ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain

Business Wire

21-05-2025

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.
CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability.
CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.
'Chronic low back pain is a debilitating condition that impacts millions of people every year. Degenerative disc disease, which is the largest driver of chronic low back pain, is especially challenging to treat and manage because there are limited treatment options between conservative care and more invasive surgeries,' said Dr. Olivier Clerk-Lamalice, MD, FIPP, a fellowship-trained interventional radiologist and chief executive officer of Beam Radiology in Calgary, Canada. '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. 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.'
More than 1 in 10 U.S. adults suffer from chronic low back pain. 1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease 2, a condition which is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. 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.
Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL® System injects a permanent hydrogel into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain.
Data used to secure CE Mark also led the FDA to approve an investigational device exemption (IDE) for ReGelTec's U.S. pivotal study of its HYDRAFIL System. The HYDRAFIL-D study is currently enrolling patients at eight sites in the U.S. and will be used to support U.S. regulatory approval. 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 6-month follow-up visit.
'Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec,' said Bill Niland, Co-Founder and CEO, 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.'
ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL® System is an outpatient disc augmentation procedure where a permanent hydrogel is injected into a degenerated disc to fill cracks and tears and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit https://regeltec.com/.
1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174.
2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, https://doi.org/10.1111/j.1526-4637.2010.01045.x