SENZA-PDN Randomized Controlled Trial Results Demonstrate Significant and Sustained Outcomes with 10 kHz Therapy at 18-Months Follow-Up.
SENZA-PDN Randomized Controlled Trial Results Demonstrate Significant and Sustained Outcomes with 10 kHz Therapy at 18-Months Follow-Up
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| [18-January-2022] |
| REDWOOD CITY, Calif., Jan. 18, 2022 /PRNewswire/ --Nevro Corp (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the results from data presentations at the 2022 North American Neuromodulation Society (NANS) Annual Meeting supporting the use of 10 kHz spinal cord stimulation (SCS) therapy for patients with chronic pain, including results from the SENZA Painful Diabetic Neuropathy (PDN) and SENZA Non-Surgical Refractory Back Pain (NSRBP) randomized clinical trials (RCT). Results were presented on Saturday, January 15, 2022. “Nevro once again had a substantial presence at this year’s NANS meeting, with data presented from 17 clinical abstracts, including late-breaking results from our SENZA-PDN and SENZA-NSRBP randomized clinical trials, both of which demonstrated significant and sustained outcomes at 18-months in the PDN study and 12-months in the NSRBP study,” said D. Keith Grossman, Chairman, CEO and President of Nevro. “In addition, both studies demonstrated cost savings with 10 kHz SCS in healthcare utilization at 12 months. No other SCS treatments have demonstrated such benefits with durable clinical outcomes 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 current standard of care.” “We would like to thank our Principal Investigators Dr. Erika Petersen and Dr. Leonardo Kapural, all of the SENZA-PDN and SENZA-NSRBP investigators, and the many other clinical investigators studying HFX 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.” Durability of 10 kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 18-Month Multicenter 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 18-month results, including 12-month crossover results and an analysis of healthcare resource utilization. Key findings at 18 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 significant and sustained outcomes with 10 kHz SCS. No explants were required for loss of efficacy. In addition, analysis of healthcare resource utilization through the first 12 months of the trial indicated reduced spending associated with 10 kHz SCS treatment, particularly for hospitalizations. Twelve-month Outcomes from RCT: 10kHz Spinal Cord Stimulation for Treating Non-Surgical Refractory Back Pain² Nevro’s SENZA-NSRBP RCT data included 12-month results comparing Nevro’s proprietary high-frequency (10 kHz) SCS plus CMM (Conventional Medical Management) to CMM alone in 159 randomized patients at 15 study centers. All primary and secondary endpoints were met (P-value < 0.001). Key findings at 12 months, presented by lead investigator Dr. Leonardo Kapural, Medical Director for the Carolinas Pain Institute, showed profound improvements in pain relief, function, quality of life, awareness of positive change and reduction in daily opioid use in NSRBP patients receiving 10 kHz Therapy at 12-months post-implant. Results also included comparable improvements for patients that crossed over from CMM to 10 kHz after 6 months. At six months, 75% of patients who met criteria in the CMM arm elected to crossover and were implanted; no one in the 10 kHz SCS + CMM treatment arm elected to stop 10 kHz Therapy. No explants were required for loss of efficacy. Study participants will continue to be followed out to 24 months. Cost-Effectiveness of 10 kHz Spinal Cord Stimulation When Combined with Conventional Medical Management (CMM) for the Treatment of Non-Surgical Refractory Back Pain (NSRBP)3 Nevro’s SENZA-NSRBP trial is the first RCT to prospectively gather health care utilization (HCU) information in the NSRBP population. This analysis, presented by Dr. Jessica Jameson, Founder, Axis Spine Center in Coeur d’Alene, Idaho, on behalf of the SENZA-NSRBP investigators, supports a cost-effective conclusion for 10 kHz SCS over CMM alone with the cost-effectiveness time frame dependent on the upfront cost of SCS device and procedure. Health-related quality of life showed a clinically significant improvement at 12-months post baseline for all implanted patients and was close to the U.S. norm for age group. Data from the SENZA-NSRBP trial formed the basis of the company’s Premarket Approval supplement submission to the U.S. Food & Drug Administration. If approved, Nevro will be the only SCS company with a specific, on-label indication for treating NSRBP. 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 delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally. Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro’s proprietary 10 kHz Therapy. Nevro’s unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management. Senza, Senza II, Senza Omnia, HFX, HXF Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp. To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram. References 1 Petersen, Stauss, Scowcroft, et al. Durability of 10 kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 18-Month Multicenter Randomized Controlled Trial Results. Presented at North American Neuromodulation Society (NANS); January 13-15, 2022; Orlando, FL. 2 Kapural, Jameson, Johnson, et al. Twelve-month Outcomes from RCT: 10kHz Spinal Cord Stimulation for Treating Non-Surgical Refractory Back Pain. Presented at North American Neuromodulation Society (NANS); January 13-15, 2022; Orlando, FL. 3 Kapural, Jameson, Johnson, et al. Cost-Effectiveness of 10 kHz Spinal Cord Stimulation When Combined with Conventional Medical Management (CMM) for the Treatment of Non-Surgical Refractory Back Pain. Presented at North American Neuromodulation Society (NANS); January 13-15, 2022; Orlando, FL. 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 SENZA-PDN and SENZA-NSRBP study results, there is a significant opportunity to expand an innovative treatment option to patients who are unable to find relief with current standard of care. 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 8, 2021, 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:
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Company Codes: NYSE:NVRO |
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