Clinical Data Presented at 2021 North American Neuromodulation Society (NANS) Virtual Meeting Reinforce Significant Benefits of Nevro`s HF10® Therapy
Redwood City, CA -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced the results from data presentations at NANS supporting the use of HF10® therapy for patients with chronic pain, including results from the Painful Diabetic Neuropathy (PDN) and Non-Surgical Refractory Back Pain (NSRBP) randomized clinical trials (RCT). Results were presented at the 2021 North American Neuromodulation Society (NANS) Virtual Meeting held from January 14-16, 2021.
'Nevro once again had a substantial presence at this year's NANS meeting, with data presented from 20 clinical abstracts, including late-breaking abstract results from our SENZA-PDN and SENZA-NSRBP randomized clinical trials, both of which demonstrated highly favorable results to important pre-specified endpoints at six- and 12-months in the PDN study and three-months in the NSRBP study,' said D. Keith Grossman, Chairman, CEO and President of Nevro. 'No other SCS treatments have demonstrated such positive results in treating PDN and NSRBP patients, and we believe there is a significant opportunity to expand an innovative treatment option to patients who are unable to find relief with currently available options.'
'We would like to thank Dr. Petersen, Dr. Kapural, the SENZA-PDN and SENZA-NSRBP investigators, and the many other clinical investigators studying HF10 therapy for presenting their results at NANS,' Mr. Grossman continued. 'We are proud to continue our longstanding commitment to investing in the field of neuromodulation and expanding our growing body of clinical evidence to treat underserved patient populations suffering from debilitating chronic pain.'
Sustained Benefits of 10 kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 6-Month Randomized Controlled Trial Results1
Nevro's SENZA-PDN trial is the largest PDN RCT of SCS treatment conducted to date with 216 randomized subjects. The data presented at NANS highlighted complete 6-month results and analysis of all prespecified secondary endpoints and a first look at 12-month pain relief and preliminary crossover results. Key findings at six months, presented by lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, included significantly improved and sustained outcomes with 10kHz Spinal Cord Stimulation versus Conventional Medical Management.
Data from the SENZA-PDN trial formed the basis of the company's recent PMA supplement submission to the FDA. This submission, assuming a six-month review cycle and regulatory approval from the FDA, would position the company to achieve approval and initiate U.S. launch activities for the Senza System and HF10 therapy for treatment of chronic pain in PDN patients in the second half of 2021.
Spinal Cord Stimulation at 10kHz for Non-Surgical Refractory Back Pain: Multicenter RCT Primary Endpoint Results2
Nevro's SENZA-NSRBP RCT data included 3-month primary endpoint results in 159 randomized subjects from 15 study centers. Key findings at 3 months, presented by lead investigator Dr. Leonardo Kapural, Medical Director for the Carolinas Pain Institute, included superior responder rate and significant pain relief for 10kHz SCS cohort versus Conventional Medical Management.
RESCUE3 and Waveform Pairing Studies4
Other Nevro data presented at this year's NANS meeting included the RESCUE study, which evaluated 120 patients who failed traditional SCS, and the Waveform Pairing study, which evaluated 230 patients who were provided waveform pairing programming to optimize their treatment. The RESCUE study demonstrates HF10 therapy as an effective therapeutic option to 'rescue' failed traditional SCS patients with relief from chronic pain and provides more evidence that HF10 operates with a frequency dependent mechanism of action. The Waveform Pairing study demonstrated increased versatility and waveform pairing may help improve therapeutic outcomes in difficult to treat patient populations. Both of these studies reinforce the importance of access to 10 kHz therapy, whether independently or paired, to help patients achieve the best possible outcomes.