The US Food and Drug Administration (FDA) has approved Multi Radiance Medical’s (MRM) FibroLux laser therapy to treat pain related to fibromyalgia.
The new patent-pending therapy uses a photoceutical approach to provide a non-pharmacological, non-invasive and side-effect-free treatment for fibromyalgia patients.
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It represents a breakthrough in pain management options for fibromyalgia, which is defined as chronic widespread pain and tenderness in specific tender points by the American College of Rheumatology.
MRM stated that the photoceutical devices are validated through clinical trials. Optimal light energy doses are provided through curated wavelengths that are given with the correct time and power.
The company’s FibroLux laser was found to reduce mean pain ratings, tender point count and Fibromyalgia Impact Questionnaire (FIQ) scores when compared to a placebo in a clinical study.
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The total findings showed that MRM laser therapy offers an effective and safe treatment to reduce fibromyalgia pain, with the time taken for the treatment lasting an average of three to six minutes.
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By GlobalDataMRM CEO Max Kanarsky said: “Laser therapy has been a game-changer in the rehabilitation and pain management space for years.
“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.
“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.”
The company stated that fibromyalgia has no known cause or cure and is generally treated with prescription medicines.
