The Redwood City, Calif.-based company said the prospective, multicenter, randomized controlled trial compares its HF10 therapy plus conventional medical management to conventional treatment alone in 216 patients at 18 centers in the U.S. The primary endpoint of the study is the difference in the proportion of treatment responders at 3-month follow-up. The study will collect outcomes out to 24 months.
“This is an important step in the evaluation of Nevro’s Senza HF10 therapy for this very large and often undertreated patient population,” said Nevro president & CEO D. Keith Grossman in a news release. “Diabetes affects nearly one in 10 adults in the United States and can damage peripheral nerves, resulting in severe pain and numbness in the hands and feet. According to published literature, there are approximately 4 million diabetic patients suffering from painful diabetic neuropathy in the U.S. alone.”
Dr. Erika Petersen, director of functional and restorative neurosurgery at the University of Arkansas for Medical Sciences is lead principal investigator for the study.
Earlier this month, shares in Nevro climbed after the company beat Wall Street expectations with its second-quarter financial results.