Neuralace Medical, Inc., an innovator in pain management technology,  proudly announces the FDA clearance of its groundbreaking product, Axon Therapy (mPNS), for the treatment of chronic Painful Diabetic Neuropathy (PDN). This landmark approval marks the first-ever FDA clearance of a non-invasive, magnetic peripheral nerve stimulation (mPNS) treatment for Painful Diabetic Neuropathy, offering new hope to millions suffering from this debilitating condition.

Axon Therapy utilizes a pioneering approach of magnetic peripheral nerve stimulation (mPNS) to deliver a quick, painless, and non-invasive treatment. Each session, painless and lasting just 13.5 minutes, harnesses the power of magnetic pulses to provide relief, representing a significant advancement in pain management.

"The FDA clearance of Axon Therapy is a monumental step forward in the treatment of PDN," said Keith Warner, CEO of Neuralace Medical. "This first-of-its-kind, non-invasive solution embodies our commitment to innovative, patient-centered care, offering effective pain relief without the drawbacks of conventional, more invasive treatments."

In a recent double-blind Multi-Center Randomized Controlled Trial (RCT) involving 71 patients, Axon Therapy demonstrated remarkable efficacy. The study included 21 participants in a sham group and 50 in the mPNS active group, with the sham group given an opportunity to cross over (CX group) at 30 days. The primary endpoint, Day 30 Visual Analog Scale Pain Score (VAS), alongside secondary endpoints including Patient Reported Outcomes, highlighted significant improvements in subject outcomes.

Key findings include:

A 72.3% responder rate in the treatment group at Day 30.
A 57.6% average reduction in VAS Pain Score in the treatment group at Day 30.
A 35% average reduction in numbness in the treatment group at Day 30.
A 20% average reduction in QoL-DN total score at Day 30.
At Day 90, the treatment group exhibited an 81.4% responder rate, with the CX group showing an 88.9% responder rate.
At Day 90, PGIC responder rates of 93.0% in the treatment group and 83.3% in the CX group.

"These results not only demonstrate the effectiveness of Axon Therapy in reducing pain and numbness associated with PDN but also highlight its role in significantly enhancing the quality of life for patients," stated Lora Brown, MD, Principal investigator of the study.

Neuralace Medical's Axon Therapy represents a paradigm shift in PDN treatment, offering a non-pharmacological and non-invasive option that could reduce dependence on medications and their associated side effects. This clearance paves the way for broader access to innovative pain management strategies and underscores Neuralace's commitment to advancing patient care through technology.