Remedee Labs' Solution becomes the first CE marked medical device (class IIa) approved for the treatment of fibromyalgia in Europe
PARIS, Sept. 16, 2024 /PRNewswire/ -- Remedee Labs, a French start-up that specializes in non-pharmacological treatments for chronic pain, is announcing today that it has obtained medical device status in Europe for its millimeter wave endorphin stimulator wristband. The Remedee Labs solution is now the first medical device clinically validated and certified in Europe to provide symptom relief for fibromyalgia, a disorder for which no specific treatment had previously been identified. This achievement marks a major advance in care for the millions of patients suffering from fibromyalgia.
"Obtaining European medical device status for the indication fibromyalgia is a major milestone for Remedee Labs, but above all for people living with fibromyalgia, who previously lacked access to any approved and dedicated treatments for their condition," says Dr. David Crouzier (PhD), co-founder, CEO of Remedee Labs.
The solution's obtention of medical device status was supported by the FIBREPIK clinical study, the results of which were presented at the annual meeting of the American College of Rheumatology (ACR) in 2023. The study's results showed that using the Remedee™ wristband for three 30-minute sessions per day produced a clear improvement in participants' quality of life, with a significant decrease in pain, generalized and physical fatigue, anxiety, and depression, as well as an improvement in sleep quality.
Remedee Labs' solution for patients with fibromyalgia has also been recognized in the United States, where it received Breakthrough Device Designation from the Food & Drug Administration (FDA) in 2022.
Remedee Labs will launch its dedicated medical offer for fibromyalgia patients on the French market in 2025.
About the Remedee Labs Solution
Remedee Labs offers an innovative, non-pharmacological solution to relieve the symptoms of fibromyalgia. The solution combines Remedee Labs' millimeter wave neuromodulation technology (endorphin stimulator wristband) with a comprehensive support program, which is a key part of chronic pain management.
About Remedee Labs
Remedee Labs is a start-up that specializes in non-pharmacological treatments for chronic pain. Founded by three experts in medical micro- and nanotechnology and biomedical research, Remedee Labs has developed an innovative solution to improve the lives of patients suffering from chronic pain.
Two clinical trials have demonstrated the effectiveness of Remedee Labs' technology as a treatment for chronic pain caused by arthritis and fibromyalgia.
More about Remedee Labs: https://remedeelabs.com
Contact:
Quentin RICHARD
[email protected]
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