Overview

Comprehensive overview of Revascor®, from how it works to Market Opportunity and the Global Development Program

What is Revascor®?

Revascor®® (rexlemestrocel‑L) is Mesoblast's breakthrough allogeneic cellular therapy for advanced heart failure. With completed Phase 3 trials and dual RMAT (Regenerative Medicine Advanced Therapy) designations from the FDA, Revascor® represents the most advanced cellular therapy approach for patients with ischemic heart failure and reduced ejection fraction (HFrEF).

Proven Clinical Results

60% reduction in cardiovascular death (NYHA Class II)
58% reduction in heart attacks and strokes
537 patients completed Phase 3 DREAM-HF trial

FDA Recognition

RMAT designation for adult heart failure
RMAT designation for pediatric HLHS
BLA filing planned for end of 2025

How Revascor® Works

Revascor® uses mesenchymal precursor cells (MPCs) delivered via a single transendocardial injection to target the underlying inflammation that drives heart failure progression. Unlike traditional treatments that manage symptoms, Revascor® addresses root causes through multiple mechanisms:

Mechanisms of Action:

1.
Anti-Inflammation: Reduces damaging immune responses in cardiac tissue
2.
Angiogenesis: Stimulates new blood vessel growth for enhanced oxygen delivery
3.
Anti-Fibrosis: Reduces scar tissue formation and promotes cardiac flexibility
4.
Regeneration: Supports cardiac cell repair and functional improvement

Treatment Advantages:

✓
Single treatment: One-time injection via cardiac catheterization
✓
Off-the-shelf: Allogeneic cells ready for immediate use
✓
Excellent safety: No serious adverse events in clinical trials
✓
Disease-modifying: Targets underlying pathophysiology

Market Opportunity

$18.5B

Heart failure market by 2035

250K+

US patients progress to advanced HF annually

44%

Of HF patients have ischemic disease with inflammation

Global Development Program

Mesoblast has established a comprehensive global development and manufacturing program for Revascor®, with strategic partnerships enabling worldwide access to this breakthrough therapy.

Manufacturing Excellence:

• 14-year partnership with Lonza for industrial-scale production
• FDA-validated manufacturing at Singapore facilities
• Passed Pre-License Inspection with no Form 483 observations
• Off-the-shelf cryopreserved product with global distribution

Global Partnerships:

• Tasly Pharmaceutical: $90M agreement for China market
• JCR Pharmaceuticals: Japan commercialization rights
• Grünenthal: European development and distribution
• Cencora: US specialized cryogenic logistics network