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# Clinical Hold on Ortho Regenerative Rotator Cuff Trial
- URL: https://www.fdaweb.com/clinical-hold-on-ortho-regenerative-rotator-cuff-trial/
- Published: 2021-06-04T12:00:00.000Z
- Updated: 2026-09-14T17:01:47.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149474

FDA has issued a clinical hold on a Ortho Regenerative Technologies Phase 1-2 clinical trial for Ortho-R, a drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair. The agency hold is related to a request for additional chemistry, manufacturing, and control-related information. The company says it will provide the agency with the required information and testing data over the coming four to six weeks. Ortho-R is described as a Chitosan-based matrix biopolymer mixed with platelet-rich plasma to form an in-situ deliverable biologic implant to augment the repair of rotator cuff tears after standard of care surgery.