Prolacta Bioscience

About Prolacta Bioscience

Prolacta Bioscience operates as a life sciences company focused on the niche market of human milk-based nutrition for critically ill, premature infants in neonatal intensive care units (NICUs).

The company was founded in 1999 by Elena Medo, a serial entrepreneur who identified the unmet need for a human milk-based protein fortifier while running a medical device company that supplied breast pumps to NICUs. At the time, cow's milk protein was the standard for fortifying maternal milk, despite associated health risks for premature infants. Medo secured venture capital to develop the first human milk fortifier, initiating clinical trials to validate its efficacy. She departed in 2008. Since 2006, the company has been led by CEO Scott Elster, whose background in biosciences and finance, including roles at Baxter Healthcare and Deloitte & Touche, has guided the company's growth.

Prolacta's business model centers on processing donated human breast milk into specialized, high-calorie nutritional products. The company sources surplus milk from a network of affiliated milk banks and individual donors, who are compensated for their contributions. This milk undergoes rigorous testing—including for drugs, adulterants, and viruses—and is processed in what the company describes as pharmaceutical-grade facilities. The finished products are then sold to hospitals for in-patient use, with costs often covered by medical insurance or absorbed by the hospital, which may see net savings from reduced patient complications.

The core of Prolacta's offering is its line of 100% human milk-based fortifiers, such as Prolact+ H2MF®, designed to be added to a mother's own milk or donor milk to increase protein and caloric content for very low birth weight infants. Clinical studies have indicated that an exclusive human milk diet using Prolacta's products can lower mortality and reduce the incidence of serious conditions like necrotizing enterocolitis (NEC) compared to diets using cow milk-based products. Recently, Prolacta has expanded its product line, gaining FDA approval in February 2025 for Surgifort®, the first human milk-based fortifier specifically for term infants recovering from gastroschisis surgery.

The company is also venturing into therapeutics, leveraging its expertise in human milk science. A current focus is the development of a drug combining human milk oligosaccharides and beneficial bacteria to restore the gut microbiome in patients who have undergone stem cell transplants, with a Phase 2a clinical trial underway. Prolacta has raised significant capital to fuel its expansion and research, with total funding reported between $83.6 million and $98.7 million.