FDA Approves First Human Milk-Based Fortifier for Term Infants

Prolacta Bioscience Hospital, a supplier of 100 percent human milk-based nutritional supplements, has received U.S. Food and Drug Administration approval for Surgifort human milk fortifier, a pasteurized, human milk-based product designed for term infants recovering from gastroschisis surgery. Surgifort fortifier is the first human milk-based fortifier approved for use in full-term infants and is formulated to provide essential protein and calories necessary for optimal growth. Gastroschisis, a birth defect in which the intestines protrude through the abdominal wall, requires surgical correction, after which infants need increased macronutrient intake. When mixed with term human milk and administered in appropriate volumes, Surgifort fortifier helps meet the nutritional recommendations established by the National Academy of Medicine.

Prolacta developed Surgifort fortifier to address the unique nutritional needs of this small but critical patient population, with fewer than 2,400 cases of gastroschisis reported in the U.S. each year. Studies indicate that infants receiving Surgifort fortifier as part of an Exclusive Human Milk Diet experience faster weight gain and a reduced time to full feeds. The product contains essential nutrients derived from donated human milk, with added minerals to support recovery. Scott Elster, CEO of Prolacta, said, “With Surgifort fortifier, we’re entering a new chapter in specialized human milk-based nutrition, extending its clinically proven benefits to babies who are not born prematurely. This advances our commitment to develop human milk-based nutritional solutions for infant populations with complex medical needs.”

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