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.