Axon Therapy leverages magnetic peripheral nerve stimulation (mPNS) in sessions lasting 13.5 minutes each, to provide a non-pharmacological and non-invasive option for the treatment of chronic painful diabetic neuropathy (PDN)
Neuralace secures FDA approval for Axon Therapy. (Credit: Nino Liverani on Unsplash)
US-based pain management technology company Neuralace Medical has received the US Food and Drug Administration (FDA) approval for its Axon Therapy to treat chronic painful diabetic neuropathy (PDN).
Axon Therapy leverages magnetic peripheral nerve stimulation (mPNS) to deliver a rapid, painless, and non-invasive treatment of PDN.
The treatment sessions, which last 13.5 minutes each, will harness the power of magnetic pulses to provide relief.
Neuralace said its Axon Therapy offers a non-pharmacological and non-invasive option that could reduce dependency on medications and their side effects.
Neuralace Medical CEO Keith Warner said: “The FDA clearance of Axon Therapy is a monumental step forward in the treatment of PDN.
“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.”
Recently, the company conducted a double-blind multi-center Randomized Controlled Trial (RCT) of Axon Therapy in 71 patients, which showed significant efficacy.
The study randomised 21 participants into a sham group and 50 into mPNS active group, allowing the sham group to cross over (CX group) at 30 days.
The study met the primary endpoint of the Day-30 Visual Analog Scale Pain Score (VAS), along with secondary endpoints of Patient Reported Outcomes.
In the study, Axon Therapy showed significant improvements, including a 72.3% responder rate and a 57.6% average reduction in VAS Pain Score in the treatment group, at Day 30.
It also resulted in a 35% average reduction in numbness in the treatment group and a 20% average reduction in QoL-DN total score.
Furthermore, the treatment group showed an 81.4% responder rate, and the CX group showed an 88.9% responder rate, at Day 90, said the medical technology company.
The study’s principal investigator Lora Brown said: “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.”