Erchonia received FDA clearance after submitting results from double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 documented a 49 percent average pain reduction post treatment protocol. No other therapies were used in conjunction with the laser treatment.
For comparison, the SPACE randomized clinical trial published in JAMA 2018 compared using opioids and non-opioids to treat overall chronic musculoskeletal pain. In the study, 119 patients were treated with opioids, and 119 patients were treated with non-opioids. At three months, results showed a reduction in pain of only 20 percent with opioids and 26 percent with non-opioids, mainly NSAIDS. This study also implemented many adjunctive therapies such as exercise, physical therapy and chiropractic care.
"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," comments Charlie Shanks, VP of Erchonia. "Now Erchonia has the only whole-body indication based on Level 1 clinical data. 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. 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."
Although this new 510(k) is not limited to one specific area of the body, market clearance was also based on Erchonia's previous Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002; plantar fasciitis, or heel pain, in 2014; and low back pain in 2018. Erchonia's other 510(k) market clearances for post-surgical pain in 2004 and 2008 were not part of this FDA submission as they were acute pain studies, not chronic pain.