Prolacta Bioscience, Inc.

Better Growth Has Been Associated with Improved Long-Term Neurodevelopment Prolacta's Human Milk-Based Fortifiers Proved Safe and Effective Alternative to Japan's Practice of Delaying Cow Milk-Based Fortifiers to Avoid Complications JASMINE Data Used by Japan's Ministry of Health, Labour, and Welfare to Grant Prolacta's Fortifiers Prescription Drug Status, a Global First in Neonatal Care DUARTE, Calif., April 30, 2026 /PRNewswire/ -- A landmark clinical trial published in the Journal of Perinatology has resolved a long-standing dilemma facing Japan's neonatal clinicians: how to provide the critical early nutrition that extremely premature infants need for growth and neurodevelopment while maintaining the country's exceptionally low rate (<2%) of necrotizing enterocolitis (NEC), an often fatal intestinal disease. The answer, the study found, lies in feeding these fragile infants Prolacta Bioscience's 100% human milk-based fortifiers, versus Japan's standard practice of avoiding or markedly delaying cow milk-based fortifiers (CMBF) due to the known risk of NEC and other complications. Across 11 Japanese neonatal intensive care units (NICUs), the JASMINE randomized trial found that early fortification with Prolacta's fortifiers delivered significantly faster growth (weight gain 14.30 ± 2.86 vs. 11.96 ± 3.08 g/kg/day, p < 0.0001, PPS) and earlier achievement of full feeds (20.0 vs. 25.9 days; p = 0.03), with fewer days on antibiotics (adjusted p = 0.002), while demonstrating a safety profile consistent with Japan's standard of care.1 A Clinical Trade-off and Dilemma: World-Class Survival, Sometimes at the Cost of Growth and Neurodevelopment Japan is a world leader in preterm infant survival, with 80–90% of infants born at 22–24 weeks' gestation surviving to discharge.2,3 But those outcomes came with an unintended cost. Inadequate nutritional intake potentially left vulnerable infants without the nutritional support essential for growth and brain development. "There is great hesitancy to feed and fortify infants with cow milk-based products early. In Japan, a practice has become widespread of not feeding infants until the mother's own milk becomes available, and this delay can subsequently impair infant growth and neurodevelopment," said lead author Katsumi Mizuno, MD, PhD, Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan. "In addition, there is a tendency to avoid the use of cow milk-derived human milk fortifiers in very low birth weight infants with a history of gastrointestinal surgery, which may likewise compromise growth and development. With the results of this trial and the release of the human milk-based fortifier drugs in Japan, Japanese doctors will no longer have to compromise nutrition for safety." "Japan's clinicians recognized that better growth today has direct implications for neurodevelopment, cognitive outcomes, and quality of life for their most fragile infants," said Melinda Elliott, MD, FAAP, neonatologist and chief medical officer at Prolacta. "Dr. Mizuno began by requesting Prolacta's products for compassionate use and has created a pathway that ensures Japanese infants don't just survive but thrive." The Role of Human Milk Fat in Early Brain Development Human milk contains intact milk fat globules (MFGs) that are essential for delivering brain-critical fats and nutrients that support neurodevelopment in premature infants.4 Prolacta's human milk-derived fat modular, Prolact CR®, played a central role in the JASMINE protocol. More than 95% of the infants in the human milk arm of the JASMINE study received Prolact CR, which is composed of 25% human milk fat and maintains the intact human MFG. Prolact CR was shown in a separate study to significantly increase weight and length velocity in very low birth weight infants.5 In addition to intact MFGs, all of Prolacta's nutritional products contain a wide spectrum of human milk oligosaccharides (HMOs), the third-most-abundant component in human milk after lactose and lipids.6 Compared to cow milk-based products, Prolacta's fortifiers contain significantly higher concentrations of beneficial bioactive components like immunoglobulin A and epidermal growth factor.7 Better Growth for Neurodevelopmental Support, Without Compromising Safety The Japanese-led JASMINE trial was a randomized, controlled, open-label, multicenter study that evaluated the use of Prolacta's human milk-based feeding protocol in comparison to the Japanese Standard Diet, with a common practice to withhold or delay CMBF to avoid complications. Key findings: Infants fed an Exclusive Human Milk Diet (EHMD) demonstrated significantly better weight gain velocity (13.44 vs. 11.96 g/kg/day, p = 0.006), compared to infants fed the Standard Diet (in the ITT set).1 In the per protocol set (PPS), the EHMD group demonstrated an even greater difference in weight gain compared to the Standard Diet group (14.30 vs. 11.96 g/kg/day, p < 0.0001).1 Infants fed an EHMD also demonstrated significantly better length gain velocity compared to infants fed the Standard Diet (0.85 vs. 0.66 cm/week, p ≤ 0.0016, PPS).1 Infants in the EHMD group experienced a significantly