ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back
May 21, 2025 7:05 AM Eastern Daylight Time
May 21, 2025 7:05 AM Eastern Daylight Time
BALTIMORE–(BUSINESS WIRE)–ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This approval creates a European commercial pathway for the HYDRAFIL System, an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain, improve daily function and eliminate the need for invasive surgeries.
ABOUT REGELTEC, INC:
ReGelTec, Inc. is a clinical stage medical device company commercializing HYDRAFIL™, a percutaneous treatment for low back pain due to degenerative disc disease. The company was formed when a team of chemical engineers with extensive experience in polymer science partnered with a cross-functional team of medical device professionals with multiple successful startup exits. Once approved, the HYDRAFIL™ System will offer patients suffering from chronic back pain due to degenerative disc disease a minimally invasive treatment option beyond traditional conservative care. HYDRAFIL™ is an investigational device, limited by United States law to investigational use.
