ReGelTec’s HYDRAFIL® System introduces a novel, minimally invasive solution for treating chronic low back pain caused by degenerative disc disease (DDD), one of the most prevalent and difficult-to-manage spinal conditions. Unlike traditional surgical methods, HYDRAFIL uses a percutaneously delivered hydrogel that solidifies within the intervertebral disc, filling cracks and restoring disc height and hydration. This technology is designed to mimic the disc’s natural biomechanics, offering a targeted approach that reduces structural deterioration and alleviates pain without requiring invasive spinal surgery. The receipt of CE Mark under the EU Medical Device Regulation (MDR) confirms its safety and efficacy for commercial use in Europe.
The HYDRAFIL System is performed in an outpatient setting using local anesthesia, significantly reducing the recovery time and risks associated with spinal surgeries. It has demonstrated robust clinical outcomes, with more than 80% of patients reporting significant improvements in disability and over 70% experiencing long-term pain relief. This intervention addresses a critical treatment gap for the 10+ million Americans and many more globally who suffer from DDD but have limited options beyond conservative care or major surgery. By restoring disc function and reducing nerve irritation, HYDRAFIL empowers patients to regain mobility, improve quality of life, and reduce dependence on opioids or repeated interventions.
The CE Mark approval not only validates HYDRAFIL’s clinical performance but also paves the way for its wider adoption across European markets. In parallel, ReGelTec’s U.S. pivotal study—currently enrolling patients under an FDA-approved IDE—positions the company to seek regulatory approval in the U.S. soon. With its innovative hydrogel approach, strong safety profile, and promising real-world outcomes, the HYDRAFIL System holds significant potential to redefine the treatment paradigm for chronic low back pain and set a new standard in interventional spine care.
MedTech Spectrum's Summary
Innovative Approach: HYDRAFIL® is a minimally invasive hydrogel implant designed to treat chronic low back pain by restoring disc hydration and structure, avoiding the need for major spinal surgery.
Validation: CE Mark approval was granted based on strong clinical results, including over 80% improvement in disability and 70% reduction in pain sustained over two years.
Global Expansion: With European approval secured, ReGelTec is advancing its U.S. pivotal trial and aims to scale the solution globally, offering a new standard of care for millions affected by degenerative disc disease.
