Neuralace Medical, Inc., an innovator in pain management technology, today 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 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.
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.
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.