Nevro Announces Publication of 12-Month Data from SENZA-NSRBP Randomized Controlled Trial in Journal of Neurosurgery: Spine

REDWOOD CITY, Calif., Feb. 11, 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 12-month data from the SENZA-NSRBP randomized controlled trial (RCT) was published online in Journal of Neurosurgery: Spine.¹ These data show that high-frequency 10 kHz spinal cord stimulation (SCS) therapy results in profound improvement in non-surgical refractory back pain (NSRBP) patients compared to Conventional Medical Management (CMM).    

Journal of Neurosurgery: Spine publication can be accessed online in the "Publish before Print" section at: http://thejns.org 

Published 12-month data from the SENZA-NSRBP RCT, the first RCT conducted in a large NSRBP patient population, show sustained effectiveness of 10 kHz Therapy.  Outcomes are reported on 121 patients implanted with 10 kHz SCS, including those who crossed over from the CMM arm to 10 kHz therapy.

"There is a significant unmet need for safe and effective, non-pharmacologic therapy for NSRBP, as currently there are few effective treatment options," said Dr. Leonardo Kapural, Carolina's Pain Institute, Winston-Salem, North Carolina, and lead investigator of the SENZA-NSRBP study. "This study provides high level clinical evidence and confidence to the neurosurgery community regarding a therapeutic option for intractable back pain when a patient is not a candidate for spine surgery.  All patients in this trial had tried and failed conventional medical management for an average duration of eight years, and experienced profound improvements in pain, disability and quality of life with 10 kHz SCS at 12 months post-implant."

"We are thrilled that our 12-month NSRBP trial results clearly demonstrate the durable pain relief that can be achieved with 10 kHz Therapy," said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. "We look forward to expanding access to high-frequency SCS therapy by providing the needed evidence of clinical benefit and reduced health care utilization when 10 kHz Therapy is used to treat refractory back pain in patients who have not had previous spine surgery.  No other SCS treatment has demonstrated such positive results in treating NSRBP patients, and we look forward to using this data to support increased patient access and improve market awareness and penetration."

The SENZA-NSRBP RCT 12-month data demonstrated the following benefits of 10 kHz Therapy:

Durable Pain Relief

• At 12 months, 78.2% of participants in the 10 kHz SCS study arm reported pain relief >50%, while the average pain relief was 72.1% (% reduction of VAS from baseline).
• In the crossover arm, 78.2% of participants reported pain relief >50%, and average pain relief was 70.4% (% reduction of VAS from baseline), after six months with 10 kHz Therapy.

Consistent Safety

• The study related adverse event reported rates are similar to what has been reported in the literature, including the Senza-RCT.²
• Only three of 145 permanent SCS devices were explanted for a 2.1% explant rate (all explants were due to wound complications).
• There were no explants due to loss of efficacy.

Functional Improvement

• The average score on the Oswestry Disability Index (ODI) at baseline indicated severe disability, while post-implant the scores improved to borderline minimum/moderate disability (an average 20-point reduction).
• Three-quarters of the subjects receiving 10 kHz Therapy had clinically significant improvement (≥10 points) in ODI or were in the minimally disabled category at the end of 12 months of follow-up for the 10 kHz SCS group (six-months post-implant for the crossover group).

Opioid Use

• Despite no specified opioid weaning protocol, usage in this study declined significantly by 46% on average in subjects receiving treatment at six and 12 months.

Data from the SENZA-NSRBP trial formed the basis of the company's recent FDA approval for NSRBP.  Nevro is the only SCS company with a specific, on-label indication for treating NSRBP patients.

About the SENZA-NSRBP RCT

Nevro's SENZA-NSRBP study compares Nevro's proprietary high-frequency (10 kHz) SCS plus CMM to CMM alone in 159 randomized patients at 15 study centers.  The primary endpoint at three months and the secondary endpoints at six months were all met demonstrating superior responder rate and significant pain relief for the 10 kHz SCS cohort versus CMM.  All outcomes were stable to 12 months in the 10 kHz SCS arm and participants who crossed over to the 10 kHz SCS therapy had comparable improvements post-crossover.  Study participants continue to be followed out to 24 months.

The SENZA-NSRBP RCT 12-month data show sustained effectiveness of 10 kHz SCS and also includes the results for patients that crossed over from CMM to 10 kHz after six months.  Subjects could opt to crossover to the other treatment arm if they had insufficient pain relief (<50%), were dissatisfied with treatment, and were appropriate to proceed as determined by their physician.  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. 

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.

¹ Kapural L, Jameson J, Johnson C, et al. Treatment of Nonsurgical Refractory Back Pain with High-Frequency Spinal Cord Stimulation at 10kHz: 12-month Results of a Pragmatic, Multicenter, Randomized Controlled Trial. J Neurosurg Spine. 2022; https://doi.org/10.3171/2021.12.SPINE211301.

² Kapural L, Yu C, Doust MW, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015;123(4):851-860.

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 we will expand access to high-frequency SCS therapy by providing the needed evidence of clinical benefit and reduced health care utilization when 10 kHz Therapy is used to treat refractory back pain in patients who have not had previous spine surgery; and our belief that the safety and efficacy data from the SENZA-NSRBP RCT will be used to support increased patient access and improve market awareness and penetration.  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  |  [email protected]

SOURCE Nevro Corp.