Secretome Therapeutics, a leader in regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to STM-01, its neonatal cardiac progenitor cell (nCPC) therapy, for the treatment of Heart Failure with Preserved Ejection Fraction (HFpEF).
HFpEF is a debilitating condition affecting millions worldwide, characterized by impaired heart relaxation and elevated left ventricular filling pressure, even with a normal or near-normal ejection fraction. With few disease-modifying treatments available, HFpEF represents a significant unmet need in cardiovascular care.