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            Lead Product(s): ORTHO-R

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: ORTHO-R

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 04, 2021

            Details:

            FDA has requested additional CMC related information on Ortho Regenerative's Investigational New Drug application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to SOC surgery in rotator cuff tear repair.