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Dermagraft,Profore

Phase 3

Venous Leg Ulcer | Unknown | Other |Organogenesis Holdings Inc.|Last Updated: Jun 17, 2018

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 Trials1
Total Enrollment537
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00909870Pivotal Trial of Dermagraft(R) to Treat Venous Leg UlcersPHASE3 COMPLETED 537Jun 1, 2009Aug 1, 2011Jun 17, 2018 -
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Study Design & Arms
Interventions
NameTypeDescription
Dermagraft(R)DEVICEWeekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
ProforeDEVICEWeekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
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