The first patient was treated in ReGelTec’s Hydrafil FDA investigational device exemption trial, according to a June 18 news release.
The Hydrafil system is for disc augmentation and is designed to treat pain without surgery. It delivers a permanent hydrogel into a degenerated disc through an injection and recruits water to restore natural biomechanics. After solidifying it distributes the load and strain in the intervertebral segment to improve function and reduce pain signals, according to the company.
The U.S. trial comes after the company earned the European Union’s CE mark following a study of 75 patients. The IDE study includes 225 patients across nine study sites.
