First Patient Treated in Landmark U.S. Randomized Clinical Trial of NeuraLace's Chronic Pain Treatment
SAN DIEGO, May 27, 2021 /PRNewswire/ -- NeuraLace Medical, Inc., a medical device company focused on improving pain relief among patients suffering from debilitating chronic nerve pain, announced today that the first patient has been enrolled as part of the AXON-RCT U.S. study: a prospective, randomized, controlled clinical trial comparing the safety and effectiveness of Axon Therapy® for post-traumatic peripheral neuropathic pain to conventional medical management. The Primary Investigator of the study will be Dr. Leonardo Kapural of the Carolinas Pain Institute.
"We are incredibly excited to start our Axon-RCT study with Dr. Kapural's team to begin testing Axon Therapy on patients that suffer from chronic peripheral nerve pain," said Shiv Shukla, Founder and CEO of NeuraLace Medical. "We believe Axon Therapy has the potential to dramatically improve the lives of these patients by providing sustainable relief without the use of opioids."
The study will begin at two separate clinical sites: Dr. Kapural's clinic, Carolinas Pain Institute, in Winston-Salem, North Carolina, and with Dr. Dawood Sayed at the University of Kansas Medical Center in Kansas City, Kansas. "Many of the current treatment options for chronic nerve pain patients provide minimal relief." said Dr. Kapural of the Carolinas Pain Institute, "Previous studies of NeuraLace's Axon Therapy device suggest it is the first to provide substantial pain relief in patients with chronic nerve pain while avoiding the side effects that can occur with gabapentinoids and opioids. We look forward to testing the device in our patients. Since it is non-invasive and non-addictive, the therapy could represent a significant advancement in the field of chronic pain management."
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SOURCE Neuralace Medical, Inc.