ReGelTec has secured CE Mark approval for the Class III Hydrafil System for disc augmentation, under the European Union Medical Device Regulation (MDR).
The approval is based on a clinical trial involving 75 subjects, which revealed that the system’s treatment led to significant improvements in disability and pain.
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According to the findings, an improvement exceeding 80% was observed in Oswestry Disability Index (ODI) scores and a decrease of more than 70% in Numeric Pain Rating Scale scores post-treatment, with sustained results for two years.
ReGelTec noted that the system is designed to be an outpatient procedure performed under local anaesthesia. It involves the injection of a permanent hydrogel into a degenerated disc for filling cracks and tears while also recruiting water to restore the disc’s natural biomechanics and alleviate pain.
Once solidified in the disc, the hydrogel implant helps in distributing the strain and load across the intervertebral segment, enhancing function and decreasing pain signals to the brain.
The data that supported this approval also contributed to the US Food and Drug Administration’s (FDA) decision to grant an investigational device exemption (IDE) for the company’s US pivotal study, HYDRAFIL-D.
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By GlobalDataThis single-blinded, 225-patient, randomised, controlled study is actively enrolling subjects across eight sites and aims to support future regulatory approval in the country.
The study includes an interim safety analysis scheduled after the first 60 subjects complete their six-month follow-up.
ReGelTec’s percutaneous hydrogel implant is intended for treating chronic low back pain caused by degenerative disc disease.
ReGelTec CEO and co-founder Bill Niland said: “Receiving CE Mark for the Hydrafil System is another major milestone for ReGelTec. We are leveraging this momentum to drive enrolment in the HYDRAFIL-D pivotal study required for FDA approval, and look forward to securing additional capital to support ongoing investment in the US and globally.”
In June 2023, the company reached an exclusive distribution agreement with BCWorld Healthcare for the system in South Korea.
