ByHeart, a baby nutrition company, has secured $90 million in Series B funding, coinciding with the successful completion of its multicenter clinical trial involving 311 infants. The trial, designed to evaluate ByHeart's new infant formula, met all primary and secondary endpoints, marking a significant milestone for the company.
The funding round was led by D1 Capital Partners, with participation from OCV Partners, Polaris Partners, Bellco Capital, Two River, Red Sea Ventures, AF Ventures, and Gaingels. This investment will be used to support the launch of ByHeart's first infant formula and to further develop its pipeline of products for mothers and babies.
Clinical Trial Details
ByHeart's clinical trial, the largest conducted by a new US infant formula brand in over 25 years, was designed to meet and exceed FDA requirements. A notable aspect of the study was the inclusion of a breastfed reference arm, an elective addition that will provide valuable comparative data. According to ByHeart, this comprehensive approach underscores their commitment to advancing infant nutrition science.
"Five years ago, we set out to build a company that would transform baby nutrition with products and resources grounded in breakthrough nutrition science and breast milk research," said Ron Belldegrun, co-founder of ByHeart. "When we discovered that much of the industry was still relying on existing research as opposed to conducting new, more comprehensive clinical trials, we knew that true innovation would require starting from scratch and building entirely from the ground up."
Market Context and Future Plans
ByHeart aims to address a $70 billion global market by modernizing the nourishment continuum from pregnancy through early childhood. The company emphasizes next-to-nature quality, leading nutrition science, and ingredient transparency. Their integrated approach includes ownership of the entire manufacturing process, ensuring control over ingredient sourcing and production.
ByHeart launched Cluster in June 2021, a digital platform offering resources and education to support parents in their feeding decisions from pregnancy through toddlerhood. The company's focus extends beyond formula to encompass a broader range of products and services aimed at supporting parents and improving infant nutrition.
