Posted by Michael Wonder on 09 Dec 2020
ReGelTec receives FDA breakthrough designation for its Hydrafil system
9 December 2020 - ReGelTec announced today that it has received breakthrough device designation from the Center for Devices and Radiological Health of the U.S. FDA.
The company’s leading product is Hydrafil, a patented hydrogel that is heated prior to injection into the nucleus of a degenerated disc via a 17 gauge needle.
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.
