ReGelTec’s HYDRAFIL System receives CE Mark for treating chronic low back pain

ReGelTec's Hydrafil System: ©ReGelTec

ReGelTec Inc. announced Tuesday that its HYDRAFIL System, a percutaneous hydrogel implant designed to treat chronic low back pain caused by degenerative disc disease, has received CE Mark approval under the European Union Medical Device Regulation.

The Class III device offers a minimally invasive alternative to surgery by allowing interventional pain physicians to inject a hydrogel into damaged spinal discs. The hydrogel solidifies inside the disc, helping restore function and relieve pain by redistributing load and strain in the spine.

The CE Mark was granted based on results from a clinical trial involving 75 patients. According to ReGelTec, the study demonstrated more than 80% improvement in Oswestry Disability Index scores and more than 70% reduction in pain, as measured by the Numeric Pain Rating Scale. These improvements were sustained over two years in patients who completed follow-up.

“Chronic low back pain is a debilitating condition that impacts millions of people every year,” said Olivier Clerk-Lamalice, MD, FIPP, 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.”

HYDRAFIL is now commercially available in Europe and is undergoing evaluation in the U.S. through a clinical trial. The U.S. study, known as HYDRAFIL-D, is enrolling 225 patients across eight sites. An interim safety analysis is planned after the first 60 patients reach their six-month follow-up.

“Receiving CE Mark for the HYDRAFIL System is another major milestone for ReGelTec,” said Bill Niland, co-founder and CEO of the company. “We are leveraging this momentum to drive enrollment in the HYDRAFIL-D pivotal study required for FDA approval.”

Advances in the treatment of degenerative disc disease

Degenerative disc disease, which affects more than 10 million Americans, is one of the leading causes of chronic low back pain. Traditionally, patients faced a limited spectrum of treatment options—ranging from physical therapy and pain management to invasive spinal fusion or artificial disc replacement surgeries.

In recent years, however, the field has seen a wave of innovation aimed at filling the treatment gap between conservative care and surgery. One of the most promising areas involves biomaterials, such as injectable hydrogels, designed to mimic the cushioning function of healthy intervertebral discs.

According to a 2023 review in Nature Reviews Rheumatology, hydrogels have gained attention for their ability to integrate with native tissue, reduce inflammation, and restore disc biomechanics without the need for major surgery. Early-stage studies have shown that these implants can provide long-lasting pain relief with fewer complications compared to surgical interventions.

Regenerative medicine approaches are also advancing. Stem cell therapy has been explored as a means to regenerate disc tissue, though clinical outcomes remain mixed and regulatory hurdles persist. According to the Journal of Orthopaedic Research, several trials are underway to evaluate the efficacy of mesenchymal stem cells injected directly into the disc, with results expected to influence future guidelines.

Minimally invasive spine care is another growing sector. The global market for spinal implants and surgery devices is projected to reach $14.3 billion by 2027, fueled by demand for outpatient solutions and technological innovation, according to a 2024 report by MarketsandMarkets.

As the U.S. population ages and chronic low back pain remains a leading cause of disability, approaches like ReGelTec’s HYDRAFIL system may reshape the landscape of spinal care—offering patients a chance at improved mobility without the risks and downtime of major surgery.