FDA clears laser therapy to treat fibromyalgia pain
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The FDA has granted clearance to Multi Radiance Medical’s FibroLux therapy laser for the treatment of pain in patients with fibromyalgia, according to a company press release.
The clearance approves the laser as a way for patients with fibromyalgia to undergo non-invasive, non-pharmacologic therapy for pain.
“Laser therapy has been a game-changer in the rehabilitation and pain management space for years,” Max Kanarsky, the CEO of Multi Radiance Medical, said in the release. “Now, as the first laser company to achieve a patent and FDA clearance for relief of fibromyalgia pain, this opens the door for how to effectively manage this tough condition.”
According to the company, the FibroLux therapy laser uses a photoceutical approach to patient therapy. A clinical trial found the newly cleared device reduced tender point counts, pain ratings on average and Fibromyalgia Impact Questionnaire scores, compared with placebo, the release said.
The prospective, placebo-controlled, randomized, double-blind, parallel-group, multicenter trial examined the difference in the proportion of subjects between active and control groups who achieved a clinically meaningful and statistically significant decrease in tender point count of 20% or greater at study endpoint, according to research published by Multi Radiance Medical. In all, 86.7% of patients who received the FibroLux therapy met conditions defining a successful study, compared with 48.89% of patients who received placebo therapy (P < .0005), according to the company. Treatments last 3 to 6 minutes on average.
“We want to thank our research team for their efforts in the clinical trial process as we continue to expand the applications of laser therapy,” Karnasky said.
References:
A photoceutical approach to treating fibromyalgia. https://info.multiradiance.com/clinical-download-fibromyalgia-scientific-monograph. Accessed Oct. 5, 2022.
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