Devices & Diagnostics, Startups

Startup gets FDA-clearance for device to treat chronic pain

Neuralace Medical, a San Diego-based startup, recently got FDA clearance for a non-invasive device to treat chronic pain. It works by stimulating nerve fibers that have been damaged in a traumatic injury. 

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Patients suffering from chronic pain often face limited options. In the past, they’ve have been doled out painkillers, tried TENS units, and are offered implantable devices as a final resort, though this is changing in the midst of the opioid epidemic.

While working in research at a VA Pain Clinic, NeuraLace Medical CEO Shiv Shukla and his team discovered a new approach to treating chronic pain using magnetic pulses to activate damaged nerves. After nearly a decade of work, the company’s device received 510(k) clearance from the Food and Drug Administration.

Most of the patients NeuraLace treats have chronic pain as the result of a physical injury, such as a car crash. The technology works by stimulating A-beta nerve fibers by emitting magnetic pulses to the area.

In an injury, the signal to these nerve fibers stops, resulting in pain.

“For whatever reason, either the tissue’s not there anymore and the nerve couldn’t reconnect, or there’s scar tissue in the way, or it’s too jumbled, it wasn’t able to recover,” Shukla said. “Even though the tissue heals and it might be healthy, just because the signal is not present, the body can’t tell the difference.”

NeuraLace received 510(k) clearance for its Axon Therapy device. Photo credit: NeuraLace Medical

Each treatment takes about 15 minutes. Initially, patients come in more frequently, but over time, it tapers down to once per week, and then once per month. Shukla plans to charge roughly $275 per treatment, for a total annual cost of $4,400.

As part of its FDA clearance, the San Diego-based company submitted data from several smaller clinical trials. Now, NeuraLace is planning a larger trial of a little more than 120 patients in Winston-Salem, North Carolina and Kansas City. The goal is to prove that its device is more effective at treating pain than conventional medication management, and more economical.

Shukla also has other big plans, including bringing  NeuraLace’s technology to 22 clinics in the next year. The company also is building a robotic arm to hold the device in the precise location for treatment and plans to raise funding.

“It gets them to a place where they have hope. (Chronic pain) is so taxing on the brain, it’s hard to function,” Shukla said. “I think we’re able to give them almost space to have a break from their chronic pain and they can think about their options.”

Photo credit: Srisakorn, Getty Images