Medtronic eyes more investment in Israel

Medtronic‘s (NYSE:MDT) chief executive Omar Ishrak traveled to Israel on Sunday with a team of senior executives to reportedly meet with some of the firms that the medtech giant has recently acquired, including Mazor Robotics and Nutrino.

Ishrak is also scheduled to meet with Israel’s prime minister Benjamin Netanyahu and Eli Cohen, the minister of economy and industry.

Also on this week’s trip, Medtronic reportedly signed a deal with the Israel Innovation Authority to support a new center focused on research and development.

The company has long signaled interest in the Israeli medtech arena and this year it has doubled down. Earlier this month, Medtronic announced it would pay an undisclosed amount to purchase Israel-based nutrition tech firm Nutrino. In September, Medtronic put $1.6 billion on the table to buy Mazor Robotics, a surgical robotics company that Medtronic has held a stake in since 2016.

After the Nutrino acquisition earlier this month, Medtronic’s country director for Israel Yaron Itzhari reportedly said it would not be the company’s last purchase in Israel.

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Medtronic studies use of both heat and cold for cardiac ablation

Medtronic today said that a St. Louis heart team has treated the first patient in the company’s Terminate AF trial, which is studying the simultaneous use of heat and cold to produce cardiac ablation for atrial fibrillation treatment.

The goal is to determine the safety and efficacy of treating persistent atrial fibrillation in patients undergoing other surgical heart procedures including bypass surgery, heart valve repair or replacement, according to the Medtronic.

During a recent open-heart surgical procedure, a team led by Dr. Ralph Damiano at the Washington University School of Medicine in St. Louis used both the Cardioblate irrigated RF system and the CryoFlex surgical ablation system. The surgical team used both Medtronic devices to make a pattern of lesions in the heart muscle in order to help it return to its normal rhythm.

“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” Damiano said in a news release.

“We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease,” said Damiano, who is the national principal investigator of the Terminate AF trial.

The study will involve up to 15 centers in the U.S. and up to 160 patients. Researchers will assess patients at one, three, six and 12 months; the primary efficacy endpoint is for patients to not have AF after the removal of antiarrhythmic drug therapy (three months post-procedure).

“An indication for the surgical treatment of AF would enable physician training and education and would serve as the basis for ongoing clinical evidence generation,” said John Mack, VP and general manager of Medtronic’s Cardiac Surgery business.

FDA cleared Cardioblate in 2000 and CryoFlex in 2004.

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Alfred Mann Foundation chairman looks outward to extend founder’s legacy

When medtech pioneer Alfred Mann died in February 2016, he left behind a rich legacy of pure innovation and patient impact spanning the breadth of healthcare, from cardiology to hearing impairment, blindness and diabetes that will improve the lives of patients for decades to come.

Extending and advancing that legacy is now the mission of Dr. Robert Greenberg, who took over as the foundation’s chairman in July. Speaking ahead of his appearance next week at MassDevice.com’s DeviceTalks West event in Costa Mesa, Greenberg told us that he’s looking to expand the foundation’s reach into the early-stage medical device ecosystem.

Don’t miss Dr. Robert Greenberg’s keynote appearance Dec. 12 at DeviceTalks West!

“One of the recognitions that Al Mann had was that there are tons of physicians, and specifically academic physicians, that have great ideas, therapies that could help patients, but are not so well placed to get those products developed and into companies that could commercialize and make those therapies available to patients. That was the philosophy behind [the foundation],” Greenberg told us.

That insight led to numerous successful spinouts that became some of the biggest names in medtech. The cochlear implant technology developed at the Alfred Mann Foundation became Advanced Bionics and eventually the cornerstone of the neuromodulation business at Boston Scientific (NYSE:BSX).

More recently the organization spun out Axonics Modulation Technologies (NSDQ:AXNX), which raised $138 million this month in an initial public offering for its r-SNM sacral neuromodulation system.

The foundation was also behind a glucose sensor and insulin pump business that’s now Medtronic (NYSE:MDT) MiniMed. And the Alfred Mann Foundation also spun out Second Sight Medical (NSDQ:EYES) and its “bionic eye” technology, helmed by Greenberg, that’s in clinical trials for its Orion cortical implant technology – a potentially revolutionary device that could bring eyesight to the blind.

And the company that started it all, PaceSetter, was the cardiac rhythm management business that grew into St. Jude Medical and eventually Abbott (NYSE:ABT).

