMS) said yesterday it rebranded its dialysis service division under the new name Fresenius Kidney Care.

With the move, Waltham, Mass.-based said it launched a new website for the business which offers education on dialysis, treatment options and other tailored information for people in various stages of kidney disease, the company said.

“We created this name to better communicate our approach to helping people with kidney disease thrive and continue doing the things that matter most to them. We do this by providing high-quality, personalized care, support and resources to help people lead more meaningful and fulfilled lives,” Fresenius Kidney Care prez William Valle said in a press release.

“At FMCNA, we are building a comprehensive network to provide the full spectrum of care for the chronically ill, including those with renal disease. The Fresenius Kidney Care name underscores the focus and attention that our caregivers provide to our patients’ unique health needs at more than 2,200 dialysis centers across the nation,” CEO Ron Kuerbitz said in prepared remarks.

In March, Cardiovascular Systems (NSDQ:CSII) said it extended its supply deal with Fresenius for its ViperSlide lubricant, extending the agreement through April 4, 2021.

The extension to the agreement also gives Cardiovascular Systems final purchase rights upon the termination of the agreement or if Fresenius stops production of ViperSlide.

St. Paul, Minn.-based Cardiovascular Systems said the extended agreement included an update to the product pricing schedule as well, according to an SEC filing.

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CryoLife Inc. (NYSE:CRY) said today it exercised its right to acquire Genesee BioMedical’s PhotoFix bovine pericardium patch for $2.3 million in cash.

Atlanta, Ga.-based Cryolife said it had the option to purchase the patches after acquiring the distribution rights and a purchase option for PhotoFix in August 2014.

“PhotoFix is a highly differentiated product that complements our expanding portfolio of cardiac surgery products.  We achieved $1.4 million in PhotoFix sales in 2015 and have a significant opportunity to continue driving adoption in the market, particularly with our expanded cardiac surgery sales force that doubled in number following the acquisition of On-X earlier this year. We believe PhotoFix’s photo-oxidation process is unique and provides clinical advantages that will support its sales growth and ultimately its adoption as a leading biological patch in the $30 million market for cardiac surgery,” CryoLife CEO J. Mackin said in a press release.

Through the agreement, CryoLife acquired all rights to the PhotoFix patch for $2.3 million, including $600,000 previously paid to Genesee as an advance under the distribution agreement.

Genesee said it agreed to continue to supply PhotoFix to CryoLife until CryoLife can establish manufacturing capabilities, which it said it anticipates it will be capable of by mid 2017.

In February, CryoLife said it dealt its Hero hemodialysis access graft to Merit Medical (NSDQ:MMSI) for $18.5 million in cash.

The Hero graft put up $7.5 million in sales for CryoLife last year, the Atlanta-based company said. The deal calls for CryoLife to continue manufacturing the device for up to 6 months, when Salt Lake City-based Merit will take over production.

COO/CFO Ashley Lee said CryoLife plans to use the proceeds to pay down some of the $75 million term loan it took out for the $130 million acquisition of On-X.

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California-based medtech group RefleXion Medical said today it closed a $46 million Series B round of financing, with funds slated to expand its engineering, regulatory and commercial organizations.

RefleXion Medical said it is developing a biology-guided radiotherapy system for cancer treatment, which is designed to use positron emission tomography to locate and identify tumors during treatments.

“In just 2 years, the RefleXion team has mitigated the core technical risks in developing a disruptive biology-guided radiotherapy system. PET has been an effective tool to help diagnose and stage cancer using a radiotracer to map the higher metabolic activity of cancerous lesions. With this metabolic map, we could track multiple tumors in real time and precisely deliver targeted therapy based on that patient’s individual biology,” RefleXion prez Dr. Samuel Mazin said in a press release.

Financing in the round was led by new investor KCK Group and joined by existing investors Pfizer Venture Investments, Venrock and Sofinnova Partners, which Hayward, Calif.-based RefleXion Medical said is its largest shareholder.

“On behalf of the company and existing investors, I would like to welcome KCK Group as we work together to advance cancer care in a significant way. This major financing, along with the collective support, vision and guidance of Sofinnova Partners, Pfizer and Venrock, will allow the Company to achieve the development and regulatory milestones preceding a commercial launch of this paradigm-changing technology,” RefleXion chair Jay Watkins said in a press release.

Along with the financing, KCK Group’s Nael Kassar and Greg Garfield are joining RefleXion’s board of directors.

