Investigational New Drug (IND) Application
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Biologics
Ortho Regenerative Technologies Announces U.S. IND Clinical Hold Lifted By The FDA & Clearance To Proceed With U.S. Clinical Trial
MONTREAL, Dec. 13, 2021 /PRNewswire/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) (“Ortho” or the “Company”), a clinical-stage orthobiologics company focused on the…
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Biologics
Ortho Regenerative Technologies Announces Extension of FDA Clinical Hold of ORTHO-R Investigational New Drug Application
Most complex, and majority of additional information on characterization at point of care and CMC related data submitted accepted by…
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Biologics
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA
Additional CMC related data and characterization requested by the FDACompany confident of providing requested information over the coming weeksPhase I/II…
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Hospitals
FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain
November 28, 2018 HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using…
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Hospitals
SpinalCyte Applies with FDA to Expand Human Clinical Trial of CybroCell™ Dermal Fibroblasts as Investigational New Drug (IND)
April 12, 2018 HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using…
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