04:51 AM EST, 12/05/2024 (MT Newswires) -- Mesoblast (MESO) said late Wednesday the US Food and Drug Administration granted the company's second-generation cell therapy, Revascor, a regenerative medicine advanced therapy designation.

The decision on the industrially manufactured stromal cell therapy follows the submission of results from a randomized controlled trial in children with hypoplastic left heart syndrome, which the company said is a potentially life-threatening congenital heart condition.

The designation helps expedite the development of regenerative medicine therapies targeting serious or life-threatening diseases where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs, the company said.

Mesoblast plans to meet with the FDA to discuss a "potential approval pathway," Chief Executive Silviu Itescu said.