ReGelTec, Inc., a clinical stage medical device company developing HYDRAFIL™, a percutaneous treatment for chronic low back pain, announced the presentation of Early Feasibility Study (EFS) results by Dr Alfonso Spath at the American Society of Spine Radiology annual meeting that took place February 19-21, 2021. The EFS has been taking place in Barranquilla, Colombia with early results showing patients have an average reduction in their chronic low back pain of 78% at 3 months post-procedure.
Patients in the EFS were included based on the presence of chronic low back pain due to degenerated discs in their lumbar spine and received injections of HYDRAFIL™ at either one- or two-disc levels between August and December 2020. HYDRAFIL is a patented hydrogel that is heated prior to injection into the nucleus of a degenerated disc via a 17-gauge needle. According to the company when HYDRAFIL cools to body temperature it forms a contiguous implant within the nucleus to augment the disc, restore the biomechanical properties of that spinal segment, and alleviate pain. The company received FDA Breakthrough Device designation in December 2020 and is working to expand clinical studies in both Colombia and the United States.
“I am very excited that we could include HYDRAFIL in our annual symposium as I think it has great potential to improve the treatment of degenerative disc disease and is something our members are very interested in learning more about,” said Dr Dan Nguyen, President of American Society of Spine Radiology (ASSR). “I look forward to seeing the continued data and clinical study activities in our future meetings.”
According to ReGelTec, all patients in the ongoing EFS are now in the follow up phase with indications of significant pain relief and reduction of disability at 30 and 90 day follow up visits. The average baseline back pain score was 7.2 out of 10 on the Numeric Rating Scale for pain, with an average 3 month score of 1.6, marking a 78% reduction. Patients were also surveyed via the Oswestry Disability Index and have shown an average 85% reduction in disability scores, from a baseline of 48 out of 100 (categorized as severe disability) down to 7 out of 100 (minimal disability). The percutaneous procedure to implant HYDRAFIL was performed with patients awake and under local anesthesia in an outpatient clinic, and all patients were up and walking within one to two hours of the injection. The study will continue with patient follow up at 6 month and 1 year time points.
“I’d like to thank ASSR and its leadership team, and of course our Principal Investigator Dr Spath, for his work generating this clinical evidence for HYDRAFIL. We are very encouraged by the results to date and our ability to positively impact the lives of millions of patients who are suffering from chronic low back pain,” said Bill Niland, ReGelTec CEO and co-founder.