ReGelTec’s Hydrafil System Receives CE Mark for Disc Augmentation

ReGelTec’s Class III Hydrafil System, a percutaneous hydrogel implant for chronic low back pain, has earned CE Mark approval under the EU Medical Device Regulation. A clinical trial with 75 patients showed significant benefits, including over 80% improvement in disability scores and more than 70% reduction in pain, lasting two years.

The minimally invasive outpatient procedure uses local anesthesia to inject a permanent hydrogel into damaged discs, filling cracks and restoring natural disc function to ease pain by distributing spinal load.

These clinical results also helped secure FDA approval for an investigational device exemption (IDE) for the ongoing US HYDRAFIL-D study, enrolling 225 patients to support future approval.

CEO Bill Niland called the CE Mark a major milestone, noting plans to boost enrollment and expand distribution, including a recent exclusive partnership in South Korea.

28-05-2025