NeuraLace Medical’s peripheral nerve stimulation Axon Therapy System for treating chronic pain has been granted 510(k) clearance by the US Food and Drug Administration (FDA). Axon offers a non-invasive and non-pharmaceutical option for treating chronic pain.
In contrast to other neuromodulatory devices, which work to impede the transmission of pain signals in the nervous system, NeuraLace’s technology applies external nerve stimulation at the source of pain caused by damaged peripheral nerves. The nerve damage could be due to injuries from a fall, sports or car accidents, loss of a limb, surgical procedures, localized burns or other injuries.
The device delivers subtle magnetic pulses through the skin to specifically stimulate peripheral nerve cells involved in pain relief pathways that have been damaged in patients with chronic pain.
The 510(k) FDA clearance means that the system has been deemed safe and effective in its premarket submission and now has the green light to be marketed. As such, it will soon be commercially available in the US.
Axon Therapy is a technology that has been ten years in the making, according to Shiv Shukla, NeuraLace’s founder and CEO. In a company video, he said, “At Neuralace, we’re excited to partner with clinicians, investors and businesses to significantly disrupt chronic pain.”
And after ten years of R&D, “we are pleased to have received FDA 510(k) clearance for Axon Therapy and we’re incredibly excited to bring to market a non-opioid treatment option that provides meaningful relief for patients suffering from chronic pain,” said Shukla in a press release.
How the NeuraLace Peripheral Nerve Stimulation Device Works
The Axon system delivers magnetic pulses through a handheld treatment coil, which is placed on the skin over areas of damaged nerves. The patented low frequency electromagnetic induction technology induces neuronal stimulation through the skin, but the pulses are subtle enough so they can’t be felt by the patient, making the procedure pain-free.
While current forms of neuromodulation focus on obliterating or masking the transmission of pain signals, Axon Therapy works to override the pain signal by re-activating the body’s natural by targeting peripheral nerves involved in pain relief pathways damaged by traumatic injury.
Each treatment session with the peripheral nerve stimulation device is 15 minutes or less. The procedure is highly effective as patients have reported up to 36 percent reductions in pain after just one session, according to the company.
The company also says Axon Therapy is a good alternative to pain relief medication, offering a chronic pain relief solution without the risk of addiction or side effects that impact a patient’s wellbeing.
NeuraLace tested the pain relief system in several small clinical trials, with data from the trials allowing it to be eligible for the premarket submission. And after being granted the FDA clearance, the company recently launched its largest clinical study to date.
The randomized, controlled AXON-RCT trial began treating its first patient at the end of May and is expected to enroll 126 patients across two clinics in North Carolina and Kansas. Patients with post-traumatic peripheral neuropathic pain will be treated with either Axon Therapy or conventional medical management. Their pain levels will be measured every couple of months.
Despite the recent marketing go-ahead, NeuraLace’s Axon Therapy remains backed by a relatively small seed round that amounts to $3.85 million. That closed in mid-2019 and consisted exclusively of financing from backers in the company’s native San Diego area.