Neuralace Medical has received US Food and Drug Administration (FDA) clearance of Axon Therapy to treat chronic Painful Diabetic Neuropathy (PDN).
This marks the first FDA clearance for a non-invasive magnetic peripheral nerve stimulation (mPNS) treatment for PDN.
Axon Therapy employs the mPNS approach to deliver a non-invasive treatment that lasts approximately 13.5 minutes per session. The therapy uses magnetic pulses to alleviate pain, representing an advancement in the field of pain management.
The efficacy of Axon Therapy was demonstrated in a recent double-blind multi-centre randomised controlled trial involving 71 patients.
In the trial, there were 50 people in the active mPNS group and 21 in the sham group. The sham group had the option to switch over after 30 days.
The trial’s primary endpoint was the day 30 Visual Analog Scale Pain Score (VAS), with secondary endpoints including patient reported outcomes.
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Its key findings revealed a 72.3% responder rate in the treatment group at day 30, with a 57.6% average reduction in VAS Pain Score.
Additionally, there was a 35% average reduction in numbness and a 20% reduction in QoL-DN total score at day 30.
At day 90, the treatment group showed an 81.4% responder rate, and the cross-over group exhibited 88.9%, with Patient Global Impression of Change responder rates of 93% and 83.3% in the treatment and cross-over groups, respectively.
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.”
The non-pharmacological and non-invasive option offered by Axon Therapy could reduce dependence on medications.