Nevro ($NVRO) is celebrating positive long-term data from a pivotal study of its spinal cord stimulation therapy for chronic pain. The news marks a bright point for the California med tech as it struggles with reimbursement for its device.
The two-year results, published in the journal Neurosurgery, show that Nevro’s Senza device and corresponding HF10 therapy was better at reducing chronic pain than traditional therapies. Senza met both its primary and secondary endpoints in the study, the Redwood City, CA-based company said in a statement.
More than three-fourths of subjects, or 76%, reported reduced back pain when treated with Senza, compared to 49.3% who had low-frequency spinal cord stimulation. About 73% of individuals treated with Senza reported reduced leg pain, compared to 49.3% who had the alternative therapy.
The results come at a pivotal moment: An estimated 100 million Americans are affected by chronic pain, the company said in a statement, and opioid therapies are fraught with controversy.
“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,” Leo Kapural, principal investigator of the study, said in a statement. “HF10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients."
The positive study results also come as music to Nevro’s ears as it deals with reimbursement hurdles for Senza. In June, a pair of regional insurers decided not to reimburse the device, deeming it too experimental. That news came after the CMS approved higher reimbursement for Senza.
Still, some analysts think that there’s light at the end of the tunnel for Nevro. There’s a “high likelihood” that payers that rejected Senza will reverse their decision after considering strong clinical data, Leerink analyst Danielle Antalffy said at the time in a note to clients.
Meanwhile, Nevro doesn’t show any signs of slowing down. Senza “is now backed by two comprehensive prospective studies, each with robust two-year outcomes, representing a meaningful advance in the field of neuromodulation,” Nevro CEO Rami Elghandour said in a statement. The latest data “supports long-term positive outcomes for SCS and is critical for driving clinical and economic decision making among physicians, payers, and patients,” Elghandour said.