|Michael DeMane, CEO of Nevro|
Based: Menlo Park, CA
The Scoop: Nevro's brand of spinal-modulation pain management uses higher frequencies to cover a larger area with fewer side effects, and, with a boatload of VC funding in its back pocket, the company is moving toward FDA approval.
What Makes It Fierce: Spinal cord stimulation has long been a tool in treating chronic pain. And while it's generally effective, especially for radiating leg pain, existing treatments lack the coverage area to deal with chronic back pain, Nevro CEO Michael DeMane says.
And then there are the side effects. Low-frequency stimulation leads to paresthesia--a pervasive pins-and-needles sensation--long considered to be a necessary evil with that method of pain management.
Nevro's Senza uses a higher-frequency waveform than anything else on the market, DeMane says, and the device's higher power creates a larger coverage area ideal for treating chronic back pain. In clinical trials, patients says their back pain fell from an 8.4 to a 2.7 on the Visual Analog Scale after 6 months, all without paresthesia.
Senza got its CE mark in 2010, and Nevro is in the midst of a large-scale pivotal trial of 300 patients, planning to file for FDA approval in 2014. In the meantime, Nevro is ramping up commercialization for Senza in the EU and Australia, and the response from clinicians and patients accustomed to the pratfalls of opioid therapy has been enthusiastic, DeMane says.
The current market for spinal stimulation is about $1.5 billion worldwide, DeMane says, and while he's confident that Nevro can claim a chunk of that, he's not stopping there. With enough clinical data, Senza has a chance to take the place of pharmaceutical and surgical therapies for chronic pain.
"There are a lot of people searching for alternatives to that," he says. "Chronic low back pain is widespread, with cost implications for society. We've got a reversible, low-risk approach that can get people off the couch, off the bed, off of pharmaceuticals."
Investors seem just as optimistic. Last year, Nevro pulled in a $58 million financing round, led by Johnson & Johnson Development Corporation. DeMane says that the money will fund the PMA study and likely carry Nevro through to a future U.S. commercial launch.
What To Look For: With its pivotal trial under way, Nevro will certainly tout any positive early results that come along, and, overseas, the company is working to expand Senza's sales by collecting cost-effectiveness data on the device.
-- Damian Garde (email | Twitter)
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