All of those spinouts originated within the foundation. Greenberg said he’s turning the focus outward, seeking very early-stage enterprises that could use a leg up from the AMF.

“One of the reasons why so many of our startups have been successful is that they’ve been able to leverage the sort of back-end infrastructure, where the foundation has kind of acted as an incubator. We’re now opening up that incubator to allow other companies to rent space, rent time on our equipment, and even get access to our team as well. That’s a fairly new model for us, where we’re trying to contribute to the local infrastructure more,” he told us.

“That’s one of the things that’s the hardest for me, is that there are tons of amazing, great ideas and projects that can have a significant impact on people’s health,” Greenberg said. “Trying to focus down on the ones that are going to have the highest impact and make the best use of all these limited resources is really the bigger challenge.”

Hear the rest of Bob Greenberg’s story Dec. 12 at DeviceTalks West. Register now!

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ResMed puts $225m on the table for Propeller Health

ResMed (NYSE:RMD) said today that it inked a deal to acquire Propeller Health and its digital medicine platform for $225 million in cash.

Propeller Health, which sells small sensors that attach to inhalers and track medication use, will operate as a standalone business under ResMed’s respiratory care portfolio.

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

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Judge threatens to delay or even spike $70m CVS-Aetna merger

A federal judge last week reportedly threatened to derail the already-closed $70 billion buyout of health insurer Aetna (NYSE:AET) by CVS Health (NYSE:CVS), saying he felt “kept in the dark, kind of like a mushroom.”

At a normally routine hearing last week prior to approving the deal, Judge Richard Leon, of the U.S. District Court for the District of Columbia, said he might put off a decision until the summer or even spike the deal altogether, Reuters reported.

“I was reviewing your motion, which, of course is not opposed. And I kind of got this uneasy feeling that I was being kept in the dark, kind of like a mushroom,” Leon said, noting that the American Medical Association, among others, had objected to the deal. “I’m very concerned, very concerned that you all are proceeding on a rubber-stamp approach to this.”

The companies closed the buyout, announced in December 2017, on Nov. 28. It calls for Aetna stockholders to receive $145 in cash and 0.8378 CVS shares for each AET share, for a total value of $212 per share or roughly $70 billion. Woonsocket, R.I.-based CVS is financing the deal with cash on hand and debt, including a $40 billion senior notes offering and a two-tranche term loan of $5 billion. But in order to seal the deal, Aetna had to agree to deal its 2.2-million-member Medicare Part D drug plan to WellCare Health Plans (NYSE:WCG). That deal is slated to close within the next few business days, pending Leon’s approval.

“It’s commonplace for acquisitions to close before this final step in the process is complete, and our focus remains on delivering on the combined company’s potential,” CVS said in prepared remarks to the wire service.

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Ocular Therapeutix wins FDA nod for drug-delivery eye insert

Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery.

The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza.

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

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Doc inventor wins $113m in royalties spat with Medtronic

A state court jury in Indiana last week reportedly awarded a $112 million decision to a local spine surgeon turned medical device inventor in his five-year royalties dispute with Medtronic (NYSE:MDT).

Dr. Rick Sasso sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop, according to the Indianapolis Business Journal.

Sasso licensed some of his early inventions to Sofamor Danek, about a year before its $3.3 billion merger with Fridley, Minn.-based Medtronic in January 1999, the newspaper reported. Further deals for spine stabilization devices followed, including some that eventually hit the market under the Vertex brand. The company agreed to pay him 2% of net sales for eight years or the life of the patent if it it is used in a device covered by a valid patent claim. Sasso argued that the Vertex system is covered by several valid patents and that Medtronic left out other products that used Vertex components, undercounting the sales calculation for his royalties.

The $112.5 million verdict lodged Nov. 28 culminated a five-year campaign that saw Sasso lose several battles. In 2015 an Indiana state court found that he never transferred his patent to his corporation, meaning it could not have licensed the technology to Sofamor Danek. Medtronic, having already paid Sasso some $23 million, didn’t owe him anything more, according to the ruling, which was later upheld by the Indiana state appeals court.

After amending his complaint three times, Sasso found favor with a six-person Marshall County Circuit Court jury last week, which deliberated for six hours after a trial that lasted nearly a month, according to the business journal.

In a quarterly regulatory filing, Medtronic said it has “strong arguments to appeal the verdict” and plans to file post-trial motions appeal if necessary.

“The company has not recognized an expense in connection with this matter because it does not currently believe a loss is probable under U.S. GAAP,” the company said in the filing.

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