Majority of U.S. level III & IV NICUs in 2025 used Prolacta’s 100% breastmilk-based fortifiers & formulas to improve outcomes for premature infants

DUARTE, Calif., November 18, 2025 – Prolacta Bioscience^® is celebrating Prematurity Awareness Month with a significant milestone in neonatal care: In 2025, the majority of Level III and IV neonatal intensive care units (NICUs) in the U.S. (55%) used Prolacta’s 100% breastmilk-based fortifiers and formulas, free from cow milk.¹ This shift in feeding practices is reducing serious complications and supporting better short- and long-term health outcomes for the tiniest babies.^{2,3 ,4,5,6,7,8}

Each year in the U.S., about 36,000 babies are born weighing 1,250 grams (2.75 lbs) or less⁹ and face the highest risk of serious complications, including necrotizing enterocolitis (NEC), a life-threatening intestinal disease.^{6,7,8 ,10}

Compared to cow milk-based products, an Exclusive Human Milk Diet (EHMD) with Prolacta’s 100% breastmilk-based nutritional fortifiers and formulas is shown to increase survival¹¹ and reduce the most common complications of prematurity,^4,5,6,7,8 enabling infants born as early as 22 weeks gestation to not just survive, but to thrive.

Prolacta’s nutritional products have also been shown to impact developmental milestones years later.^2,3 Most recently, an independent study demonstrated that despite being born earlier and weighing less, premature infants fed Prolacta’s EHMD had lower motor skill disability risk by age 3 compared to preemies fed a non-EHMD.¹²

“Two decades of research have shown the benefits of breastmilk-based nutrition, free from cow milk, for the most fragile premature infants,” said Scott Elster, CEO of Prolacta. “Across the country, clinicians and parents are seeing fewer complications, shorter hospital stays, and better developmental outcomes.”

Since 2006, Prolacta has continuously supplied breastmilk-based fortifiers for the most vulnerable infants in the NICU, adding breastmilk-based formulas in 2013. With production capacity that has always been able to scale to meet demand and a robust waiting list of donors ready to contribute, Prolacta continues to provide lifesaving nutrition for every preemie born weighing 2.75 lbs or less as more hospitals adopt breastmilk-based feeding as the standard of care.

Understanding the Unique Nutritional Needs of Preemies

Premature babies need 20% to 40% more calories and protein than full-term babies to make up for the growth and development they missed during the third trimester.^13,14 As a result, hospitals add a nutritional “fortifier” to mom's own milk or donor milk to provide the extra nutrition needed for healthy growth and development.

There are two types of fortifiers available: cow milk-based and breastmilk-based. In the U.S., both are labeled “human milk fortifiers,” but only those from Prolacta are made from 100% donor breastmilk instead of cow milk. The difference can be life-changing for critically ill and premature infants. As awareness has grown regarding the two nutrition options, so too have parental requests for nutrition free from cow milk and added synthetic ingredients for their fragile preemies in the NICU. For more information about breastmilk-based nutrition, visit parents.prolacta.com.

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 infants. More than 125,000 extremely premature infants worldwide¹⁵ have benefited from Prolacta's human milk-based products, which have been evaluated in more than 30 peer-reviewed clinical studies. In a significant advancement, Prolacta has developed Surgifort^®, the first and only FDA-approved human milk-based fortifier designed for term infants recovering from corrective surgery for gastroschisis. 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 on X, Instagram, Facebook, TikTok, and LinkedIn.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310.721.9444

References

1. Data on file; number of U.S. hospitals that used Prolacta’s fortifiers and formulas in 2025.
2. Hair AB, Patel AL, Kiechl-Kohlendorfer U, et al. Neurodevelopmental outcomes of extremely preterm infants fed an exclusive human milk-based diet versus a mixed human milk + bovine milk-based diet: a multi-center study. J Perinatol. 2022;42(11):1485-1488. https://doi.org/10.1038/s41372-022-01513-3
3. Bergner EM, Shypailo R, Visuthranukul C, et al. Growth, body composition, and neurodevelopmental outcomes at 2 years among preterm infants fed an exclusive human milk diet in the neonatal intensive care unit: a pilot study. Breastfeed Med. 2020;15(5):304-311. https://doi.org/10.1089/bfm.2019.0210
4. Huston R, Lee M, Rider E, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk-based fortifier. J Neonatal Perinatal Med. 2020;13(2):215-221. https://doi.org/10.3233/NPM-190300
5. Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. https://doi.org/10.1097/ANC.0000000000000676
6. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. https://doi.org/10.1038/jp.2015.168
7. Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017;12(10):663]. Breastfeed Med. 2016;11(2):70-74. https://doi.org/10.1089/bfm.2015.0134
8. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-567.e1. https://doi.org/10.1016/j.jpeds.2009.10.040
9. Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final data for 2022. National Vital Statistics Reports; vol 73, no 2. Hyattsville, MD: National Center for Health Statistics. 2024. doi: https://dx.doi.org/10.15620/cdc:145588
10. Harris L, Lewis S, Vardaman S. Exclusive human milk diets and the reduction of necrotizing enterocolitis. Adv Neonatal Care. 2024;24(5):400-407. https://doi.org/10.1097/ANC.0000000000001183
11. Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med. 2014;9(6):281-285. https://doi.org/10.1089/bfm.2014.0024
12. Chou FS, Zhang J, Villosis MFB, et al. Exclusive human milk diet is associated with lower risk of motor function impairment at three years of corrected age. J Perinatol. 2025. https://doi.org/10.1038/s41372-025-02296-z
13. American Academy of Pediatrics. Policy statement: breastfeeding and the use of human milk. Section on Breastfeeding. Pediatrics. 2022;150(1):e2022057988.
14. Hair AB, Bergner EM, Lee ML, et al. Premature infants 750-1,250 g birth weight supplemented with a novel human milk-derived cream are discharged sooner. Breastfeed Med. 2016;11(3):133-137. https://doi.org/10.1089/bfm.2015.0166
15. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to May 2025.