lower number of days on antibiotics (adjusted p = 0.002) compared to the Standard Diet group.1 Infants in the EHMD group achieved clinically appropriate feeding volumes faster (20.0 vs. 25.9 days, p = 0.03).1 The EHMD demonstrated a safety profile consistent with neonatal expectations in Japan.1 Though randomized, the EHMD group included twice as many infants born at 22–23 weeks' gestation, 10 infants vs. five, compared to the Standard Diet group,1 making the findings even more meaningful. The JASMINE protocol included Prolact CR fat modular, Prolact+6® and Prolact+8® human milk-based fortifiers. All three products are marketed under the prescription drug name PreemieFort® Enteral Solution in Japan. A Growing Body of Evidence Links Early Human Milk-Based Fortification to Improved Neurodevelopment Because the brain is growing at its most rapid pace, the nutrition premature infants receive in the first days and weeks of life can shape their long-term neurodevelopment.8-10 A growing body of evidence links Prolacta fortifiers with improved neurodevelopment and better long-term outcomes for premature infants: A 2025 multicenter study across 13 Southern California NICUs (1,000+ infants) found premature infants who received Prolacta's Exclusive Human Milk Diet were significantly less likely to have motor skill delays by age 3, compared with infants fed a non-EHMD, despite the infants in the EHMD arm being born three weeks earlier and weighing more than 300 grams less at birth.11 A 2022 study found that infants fed Prolacta's EHMD had significantly higher cognitive scores and a trend toward improved language scores at 18–22 months corrected age, compared to those fed cow milk-based products.12 Clinical findings also show premature infants fed Prolacta's EHMD reached the same healthy growth and developmental milestones by age 2 seen in full-term infants.8 JASMINE study data drove Japan's landmark decision to approve Prolacta's human milk-based fortifiers as prescription drugs for premature and post-surgical infants, making them the first human milk-based nutritional products to receive drug-level designation anywhere in the world. About Prolacta Bioscience Prolacta Bioscience® is the global leader in human milk-based nutrition, dedicated to improving health outcomes for critically ill and premature infants. More than 125,000 vulnerable infants worldwide have benefited from Prolacta's human milk-based fortifiers and formulas since 2006.13 In a global first, Japan granted prescription drug status to Prolacta's PreemieFort® fortifiers in late 2025 for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart disease, and those recovering from gastrointestinal surgery at risk for poor growth. Prolacta adheres to the industry's strictest quality and safety standards, operating pharmaceutical processing facilities and applying more than 20 donor milk screening tests. Its use of vat pasteurization inactivates pathogens while keeping human milk closer to its natural state than other human milk processing methods, preserving the bioactive components of human milk that support immune protection, brain development, and growth in premature and medically fragile infants.14-16 Prolacta's products have been evaluated in over 30 peer-reviewed clinical studies, demonstrating the short- and long-term health benefits of its patented human milk-based fortifiers and formulas. Learn more online or at X, Instagram, Facebook, TikTok, and LinkedIn. Media Contact: Loren Kosmont [email protected] 310-721-9444 SOURCE Prolacta Bioscience 21% more press release views with Request a Demo

Japan's Ministry of Health, Labour and Welfare (MHLW) Approves PreemieFort® Enteral Solution as Prescription Medicine in the NICU DUARTE, Calif., Feb. 18, 2026 /PRNewswire/ -- Prolacta Bioscience® today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PreemieFort® Enteral Solution, a 100% human milk-based fortifier, as a prescription drug for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. This regulatory milestone was achieved in partnership with the Clinigen Group, which serves as Marketing Authorization Holder and distributor in Japan. PreemieFort is currently marketed under the brand names "Prolact+" in the U.S. and Canada. The landmark regulatory decision validates the critical role of Prolacta's 100% human milk-based fortifiers for the most fragile infants and sets a powerful precedent for neonatal intensive care units (NICUs) worldwide. "Japan's approval of PreemieFort as a prescription drug reflects the strength of the clinical evidence and the pharmaceutical grade processing that stands up to the rigor of Japan's stringent regulatory and quality requirements," said Scott Elster, CEO of Prolacta Bioscience. "The pivotal Japanese clinical study adds to the extensive evidence supporting the benefits of Prolacta's exclusive human milk-based diet for critically ill and fragile premature infants." Clinical evidence generated in Japan from the JASMINE trial ("A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants") informed Japan's world-class Pharmaceuticals and Medical Devices Agency's (PMDA) review. The Japanese-led phase