Ortho-R is designated as a Drug/Biologic combination product, by the FDA Office for Combination Products. The jurisdictional assignment for Ortho-R will be the Center for Biologics Evaluation and Research (CBER). The news was announced today by Ortho...
As a result, the Company is in the position to submit its Investigational New Drug while completing its pivotal study and confirms the timeline to initiate human clinical program by year end.
2/4/19: Both key scientific studies validate its product's ability to improve the repair of two distinct joint tissues, the rotator cuff tendon and articular cartilage.
4/2/18: Conducted by researchers from Montreal's prestigious École Polytechnique, the pilot dose escalation study used MR imaging outcomes, read by two blinded experts at 3 intervals, to compare the results of Ortho-R versus standard of care in a non-clinical rotator cuff injury model in sheep.