- Remedee Labs' solution is now the 1st dedicated technological solution for fibromyalgia to have its benefits clinically validated in Europe.
- The study showed a clear improvement in patients' quality of life as well as a significant decrease in pain, generalized and physical fatigue, anxiety, and depression, and an improvement in sleep quality.
- Remedee Labs aims to make its solution a standard treatment for fibromyalgia,
PARIS, Nov. 9, 2023 /PRNewswire/ -- Remedee Labs, a French start-up that specializes in non-pharmaceutical chronic pain management, is announcing the positive results of its clinical study (FIBREPIK), which assessed the effectiveness of its fibromyalgia solution, today. The results will be presented on Monday, November 13 by pain specialist Dr. Caroline Maindet at the annual meeting of the American College of Rheumatology (ACR) in San Diego (USA).
The therapy developed by Remedee Labs uses the first millimeter wave endorphin stimulator wristband, paired with personalized coaching.
This clinical trial included 170 patients suffering from fibromyalgia in over 8 centers in France.
The study results showed a clear improvement in patients' quality of life. 55.1% of participants reduced their Fibromyalgia Impact Questionnaire (FIQ) score after 3 months of use. Over half of patients (53%) went from severe to moderate intensity of fibromyalgia. That improvement remained in place at 6 months.
Participants also showed a significant improvement in the main symptoms of fibromyalgia, with a significant decrease in pain, fatigue, anxiety, and depression, as well as improved sleep quality.
Over 75% of patients reported an improvement in their health (Patient impression of change scores) after 3 months of use.
"This is a historic day for Remedee Labs and for everyone living with fibromyalgia. These results validate more than a decade of scientific research, demonstrating the effectiveness of our management solution for fibromyalgia patients. We are very proud of these results, which show that 2/3 of patients who use our solution as recommended see a very significant improvement in their quality of life. After obtaining Breakthrough Device Designation (BDD) from the FDA, these clinical results are a key step towards our goal of achieving FDA approval," says Dr. David Crouzier (PhD), co-founder and CEO of Remedee Labs.
For more information, visit https://remedeelabs.com/fibromyalgia
CONTACT: Remedee Labs, Quentin Richard, [email protected]
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SOURCE Remedee Labs
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