Streamlining Neurotech Commercialization


This has been a good month for the neurotech industry and investors in neurotech startups. The good news started with a unanimous vote of the FDA Neurological Devices Panel to recommend the NeuroPace RNS system for approval. Some industry observers see this as a sign that things are changing at the FDA, particularly given the fact that NeuroPace’s trial data, while very good, is not much different from what Medtronic presented from its SANTE trial of DBS for refractory epilepsy, which earned them a seven to five panel vote in 2010. There is hope that both devices will be on the market in the U.S. by the end of the year.


Whether or not the NeuroPace panel vote represents more openness to device interventions at the FDA, we continue to be encouraged by efforts on the part of agency personnel to reach out to the neurotech device industry. Two FDA representatives were on hand at last month’s International Workshop on Clinical BMI Systems in Houston [see conference report, p7], and they offered valuable input to workshop participants during the breakout sessions.


More good news came earlier this month when the U.S. Senate passed a bill to repeal the 2.3 percent medical device tax, which went into effect on January 1 of this year. The bill passed with a 79 to 20 vote, garnering considerable bipartisan support. Enactment of the bill is not guaranteed, since it still needs to be reconciled with the budget passed by the House of Representatives, but the fact that the Senate vote was so lopsided certainly sends a signal that the government recognizes the damage that the tax does to medical device firms, particularly small start-up companies.


We were also pleased when Medtronic announced earlier this month that the FDA and the Centers for Medicare & Medicaid Services accepted the company’s Symplicity renal denervation system for treatment-resistant hypertension in their parallel review program. This new program allows CMS to begin consideration for national coverage determination while the FDA completes its review of safety and efficacy.


The Symplicity system is one of the first medical devices to participate in the pilot program for concurrent review, which was designed to facilitate the development of new products and increase the efficiency of the review processes for both agencies. The two federal agencies are accepting participants in the parallel review pilot program through a selection process that is limited to a few devices per year, but hopefully, the program will be available to more participants soon.


Taken together, these three events paint a more optimistic picture of the path to commercialization in the U.S. for medical devices in general and neurotech devices in particular. We hope this trend continues and that investors recognize the opportunity to take advantage of it.





James Cavuoto

Editor and Publisher