Remedee Labs, a French start-up specializing in non-pharmacological treatments for chronic pain, has achieved a significant milestone in the fight against fibromyalgia. The company’s innovative millimeter wave endorphin stimulator wristband has recently been granted medical device status in Europe specifically for treating fibromyalgia. This landmark development represents a major advance for the millions of individuals suffering from this debilitating condition.
Fibromyalgia, a disorder characterized by widespread chronic pain, fatigue, and a myriad of other symptoms, affects between 1.4% and 2.2% of the French population, predominantly women. Despite its severe impact on daily life and the absence of proven, effective treatments, fibromyalgia has often been met with delayed diagnosis and inadequate care options. The recent approval of Remedee Labs’ wristband offers new hope for these patients, marking the first time a non-pharmacological solution has been officially recognized for treating this challenging condition.
The Remedee Labs wristband utilizes millimeter wave neuromodulation technology to stimulate nerve endings in the wrist, prompting the brain to release endorphins that modulate pain perception and enhance overall well-being. This non-pharmacological approach is complemented by a comprehensive support program, including digital resources, symptom tracking, and personalized advice, making it a holistic addition to fibromyalgia management.
The wristband’s path to medical device status was paved by the FIBREPIK clinical study, which demonstrated its effectiveness at the American College of Rheumatology (ACR) annual meeting in November 2023. The study revealed that the wristband, when used for three 30-minute sessions daily, led to significant improvements in patients’ quality of life. Participants reported notable reductions in pain, fatigue, anxiety, and depression, alongside better sleep quality.
Dr. David Crouzier, Co-founder, CEO, and CSO of Remedee Labs, expressed the company’s enthusiasm, stating, “Obtaining European medical device status is a major achievement for us, but even more so for those living with fibromyalgia who previously had no approved treatment options. Our goal is to make this groundbreaking solution a standard part of fibromyalgia care and to work with French authorities to ensure it is accessible and affordable for everyone.”
Françoise Alliot Launois, President of AFLAR, a French non-profit organization dedicated to fibromyalgia and related conditions, echoed this sentiment, calling the development “a tremendous breakthrough in the therapeutic arsenal for fibromyalgia.” She emphasized the significance of having a recognized treatment for a condition that affects over one million people in France.
As the healthcare community looks to integrate this new solution, Remedee Labs is poised to make a substantial impact on the lives of fibromyalgia patients, offering a novel and hopeful path toward relief and improved quality of life.
Article written by Remedee Labs
13/09/2024
Source:
Remedeelabs
https://remedeelabs.com/en/first-ce-marked-medical-device-fibromyalgia/