A New Era inHeart Failure Therapy
Revascor® (rexlemestrocel‑L) is a breakthrough cellular therapy demonstrating up to 60% reduction in cardiovascular death in patients with early-stage heart failure and inflammation.
How Revascor® Works
A multi-modal cellular therapy that addresses the root causes of heart failure through four key mechanisms.
Angiogenesis
Stimulates new blood vessel growth to enhance oxygen delivery and myocardial recovery.
Anti-Inflammation
Releases cytokines that reduce damaging immune responses in heart tissue.
Anti-Fibrosis
Reduces scar tissue buildup and promotes cardiac flexibility.
Tissue Regeneration
Supports cardiac cell repair and functional improvement.
Single-Injection Treatment Process
Injection
Direct transendocardial delivery via cardiac catheterization
Integration
150 million mesenchymal precursor cells integrate with cardiac tissue
Regeneration
Enhanced cardiac function and sustained mortality reduction
Path to FDA Approval
Tracking progress from breakthrough therapy designation to commercial availability
FDA Full Approval Target
Expected full FDA approval following successful BLA review process and confirmatory trial completion.
BLA Filing for Accelerated Approval
Mesoblast intends to file BLA for accelerated approval in patients with end-stage ischemic HFrEF implanted with an LVAD, following FDA alignment on key requirements.
FDA Type B Meeting - Alignment Achieved
FDA provided formal minutes confirming alignment on CMC, potency assays for commercial product release, and confirmatory trial design.
Second RMAT Designation - Pediatric HLHS
FDA granted second RMAT designation for Revascor® in children with congenital heart disease (HLHS), adding to existing adult designation.
DREAM-HF Results Published in JACC
Phase 3 results published showing 60% reduction in cardiovascular death in NYHA Class II patients and 58% reduction in heart attacks/strokes.
Phase 3 DREAM-HF Trial Completed
537 patient randomized, double-blind, placebo-controlled trial completed. Results demonstrate significant cardiovascular benefits in inflammation subgroups.