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# Mesoblast Wins Orphan Status for Revascor
- URL: https://www.fdaweb.com/mesoblast-wins-orphan-status-for-revascor/
- Published: 2024-02-15T12:00:00.000Z
- Updated: 2026-09-14T14:23:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156372

FDA has granted Mesoblast an orphan drug designation for Revascor (rexlemestrocel-L) and its use in children with congenital heart condition hypoplastic left heart syndrome. The designation is based on data from a randomized controlled trial, which the company says demonstrated that a single intramyocardial administration of Revascor at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography. “These changes are indicative of clinically important growth of the small left ventricle, facilitating the ability to have a successful surgical correction, known as full biventricular (BiV) conversion, which allows for a normal two ventricle circulation with the surgically repaired left ventricle taking over circulatory support to the body,” Mesoblast says. “Without full BiV conversion, the right heart chamber is under excessive strain with increased risk of heart failure and death.”