January 23, 2015 by Brad Perriello
Nevro shares surge on news of its receipt of an ‘approvable letter’ from the FDA for its Senza spinal cord stimulator for chronic pain.
Shares of Nevro Corp. (NYSE:NVRO) surged nearly 17% today after the company said it received an “approvable letter” from the FDA for its Senza spinal cord stimulator for chronic pain, signaling a sooner-than-expected approval for the U.S. market.
The Senza device is designed to deliver up to 10,000Hz to the spinal cord; Nevro says previous trials demonstrated that its HF10 therapy is nearly twice as successful in treating back pain as traditional SCS devices, which typically deliver between 40Hz and 60Hz.
The company is conducting the Senza-RCT study, a prospective, randomized, controlled pivotal trial comparing Senza to treatment with low-frequency spinal cord stimulation.
“We are pleased that the FDA has determined our Senza SCS system to be approvable based on the strength of the data provided in the PMA. We are working to satisfy the conditions of approval and anticipate initial commercial availability in the U.S. by mid-2015”, chairman & CEO Michael DeMane said in prepared remarks. “I would like to thank everyone involved in our Senza-RCT study, especially the investigators, study coordinators, Nevro employees, and most importantly the patients who consented to participate in the first ever comparative, prospective randomized pivotal trial in the history of spinal cord stimulation.”