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.