“KCK is extremely excited to partner with RefleXion, and is committed to seeing their technology transform care for patients suffering from cancer,” KCK Group medical tech division head Garfield said in prepared remarks.

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International Business Machine (NYSE:IBM)’s Watson Health biz CEO Deborah DiSanzo spoke yesterday on how the company aims to improve how healthcare firms handle and use their data and updated on partnerships with Boston Children’s Hospital and Medtronic.

DiSanzo spoke at the MassMedic conference in Boston, covering these and more issues involving the company’s cognitive computing system, including how it is handling regulatory hurdles with the software.

The Watson system currently works with 80,000 individuals across 26 industries, using machine learning, deep learning and cognitive technologies to integrate data from medical studies, records and images, DiSanzo explained.

“You don’t program Watson. Experts train him. We started training Watson in healthcare and reading medical images at Kaiser Permanente. We started training Watson in reading electronic health record information at Cleveland Clinic. Watson’s really first place he started helping doctors was at Memorial Sloan Kettering and MD Anderson in understanding how he could help oncologist do their job better. That is what Watson is,” DiSanzo said.

Watson only entered the healthcare sphere 5 years ago, DiSanzo explained, but now has more than 5,000 employees and has picked up $4 billion in acquisitions.

The motivation to sweep into healthcare was based upon the heaping amounts of data being produced in the industry, DiSanzo said, with over 150 exabytes of data available in 2011 alone. The numbers are doubling every 18 to 24 months, she added, expecting to reach a zettabyte, though DiSanzo could not state how much data that actually is.

“I didn’t even know what a zettabyte was. It’s like 1021 gigabytes or something, but it’s a huge amount of data,” CEO DiSanzo said.

The numbers are significantly off from the actual calculation, with a zettabyte being approximately equal to a billion terabytes or a thousand exabytes – and around 1,000,000,000,000 gigabytes.

The company updated on its partnership with Boston Children’s Hospital, specifically a program researching rare kidney diseases which affect about 7,000 children a year.

“For this particular kidney disease, there are 250 clinical trials on this disease. The patients, their genetics, their treatment, their outcomes, their parents’ genetics. What the physicians at Boston Children’s told us is that although they can read through 250 clinical trials, creating insights between those trials is really quite impossible for a human mind to do, but not impossible for Watson,” DiSanzo said.

After ingesting the information, Watson is able to provide suggested best pathways for the clinical trials, tailoring the pathways in clinical trials for the specific patients, diseases and genetic makeup, DiSanzo stated.

Watson is partnering with Medtronic (NYSE:MDT) to improve diabetes care, DiSanzo said, and will be releasing a new digital health application this summer based off that research.

With Johnson & Johnson (NYSE:JNJ), DiSanzo said it was working to improve outcomes in knee replacement surgeries – looking to improve cost effectiveness as bundled payments systems from the Centers for Medicare and Medicaid go into effect.

“IBM is working with Johnson and Johnson on is healthy knees and that is before and after knee replacement surgery, how can Johnson and Johnson help their patients prepare for the surgery so they have the best outcome possible and then recover from the surgery to reduce complications and reduce bounce backs into the hospitals. It is really a terrific program and so very glad, IBM is so very proud to be working with Johnson and Johnson on this to really help make a difference in healthy knees,” DiSanzo said.

When asked about the company’s regulatory strategy, DiSanzo reiterated that the company has had a quality management system from the 2nd day she took the reins, saying she didn’t “believe in walking to the edge” of regulatory compliance.

“A very short thing is, I don’t believe I’m walking on the edge. I believe that Watson can make a tremendous difference to the world in helping physicians treat the clinicians and for our partners like Medtronic and Teva and Johnson & Johnson. We need to certify for them that we’re medical device compliant. All of this is being developed under a quality management system with design controls, etc,” DiSanzo explained.

In January, The CEOs of Medtronic and IBM unveiled a the fruits of the project they’ve been working on since last April, combining the IBM Watson artificial intelligence platform with Medtronic’s insulin management devices.

Medtronic CEO Omar Ishrak joined IBM chief Ginni Rometty last night at the Consumer Electronics Show in Las Vegas to unveil the app, which is designed to detect low blood sugar events before they happen.

