Neuralace Medical Announces Clinical Milestones Including Presentation of the Safety and Efficacy of Axon Therapy (SEAT) Study at the American Society of Pain and Neuroscience Conference (ASPN), While Completing Enrollment in the Axon Therapy Painful Diabetic Neuropathy Study (AT-PDN) and Launching a Pilot Study Focused on the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN)

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May 30, 2023, 07:00 ET

Neuralace Medical will continue to leverage clinical milestone progress to support its current seed fundraising efforts highlighted by a recent first close of $3.1M targeting a total raise of $5-$7M

SAN DIEGO, May 30, 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 upcoming clinical study presentation of the Safety and Efficacy of Axon Therapy (SEAT) randomized controlled trial at the upcoming American Society of Pain and Neuroscience conference July 13-16 in Miami, FL. Dr. Leo Kapural, partner and pain physician at the Carolinas Pain Institute in Winston-Salem, North Carolina, and principal investigator for the SEAT study, will be presenting 3-month patient follow up data comparing conventional medical management (CMM) to Axon Therapy combined with CMM. "As the principal investigator for this study I have become very familiar with Axon Therapy and have seen encouraging results from a wide cross-section of patients. For many patients, prescription drugs have adverse side effects and surgical options are daunting and may have complications. Axon Therapy is a non-invasive approach to bring the benefits of neuromodulation to many more patients", said Dr. Kapural. Joe Milkovits, Neuralace COO added, "As the sponsor for this study, we are thrilled to see robust clinical study results matching what we are seeing in our current commercial VA patients. We are lucky to have such a talented and committed group of investigators".

Axon Therapy in Painful Diabetic Neuropathy (AT-PDN) Study Set to Complete Enrollment

Neuralace Medical has initiated a multi-center, double blind, randomized controlled trial to evaluate the clinical efficacy of its magnetic peripheral nerve stimulation (mPNS) technology in the treatment of painful diabetic neuropathy. Enrollment in the Study will be completed in June, 2023, with subsequent submission to FDA targeting Agency clearance by the close of this year. Neuralace Medical COO Joe Milkovits related, "I am especially proud of our team of investigators led by Dr. Lora Brown in St. Petersburg, FL, and also the Neuralace Clinical Team on the ground supporting the AT-PDN study. Enrollment has moved quite quickly due to the excitement from patients and our clinical investigators. We look forward to our submission to FDA and to the prospect of bringing relief to the many patients suffering from diabetes related chronic neuropathic pain".

Pilot study initiated in chemotherapy induced chronic neuropathic pain (CIPN)

In keeping with Neuralace Medical's strategy of Axon Therapy treatment expansion for additional patient types, the company will be conducting a pilot study focused on CIPN led by Carrie Johnson MD, PhD, who is the Principal Investigator for the Study and a Board Certified Pain Physician at the Carolinas Pain Institute in Winston-Salem, North Carolina. Dr Johnson noted, "Currently, options are limited for patients struggling with chemotherapy induced peripheral neuropathy. This condition can be chronic, life-changing, and too often prevents patients from being able to complete their recommended anti-cancer therapy."

Neuralace Medical CEO, Keith Warner commented, "We couldn't be more pleased with our clinical progress and anticipate the results of our studies to be in line with what we are seeing from the growing number of patients receiving Axon Therapy In our customers' pain clinics. I am pleased to see Neuralace Medical gaining momentum commercially and clinically and glad to see this translating over to our continued fundraising success".

About Neuralace Medical
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]
(760-845-6983)

SOURCE Neuralace Medical, Inc.