Nevro Announces FDA Approval for Expanded Labeling for its 10 kHz High Frequency Spinal Cord Stimulation System for Treatment of Non-Surgical Refractory Back Pain (NSRBP)
Nevro Corp. (NYSE: NVRO), based in Redwood City, California, has received FDA approval for expanded labeling of its Senza® Spinal Cord Stimulation (SCS) System to treat Non-Surgical Refractory Back Pain (NSRBP), marking it the only SCS system specifically indicated for this condition. This approval highlights Nevro's proprietary 10 kHz Therapy. Clinical trials indicate significant improvements in pain relief and quality of life for patients after 12 months of treatment. Nevro aims to enhance market access and payer coverage based on these results.
- FDA approval for Senza SCS System to treat NSRBP.
- Unique position as the only SCS system with specific labeling for NSRBP.
- Clinical trial results show significant improvements in pain relief and quality of life.
- Potential for enhanced market penetration and payer coverage.
- Approval contingent on ongoing clinical trial follow-ups.
- Dependence on third-party payor reimbursement for market success.
REDWOOD CITY, Calif., Jan. 19, 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 receipt of FDA approval for expanded labeling for its Senza® Spinal Cord Stimulation (SCS) System for the treatment of Non-Surgical Refractory Back Pain (NSRBP). This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.
"Patients who suffer from intractable back pain without a prior surgery have limited treatment options if they are not a candidate for surgery," said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. "This FDA approval marks another milestone in Nevro's commitment to expanding access to 10 kHz Therapy for these underserved patients. Nevro is now the only SCS company with specific, on-label indications for treating both NSRBP and Painful Diabetic Neuropathy patients."
Mr. Grossman continued, "We would like to thank our lead Principal Investigator team, Dr. Leonardo Kapural, Dr. Jessica Jameson and Dr. Naresh Patel, as well as the rest of our clinical trial investigators and their patients for their study participation and ongoing partnership, without whom this approval would not have been possible."
The 12-month results for the SENZA-NSRBP RCT were recently presented at the North American Neuromodulation Society (NANS) 25th Annual Meeting on January 15, 2022.¹ SENZA-NSRBP study participants receiving 10 kHz Therapy demonstrated profound improvements in pain relief, function, quality of life, awareness of positive change and reduction in daily opioid use versus Conventional Medical Management (CMM) at 12-months post-implant. Results also included comparable improvements for patients that crossed over from CMM to 10 kHz after six months.
These data will be used to support continued market penetration and market access initiatives to further expand payer coverage of this procedure. The company plans to publish these 12-month results, including the six-month crossover patient data, in a peer-reviewed journal. Study participants will continue to be followed out to 24 months.
About the SENZA-NSRBP RCT
Nevro's SENZA-NSRBP study, the largest RCT of spinal cord stimulation treatment conducted for non-surgical refractory back pain (NSRBP), compares 10 kHz SCS plus CMM to CMM alone in 159 randomized patients at 15 centers in the United States. Each randomized patient underwent a consultation with a spine surgeon where they were deemed to not be an appropriate candidate for spine surgery. The primary endpoint of the study was a responder rate (≥
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 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.
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 plans to publish the 12-month SENZA-NSRBP RCT clinical results, including the 6-month crossover patient data, in a peer-reviewed journal. 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:
Julie Dewey, IRC
Nevro Corp.
Chief Corp Communications and Investor Relations Officer
650-433-3247 | julie.dewey@nevro.com
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