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Amniotic Allograft

Phase 3

Knee Osteoarthritis | Monoclonal antibody | Musculoskeletal |Organogenesis Holdings Inc.|Last Updated: Dec 22, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials2
Total Enrollment1,110
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06000410A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneePHASE3 COMPLETED 594Sep 1, 2023Nov 1, 2025Dec 22, 2025 -
NCT04636229Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneePHASE3 COMPLETED 516Dec 1, 2020Aug 1, 2025Oct 15, 2025 -
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Study Design & Arms
Interventions
NameTypeDescription
Amniotic Suspension AllograftBIOLOGICALThis investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
PlaceboDRUGMatching placebo is 0.9% normal saline: 4 mL to be injected IA.
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