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The GPS II Platelet Separation Kit

Phase 1

Coronary Heart Failure | Unknown | Cardiovascular |Zimmer Biomet Holdings, Inc.|Last Updated: May 18, 2017

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 Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00514241Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass SurgeryPHASE1 COMPLETED 140Jan 1, 2006Aug 1, 2008May 18, 2017 -
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Study Design & Arms
Interventions
NameTypeDescription
The GPS™ II Platelet Concentrate Separation KitDEVICEThe GPS™ II Platelet Concentrate Separation Kit system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
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