A pilot study of anonymized data from 600 patients with Medtronic insulin pumps and glucometers, using “cognitive analytics” powered by Watson, found that the system could predict a hypoglycemic event up to 3 hours ahead, Medtronic’s diabetes president Annette Brüls wrote in a blog post yesterday.

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(Reuters) – After lagging a 6-year healthcare sector run fueled by fast-growing biotech companies, Johnson & Johnson (NYSE:JNJ) shares have beaten the group in 2016 as investors turn to safety in rocky equity markets.

But with the stock price now hovering near its $110.35 record high, that strategy may be in doubt. J&J shares already have risen to the level that the average analyst has targeted for them, and sell at a healthy premium to large pharmaceutical companies such as Pfizer (NYSE:PFE) and Merck (NYSE:MRK). Relative to their own future earnings, the shares are more expensive than they have been in more than a year.

“What I am more concerned at this juncture is, do we see more follow-through or do we see profit taking?” said Arthur Henderson, portfolio manager of the global healthcare equity fund at the Tennessee Consolidated Retirement System, where he has recently sold some J&J shares so they account for a smaller part of the fund’s holdings.

J&J shares could build on their gains if investors rekindle worries about the broader economy or continue to hide from concerns facing the pharmaceutical and biotech industries, and some analysts are optimistic about the company’s pipeline of experimental medicines. But, ultimately, the company will have to produce enough earnings growth to justify the higher prices.

On that front, the company faces a fresh competitive threat to its biggest drug franchise. U.S. regulators earlier this month approved a rival version of the company’s Remicade treatment for conditions such as rheumatoid arthritis.

J&J’s 1st-quarter report, due on April 19, is expected to show earnings up 6% over the same quarter a year ago, on a 0.6% increase in sales, according to Thomson Reuters data. Wall Street analysts are predicting fairly consistent annual earnings growth between 5% to 6% over the next few years.

In January, the company projected that its calendar year 2016 profits would ultimately be up 5% to 8% over 2015 and it would aim to significantly increase its operating margins.

“Most pharmaceutical companies have cut fat over the past years and my sense is what it implies is they can cut some extra fat,” said Tony Butler, analyst at Guggenheim Securities.

J&J’s product diversity makes it more immune than other drug stocks to political pressures on the cost of medicines.

The company’s pharmaceutical unit accounted for 45% of its $70 billion in sales last year, with medical devices totaling more than a third and over-the-counter medicines and other consumer products making up the rest.

The shares are up 7% in 2016 against a 3% decline for the S&P healthcare sector. The company’s shares had underperformed the sector every year dating back to 2009 as J&J also grappled with a slew of product recalls and manufacturing setbacks for its consumer division.

At 16.6 times estimated earnings over the next 12 months, the stock is still slightly cheaper than the valuation for the overall S&P 500.

Investors also are drawn to J&J’s 2.7% dividend yield, which nonetheless lags Merck and Pfizer, which both yield more than 3%.

“People right now are paying up quite a bit for that safety piece of it,” said Morningstar analyst Damien Conover, who puts fair value for the shares at $102. “I think it’s overvalued, but I do think there are characteristics in the economy and political landscape that bode well for J&J.”

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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. Fresenius rebrands dialysis division to Fresenius Kidney Care

Fresenius Medical Care said yesterday it rebranded its dialysis service division under the new name Fresenius Kidney Care.

With the move, Waltham, Mass.-based said it launched a new website for the business which offers education on dialysis, treatment options and other tailored information for people in various stages of kidney disease, the company said. Read more

4. Battelle’s NeuroLife uses thought to control paralyzed limbs

Researchers at Battelle today published a paper in Nature covering the progress of its NeuroLife system, implanted in quadriplegic patient Ian Burkhart. In 2014, Burkhart became the 1st patient ever to achieve motor control of his paralyzed arms and hands through his own thoughts.

The NeuroLife system restored enough motion for Burkhart to perform tasks such as pouring out bottles, mixing liquids and taking a credit card from his wallet and swiping it. Burkhart, a quadriplegic, was injured in a 2010 diving accident that paralyzed him from the chest down. Read more

3. CryoLife buys Genesee BioMed’s PhotoFix pericardium patch

CryoLife Inc. said today it exercised its right to acquire Genesee BioMedical’s PhotoFix bovine pericardium patch for $2.3 million in cash.

