InCHOIRInternational Center for Health Outcomes and Innovation Research (Columbia University; New York, NY)
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We will work closely with the FDA and InCHOIR to generate the confirmatory clinical data needed for full marketing approval of Revascor in the prevention of this life-threatening inflammatory complication of an LVAD implant in end-stage heart failure patients.'
"Confirmation of our previous observations that Mesoblast's cell therapy reduced major bleeding episodes and related hospitalizations would identify a therapeutic approach that could greatly benefit these patients," said cardiac surgeon of the University of Michigan, co- principal investigator of the recently completed 159-patient study coordinated by InCHOIR.
Ventracor's US DT protocol and strategy was developed in collaboration with the FDA and the International Centre for Health Outcomes and Innovation Research (InCHOIR) at Columbia University in New York.