Nevro Corp. (NYSE:NVRO) today released 2-year results from Senza-RCT study of its HF10 spinal cord stimulation system, touting superior results over low-frequency SCS therapy treatments.
The Redwood City, Calif.-based company said results from the study were published in the journal Neurosurgery. Nevro said the trial is the largest prospective randomized trial of SCS systems and the 1st to evaluate the comparative effectiveness of spinal cord stimulation therapies.
The primary endpoint for the trial was a responder rate signifying a greater-than 50% reduction in back pain from the baseline at 3 months, with a secondary endpoint set at 12 months. Leg pain reductions and 24 month results from back pain reduction were also polled for secondary endpoints.
Patients treated with the company’s HF10 SCS reported significant improvements in superior back pain and leg pain 76.5% and 72.9% respectively, much higher than the 49.3% rates reported with traditional SCS for both back and leg pain.
Superior and durable pain relief results also indicated superiority for the HF10, with Visual Analog Scale scores for back and leg pain of 2.4 cm with HF10 versus 4.5 cm and 3.9 cm with traditional SCS, according to the study.
The company reported no paresthesia or paresthesia-related discomfort in patients with the HF10 system, as well as similar rates of adverse events between both groups at 5% for HF10 and 7.2% for traditional SCS.
“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. 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,” principal investigator Dr. Leo Kapural said in a press release.
“Nevro is committed to delivering innovative, evidence-based therapies that significantly improve outcomes for patients living with chronic pain. 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 and North 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,” CEO Rami Elghandour said in a prepared statement.
In August, Nevro saw shares soar after reporting a significant 2nd quarter, with losses shrinking by more than 50% while sales exploded nearly 400%, causing the company to lift its guidance for the full year.
The Redwood City, Calif.-based company reported losses of $8.8 million, or 31¢ per share, on sales of $55.4 million for the 3 months ended June 30. That amounts to a 55.5% reduction in losses as sales grew a whopping 385% compared with the same period last year.
Analysts on Wall Street were looking for the company to post losses per share of 47¢ with revenue of $47 million for the quarter, both of which Nevro managed to top.
