Nevro Corp. issued the following announcement on Dec. 28.
Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that the company has submitted a pre-market approval supplement to the U.S. Food and Drug Administration (FDA) to seek approval of its Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).
"This submission is a significant milestone in the evaluation of Nevro's proprietary HF10 high frequency spinal cord stimulation therapy to address the many PDN patients who are unable to find relief with currently available pharmacologic options," said D. Keith Grossman, Nevro's Chairman, CEO and President.
Mr. Grossman continued, "We would like to thank lead Principal Investigator Dr. Erika Petersen, Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, and the entire team of clinical trial investigators and their patients for their study participation and ongoing partnership, without whom this submission would not have been possible."
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.
Painful Diabetic Neuropathy (PDN)
Diabetes affects nearly one in ten adults in the United States and can damage peripheral nerves, resulting in severe pain and numbness in the extremities. According to published literature, there are approximately 4 million diabetic patients suffering from painful diabetic neuropathy in the U.S. alone. Nevro's SENZA-PDN study, the largest randomized clinical trial (RCT) of spinal cord stimulation treatment conducted thus far, compares HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States. The primary endpoint of the study is the difference in proportion of treatment responders at 3-month follow-up with all study participants continuing to be followed out to 24 months. This RCT is designed to provide safety and efficacy data, which will be used to support customer adoption and efforts to ensure adequate payor coverage of this procedure.
The SENZA-PDN study data will be presented at the upcoming 2021 North American Neuromodulation Society (NANS) Virtual Meeting and will highlight complete 6-month results and analysis of all prespecified secondary endpoints. Additionally, a first look at preliminary 12-month pain relief and preliminary crossover results will be included. Results will be presented by Dr. Erika Petersen on January 15, 2021, from 4:53-5:05 pm Central Time, at NANS 2021 Late-Breaking Abstract Plenary Session 1.
Internet Posting of Information
Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.
About Nevro
Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy. Senza, Senza II, Senza Omnia, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.
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