Neuralace Medical Completes Enrollment of Painful Diabetic Neuropathy Label Expansion Study (AT-PDN) Paving the Way for FDA Clearance and a Breakthrough, Non-invasive Treatment for Diabetes related Neuropathic Pain

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Neuralace Medical Completes Enrollment of Painful Diabetic Neuropathy Label Expansion Study (AT-PDN) Paving the Way for FDA Clearance and a Breakthrough, Non-invasive Treatment for Diabetes related Neuropathic Pain

This milestone marks the potential for significant expansion of the clinical benefits of neuromodulation to the millions of patients suffering from PDN who may not be candidates for implantable solutions but can benefit from non-invasive neuromodulation

DLC, Dec. 18. 2023 /PRNewswire/ — The AT-PDN study, which randomized 70 patients between treatment and sham groups, included 50 patients receiving Axon Therapy in combination with conventional medical management (CMM), and 20 patients receiving a sham Axon treatment alongside CMM. Neuralace Medical is excited to report that study enrollment and progress to the primary endpoint is complete, setting the stage for FDA review and a potential breakthrough in the treatment of PDN

Building on momentum from the previously reported results of the Safety and Efficacy of Axon Therapy study (SEAT), presented at the 2023 American Society of Pain and Neuroscience conference (ASPN) by Dr. Leonardo Kapural and awarded Best Abstract at the 2023 ASPN meeting, these latest findings highlight the promising potential of Axon Therapy. The SEAT study demonstrated a remarkable 71% responder rate across a diverse patient group receiving Axon Therapy at the 90-day mark, all while maintaining a spotless safety profile with no safety concerns or adverse events reported.

“My heartfelt thanks to our clinical team, our investigators and to the many patients who participated in the AT-PDN study. Thanks to you we are optimistic there will soon be a non-invasive neuromodulation option available for this patient group”, said Keith Warner, CEO of Neuralace Medical.

Neuralace Medical’s commitment to innovation and patient care remains unwavering, as the company plans to submit the results of these groundbreaking studies to the FDA in September. Anticipating a decision from the FDA by year-end, Neuralace Medical is dedicated to advancing the field of neuropathic pain treatment and improving the lives of those affected by this debilitating condition.

For media inquiries or more information about Neuralace Medical and its groundbreaking research, please contact:

Joe Milkovits, COO
Neuralace Medical,Inc
joe@neuralacemedical.com
1-855-473-AXON

About Neuralace Medical:

Neuralace Medical is a pioneering medical device company dedicated to improving the lives of patients suffering from chronic neuropathic pain with its magnetic peripheral nerve stimulation (mPNS™) technology. Through the innovative treatment of Axon Therapy, Neuralace Medical is at the forefront of advancing the field of pain management. With a commitment to rigorous clinical research and patient-centered care, Neuralace Medical strives to provide effective solutions for those in need. For more information visit www.neuralacemedical.com

Follow Neuralace on LinkedIn and Twitter at @Neuralace.

SOURCE Neuralace Medical, Inc.