Nevro Announces FDA Submission for HF10® Therapy in Patients with Painful Diabetic Neuropathy
Nevro Corp. (NYSE: NVRO) submitted a pre-market approval supplement to the FDA for its Senza® System, targeting Painful Diabetic Neuropathy (PDN). CEO D. Keith Grossman highlighted this milestone as critical for patients lacking relief from pharmacologic treatments. If approved, the Senza System could launch in late 2021, potentially addressing the needs of 4 million U.S. diabetic patients suffering from PDN. The SENZA-PDN study, the largest of its kind, aims to provide safety and efficacy data, with results to be presented at the NANS 2021 meeting on January 15, 2021.
- FDA submission for Senza System could address unmet needs in PDN treatment.
- Potential launch in late 2021 could capture significant market share among 4 million PDN patients.
- Approval is contingent upon FDA review; any delays could affect the launch timeline.
- Market competition and reimbursement challenges could impact product adoption.
REDWOOD CITY, Calif., Dec. 28, 2020 /PRNewswire/ -- 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 ≥
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Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that this new indication will address the many PDN patients who are unable to find relief with currently available pharmacologic options; and our expectations that we will be in a position to achieve approval and initiate launch activities for the Senza System and HF10 therapy for treatment of chronic pain in PDN patients in the second half of 2021. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Quarterly Report on Form 10-Q filed on November 5, 2020, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Vice President, Investor Relations & Corp Communications
650-433-3247 | julie.dewey@nevro.com
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SOURCE Nevro Corp.
FAQ
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