Sam Brusco01.11.24
Neuralace Medical has gained U.S. Food and Drug Administration (FDA) clearance for its Axon Therapy (mPNS) to treat chronic painful diabetic neuropathy (PDN).
This approval marks the first FDA clearance for a non-invasive, magnetic peripheral nerve stimulation (mPNS) for PDN, according to the company. Axon therapy mPNS delivers a painless, non-invasive treatment that lasts 13.5 minutes. It harnesses the power of magnetic pulses to provide relief, 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."
A recent trial of 71 patients showed efficacy of the Axon Therapy treatment. 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.
A 72.3% responder rate was shown in the treatment group at day 30, with 57.6% average reduction in VAS Pain Score in the treatment group. There was A 35% average reduction in numbness in the treatment group and 20% average reduction in QoL-DN total score at Day 30.
At Day 90, the treatment group demonstrated an 81.4% responder rate, with the CX group showing an 88.9% responder rate. 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, M.D., principal investigator of the study.
This approval marks the first FDA clearance for a non-invasive, magnetic peripheral nerve stimulation (mPNS) for PDN, according to the company. Axon therapy mPNS delivers a painless, non-invasive treatment that lasts 13.5 minutes. It harnesses the power of magnetic pulses to provide relief, 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."
A recent trial of 71 patients showed efficacy of the Axon Therapy treatment. 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.
A 72.3% responder rate was shown in the treatment group at day 30, with 57.6% average reduction in VAS Pain Score in the treatment group. There was A 35% average reduction in numbness in the treatment group and 20% average reduction in QoL-DN total score at Day 30.
At Day 90, the treatment group demonstrated an 81.4% responder rate, with the CX group showing an 88.9% responder rate. 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, M.D., principal investigator of the study.