FDA Approves First Human Milk-Based Fortifier for Term Infants to Support Growth and Recovery Following Surgery for Gastroschisis

News provided by

Feb 25, 2025, 09:05 ET

Surgifort® Human Milk Fortifier, Developed by Prolacta Bioscience, Is the First Human Milk-Based Nutritional Fortifier Indicated for Term Infants

DUARTE, Calif., Feb. 25, 2025 /PRNewswire/ -- Prolacta Bioscience, the world's leading hospital provider of 100% human milk-based nutritional products, today announced the U.S. 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.¹ 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.²

Annually, fewer than 2,400 babies are born with gastroschisis in the U.S.³ 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).⁴

"Clinicians caring for infants requiring gastroschisis repair now have a human milk-based nutritional option to support healthy growth and recovery," said Melinda Elliott, MD, FAAP, 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."

About Prolacta Bioscience
Prolacta Bioscience^® is a global life sciences company dedicated to Advancing the Science of Human Milk^® to improve health outcomes for critically ill and premature babies. More than 100,000 extremely premature infants worldwide⁵ have benefited from Prolacta's human milk-based products, which have been evaluated in more than 30 peer-reviewed clinical studies. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity. Learn more at page.prolacta.com/surgifort, on X, Instagram, Facebook, and LinkedIn.

Media Contact:
Loren Kosmont
[email protected]
310-721-9444

References

Riddle S, Karpen H. Special populations-surgical infants. Clin Perinatol. 2023;50(3):715-728. doi:10.1016/j.clp.2023.04.008
National Institutes of Health. Nutrient recommendations: dietary reference intakes (DRI). Accessed February 24, 2025. https://ods.od.nih.gov/HealthInformation/Dietary_Reference_Intakes.aspx
Centers for Disease Control and Prevention. Birth Defects: Gastroschisis. Published November 21, 2024. Accessed January 22, 2025. https://www.cdc.gov/birth-defects/about/gastroschisis.html
Data on file; subset analysis of term infants who only received Surgifort following corrective surgery for gastroschisis at Emory University.
Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023.