Clinical Data Presented at 2021 North American Neuromodulation Society (NANS) Virtual Meeting Reinforce Significant Benefits of Nevro's HF10® Therapy

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced promising results from its HF10 therapy for chronic pain at the 2021 North American Neuromodulation Society (NANS) Virtual Meeting, held January 14-16. The SENZA-PDN trial, with 216 randomized subjects, demonstrated significant pain relief in Diabetic Neuropathy patients over 6 months. The SENZA-NSRBP trial showed superior outcomes in Non-Surgical Refractory Back Pain patients after 3 months. The data supports a PMA supplement submission to the FDA for U.S. launch activities in the second half of 2021, marking a significant advancement in the treatment of chronic pain.

Positive

• SENZA-PDN trial results showed significant pain relief and sustained outcomes for 216 subjects over 6 months.
• SENZA-NSRBP trial indicated superior responder rates for 159 subjects after 3 months.
• Potential FDA submission may enable U.S. launch of HF10 therapy in the second half of 2021.
• HF10 therapy has demonstrated capabilities to reduce opioid usage in ≥65% of patients.

Negative

• None.

REDWOOD CITY, Calif., Jan. 19, 2021 /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  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.

For a complete list of Nevro's NANS presentations, please visit https://conferences.nevro.com/nans21/.

Replay of Nevro NANS Investor Briefing

An archived recording of Nevro's virtual investor briefing at NANS is available in the "Investors" section of Nevro's website at www.nevro.com. 

¹ Petersen et al. Sustained Benefits of 10 kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 6-Month Randomized Controlled Trial Results.
² Kapural et al.  Spinal Cord Stimulation at 10kHz for Non-Surgical Refractory Back Pain: Multicenter RCT Primary Endpoint Results.
³ Kapural et al. Journal of Pain Research 2020:13 2861–2867.
⁴ Russo, M et al. Improved Versatility and Frequency Pairing Capabilities with 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain.       
E-Poster presented at the North American Neuromodulation Society Meeting 2021 Orlando, FL.

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.

To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.

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, in relation to our SNZA-PDN and SENZA-NSRBP study results, no other SCS treatments have demonstrated such positive results in treating PDN and NSRBP patients and there is a significant opportunity to expand an innovative treatment option to patients who are unable to find relief with currently available options; and our belief that our PDN submission to FDA, 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.  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

What were the key findings from the SENZA-PDN trial presented by Nevro?

The SENZA-PDN trial demonstrated significant pain relief and sustained outcomes in patients with Painful Diabetic Neuropathy over a 6-month period.

What did the SENZA-NSRBP trial results indicate?

The SENZA-NSRBP trial showed superior responder rates and significant pain relief for patients with Non-Surgical Refractory Back Pain after 3 months.

When is the expected FDA submission for Nevro's HF10 therapy?

The FDA submission for HF10 therapy is anticipated to occur in the second half of 2021, based on the results from the SENZA trials.

What is the potential market impact of Nevro's HF10 therapy?

HF10 therapy could provide a significant treatment option for patients suffering from chronic pain, particularly those who have not found relief from existing treatments.