The Florida company evaluated its experimental stem cell therapy, laromestrocel, as an adjunct to heart surgery in babies with the rare congenital defect hypoplastic left heart syndrome (HLHS).
The topline results show that the study did not achieve its primary endpoint — an improvement in right ventricular ejection fraction (RVEF) one year after treatment. The company says, however, that there were exploratory clinical endpoints that it continues to analyse and intends to discuss with the FDA to assess possible paths forward for laromestrocel.
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