Tuesday, May 30, 2023
HomeHealthcareStart-up company obtains FDA approval for treatment of chronic pain device

Start-up company obtains FDA approval for treatment of chronic pain device

Patients with chronic pain often face limited options. In the past, they have been distributing painkillers, trying TENS devices, and providing implantable devices as a last resort. Although this is changing During the opioid epidemic.

While conducting research at the VA Pain Clinic, NeuraLace Medical CEO Shiv Shukla and his team discovered a new method of using magnetic pulses to activate damaged nerves to treat chronic pain.After nearly ten years of hard work, the company’s equipment 510(k) license received From the Food and Drug Administration.

Most patients treated by NeuraLace have chronic pain due to physical injuries (such as car accidents). This technique stimulates A-β nerve fibers by sending magnetic pulses to the area.

Upon injury, the signals from these nerve fibers stop, causing pain.

“For whatever reason, either the tissue no longer exists, the nerves cannot be reconnected, there is scar tissue, or it is too messy to recover,” Shukla said. “Even if the tissue heals and may be healthy, the body cannot tell the difference just because there is no signal.”

Each treatment takes about 15 minutes. Initially, patients will see the doctor more frequently, but as time goes by, it gradually decreases to once a week and then once a month. Shukla plans to charge approximately US$275 per treatment, for a total annual cost of US$4,400.

As part of the FDA approval, the San Diego-based company submitted data from several small clinical trials. Now, NeuraLace is planning to conduct larger trials with more than 120 patients in Winston-Salem and Kansas City, North Carolina. The goal is to prove that its equipment is more effective and economical than traditional drug management in treating pain.

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

“This brings them to a promising place. The burden on the brain (chronic pain) is too great to work,” Shukla said. “I think we can give them almost room to get rid of chronic pain, and they can consider their own options.”

Photo credit: Srisakorn, Getty Images

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