Remedee Labs, a startup based in Paris, France, has received a European approval for its device-based approach to treating chronic fibromyalgia pain.
The company’s noninvasive, millimeter-wave wristband—which delivers low-energy, high-frequency electromagnetic pulses—aims to stimulate the release of the endorphins through the nervous system to counteract the condition and provide relief.
A previous clinical study—including 170 patients, 95% of whom were women—showed that three, 30-minute sessions per day, alongside coaching and support, were able to decrease reported pain as well as help address levels of fatigue, anxiety and sleep quality.
About 55% of participants reduced their fibromyalgia impact scores in questionnaires after three months, while about 53% dropped their ratings from severe pain down to moderate intensity. More than 75% of patients reported improvements in their perceptions of health and quality of life. The study’s abstract was presented in late 2023 at the annual meeting of the American College of Rheumatology.
Remedee bills its wristband as the first device-based treatment to specifically receive a CE mark for the treatment of fibromyalgia. Wearable developer NeuroMetrix previously received a green light on the continent in 2016 for its Quell device, but under the broader label of chronic pain.
“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,” Remedee’s co-founder, CEO and chief scientific officer, David Crouzier, said in a statement. “We will now be working with the French authorities to obtain reimbursement of our treatment, to make it affordable for everyone.”
In May 2022, Remedee received a breakthrough designation from the FDA for its endorphin stimulator. It estimates that more than 10 million people in the U.S. are living with fibromyalgia. The company is also studying its wristband in osteoarthritis pain.
NeuroMetrix, meanwhile, launched its Quell wearable in the U.S. with a prescription version targeting fibromyalgia and an over-the-counter version aimed at broader pain relief. Sales of the OTC neuromodulation device were previously paused in late 2022, but the company said it plans to restart its commercial push in the fourth quarter of this year.
NeuroMetrix has also spent this year courting buyers, as it reviews strategic alternatives following “a substantial reduction-in-force” in the first quarter. The company said in August that it has performed due diligence on multiple opportunities, but so far has passed on the proposals.