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Novel Neurostimulator Wins FDA Approval

Brian Buntz

May 11, 2015

2 Min Read
Novel Neurostimulator Wins FDA Approval

The Senza from Nevro

Things are looking up for the neurostimulator startup Nevro: its stock is performing well, its revenue is way up, and now it has won a PMA for its unique Senza device.

Brian Buntz

Menlo Park, CA-based startup Nevro won a PMA for its neurostimulator technology several months ahead of its projections. And the agency will let the company state market the Senza product as being superior to older spinal cord stimulation technology for chronic back and leg pain. It won that designation based on a clinical trial involving nearly 200 patients.

The company's neurostim technology is unique in that it can relieve chronic pain without causing the tingling and buzzing sensation known as paresthesia that was a common side effect caused by older spinal cord stimulation devices.

Founded in 2007, Nevro went public in November 2014, becoming the best performing IPO of the year in the medical device industry.

The company has fared well in the first quarter of 2015 as well. It recently announced that its revenue of $9.7 million in the quarter was 45% higher than the same period a year earlier.

Nevro also announced that its 18-month clinical study used to obtain FDA approval was chosen as 2015 "Best Clinical Abstract" at the International Spine Intervention Society, held in July 2015 in Las Vegas.

Last year, the company's founder and senior vice president Andre Walker said that company officials had initially predicted that obtaining the regulatory go ahead from FDA would take about three years. But the relevant regulations changed mid-stream during product development.

The company also managed to secure millions in funding before the financial meltdown of 2008.

To manufacture the device, the company is partnering with the Silicon Valley-based EMS provider Hunter Technology.

Refresh your medical device industry knowledge at MD&M East in New York City, June 9-11, 2015.

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