The Year in Review

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. Brainsway’s TMS device was one of eight selected for preferential regulatory consideration. The FDA also pursued initiatives to promote patient engagement.

The NIH also announced some key initiatives in 2018. These include the HEAL Initiative, a trans-agency effort to address the opioid crisis. The agency funded several pain management research programs, as well as new therapies to treat addiction. NIH director Francis Collins introduced the All of Us Initiative in 2018, which promises to bring personalized medicine to a new level.

Several highly successful IPOs took place in the last year. Inspire Medical raised $75 million, Neuronetics raised $93 million, electroCore Medical raised $73 million, and Axonics Modulation raised $86 million during the year. Noteworthy neurotech mergers during the year included Laborie Medical’s purchase of Cogentix, Cirtec’s acquisition of Cactus Semiconductor, and EnteroMedics’ merger with ReShape.

Among the most significant device approvals of last year were FDA approval of Brainsway’s rTMS system for OCD, Medtronic’s DBS system for epilepsy, and Boston Scientific’s Vercise DBS system.

Venture capital funding for neurotech startups was also significant in 2018. These included Respicardia’s $58 million round, Neuspera’s $26 million round, and NeuroPace’s $74 million round.

Not all the news was good however. As we reported last month, Mainstay Medical announced that its ReActiv8-B trial failed to meet its primary endpoint. And neuromodulation therapies came under attack by some news media accounts of failed therapies, including a series of articles from the Associated Press that were critical of SCS therapies and clinicians. In response to the AP, International Neuromodulation Society president Robert Levy distributed a statement contradicting some of the claims in the AP articles.

Levy advised his colleagues to remain steadfast. “So how are we to react to such a flurry of critical articles? I would suggest by simply continuing to practice good medicine. Inform patients of our potential real or perceived conflicts of interest, fully inform them of the risks, benefits and alternatives of the procedures we perform, and continue to have our patients’ best interest at heart,” he wrote.

That sounds like good advice as we approach a new year with new uncertainties.

James Cavuoto
Editor and Publisher