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
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.