FDA Approves First Human Milk-Based Fortifier for Infants with Gastroschisis

Prolacta Bioscience, a global life sciences company dedicated to advancing the science of human milk to improve health outcomes for critically ill and premature babies, and the global leading hospital provider of 100 per cent human milk-based nutritional products,  announced the US Food and Drug Administration (FDA) has approved Surgifort human milk fortifier (human, pasteurized) for term infants (> 37 weeks) following corrective surgery for the gastrointestinal disorder gastroschisis.

Surgifort fortifier is the latest addition to Prolacta’s line of human milk-based nutritional products, and it is the first fortifier indicated for use in term babies.

Gastroschisis is a birth defect where the intestines, and sometimes other organs, protrude through the abdominal wall. Similar to premature infants, term infants recovering from corrective gastroschisis surgery require high macronutrient intake for optimal growth. Surgifort fortifier is specifically formulated to deliver optimal protein and calories to promote growth. When Surgifort fortifier is mixed with term human milk, and given at an appropriate volume, clinicians can achieve nutrition that is within the recommendations established by the National Academy of Medicine.

Annually, fewer than 2,400 babies are born with Gastroschisis in the US,  despite this exceptionally small patient population, Prolacta’s dedication to the lifesaving benefits of human milk nutrition inspired the development of Surgifort fortifier to address the unmet nutritional needs of these critically ill infants.

“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,” said Scott Elster, CEO of Prolacta. “This advances our commitment to develop human milk-based nutritional solutions for infant populations with complex medical needs.”

Surgifort fortifier is a concentrated, pasteurized, liquid human milk-based product that contains calories, protein, fat, and carbohydrate derived from donated human milk, with added minerals. As part of an Exclusive Human Milk Diet (EHMD), Surgifort fortifier has been found to reduce the time to full feeds as well as improve weight gain velocity in babies recovering from gastroschisis repair (weight gain from the day Surgifort fortifier started until the day it was discontinued = 33.3 g/day).

“Clinicians caring for infants requiring gastroschisis repair now have a human milk-based nutritional option to support healthy growth and recovery,” said Melinda Elliott, practicing neonatologist and chief medical officer at Prolacta. “Surgifort fortifier extends the benefits of Prolacta’s Exclusive Human Milk Diet beyond premature infants to this fragile surgical population.

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