Neuralace Medical intends to utilize the output of the AT-PDN multicenter study to support the FDA 510(k) application for Axon Therapy label expansion to include Treatment for Painful Diabetic Neuropathy
SAN DIEGO, Jan. 9, 2023 /PRNewswire/ -- Neuralace Medical, Inc., a commercial-stage medical technology company focused on innovative, non-invasive solutions for the treatment of chronic neuropathic pain, is announcing the commencement and first patients enrolled in the Axon Therapy and Painful Diabetic Neuropathy (AT-PDN) study.
The AT-PDN multi-center study has a targeted enrollment of 80 patients and will be led by Dr. Lora Brown at TruWell Health, St. Petersburg, FL as study Principal Investigator and will include a total of three clinical investigators and five clinical sites, primarily in the southeast US.
Alongside the company's ongoing SEAT clinical study (Safety and Efficacy of Axon Therapy), which is nearing completion of enrollment, the newly launched AT-PDN study will lead the company's entry into a large, fast-growing segment of patients with diabetic neuropathy for which there are no effective, non-invasive solutions available alongside or following prescription drugs. Neuralace Medical plans to continue to build a robust body of clinical evidence to support FDA labeling, therapy adoption, and as important evidence in the company's pursuit of Medicare and private payor reimbursement.
"We are very excited to be part of the AT-PDN study as non-invasive, opioid-sparing therapies are an important part of the care continuum, especially for PDN patients that have an elevated risk of infection but for whom peripheral neuromodulation may be a useful clinical strategy," said Dr. Lora Brown, MD and Principal Investigator of the AT-PDN clinical study.
"We are pleased to have a thought-leading team of investigators participating in this very important clinical trial, said Joe Milkovits, COO of Neuralace Medical. Joe continued, "Assuming a successful completion of the trial and subsequent expansion of the FDA label to include treatment of PDN, Neuralace Medical will be able to provide a non-invasive, peripheral neuromodulation option for the millions of patients suffering from this debilitating condition."
Neuralace Medical is a commercial stage medical device company focused on the treatment of chronic neuropathic pain with its proprietary magnetic peripheral nerve stimulation (mPNS™) technology. Supported by mPNS, the company's FDA 510(k) cleared Axon treatment device is a transcutaneous magnetic stimulation device providing non-invasive, rapid, effective treatment for chronic neuropathic pain. Foundational to Axon Therapy is the belief that clinically effective, non-invasive and easy to administer therapies with no side effects should be used alongside, or to decrease, prescription drug use, and ahead of all other traditionally recommended invasive or minimally invasive therapies. With its unique patent protected product portfolio, Neuralace Medical is well positioned to establish a leadership position in the chronic neuropathic pain market. For more information, please visit www.neuralacemedical.com.
Contact: Mike Houlihan at [email protected]
SOURCE Neuralace Medical, Inc.