Remedee Labs’ Solution becomes the first CE marked medical device (class IIa) approved for the treatment of fibromyalgia in Europe Read the press release.

A clinically validated innovative technology

Following years of intensive research and development, Remedee Labs has developed a breakthrough approach to pain relief, by stimulating a person’s own endorphins.

In light of significant interest from the medical community to find new ways to relieve pain safely and effectively, the Remedee Labs endorphin-stimulation solution is being tested in multiple clinical trials.

Today, its effectiveness has been demonstrated in osteoarthritis and fibromyalgia
thérapie par ondes millimétriques

FIBROMYLAGIa

1st CE marked medical device approved for the treatment of fibromyalgia in Europe

bracelet remedee

The Remedee Labs solution, which uses the first millimeter wave endorphin stimulator wristband, is the first medical device clinically validated and certified in Europe to provide symptom relief for fibromyalgia.

La solution de Remedee Labs est le premier dispositif médical validé cliniquement et certifié en Europe pour soulager les symptômes de la fibromyalgie L’obtention du statut de dispositif médical a été appuyée par l’étude clinique FIBREPIK. Les résultats ont été présentés en novembre 2023 au congrès de l’American College of Rheumathology (ACR) à San Diego (USA).

Les résultats ont montré qu’une utilisation trois fois par jour (30 minutes) du bracelet Remedee™ avait permis une nette amélioration de la qualité de vie des participants, avec une diminution significative de la douleur, de la fatigue générale et physique, de l’anxiété et de la dépression ainsi qu’une amélioration de la qualité du sommeil.

bracelet remedee

Significant improvement in quality of life.(FIQ)

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. That figure reached 62.3% for participants who followed the clinical protocol for use of the solution (per protocol results).

An improvement
in health status (PGIC)

When asked “Since you started participating in the study, has your health improved?,” over 75% of patients reported an improvement after 3 months of use.
"Providing care for patients suffering from fibromyalgia is currently a major public health challenge. The positive results of the FIBREPIK study are very encouraging. Remedee Labs’ solution fits perfectly into a coordinated care approach, in which non-pharmaceutical treatments are the first choice.”
Caroline Maindet
Dr Caroline MAINDET
Pain Specialist at Grenoble Alpes University Hospital and lead investigator for the FIBREPIK study

hôpitaux impliquées

References: : Maindet.C, Dumolard.A, Veloso.M, Barmaki M, et al. Therapy Combining Millimeter Wave-based Neuromodulation with Coaching for the Improvement in Quality of Life of Patients with Fibromyalgia: A Prospective, Multicenter, Randomized, Controlled Trial. Presented at: American College of Rheumatology Convergence 2023. San Diego, CA. November 10-15, 2023.

OSTEOARTHRITIS

A new approach to relieve osteoarthritis

Remedee Labs’ innovative, non-invasive technology has been clinically tested on 60 volunteers with peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, digital) by the Grenoble-Alpes University Hospital.

The results of the study showed that regular use (1 to 3 times a day) of the endorphin stimulator for 3 months resulted in a significant reduction in pain (VAS) in osteoarthritis patients.

The authors of the study also noted an overall improvement in the quality of life (EQ5D-5L) and sleep quality (VAS) of the patients included. No adverse events considered severe were observed.

Une amélioration du sommeil
et de la qualité de vie

Les résultats de l’étude ont montré une amélioration de la qualité du sommeil et plus globalement de la qualité de vie des patients inclus.

Une diminution de
la douleur à 3 mois

Echelle EVA

"The study results showed that regular use of the wristband (1 to 3 times per day) for 3 months significantly reduced pain (VAS) in patients with peripheral osteoarthritis. This is the first set of clinical results to demonstrate the efficacy of millimeter waves neuromodulation in the management of patients with osteoarthritis."
Docteur Laurent Grange
Dr Laurent Grange
Rheumatologist at Grenoble Alpes University Hospital (CHUGA)