FDA Approves First Human Milk-Based Fortifier for Term Infants to Support Growth and Recovery Following Surgery for Gastroschisis
MWN-AI** Summary
On February 25, 2025, Prolacta Bioscience announced that the U.S. Food and Drug Administration (FDA) has approved Surgifort®, the world's first human milk-based fortifier specifically designed for term infants recovering from gastroschisis surgery. Gastroschisis is a serious congenital defect where the intestines protrude through the abdominal wall, requiring surgical intervention. Although fewer than 2,400 infants are diagnosed with this condition annually in the U.S., the approval of Surgifort offers significant nutritional support tailored to these critically ill babies.
Surgifort fortifier is a concentrated liquid product that combines human milk-derived protein, carbohydrates, and fats, as well as essential minerals. When mixed with human milk and administered in appropriate volumes, it helps meet the high macronutrient needs of these infants, aligning with the guidelines established by the National Academy of Medicine. Clinical studies indicate that utilizing Surgifort can enhance weight gain velocity in infants recovering from surgery, thereby promoting healthier growth and a faster return to full feeds.
Scott Elster, CEO of Prolacta, emphasized the fortifier's critical role in addressing the unique nutritional challenges facing term infants, signaling a crucial advancement in specialized human milk-based nutrition. With the introduction of Surgifort, Prolacta extends its commitment to developing nutritional solutions for babies with complex medical needs, solidifying its position as a leader in human milk-based products.
Dr. Melinda Elliott, the chief medical officer at Prolacta, noted that clinicians now have access to an effective nutritional option that both promotes recovery and supports overall health in this vulnerable population. This breakthrough underscores the potential benefits of human milk in enhancing pediatric care for surgical infants.
MWN-AI** Analysis
The FDA’s approval of Prolacta Bioscience’s Surgifort®, the first human milk-based fortifier specifically designed for term infants recovering from gastroschisis surgery, represents a significant advancement in neonatal nutrition. This fortifier is crucial as it collectively addresses the nutritional deficiencies faced by the roughly 2,400 U.S. infants born annually with this condition.
From a market perspective, Prolacta stands to benefit because Surgifort enhances the company’s existing portfolio of human milk-based products, targeting a previously underserved niche. The focus on a specialized population not only positions Prolacta as a leader in human milk nutrition but also as a pioneering entity in a specialized healthcare segment that demonstrates rising demand for tailored health solutions.
Investors should closely monitor Prolacta’s performance and market penetration, particularly in pediatric and neonatal intensive care units. With growing recognition of the health benefits associated with human milk nutrition, including improved growth and recovery outcomes for infants, the potential for increased adoption among healthcare providers is high. Prolacta’s commitment to stringent quality and testing procedures strengthens its reputation, thus attracting more healthcare partnerships and driving sales.
Moreover, this approval may catalyze further research and development within the human milk fortification market, prompting competitors to innovate in nutritional support for term and preterm infants. As the market continues to evolve, investors should consider the implications of expanding product lines and competitive dynamics.
In summary, Prolacta's Surgifort® presents promising growth potential, not only through its unique position aimed at enhancing infant recovery post-surgery but also by setting a precedent for future developments in nutritional solutions within neonatal care. Investors should evaluate these dimensions as they assess Prolacta’s long-term outlook and market strategy.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
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 worldwide 5 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
Lkosmont@prolacta.com
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 .
SOURCE Prolacta Bioscience
FAQ**
How does the approval of Surgifort® by the FDA enhance the competitive positioning of Prolacta Bioscience compared to other nutritional products, specifically regarding Douglas Emmett Inc. (DEI)?
What financial impacts could the introduction of Surgifort® have on Prolacta Bioscience's revenue growth, especially in relation to hospital partnerships like those with Douglas Emmett Inc. (DEI)?
Considering the small patient population of gastroschisis, what is Prolacta's strategy to increase adoption of Surgifort® among healthcare providers and institutions associated with Douglas Emmett Inc. (DEI)?
How might the approval of Surgifort® influence investor perceptions and stock performance of companies in the human milk-based nutrition sector, including potentially Douglas Emmett Inc. (DEI)?
**MWN-AI FAQ is based on asking OpenAI questions about Douglas Emmett Inc. (NYSE: DEI).
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