III, randomized, controlled, open-label, multicenter trial evaluated growth and safety associated with Prolacta's 100% human milk-based fortifiers, demonstrating significantly better growth in VLBW infants with no change in morbidity or mortality. Japan is recognized as a global leader in neonatal care, with among the highest preterm survival rates and lowest rates of necrotizing enterocolitis (NEC),1,2 a life-threatening intestinal disease primarily affecting premature infants. By granting pharmaceutical approval to PreemieFort, Japan is affirming that Prolacta's human milk-based fortifiers, free from cow milk, are not simply a nutritional choice but an Rx medicine in the NICU. Japan's approval includes three Prolacta products — PreemieFort Enteral Solution 6, PreemieFort Enteral Solution 8 (Prolact+6 and Prolact+8 human milk-based fortifiers in the U.S. and Canada), and PreemieFort Enteral Solution CF (Prolact CR human milk caloric fortifier in the U.S. and Canada) — which provide concentrated nutrition to support growth by delivering essential calories and nutrients, while retaining the highest level of human milk bioactivity. The approval demonstrates clinical confidence in the benefits and safety of PreemieFort human milk-based fortifiers across a wider range of vulnerable infants with complex nutritional needs. "In the NICU, what we feed our smallest patients can influence their entire life," said Kate Tauber, MD, MA, professor of pediatrics and director of the Human Milk Program at Bernard and Millie Duker Children's Hospital. "Human milk-based fortifiers should be held to the same expectations as other therapies, consistent, tightly controlled, and safe. Prolacta's commitment to pharmaceutical-quality manufacturing requirements helps protect vulnerable infants and supports better outcomes." Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor milk — standards that extend through pharmaceutical grade product manufacturing. Together, these controls earned Japan's prescription drug approval, one of the world's highest regulatory benchmarks. About Prolacta Bioscience Prolacta Bioscience® is the global leader in human milk-based nutrition, dedicated to improving health outcomes for critically ill and premature infants. The company's 100% human milk-based fortifiers and formulas have been used in more than 125,000 vulnerable premature infants worldwide.3 In a global first, Japan granted Prolacta's PreemieFort® fortifiers prescription drug status in late 2025 for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. Prolacta operates pharmaceutical-grade human milk processing facilities and maintains the industry's strictest quality and safety standards, with more than 20 tests to screen donor milk and the use of vat pasteurization to inactivate pathogens and ensure safety. Its vat pasteurization also preserves the bioactive components of human milk that support immune protection, gut development, and growth — benefits that are especially important for premature and medically fragile infants.4-6 Vat pasteurization keeps human milk closer to its natural state than other processing methods, while still ensuring safety. Prolacta has built a secure, independent donor milk supply chain supported by long-term partnerships with thousands of rigorously screened donors, ensuring ample supply to meet NICU demand. Prolacta's products have been evaluated in over 30 peer-reviewed clinical studies, demonstrating the short- and long-term health benefits of its patented human milk-based fortifiers and formulas. Learn more online or at X, Instagram, Facebook, TikTok, and LinkedIn. Media Contact: Loren Kosmont [email protected] 310-721-9444 References Kusuda S, Bennett MV, Gould JB, et al. Comparative analysis of necrotizing enterocolitis in preterm infants born in Japan and born to mothers of Japanese ethnicity in California. Sci Rep. 2025;15:9943. doi:10.1038/s41598-025-92393-y Isayama T. The clinical management and outcomes of extremely preterm infants in Japan: past, present, and future. Transl Pediatr. 2019;8(3):199-211. doi:10.21037/tp.2019.07.10 Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to May 2025. Ozturk G, Paviani B, Rai R, et al. Investigating milk fat globule structure, size, and functionality after thermal processing and homogenization of human milk. Foods. 2024;13(8):1242. doi:10.3390/foods13081242 Liang N, Koh J, Kim BJ, et al. Structural and functional changes of bioactive proteins in donor human milk treated by vat-pasteurization, retort sterilization, ultra-high-temperature sterilization, freeze-thawing and homogenization. Front Nutr. Published online September 15, 2022. doi:10.3389/fnut.2022.926814 Meredith-Dennis L, Xu G, Goonatilleke E, Lebrilla CB, Underwood MA, Smilowitz JT. Composition and variation of macronutrients, immune proteins, and human milk oligosaccharides in human milk from nonprofit and commercial milk banks. J Hum Lact. 2018;34(1):120-129. doi:10.1177/0890334417710635 SOURCE Prolacta Bioscience 21% more press release views with Request a Demo

