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Neuronetics' FDA Nod Opens Doors to New CNS Market

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.

More than a decade ago venture capitalists identified neurostimulation as a fertile new field for investment. The use of energy pulses—usually electricity—to manipulate the body’s nervous system had the potential to treat neurological, metabolic, and numerous other diseases. But those seeds planted in neurostimulation ventures over the past 10 years have produced more disappointments than results, with companies like LivaNova PLC and Northstar Neuroscience Inc. running into troubles over the past two years.

But the losing streak is over. The Food & Drug Administration recently cleared Neuronetics Inc. 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. Although this regulatory approval doesn’t validate all the efforts, dollars, and optimism that have been poured into neurostimulation companies over the years, the win likely will serve as a positive notice for other companies in this seemingly infinite field

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