Nevro (NVRO) Announces Publication of Positive SENZA-RCT Data in Neurosurgery Chronic Pain

September 6, 2016 7:32 AM EDT

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Nevro Corp. (NYSE: NVRO) announced the publication of long-term data for the treatment of chronic pain in Neurosurgery, the official Journal of the Congress of Neurological Surgeons. The SENZA-RCT is a groundbreaking pivotal study that was both the largest prospective randomized clinical trial ever conducted in SCS history and the first to evaluate comparative effectiveness of spinal cord stimulation (SCS) therapies.

The published two-year results demonstrate the sustained superiority of HF10 therapy versus traditional low-frequency SCS therapy across all primary and secondary endpoints. Significant findings from the SENZA-RCT study include:

  • Superior back pain responder rate with HF10 therapy: 76.5% versus 49.3%; P<0.001
  • Superior leg pain responder rate with HF10 therapy: 72.9% versus 49.3%; P=0.003
  • Superior and durable pain relief with HF10 therapy: average VAS scores for back and leg pain of 2.4 cm with HF10 therapy versus 4.5 cm and 3.9 cm with traditional SCS; P<0.001 and P=0.027
  • HF10 therapy delivered pain relief with no paresthesia or paresthesia-related discomfort
  • Consistent safety results with limited study-related serious adverse events in each treatment group at two years (5.0% for HF10 therapy, 7.2% for traditional SCS; P=0.56)

"Chronic pain is a significant public health problem that impacts an estimated 100 million American adults. More Americans are impacted by chronic pain than diabetes, heart disease and cancer combined and innovative, non-opioid treatments that work over a longer period of time are needed," said Leo Kapural, M.D., Ph.D, the Principal Investigator of the study. "By demonstrating a significant and durable decrease in back and leg pain over a two-year period, Nevro's HF10 therapy represents an important and evidence-based advance in pain medicine. As we read in the paper every day and hear mounting concern from regulatory agencies, treating chronic pain conditions with opioids is fraught with risks. HF10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients."

"Nevro is committed to delivering innovative, evidence-based therapies that significantly improve outcomes for patients living with chronic pain," said Rami Elghandour, President and CEO of Nevro. "HF10 therapy is now backed by two comprehensive prospective studies, each with robust two-year outcomes, representing a meaningful advance in the field of neuromodulation. We are honored to have this data published in the prestigious Neurosurgery journal, which has a rich history of publishing seminal SCS clinical trials including the Kumar (PROCESS, 2008) and North (2005) studies. This Level I RCT supports long-term positive outcomes for SCS and is critical for driving clinical and economic decision making among physicians, payers, and patients."

The Senza® SCS system received FDA approval in May of 2015. The 12-month results of the SENZA-RCT, first presented by Dr. Leonardo Kapural at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy's superiority labeling from FDA, a first in the SCS space. The two-year results of the SENZA-RCT were first presented by Dr. Todd Sitzman at the North American Neuromodulation Society meeting in December of 2015.

The full two-year SENZA-RCT publication is available at http://journals.lww.com/neurosurgery/Abstract/publishahead/Comparison_of_10_kHz_High_Frequency_and.97253.aspx.



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