Clinigen obtained approval for Prolacta's "PreemieFort® Enteral Solution", a human milk-based fortifier, as an approved pharmaceutical product in Japan indicated for the "Nutritional management of neonates and infants presenting with weight gain failure such as very low birth weight (VLBW) infants." The approval was supported by data from the pivotal Japan-based JASMINE Phase III clinical trial, a randomised, open-label, parallel-group comparison study in VLBW infants. This first-of-its kind approval set a new regulatory precedent, bridged innovation to market access gaps, and most importantly, advanced infant care and patient access in a rigorous regulatory environment. LONDON, Feb. 12, 2026 /PRNewswire/ -- Clinigen, the global pathfinder accelerating patient access to critical medicines across the lifecycle, today announces a landmark regulatory achievement in the Japanese market. In a pharmaceutical industry-first, Clinigen K.K., in partnership with Prolacta Bioscience®, has successfully obtained the approval of "PreemieFort® Enteral Solution" as a pharmaceutical product with the Ministry of Health, Labour and Welfare. While regulated as an infant formula in the U.S. and Europe, Prolacta Bioscience's "PreemieFort® Enteral Solution", was successfully approved in Japan as a pharmaceutical product, marking the world's first prescription drug approval for a nutritional fortifier made from human milk. With no existing approved drugs made from human milk, Prolacta's quality and safety standards met Japan's rigorous pharmaceutical standards. Along with Clinigen's leading regulatory expertise, the two companies pioneered, defined, and executed the regulatory architecture to meet the quality, safety and efficacy required for pharmaceutical approval. This success is further made more notable hailing from Japan, a global leader in neonatal care with some of the highest preterm survival rates. Prolacta has appointed Clinigen as its exclusive licensee and Marketing Authorisation Holder in Japan. Fortifiers derived from human milk form part of nutritional strategies for specific patient populations. While the category remains specialised, its continued growth highlights the increasing importance of robust regulatory frameworks to support product safety, quality, and patient access. Clinigen's recent regulatory approval in Japan reflects the company's continued focus on navigating complex regulatory environments to support access to specialised products. Prolacta's "PreemieFort® Enteral Solution" is designed for VLBW infants, and in other neonates and infants in particular if the following conditions indicate failure to gain weight, such as congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. The approval acknowledges the critical role of human milk-based nutrition for these at-risk babies. Extensive clinical data, including the JASMINE Phase III trial, supported Clinigen's regulatory strategy to secure pharmaceutical approval in Japan. "Japan's approval reflects a clear regulatory judgment that this category warrants pharmaceutical-level oversight." Dr. Varun Sethi, CEO, Clinigen commented, "Our role was to work closely with regulators to define a pathway where none previously existed, enabling a human milk-based product such as "PreemieFort® Enteral Solution" to be reviewed and approved to the standards applied to medicines. This ensures that patient access is determined by quality safety, and efficacy, not geography. We took a complex, new science asset and updated its regulatory status in Japan, unlocking a major market for our partner while helping to address the needs of vulnerable infants." Scott Elster, CEO, of Prolacta said: "We are proud to have broken through this regulatory ceiling with our partners at Clinigen. Securing Japan's approval for the world's first human milk-based fortifier as an important medicine in Japan underscores the strength of our pharmaceutical-grade manufacturing, quality systems, and clinical evidence. Clinigen's regulatory expertise, combined with Prolacta's patented human milk-based products, helped make this landmark approval possible, and enables access to more babies in need worldwide." This press release contains information about medicines that are not approved in the relevant territories. Not all products or indications described are available in every market. The intent of this press release is to share pertinent information with the investment community about this collaboration between Clinigen and Prolacta. This communication does not constitute, and should not be construed as, promotion or advertising for any medicine or indication. About Clinigen Clinigen is a global pharmaceutical services company trusted by over 1,000 pharma and biotech partners. With more than 35 years of experience, we accelerate access to critical medicines at every stage of the product lifecycle. As pathfinders, our team of over 1,100 specialists expertly navigate the complexities of clinical trial supply, early access programs, regulatory services, and long-term commercialisation through both licensed and unlicensed pathways. Operating across five continents, we deliver innovative solutions to over 130 countries each year. Whatever the challenge, we find a way. Explore our services at SOURCE Clinigen 21% more press release views with Request a Demo