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              Ortho Regenerative Technologies

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              Ortho Regenerative Technologies Receives Clinical Hold Letter from The U.S. FDA

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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.

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