FDA approves Surgifort human milk-based fortifier for term infants after gastroschisis surgery

FDA approves Surgifort human milk-based fortifier in term infants after gastroschisis surgery | Image Credit: © Calin - © Calin - stock.adobe.com.

The FDA has approved the first human milk-based nutritional fortifier indicated for term infants, with the approval of Prolacta Bioscience's Surgifort, according to a press release from the company.

The human, pasteurized fortifier is indicated for term infants at or older than 37 weeks, following corrective surgery for the gastrointestinal disorder gastroschisis.

Gastroschisis, a birth defect that causes the intestines and sometimes other organs to protrude through the abdominal wall, results in infants requiring high macronutrient intake for optimal growth.

The newly-approved fortifier is "specifically formulated to deliver optimal protein and calories to promote growth," stated Prolacta. "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," the company said.

Surgifort is a pasteurized, concentrated, liquid human milk-based product that contains calories, protein, fat, and carbohydrates, all derived from donated human milk and added minerals.

"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 in a statement.

"Surgifort fortifier extends the benefits of Prolacta's Exclusive Human Milk Diet beyond premature infants to this fragile surgical population," said Elliott.

According to Prolacta, and 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).

"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," added Scott Elster, CEO of Prolacta. "This advances our commitment to develop human milk-based nutritional solutions for infant populations with complex medical needs."

Reference:

FDA Approves First Human Milk-Based Fortifier for Term Infants to Support Growth and Recovery Following Surgery for Gastroschisis. Prolacta Bioscience. Press release. February 25, 2025. Accessed February 25, 2025. https://www.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