Remedee Labs’ Endorphin Stimulator for Fibromyalgia Earns Breakthrough Status

French startup Remedee Labs earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its non-pharmaceutical endorphin stimulation technology for fibromyalgia, adjunctively with standard of care.
 
“Achieving Breakthrough Device status for our endorphin stimulator is a major step, one that recognizes its potential for treating fibromyalgia patients’ pain. We look forward to working closely with the FDA to bring our solution to patients in the United States as fast as possible,” David Crouzier, co-founder and CEO of Remedee Labs told the press.
 
Remedee’s technology is a new approach to treating fibromyalgia patients’ pain and can help to relieve pain, sleep disorders, fatigue, and stiffness.
 
The company began a 170-patient multicenter study in France in November to assess its endorphin stimulator’s benefits for treating fibromyalgia. Recruitment ended May 12, and the company expects results early next year.