The Nevro Senza, as shown in a video on the company's website.
Nevro’s stock is now up more than 20% from where it was late last week, after the Menlo Park, CA–based company said that the FDA has deemed the PMA for its spinal pain-killing device as "approvable."
Nevro must still satisfy FDA’s regulatory inspections and audits of manufacturing facilities, methods, and controls for its Senza spinal-cord stimulation (SCS) system to ensure compliance with the agency’s quality system regulation and labeling requirements, the company said.
Still, its stock as of late Monday was trading at more than $44 per share, up more than a fifth from where its was before the Thursday announcement and more than double its an initial $18 trading price from its 2014 IPO.
The Senza system delivers Nevro's proprietary HF10 therapy, which provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads placed near the spinal cord and connected to a compact, battery-powered generator implanted under the skin. The device provides pain relief without paresthesia, a constant tingling sensation that is the basis of traditional SCS therapy, the company said.
Nevro is a start-up that has embraced the concept of rapid iteration, and was already working on the 10th generation of its pain-relieving neuromodulation technology before taking the product to the market.
After receiving CE Mark approval to commercialize the technology in Europe, the company enlisted the help of contract manufacturer Hunter Technology (Milpitas, CA) to produce and ship more than 1000 units in two years.
The news of its approvability moves the startup closer to claiming a significant piece of the $1.5-billion global spinal stimulation market and providing an alternative to some pharmaceutical and surgical therapies for treating chronic back and leg pain.
Nevro conducted a randomized, pivotal U.S. study that cost more than $90 million. Leonardo Kapural, MD, the lead investigator of the SENZA-RCT study, presented the study results at the 2014 North American Neuromodulation Society Meeting in December.
Nevro was fortunate to begin receiving millions in funding before the financial meltdown of 2008. The company has obtained several rounds of funding since, including from the likes of Johnson & Johnson, Covidien, Mayo Clinic Ventures, and several other VC firms.
Nevro was the top-performing IPO among the 18 medical device and diagnostic companies that debuted on the public markets in 2014, according to Renaissance Capital, an IPO investment and research firm. The company had a return of 90% after its initial offer price of $18 was buoyed by investors eager to support its implanted device to treat leg and back pain through spinal cord stimulation.
Nevro anticipates making the Senza system available for sale in the U.S. by mid-2015, according to company chair and CEO Michael DeMane.
