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Details:
The Company will provide the PRP system disposable kits for all enrolled patients in the study. Ortho, has in return, provided the Strategic Company with a right of “first offer” to distribute ORTHO-R in combination with their proprietary PRP System.
Lead Product(s): Chitosan-PRP
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: ORTHO-R
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 07, 2022
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.
Lead Product(s): ORTHO-R
Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: ORTHO-R
Highest Development Status: IND EnablingProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2021
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