In mid-2021, after a decade of R&D, Neuralace Medical earned FDA clearance for its Axon Therapy, a noninvasive treatment option for chronic pain caused by nerve damage. The road to its next regulatory nod was much shorter: Less than three years later, the system now has a green light for use in treating nerve pain associated with diabetes, too.
The Axon Therapy system is completely noninvasive: It works from outside the body to send magnetic pulses through the skin. Those pulses are meant to stimulate peripheral nerve cells that are responsible for the body’s pain relief mechanism but that have been damaged due to injuries, burns, surgical procedures or health conditions like diabetes.
According to Neuralace, its technology is now the first such system to be cleared for use in relieving pain caused by diabetic neuropathy, which CEO Keith Warner said in the company’s announcement Thursday represents a “monumental step forward” for the millions of people living with the condition.
Treatment sessions with the system’s handheld treatment coil are meant to be quick and painless, per Neuralace, with each session lasting 13.5 minutes.
In addition to offering a noninvasive option for treating chronic pain, compared to other neurostimulation devices that are implanted under the skin, Neuralace also regularly emphasizes the non-pharmacological aspect of its technology, noting that Axon Therapy represents a non-addictive alternative to the opioids and other drugs commonly prescribed for hard-to-treat nerve pain.
Neuralace kicked off 2023 with the announcement that it had begun a clinical trial of the technology for painful diabetic neuropathy, and it reported in September that enrollment was complete and that the results of the study would soon be sent to the FDA for review.
The company shared a sampling of the study’s findings in this week’s announcement that the FDA had indeed looked favorably upon the results.
The trial recruited a total of 71 patients, 50 of which were assigned to use the Axon Therapy system. Its primary endpoint focused on one-month changes in the participants’ scores on the Visual Analog Scale, the commonly used system that asks patients to rate their pain on a scale of one to 10. After 30 days, those in the treatment group reported an average 57.6% reduction in their pain scores.
In total, more than 70% of the patients assigned to use Axon Therapy responded to the technology by day 30, a rate that grew to more than 80% by day 90. Meanwhile, participants originally assigned to a sham treatment for the first 30 days were given the option to switch over to Axon Therapy for the next two months; among that crossover group, the responder rate reached nearly 89% after 90 days.