Research & Development
Erchonia granted FDA approval of FX 635 for relief of chronic musculoskeletal pain
18 July 2019 -

Laser therapy technology company Erchonia Corporation reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.

The FDA clearance was based on the results from the company's double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 documented a 49% average pain reduction post treatment protocol. No other therapies were used in conjunction with the laser treatment.

Concurrently, the SPACE randomised 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% with opioids and 26% with non-opioids, mainly NSAIDS. This study implemented many adjunctive therapies including exercise, physical therapy and chiropractic care.

In addition, the FDA's market clearance was based on the company's prior Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002, plantar fasciitis, or heel pain, in 2014 as well as low back pain in 2018.