News

In the years following two failed clinical trials of deep brain stimulation for treatment-resistant depression, neural engineers and psychiatrists have sought to hone in on an appropriate stimulation target for the neuromodulation therapy. Medtronic’s trial targeted the ventral capsule/ventral striatum, while St. Jude Medical’s BROADEN trial targeted Cg25 in the subcallosal cingulate white matter.

Mainstay Medical International plc, the Dublin, Ireland manufacturer of neuromodulation systems, announced headline from its ReActiv8-B study. The clinical study is a prospective, randomized, active-controlled, blinded trial with one-way cross-over. A total of 204 patients were implanted with ReActiv8 and randomized 1:1 to therapy or control 14 days after implant. In the treatment group, the ReActi…

LivaNova plc, the London, U.K. manufacturer of vagus nerve stimulation systems, expressed optimism after the U.S. Centers for Medicare & Medicaid Services announced a proposed decision memo regarding its national coverage determination for the company’s VNS therapy for treatment-resistant depression. Within the memo, CMS proposes to change the NCD for VNS therapy for TRD to expand Medicare coverage.

Medtronic plc, the Minneapolis, MN manufacturer of neuromodulation systems, announced that its co-founder, Earl Bakken, passed away peacefully on October 21, 2018 at his home on Kiholo Bay on the Big Island of Hawaii. He was 94 years old. “Today we are saddened Bakken, but we also honor and will forever cherish the life of a beloved man whose brilliance and vision have improved the lives of millions of people around the world,” said Omar Ishrak, Medtronic chairman and CEO.

At first glance, Mainstay Medical’s announcement that its Reactiv8 B study for back pain failed to meet its primary endpoint [see article, p5] seems all too familiar. A promising neurotech startup with a novel therapy achieves good results in preliminary trials, raises significant funds from investors, goes public, then crashes and burns after a failed pivotal trial. As was the case with Northstar…

The emerging market for bioelectronic medicine is being driven in large part cardiovascular, circulatory, and inflammatory disorders. But recently, there have been key developments in the market segment for gastrointestinal disorders. More than 60 million people in the U.S. suffer from disorders in the gastrointestinal tract that could be cured , but scientists don’t fully understand the therapy’s effects on a critical organ: the stomach.

About 120 management, investment, and research professionals from the neurotechnology industry came to San Francisco for the 18th annual Neurotech Leaders Forum earlier this month. Two keynote speakers set the tone on each day of the event. Frank Fischer, CEO of Neuropace, shared his experience bringing an implanted closed-loop system from the lab to market. “The brain is a beautiful, complex, and extraordinary system,” he said.

Neurotech Reports, the publisher of this newsletter, announced the winners of the 2018 Gold Electrode Awards. The awards were presented at the 2018 Neurotech Leaders Forum in San Francisco earlier this month. The award for best new product went to Boston Scientific for its Spectra WaveWriter SCS system. The award for most promising startup went to Tivic Health. The award for most valuable financial professional went to Doug Clinton of Loup Ventures.

Attendees at this year’s Neurotech Leaders Forum observed a number of informative sessions that dealt with the changing landscape of the neurotechnology industry [see p7]. Although the industry still faces some challenges, there was general consensus that getting new neurotech products to market has become smoother in recent years. In a session devoted to the regulatory climate in the U.S. and abro…

Research institutions and commercial firms pursuing epidural stimulation as part of a new therapeutic approach for treating spinal cord injury have continued to show progress. In recent weeks, investigators at three institutions in the U.S. published findings that broke new ground. Earlier this month, a team of researchers from the Mayo Clinic and UCLA published results in Nature Medicine showing that neuromodulation of lumbosacral spinal networks enabled independent stepping after complete paraplegia.