Cyberonics' Two-Front War
Most medical device executives are reluctant to say anything that could in any way be construed as critical of the FDA or the agencies that determine reimbursement coverage decision. But not Robert "Skip" Cummins, president and CEO of neurostimulation pioneer Cyberonics. For the past two years, Cummins has been waging what has been a virtual one-man war with the FDA and major payers to make sure that psychiatrists and their patients have access to the only FDA-approved treatment for severe treatment resistant depression.
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Neuronetics Inc. forged a new specialty of sorts, the interventional psychiatrist. Unlike other interventional approaches, the externally applied NeuroStar delivers transcranial magnetic stimulation to the precise area of the brain responsible for intractable depression. The device is changing the lives of psychiatrists who launched “TMS” clinics, hoping to capture the early success, and potentially creating opportunities for medical devices designed to treat other brain-related disorders.
The seeds planted in neurostimulation ventures over the past 10 years have produced more disappointments than results, but the fallow period is over. The Food & Drug Administration recently cleared Neuronetics to begin selling its NeuroStar TMS as a treatment for people who haven't responded to a drug regimen taken during their current episode of depression. This is good news for scores of venture-backed neurostimulation companies, although Neuronetics is somewhat unique. It is developing a non-invasive device that delivers magnetic, rather than electrical pulses.
Medtronic is the acknowledged leader in one of the hottest device sectors-neurostimulation-but even this giant struggles with problems of limited market penetration. So Medtronic is bringing a new approach to this area: an aggressive clinical trials strategy to differentiate its products and drive physician adoption. Who better to run the business than a clinical trials expert? Richard Kuntz talks about future neuro opportunities and the current challenges facing device clinical trials.