ReGelTec Wins CE Mark for Hydrafil Chronic Low Back Pain Treatment

ReGelTec, a company developing a percutaneous hydrogel implant to treat low back pain caused by degenerative disc disease, has earned a CE mark under the EU MDR for its Hydrafil system for disc augmentation.

Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. The outpatient Hydrafil procedure offers interventional pain physicians and patients a new treatment to reduce pain, improve daily function, and remove the need for invasive surgeries.

The Hydrafil system injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to recover natural biomechanics and relieve pain. When the implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to boost function and reduce pain signals to the brain.

CE mark approval was based on a 75-patient clinical study showing those treated with Hydrafil has clinically and statistically significant pain and disability improvements. Data showed over 80% improvement in Oswestry Disability Index (ODI) scores and over 70% reduction in Numeric Pain Rating Scale scores. These reductions were sustained for two years in the 63 patient who completed their two-year follow-up visit.

The data used to win the CE mark also led the U.S. Food and Drug Administration (FDA) to approve an investigational device exemption (IDE) for ReGelTec’s U.S. study of Hydrafil. The study is enrolling patients at eight U.S. sites to support U.S. regulatory approval.

“After following 35 patients treated with HYDRAFIL over the last three years, I’ve witnessed how effective this minimally invasive outpatient procedure is in reducing pain and disability,” said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. “HYDRAFIL addresses a massive treatment gap for degenerative disc disease patients looking to avoid major spine surgery, and we are excited to start enrolling patients in the HYDRAFIL-D U.S. pivotal study.”

The study is a 225-patient, multicenter, single-blinded, randomized, controlled trial that includes an interim safety analysis when the first sixty patients complete their six-month follow-up visit.

“Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec,” said Bill Niland, co-founder and CEO of ReGelTec. “We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the U.S. and globally.”