Atlanta, Ga.-based Cryolife said it had the option to purchase the patches after acquiring the distribution rights and a purchase option for PhotoFix in August 2014. Read more

2. RefleXion closes $46m Series B

California-based medtech group RefleXion Medical said today it closed a $46 million Series B round of financing, with funds slated to expand its engineering, regulatory and commercial organizations.

RefleXion Medical said it is developing a biology-guided radiotherapy system for cancer treatment, which is designed to use positron emission tomography to locate and identify tumors during treatments. Read more

1. Report: Feds impanel grand jury in Boston Scientific pelvic mesh probe

A federal probe into allegations that Boston Scientific used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas.

The accusations 1st surfaced in January with the filing of a purported class-action racketeering lawsuit in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse. Read more

The post MassDevice.com +5 | The top 5 medtech stories for April 14, 2016 appeared first on MassDevice.

BMC Medical today claimed the approval of a motion for a voluntary dismissal of an appeal from ResMed (NYSE:RMD) in a long running patent spat as a win for the company.

The dispute is part of a long-standing conflict between the 2 companies over patents related to continuous positive airway pressure devices.

BMC said that it cross-appealed the ITC’s orders related to ResMed patents related to masks used with CPAP products, and in March the ITC remanded the case to itself to determine “whether ResMed’s activities and investments in the United States qualify as a “domestic industry,” according to a press release.

The Chinese company reported that the ITC said that a recent decision from the Federal Court “would appear to stand as an obstacle to ResMed’s proof of the existence of a domestic industry related to the mask patents,” and that it would “suspend its remedial orders, which are directed to the mask patents, as it considers the issue,” according to the press release.

BMC said the German Federal Patent Court had accepted all requests from BMC and nullified the German part of a European patent relating to a CPAP system with a detachable water tank in the attacked scope, while non-attacked claims were maintained.

Last July, BMC said it won a European litigation against ResMed over an infringed patent for a continuous positive airway pressure respiratory system machine with a detachable water tank.

The 1st District Court of Munich lifted a preliminary injunction against BMC’s CPAP machine during the hearing and issued a judgement in favor of BMC Medical, the Beijing, China-based company said.

The court also ruled to suspend parallel patent infringement proceedings until a decision is made in the invalidation proceedings, BMC Medical said.

ResMed general counsel David Pendarvis told MassDevice.com in an email that a final decision on BMC’s infringement on ResMed’s flow generator patents “will not be made until later this year when the German court addresses the validity of the ResMed patent asserted in the case.”

“The decision made by the German court that is the subject of the BMC press release issued on Tuesday, June 23 is an interim decision on a single issue involving a single patent asserted against the sale of BMC flow generators in Germany,” Pendarvis said.

In December 2014, BMC claimed a win in a related proceeding in Germany. In August, ResMed and BMC each declared victory after the International Trade Commission issued a mixed decision, ruling that 9 of BMC’s products each violated at least 1 of ResMed’s patents and that certain of ResMed’s patents were invalid.

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Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it closed its purchase of soft-tissue microwave ablation system maker NeuWave Medical for an undisclosed amount.

NeuWave Medical’s ablation technology was developed at the University of Wisconson, Ethicon said. The company’s Certus 140 ablation system allows for single or simultaneous multiple probe procedures in patients with soft tissue lesions.

“Currently, there are limited treatment options for soft-tissue, non-resectable lesions. Together with NeuWave Medical, Ethicon can bring minimally invasive treatment options to make a difference for patients around the world. This is especially important for patients who may not be medically eligible for traditional surgery. We can now offer physicians and patients more choice in treatment options for soft-tissue lesions.,” Ethicon company group chair Michael del Prado said in a statement to the press.

NeuWave won FDA premarket approval for its Ablation Confirmation software last July, saying it would be integrated into its Intelligent Ablation system.

The computer-controlled ablation system also has greater access to data gained during the process and is able to use it to streamline the procedure, CEO Dan Sullivan told MassDevice.com in an interview.

“NeuWave Medical’s unique ablation technology was originally developed by physicians and microwave scientists from theUniversity of Wisconsin to maximize energy delivery to tissue, minimize invasiveness and provide physician-friendly workflow. This acquisition now provides NeuWave Medical with the ability to accelerate our innovation pipeline and expand the global footprint of our unique technologies, while allowing Ethicon to reach new patients by expanding the availability of a novel intervention that goes beyond surgical options in wide use today,” CEO Sullivan said.

The acquisition was 1st announced in March. Financial and other terms of the deal were not announced.

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