FDA Approves Prolacta Bioscience’s Surgifort for Infants Recovering from Gastroschisis Surgery

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The FDA has approved Prolacta Bioscience’s Surgifort human milk fortifier, making it the first human milk-based fortifier specifically designed for term infants recovering from gastroschisis surgery. According to the company, Surgifort, which is 100% derived from human milk, provides concentrated protein and calories to help meet nutritional targets recommended by the National Academy of Medicine.¹

"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, Prolacta, in a press release. "This advances our commitment to develop human milk-based nutritional solutions for infant populations with complex medical needs."

According to Prolacta, clinical data has demonstrated that Surgifort fortifier improves weight gain (33.3 g/day) and reduces time to full feeds when included as part of an exclusive human milk diet. The company added that despite a small patient population affected by gastroschisis, the milk was developed with the purpose of addressing an unmet need in neonatal nutrition.¹

According to Cincinnati Children’s Hospital, the prevalence of gastroschisis has increased in recent years, despite its status as a rare birth defect, with an estimated prevalence rate of one in every 2,000 babies. Gastroschisis develops between the fourth and eighth weeks of pregnancy, resulting from weaknesses in a baby’s abdominal wall muscles near the umbilical cord. Gastroschisis is usually discovered between 18 and 20 weeks of pregnancy via ultrasound.

In addition to the complications associated with gastroschisis, 10% of babies born with it will experience further bowel development issues. This will result in the need for a bowel resection, colostomy bag, intestinal transplantation, and can also result in short bowel surgery.²

According to the Centers for Disease Control and Prevention (CDC), the risk of gastroschisis increases when expectant mothers are at a younger age, alcohol or tobacco is used early in the pregnancy, and if a urinary tract or sexually-transmitted infection is found in early pregnancy.³ The CDC reported that between 1995 and 2012, the biggest increases in gastroschisis were reported in babies born of mothers under 20 years of age. Between 2011 and 2015, prevalence was 4.5 per 10,000 live births, 10% higher than the time between 2006 and 2010.

The CDC stated that the increase is a result of an increased exposure to opioids during pregnancy. Despite mothers under 20 years of age having the highest prevalence, data show that significant increases were found in mothers between 25 and 29 years of age and over 30 years of age. Further, gastroschisis prevalence was higher among non-Hispanic White mothers and Hispanic mothers than among non-Hispanic Black mothers in most age groups.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, chief medical officer, Prolacta, in the press release. "Surgifort fortifier extends the benefits of Prolacta's Exclusive Human Milk Diet beyond premature infants to this fragile surgical population."

References

1. FDA Approves First Human Milk-Based Fortifier for Term Infants to Support Growth and Recovery Following Surgery for Gastroschisis. PR Newswire. February 25, 2025. Accessed February 25, 2025. https://prnmedia.prnewswire.com/news-releases/fda-approves-first-human-milk-based-fortifier-for-term-infants-to-support-growth-and-recovery-following-surgery-for-gastroschisis-302384191.html

2. Gastroschisis. Cincinnati Children’s Hospital. Accessed February 25, 2025. https://www.cincinnatichildrens.org/health/g/gastroschisis#:~:text=This%20condition%20is%20relatively%20rare,muscles%20near%20the%20umbilical%20cord.

3. Gastroschisis. CDC. Accessed February 25, 2025. https://www.cdc.gov/birth-defects/about/gastroschisis.html

4. Gastroschisis Trends and Ecologic Link to Opioid Prescription Rates — United States, 2006–2015. CDC. Accessed February 25, 2025. https://www.cdc.gov/mmwr/volumes/68/wr/mm6802a2.htm