Why Nevro Is Trading 25% Higher

Nevro Corp NVRO was trading 25 percent higher Friday on the news that the company received an Approvable Letter from the FDA for the Senza spinal cord stimulation system.

Senza is used to treat chronic back pain. Traditional therapies use low-frequency spinal cord stimulation, but Nevro has developed Senza to deliver up to 10,000 Hz of high-frequency stimulation.

The letter stated that Senza is approvable by the strength of the clinical data, but still will need to meet compliance with the FDA's Quality System Regulation, which evaluates the manufacturing facilities and process.

Nevro and the FDA also need to finalize the products labeling, but the company expects the system to be commercially available in the U.S. by mid-2015.

The data evaluated by the FDA was from the SENZA-RCT study.

The SENZA-RCT study evaluated the safety and effectiveness of the Senza system. The following was also evaluated in the trial:

  • Change in back pain VAS
  • Change in disability as measured by Oswestry Disability Index
  • Number of subjects with adverse events.

The trial results were presented at the Groundbreaking Clinical Trial Results plenary session at the 2014 North American Neuromodulation Society Meeting in December.

Currently, the Senza system is available in Europe and Australia.

Shares traded recently at $47.69, up 26.3 percent.

Posted In: NewsFDA
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