Remedee Labs, a French startup that specializes in non-pharmaceutical treatments for chronic pain, is announcing the highly anticipated results of its clinical study assessing the effectiveness of its millimeter waves neuromodulation device for osteoarthritis patients today. The initial results showed a significant decrease in pain and an improvement in sleep quality and overall quality of life among patients who used the device.
Remedee Labs’ innovative non-invasive technology, which was tested in this clinical trial, is based on a unique millimeter waves neuromodulation technique that stimulates the release of endorphins, the body’s natural painkillers, to improve users’ quality of life.
This randomized crossover study was conducted by the Grenoble Alpes University Hospital on 60 volunteers with peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, finger).
“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,” says Dr. Laurent Grange, a Rheumatologist at Grenoble Alpes University Hospital. “This is the first set of clinical results to demonstrate the efficacy of millimeter waves neuromodulation in the management of patients with osteoarthritis.”
The study authors also observed an overall improvement in quality of life (EQ5D-5L) and better sleep quality (VAS) in the patients in the study. No severe side effects were observed. These results will be presented at the European Congress of Rheumatology (EULAR) in Milan on June 2 and the full results of the trial will be published soon in a peer-reviewed journal.
“We are extremely excited to share the initial results of this clinical trial. We need new, non-pharmaceutical approaches. This non-pharmaceutical therapy is safe and easy to use, opening up new perspectives for osteoarthritis pain management thanks to its holistic impact on patients’ quality of life.” Dr. Caroline Maindet, Pain Specialist at Grenoble Alpes University Hospital and principal investigator of the EPIKARTHROSE study.
The study results confirm the effectiveness of millimeter s neuromodulation in the management of patients with peripheral osteoarthritis and indicate that it has potential for other conditions that present central hypersensitization with no satisfactory solution, including fibromyalgia, for which a clinical trial is also under way, with results to be released soon.
Based on these results, Remedee Labs plans to continue the certification process to earn medical device approval for the indication osteoarthritis and aims to begin marketing the medical device version of its solution in 2024. In the meantime, it is marketing a “well-being” version, which is available directly on its website at www.remedee.com
“This study is a major turning point for Remedee Labs. These clinical results validate over a decade of research and clearly prove the effectiveness of millimeter waves in the management of patients with peripheral osteoarthritis and they are entirely consistent with our real-world data generated using our ‘well-being’ solution. They also indicate our technology’s potential for other conditions that present central hypersensitization with no satisfactory solution, such as fibromyalgia,” says Dr. David CROUZIER (PhD), cofounder and CEO of Remedee Labs.
About Remedee’s technology
Remedee Labs has developed an innovative, comprehensive non-pharmaceutical solution based on a biopsychosocial approach that takes patients’ biological, psychological, and social factors into account. The solution combines Remedee Labs’ millimeter waves neuromodulation technology (validated by the EPIKARTHROSE study) with a personalized support program for long-term improvement in quality of life.
“Millimeter waves, which are emitted at a frequency of 60 Ghz, penetrate the superficial layer of the skin (less than 0.5 mm) and stimulate the subcutaneous nerve endings, triggering an increase in the production of intracerebral endogenous opioids (endorphins) as well as other neuromediators (dopamine, serotonin). That reduces the sensation of pain and has a positive impact on overall quality of life (sleep, anxiety, mood, etc.),” explains Dr. David CROUZIER (PhD), co-founder and CEO of Remedee Labs.
ABOUT OSTEOARTHRITIS
Osteoarthritis is a joint disease characterized mainly by the destruction of cartilage. It is often associated with severe pain of mixed mechanical and nociplastic origin. Symptomatic osteoarthritis manifests as severe pain and/or restricted movement, which negatively affects patients’ quality of life. Osteoarthritis, including all locations, affects approximately 15% of the population. In France, that means some 10 million people have osteoarthritis, 6 to 7 million of whom are symptomatic. There is currently no medication that can cure osteoarthritis or stop its progress. A combination of pharmaceutical and non-pharmaceutical treatments is recommended to manage patients’ pain.
