BALTIMORE — ReGelTec Inc. has announced that it has received CE Mark approval under the European Union Medical Device Regulation (MDR) for its HYDRAFIL® System, a minimally invasive device designed to treat chronic low back pain caused by degenerative disc disease (DDD). The approval clears the way for commercial launch of the system in Europe and marks a significant step toward broader international use of the technology.
The HYDRAFIL System is a Class III percutaneous disc augmentation device that delivers a permanent hydrogel implant into degenerated intervertebral discs. The procedure is performed on an outpatient basis under local anesthesia and is intended to restore disc biomechanics, relieve pain, and improve physical function—offering a potential alternative to more invasive spinal surgeries.
The CE Mark was granted following results from a clinical study involving 75 patients, where those treated with HYDRAFIL experienced clinically and statistically significant reductions in both pain and disability. According to the data, patients reported an average 70% decrease in pain levels (based on the Numeric Pain Rating Scale) and more than an 80% improvement in disability scores (as measured by the Oswestry Disability Index). These benefits were sustained through two years of follow-up among 63 patients.
“Degenerative disc disease is notoriously difficult to manage, with limited treatment options between physical therapy and spine surgery,” said Dr. Olivier Clerk-Lamalice, an interventional radiologist and CEO of Beam Radiology in Calgary, Canada. “After treating dozens of patients with HYDRAFIL over the past three years, I’ve seen firsthand how this approach can offer meaningful relief without the need for major surgery.”
Degenerative disc disease is a leading cause of chronic low back pain, which affects more than 1 in 10 adults in the U.S. Roughly 42% of these individuals—over 10 million people—suffer from DDD, a condition characterized by the deterioration of spinal discs, which leads to inflammation, nerve irritation, and persistent pain.
The HYDRAFIL implant works by filling cracks and tears in the disc, recruiting water to the area and redistributing mechanical stress, which helps restore more natural movement and decreases pain signaling. The device’s successful clinical performance in Europe also supported the FDA’s approval of an Investigational Device Exemption (IDE) for a U.S. pivotal trial.
That trial, known as HYDRAFIL-D, is now enrolling patients at eight sites across the U.S. and will include 225 participants in a randomized, controlled, single-blinded study. An interim safety analysis will be conducted after the first 60 patients reach six-month follow-up. Data from this study will be used to support a potential U.S. regulatory submission.
“Receiving the CE Mark for HYDRAFIL is a key achievement for our team and opens a critical pathway to offer this therapy to patients in Europe,” said Bill Niland, Co-Founder and CEO of ReGelTec. “We are now focused on driving enrollment in our pivotal U.S. trial and raising additional capital to expand our investment both in the United States and globally.”
The CE Mark approval not only validates HYDRAFIL’s clinical potential but also reflects growing demand for innovative, non-surgical treatments for chronic back pain—a condition with limited effective options and rising global prevalence.
