Mesoblast achieves key FDA designation

Mesoblast (ASX:MSB) has announced that the FDA granted RMAT designation to Revascor® for treating hypoplastic left heart syndrome in children. This follows previous designations, aiming to expedite development for serious conditions.

Summary of Mesoblast's FDA announcement

Mesoblast received RMAT designation for Revascor®, aimed at treating children with hypoplastic left heart syndrome, enhancing its development and approval process. This follows previous designations, underscoring its potential impact. The therapy showed promising trial results, with significant improvements in heart volume essential for surgery. Revascor uses mesenchymal precursor cells to aid heart function. Mesoblast continues to advance cellular therapies for various conditions, leveraging its IP and partnerships globally.

Executive insights on FDA recognition

The RMAT designation provides a pathway for expediting the availability of this therapy to children with hypoplastic left heart syndrome who have limited options,' said the company.