[{"orgOrder":0,"company":"Ortho Regenerative Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ortho Regenerative Technologies Receives Clinical Hold Letter from The U.S. FDA","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"IND Enabling"},{"orgOrder":0,"company":"Ortho Regenerative Technologies","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Ortho Regenerative Technologies Enters Into A Material Transfer Agreement With A Global Strategic Medical Company For Its Ortho-R Rotator Cuff Tear Repair Phase I\/II U.S. Clinical Trial","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CANADA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals by Ortho Regenerative Technologies
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.
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.