News

One of the greatest challenges confronting both startup and established neurotechnology firms seeking to commercialize new therapies is obtaining reimbursement. Even after a new device has run the gauntlet of clinical trials and paperwork to obtain FDA approval, a vendor must often begin the process all over again with CMS in order to obtain coverage and there is no guarantee that a decision will ever come.

Neurotech Reports, the publisher of the Neurotech Business Report newsletter, announced the appointment of Jo Jo Platt as Director of Strategic Development. She will head up marketing efforts for the upcoming Bioelectronic Medicine Forum in New York City, April 4, 2019. Platt, based in San Francisco, CA, brings more than 10 years experience as a neurotechnology consulant to Neurotech Reports. As th…

Two different research teams in the U.S. and Australia have recently reported progress in developing alternative forms of brain neuromodulation. The two independent efforts have spawned commercial neurotech startup firms and may eventually impact the market for deep brain stimulation systems. A team of researchers in Australia recently reported that electrical stimulation can be delivered into the brain from a 4 mm diameter “Stentrode” device permanently implanted inside a blood vessel.

More than 300 interventional pain physicians, fellows, and other medical professionals attended the 9th annual California Society of Interventiional Pain Physicians conference held at the Ritz-Carlton Bacara Resort and Spa in Santa Barbara, CA last month. The event was supported , and gold sponsors Medtronic, Abbott, and Nevro, along with many others. New to CASIPP this year was a Mobile Cadaver Lab conducted in the resort parking lot.

As 2018 comes to a close, most industry observers would agree that this was one of the best years ever for neurotechnology. A combination of regulatory, funding, and financial events make this past year stand out. As in previous years, there were several encouraging government initiatives announced in 2018. The FDA launched an innovation challenge to spur the development of devices to address the opioid epidemic.

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…