In June 2020, the privately-held company was granted orphan drug and rare pediatric disease designations by the US Food and Drug Administration (FDA) for its first product, Protego-PD, for the prevention of necrotizing enterocolitis (NEC) in early preterm infants.

The US company is expanding its successful preclinical data and achieving the regulatory milestones to develop the first FDA-approved treatment for the prevention of NEC.