The FDA Approves IDE for ReGelTec’s Pivotal Study HYDRAFIL for Chronic Low Back Pain due to Degenerative Disc Disease

BALTIMORE/ September 28, 2023/ BUSINESS WIRE/ – 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. The HYDRAFIL System contains an injectable polymer that is implanted percutaneously via a needle to augment the native disc in a procedure performed under local anesthesia at an outpatient surgery center. — Read More…