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."
ABOUT AXON THERAPY Axon Therapy delivers focused magnetic pulses which activate the damaged peripheral nerve axons that are required to provide relief from chronic nerve pain. The Axon Therapy coil, connected to a compact stimulation module, produces strong magnetic pulses near the injured nerve during the course of the treatment. NeuraLace's patented low frequency waveform leverages the principles of electromagnetic induction to create a voltage differential that elicits neuronal stimulation in the axon of the damaged nerve resulting in pain relief. Current forms of neuromodulation focus on masking the transmission of pain signals to the brain, whereas Axon Therapy seeks to suppress the pain signal by re-activating the body's natural modulatory mechanism which is disrupted, and often dormant, after traumatic injury to the nerve. In the United States, Axon Therapy is limited by federal law to investigational use only and is not available for commercial use.
ABOUT THE CLINICAL STUDY The primary objective of the NeuraLace clinical trial is to evaluate the safety and efficacy of the Axon Therapy device for post-traumatic peripheral neuropathic pain. Sample size is estimated at 126 subjects. Subjects will be enrolled in the study for 12 months. Baseline measures will be obtained and subjects will be randomly assigned in a 1:1 fashion to receive either Axon Therapy with Conventional Medical Management (CMM) or CMM alone. Pain scores will be assessed using the VAS scale at 1 month, 3 months, 6 months and 12 months. Additionally, opioid-sparing and pharmacoeconomic benefits will be measured along with changes in activities of daily living (ADLs) as secondary and tertiary endpoints.
ABOUT NEURALACE MEDICAL, INC. Privately held NeuraLace Medical, Inc., headquartered in San Diego, Calif., is committed to leading the charge in non-invasive chronic pain management and sustainable relief. Our mission to end chronic pain inspired us to develop Axon Therapy, with the goal of being the first non-invasive, non-addictive way to effectively treat chronic nerve pain.
Axon Therapy® and the NeuraLace logo are trademarks of NeuraLace Medical, Inc. Axon Therapy is an investigational device, limited by Federal (or United States) law to investigational use.