Nevro Corp. announced the publication of new 24-month data from the SENZA Nonsurgical Refractory Back Pain (NSRBP) multicenter randomized controlled trial (RCT) in the Journal of Neurosurgery: Spine. Acute back pain causes more disability around the world than any other condition and a quarter of adults in the U.S. report they have experienced back pain within the past three months More than 500,000 Americans are living with back pain and either aren't good candidates for it or don't want to have spine surgery to treat it, leaving them with few treatment options.

The published 24-month data evaluated outcomes for NSRBP patients treated with Nevro's high-frequency (10 kHz) spinal cord stimulation (SCS) system plus conventional medical management (CMM) versus CMM alone. The data show that patients in the high-frequency SCS arm experienced profound improvements in pain, function, and quality of life, plus reduced opioid use compared to the CMM arm at 24 months. The long-term data provides further evidence of the benefits of high-frequency SCS in managing patients with NSRBP.

The 24-month data demonstrated the following benefits for the 125 patients who received 10 kHz Therapy? within the RCT: Pain Relief: 81.6% of all patients who received a permanent implant were classified as pain responders (achieved =50% pain relief) at 24 months, with 58.4% of patients classified as profound responders who achieved =80% pain relief. The mean back pain (as measured by the visual analog scale VAS) significantly decreased from 7.4 at baseline to 1.9, representing a 5.5-point (74%) decrease from baseline.

Function: Patients reporting a severe level of disability (based on the Oswestry Disability Index, ODI) decreased from 73% at baseline to 26% of patients at 24 months. 75.2% of patients were classified as ODI responders, achieving a =10-point improvement in ODI score. This signals improvements in the ability to perform daily living activities.

Quality of Life: Mean EuroQoL-5 Dimension-5 Level (EQ-5D-5L) instrument index score was significantly increased from 0.570 at baseline to 0.766 at three months after implantation. This 0.19-point improvement was maintained at 6, 12, 18, and 24 months after implantation. This score represents =2.5 times the minimal clinically important improvement.

High levels of patient satisfaction were recorded at 24 months, with 76% of patients reporting their condition was "better" or "a great deal better" on Patient-Reported Global Impression of Change (PGIC). Opioid usage was decreased or stopped in 62% percent of patients who were using opioids at baseline, with the mean dose decreasing from 35±39 morphine milligram equivalent (MME) at baseline to 15±35 MME at 24 months. Safety: No new safety signals were identified during the 24-month follow-up, with most study-related adverse events occurring in the first six months after permanent implantation and no additional serious adverse events beyond the six reported at 12 months.

The observed safety profile is consistent with types and rates of real-world adverse events reported for high-frequency SCS, as well as safety outcomes generally associated with SCS.