FibroLux, a laser-based therapy designed to specifically treat fibromyalgia-related pain, could make waves in the area of non-invasive, non-pharmaceutical-based pain management.
Developed by Solon, Ohio-based Multi Radiance Medical, FibroLux Laser Therapy received US Food and Drug Administration (FDA) clearance in October 2022 and was launched towards the end of 2023. It is the first and only therapeutic laser that is FDA-cleared for the specific treatment of pain associated with fibromyalgia syndrome.
Fibromyalgia, a chronic condition characterized by widespread pain and tenderness, fatigue and a range of other symptoms, has long been a challenge for both patients and healthcare providers. Traditional treatments, such as medication, physical therapy and lifestyle adjustments, offer varying degrees of relief, often with adverse side effects and frequently falling short of providing a comprehensive solution.
FibroLux Laser Therapy is a laser-based treatment designed to alleviate fibromyalgia-related symptoms more effectively to improve quality of life.
FibroLux is a portable, handheld device that targets 18 tender points with precision. With an average treatment duration of six to ten minutes, it delivers immediate relief in only two minutes per point, according to Multi Radiance Medical. FibroLux therapy laser uses light energy, in the form of photons, to increase blood circulation and block pain signals.
In the US, it is estimated that 5 to 8 million individuals are affected by fibromyalgia. It is one of the most common rheumatic diseases, affecting one to nine percent of the general population.
“FibroLux, as one of the first medical devices cleared for fibromyalgia, represents a transformative paradigm shift, providing life-changing relief without side effects,” said Max Kanarsky, president and CEO of Multi Radiance Medical in a press release. “This laser technology empowers individuals to perform daily activities free from the burden of pain, offering a beacon of hope for those handicapped by fibromyalgia. Recent positive reception at medical conferences underscores the importance of raising awareness among both patients and clinicians.”
The device first received FDA approval around a decade ago for general pain management and accelerated healing, according to Multi Radiance Medical’s global president Tom Kelly.
“We’ve done very well in the sports market where we have 200 lasers in major pro-sports teams and major colleges. Most pro-sports champs have all used our lasers,” he said.
Research into the laser therapy specifically for fibromyalgia was kickstarted when an athletic trainer used it to treat a patient with the condition with good success.
How FibroLux Laser Therapy Works
FibroLux Laser Therapy employs low-level laser therapy (LLLT) technology, specifically tailored for fibromyalgia patients. Unlike high-power lasers that cut through tissue, LLLT uses low-level lasers or light-emitting diodes (LEDs) to emit specific wavelengths of light. This light penetrates the skin without causing heat or injury. The process is believed to stimulate cellular repair and reduce inflammation, leading to pain relief and enhanced tissue healing.
The Science Behind the Therapy
The mechanism of action for FibroLux involves its ability to enhance cellular function. The therapy targets the mitochondria, stimulating them to produce more adenosine triphosphate (ATP), the energy currency of the cell. Increased ATP production can lead to faster healing and regeneration of tissues, reduction in inflammation and alleviation of pain. Furthermore, the therapy is thought to release endorphins, the body’s natural painkillers, and reduce the transmission of pain signals to the brain.
Benefits of FibroLux Laser Therapy for Fibromyalgia
The primary benefit of FibroLux is its potential to provide significant pain relief without the side effects associated with many conventional treatments. Patients have reported improvements in pain levels, increased mobility and enhanced overall well-being. Additionally, the non-invasive nature of the therapy, coupled with its lack of side effects, makes it an attractive option. FibroLux can be customized to meet individual needs, targeting specific areas of pain and adjusting the treatment intensity as necessary.
Clinical Evidence and Patient Experiences
While FibroLux Laser Therapy is relatively new, preliminary clinical studies and patient reports suggest positive outcomes. Research indicates improvements in pain, fatigue and quality of life for fibromyalgia patients undergoing the therapy. Multi Radiance Medical shared data from clinical trials evaluating FibroLux. The treatment has been shown to lead to a 52 percent decrease in tender points, a 53 percent reduction in pain and a 45 percent enhancement in Fibromyalgia Impact Questionnaire scores.
In a pivotal placebo-controlled trial, 86.67 percent of participants treated with FibroLux met the success criteria compared to the only 48.89 percent success rate in the placebo group.
Considerations and Accessibility
As with any treatment, patient experiences with FibroLux Laser Therapy can vary. Individuals are advised to consult with a healthcare professional to determine if the therapy is suitable for their specific condition. Availability may also be a factor, as the technology is not yet widespread.
According to Allied Market Research, the fibromyalgia treatment market was valued at $3.2 billion in 2022 and is expected to hit $4.6 billion by 2032 at a compound annual growth rate (CAGR) of four percent. Currently, the treatment market is almost exclusively drug-based, with anticonvulsants holding the largest revenue share in 2022.
Medical devices specifically designed for fibromyalgia pain relief are limited but could be a growing segment. Recently, notable devices for treating fibromyalgia pain include NeuroMetrix’s Quell, a wearable neuromodulator that received FDA clearance in 2022.
In 2021, Sana Health received FDA breakthrough designation for its Sana Device, an at-home audio-visual-stimulation (AVS) device that uses synchronized pulses of light and sound for the treatment of fibromyalgia. The company is awaiting FDA approvals for the device not only for fibromyalgia, which is expected in the first half of this year, but also for neuropathic pain and post-traumatic stress disorder (PTSD).