Spreading Cortical Depression

The announcement earlier this month that Northstar Neuroscience would close its doors [see article, page 1] wasn’t a great shock to most neurotechnology industry observers. The company had been teetering for nearly a year in the wake of its failed pivotal trial of its Renova device for motor recovery from stroke.

But the victims from this latest neurotech industry catastrophe extend far beyond the employees and shareholders of the Seattle firm. To begin with, the failed EVEREST trial for stroke recovery may have a negative impact on other research teams pursuing cortical plasticity approaches to treating stroke. If concerns raised by investigator Robert Levy about improper dosing levels are borne out, it would be most unfortunate for a legitimately useful therapy such as this to fail its trial because of undue pressure from Northstar management or investors. Two reports in this issue, concerning the Drake/Nexstim study of navigated brain stimulation for stroke [p3] and the NINDS study of tDCS for enhancing motor learning [p5], are among the numerous examples of promising indications for cortical stimulation as a viable stroke therapy.

The Northstar failure also throws into question the future of cortical stimulation as a treatment for other disorders such as depression and tinnitus. Even though there were no study failures or negative data published about these applications, the EVEREST failure will likely loom large in the minds of investors, regulators, and clinicians contemplating the future of the Renova device.

Finally, this whole episode casts a long negative shadow on the entire neurotechnology industry at a time when promising startups are having a difficult enough time raising capital. While the track record of neurotechnology device startups is still very good compared to bio/pharma ventures, venture capital firms tend to remember failures of firms that have been well received in the media and the public. Coming on the heels of the Cyberkinetics demise and Cyberonics’ troubles in the depression market, the timing of the Northstar failure is not optimal.

While it’s easy to play Monday morning quarterback and criticize Northstar management for their preparation for the EVEREST trial, the full story is likely to be more complicated than we know now. There is a fine line between building financial success with a new product and meddling unnecessarily with a research study. It does not escape our notice that the market—and industry publications such as this one—may contribute to the climate that might motivate entrepreneurs to rush products to market before they are ready.

But our hope is that our industry learns what lessons they can from the Northstar failure so that in the future solid science stands or falls on its own merits and not on extraneous factors.

James Cavuoto
Editor and Publisher