Mesoblast (ASX:MSB; Nasdaq: MESO) announced that the U.S. FDA granted the company’s product candidate, Revascor, Orphan Drug Designation for prevention of gastrointestinal bleeding in patients with left ventricular assist devices.
Revascor, Mesenchymal Precursor Cells
Revascor is Mesoblast’s investigational cell therapy composed of 150 million allogeneic mesenchymal precursor cells (MPCs). This unique cell therapy is injected into the hearts of patients with moderate-advanced to end-stage chronic heart failure. Its intended function is to limit bleeding from the gastrointestinal (GI) tract, a common secondary effect in those who require a left ventricular assist device (LVAD).
As stated by the company, “In a 30-patient placebo-controlled pilot trial in end-stage heart failure patients with LVADs, conducted by the United States National Institutes of Health (NIH), a single intra-myocardial dose of Revascor resulted in a 70% reduction in GI bleeding and associated hospitalizations. These results supported the RMAT designation granted in December 2017 by the FDA for use of Revascor in LVAD patients.”
To view the full announcement, click here.