Prolacta Bioscience Approaches 20 Years Nourishing Extremely Premature Babies as #1 Hospital Provider of Human Milk-Based Fortifiers and Formulas

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Oct 14, 2025, 09:05 ET

Company Introduced Fortifiers Free From Cow Milk in 2006 to Improve Long-Term Outcomes

DUARTE, Calif., Oct. 14, 2025 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill and premature infants, approaches two decades of providing the only alternative to cow milk-based fortifiers in the U.S. for the most fragile preemies born weighing < 1,250 grams (2.75 pounds).

Multiple studies conducted over the past 15 years show that cow milk-based fortifiers increase the risk of the life-threatening intestinal disease necrotizing enterocolitis (NEC) in extremely premature infants. These studies compared infants fed cow milk-based fortifiers to those fed 100% human milk-based fortifiers as part of an exclusive human milk diet (EHMD).^1-3 For each 10% increase in cow milk-based protein in an infant's diet, there is a 11.8% increase in the risk of NEC, 20.6% increase in the risk of surgical NEC, and 17.9% increase in the risk of sepsis.⁴

Additionally, a recent independent study evaluated the association between an EHMD and motor function impairment at 3 years of corrected age. Read more about the published findings here.⁵

Since introducing Prolact+ H²MF®, the world's first and only 100% human milk-based fortifier, in 2006, Prolacta has contributed to changing the standard of care for critically ill and premature infants in neonatal intensive care units (NICUs) across the country. The company's nutritional products are made from 100% breast milk and are free from cow milk and other added fats and sugars, including corn syrup solids. The products have been studied extensively throughout the company's nearly 20-year history, showing reduced complications and improved outcomes for vulnerable infants.^1-3,6-9

"Our company's history and commitment to advancing neonatal nutrition is supported by extensive clinical data and two decades of real-world use of our products," said Scott Elster, CEO of Prolacta. "Our legacy and continued mission reflect the vital role of human milk nutrition in helping extremely premature infants not just survive their earliest days but also grow and develop so they can thrive throughout their lives."

Prolacta's advancements in neonatal nutrition have been marked by several key milestones:

2006: Prolacta introduces Prolact+ H²MF® – the first and only 100% human milk-based fortifier as an alternative to cow milk-based products for extremely premature infants
2007: Prolacta introduces Prolact HM® – the industry's first protein- and calorie-standardized pasteurized donor human milk for use alone or with Prolact+ H²MF human milk fortifier when mother's own milk is unavailable
2007: Prolacta enters the European market with first international sale
2010: First randomized clinical trial published demonstrating the benefits of Prolacta's human milk-based fortifiers³
2013: Prolacta introduces Prolact RTF™ – the first and only 100% human milk-based "ready to feed" (RTF) premature infant formula indicated for when a mother's own milk is unavailable and fortification is needed
2014: Prolacta introduces Prolact CR® – the world's first and only 100% human milk caloric fortifier made from pasteurized human milk cream to help preemies increase weight and length
2017: Prolacta develops world's first test to directly detect bacteria and viruses in donor breast milk, setting the highest safety standard in the human milk industry
2017: Prolacta begins directly testing donor milk for traces of drugs, including opiates, nicotine, and marijuana, as well as adulterants
2020: Prolacta introduces products in the Middle East
2023: Australia approves use of Prolacta's nutritional products
2024: More than 50% of Level III and IV NICUs in the U.S. used Prolacta's 100% human milk-based fortifiers and formulas for the tiniest preemies weighing less than 1,250 g (2.75 lbs.)
2025: U.S. Food and Drug Administration approves Prolacta's Surgifort® fortifier – the first and only 100% human milk-based fortifier designed for term infants recovering from corrective surgery for gastroschisis

A growing body of clinical evidence demonstrates the short- and long-term health benefits of human milk-based nutrition for critically ill and premature infants. Compared to cow milk-based products, an EHMD with Prolacta's 100% human milk-based nutritional fortifiers has been clinically proven in numerous studies to:

Lower mortality and morbidity^4,10
Reduce risk of NEC^1-3
Reduce incidence of feeding intolerance¹
Achieve adequate growth^8,11,12
Reduce incidence of bronchopulmonary dysplasia (BPD)^1,2,8,9
Reduce incidence of retinopathy of prematurity (ROP)^1,2,9,13
Reduce late-onset sepsis incidence^2,13 and evaluations⁹
Improve long-term outcomes such as neurodevelopment^6,7
Shorten stays in the NICU¹
Reduce hospital costs^1,14

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 online, or on X, Instagram, Facebook, TikTok, and LinkedIn.

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

References

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. doi:10.1038/jp.2015.168
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 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
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. doi:10.1016/j.jpeds.2009.10.040
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. doi:10.1089/bfm.2014.0024
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;45:1274–1280. doi:10.1038/s41372-025-02296-z
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. doi: 10.1038/s41372-022-01513-3
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. doi:10.1089/bfm.2019.0210
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. doi:10.3233/NPM-190300
Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676
Lucas A, Boscardin J, Abrams SA. Preterm infants fed cow's milk-derived fortifier had adverse outcomes despite a base diet of only mother's own milk. Breastfeed Med. 2020;15(5):297-303. doi:10.1089/bfm.2019.0133
Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants ≤1250 grams birth weight. BMC Res Notes. 2013;6:459. doi:10.1186/1756-0500-6-459
O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial [published correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears in Am J Clin Nutr. 2020 May 1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067
Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002
Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to May 2025.