ReGelTec has secured the CE mark for its Hydrafil system, a percutaneous hydrogel implant designed to treat chronic low back pain caused by degenerative disc disease.
The approval was granted under the European Union Medical Device Regulation (EU MDR).
It opens a commercial pathway for the outpatient procedure that reduces pain, enhances daily function, and eliminates the need for invasive surgeries in Europe.
The CE mark approval was based on a clinical study, in which the Hydrafil system showed significant improvements in pain and disability in 75 patients.
Also, the study showed more than 80% improvement in Oswestry Disability Index scores and over 70% reduction in Numeric Pain Rating Scale scores.
The improvements were sustained over two years in 63 patients, after their follow-up.
ReGelTec co-founder and CEO Bill Niland said: “Receiving the 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.”
Degenerative disc disease occurs when intervertebral discs deteriorate, causing abnormal vertebral movement and inflammation of structures that lead to back and leg pain.
The Hydrafil system involves an outpatient procedure performed under local anaesthesia.
A permanent hydrogel is injected into a degenerated disc to fill cracks and tears, recruiting water to restore natural biomechanics and relieve pain.
Once solidified, the hydrogel distributes load and strain, improving function and reducing pain signals to the brain.
The data supporting the CE mark also backed the US Food and Drug Administration’s (FDA) decision on investigational device exemption (IDE) for a study of the Hydrafil system.
Hydrafil-D is a 225-patient, multicentre, single-blinded, randomised, controlled trial that includes an interim safety analysis after the first 60 patients complete their follow-up.
The study is currently enrolling patients at eight US sites and will support US approval.
Beam Radiology CEO Olivier Clerk-Lamalice said: “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.
“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 US pivotal study.”
