The Erchonia Corp. product reportedly reduced patient pain by nearly 50% in clinical trials.
The US Food and Drug Administration (FDA) has given 510(k) clearance to FX 635, a low-level laser for temporary relief of chronic, nociceptive musculoskeletal pain.
The clearance for the Erchonia Corp. product comes on the heels of a successful double-blind and placebo-controlled clinical trial that included 255 patients. It reduced the average pain by 49% for patients in post-treatment protocols without any other therapies used in conjunction with the laser treatment.
The FDA approval is not limited to 1 specific area of the body, and Erchonia’s market clearance was based on their previous blinded and controlled clinical trials on chronic neck and shoulder pain (conducted in 2002), plantar fasciitis or heel pain (conducted in 2014), and lower back pain (conducted in 2018).
According to Erchonia, FX 635 is the first ever low-level laser to be market cleared by the FDA for chronic low back pain.
The Melbourne, FL-based company’s other 510(k) market clearances for post-surgical pain in 2004 and 2008 were not part of the current FDA submission because they were acute, not chronic, pain studies.
In recent years, there has been an effort to treat chronic musculoskeletal pain without needing opioids.
In 2018, a SPACE randomized clinical trial showed that after 3 months, 119 patients treated without opioids reported a 26% reduction in pain, compared to the 20% pain reduction reported by 119 patients treated with opioids. Those treated without opioids were mainly treated with nonsteroidal anti-inflammatory drugs (NSAIDs).
In the 2018 study, published in JAMA, investigators also implemented several adjunctive therapies, including exercise, physical therapy and chiropractic care.
Charlie Shanks, vice president of Erchonia, said this clearance gives the company the first whole-body indication based on Level 1 clinical data.
“While our previous clearances from the FDA have already set us apart from the rest of the therapeutic laser industry, until now, they have all been limited to specific areas of the body,” Shanks said in a statement.
“Based on these results, the fact that there are no known negative side effects, and that it's non-addictive, our low-level laser technology should be considered first,” he added. “It's more effective than opioids or NSAIDS when treating chronic musculoskeletal pain when you compare the SPACE study results with those Erchonia submitted to the FDA.”