Latest News
ReGelTec Honored as MedTech Innovator Breakthrough Medtech Startup
ReGelTec is named among the 64 breakthrough Medtech Startups. MedTech Innovator (MTI), the world’s largest and most impactful accelerator for medical technology startups, today announced the 64 companies selected for its highly competitive 2025 Accelerator Cohort. These companies, representing the top 4% of nearly 1,500 global applicants, will participate in MTI’s flagship four-month program designed to de-risk innovation and accelerate the path to U.S. market success.
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back
Clinical data show the percutaneous disc augmentation system generated significant improvements in pain and disability scores through 2-year follow-up. ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has received CE Mark under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation.
ReGelTec Enrolls 1st Patient in the HYDRAFIL®-D Study
ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation.
HYDRAFIL® Presentation Receives Top Abstract Award at the 6th Annual American Society of Pain and Neuroscience Annual Meeting
ReGelTec, Inc., announced that Dr. Douglas Beall received the “Top Abstract Award” from the American Society of Pain and Neuroscience (ASPN) for his presentation of the 3-Year follow-up data on chronic low back pain patients treated with ReGelTec’s HYDRAFIL System.
ReGelTec’s Hydrafil Injectable Hydrogel Studied to Treat Low Back Pain Caused by Degenerative Disc Disease
According to the Society of Interventional Radiology (SIR), a small study showed an experimental formulation of a hydrogel injected into spinal discs was safe and effective in substantially relieving chronic low back pain caused by degenerative disc disease (DDD).
The FDA Approves IDE for ReGelTec’s Pivotal Study of HYDRAFIL® for Chronic Low Back Pain due to Degenerative Disc Disease
ReGelTec, Inc., announced that the U.S. Food and Drug Administration has approved an IDE for the company’s pivotal study to support premarket approval of its HYDRAFIL® System.
