Two Women-Led Startups Look To Solve Baby-Formula Crisis With Synthetic Breast Milk

Though they’re years from FDA approval, Helaina and BioMilq are banking on parents’ willingness to feed their newborns a product developed in a lab

The shortage of baby formula is one problem that Laura Katz and Michelle Egger envisioned when they separately decided to develop synthetic alternatives to breast milk.

Helaina, Katz’s startup, and Egger’s BioMilq have each raised over $20 million from buzzy backers who include, in the case of BioMilq, Bill Gates. Though their products are likely years from FDA approval, the respective 29-year-old founders are confident that their scientific innovations will provide caretakers with healthier alternatives that will be easier for modern families to come by than actual breast milk. The question they need to answer: Will enough parents make the leap to synthetics?

For Katz, the idea for Helaina came at 23, long before parenthood crossed her mind. She had left her global nutrition class at New York University’s Master of Food Science program and boarded the N train, playing Gimlet Media’s Reply-All podcast to distract herself from the packed subway car. It was when the host described a new mom who drove hours and paid dubious internet characters for breast milk to nurse her infant that Katz realized no one had successfully brought to market synthetic breast milk. Katz decided she would be the first. She established Helaina to use precision fermentation — the process of programming yeast to ferment into breast milk protein — to make and market science-made mothers’ milk.

“The shortage is showing us how critical it is to drive innovation in this space, to bring more and better access to parents who need to feed their children with something other than breast milk,” Katz says. “We’re humanizing infant formula and making it close to breast milk in terms of the properties that breast milk brings to the babies who drink it.”

Currently caregivers have the option of feeding infants with naturally pumped breast milk or infant formula, which is cow’s milk that’s scientifically altered to resemble human milk.

Katz has raised $25 million in funding from backers like Spark Capital and Siam Capital. She and her 30-person team operate out of a New York City lab where they experiment with precision fermentation and its uses for infants and elderly consumers. She’s currently in the early stages of clinical trials. Katz declined to offer an estimate of when Helaina will be available to fill infant-nutrition aisles, but she says its debut will stabilize prices, offer caregivers a milk alternative with no time cost and break up the oligopoly of the four companies — Abbott, Nestle, Perrigo and Reckitt Benckiser — which together make up 90% of the U.S. market.

Despite what may be an initial reluctance to suckle their babies with milk made in a test tube, Stefani Bardin, who teaches food technology and design at New York University and Parsons School of Design, says there will be takers. “I think technology can be really helpful in addressing gaps in the food system,” says Bardin, who was one of Katz’s instructors at NYU but has had no contact with her since. “My only concern about these kinds of replacements is that companies [need] to look holistically at the body.” Bardin cites Soylent, a meal-replacement drink that had to recall its product multiple times due to unintended consequences.

From a market standpoint, infant-nutrition companies see small growth, helping to explain the lack of innovation and consolidation in the space. “Synthetic milk could provide a solution,” says Shagun Singh, a director of research at RBC Capital Markets. “I’m sure there could be a future for it.”

BioMilq is another company hoping to capitalize on this vision of the future. With the backing of $25 million from investors like Gates, Novo Holdings and Breakthrough Energy Ventures, Egger, BioMilq’s CEO and cofounder, plans to launch the synthetic human milk in the next three to five years. Rather than ferment yeast, like Helaina does, BioMilq takes breast milk and breast tissue, donated by women in exchange for Target giftcards, and grows human cells that can secrete milk.

BioMilq is technically ready for consumers, Egger says, but it won’t be available until at least 2025 because, like Helaina, it’s undergoing trials. “Infant nutrition hasn’t really interested traditional entrepreneurs and investors because for the last decade or so it was relegated to a women’s issue,” Egger says. “Not anyone off the street can launch an infant-nutrition product, to some extent with good reason. That has locked out innovation because it’s not an easy process to bring a product to market. It requires a lot of capital and scientific expertise.”

When BioMilq gets approval to go to market, Egger will start by selling it directly to consumers at a premium price to compensate for the technology’s high production cost. She believes her product will help women achieve workplace equality without compromising on infant nutrition. “Breast milk is the absolute best source of nutrition,” she says. “The reality is exclusive breastfeeding for most modern families is circumstantially out of reach.”