FDA hold on Ortho RTI’s regenerative drug lifted, trials to resume

The FDA’s clinical hold on Ortho RIT’s Ortho-R drug has been lifted, according to a Dec. 13 news release.

Advertisement

Ortho RTI received a clinical hold letter for Ortho-R, a regenerative product for rotator cuff repairs in June.

After addressing concerns, the company was cleared to proceed with clinical trials for Ortho-R. Ortho RTI plans to enroll 78 patients across 10 clinical sites for the trial.

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Register to Attend Webinar

Is ambulatory care healthcare’s big margin engine? 4 leaders weigh in

Wednesday, July 29
1:00 PM - 2:00 PM CDT

Presenters: Joe Ganley, athenahealthJeffrey Flynn, CASC, Gramercy Surgery CenterBryan Tsao, Access Center, Loma Linda University HealthJason Zepeda, Northridge Hospital Medical Center, CommonSpirit HealthGreg DeConciliis, PA-C, CASC, Boston Out­Patient Surgical Suites

Advertisement

Next Up in Biologics

Advertisement

Comments are closed.