ByHeart Completes Largest US Clinical Trial for a New Infant Formula Brand in the Last 25 Years Supporting their Innovation in Baby Nutrition

June 02, 2021

NEW YORK, June 2, 2021 /PRNewswire/ -- ByHeart, a new-to-market baby nutrition company announced that it has completed the largest infant formula clinical trial for a new brand in the last 25 years and is on track to become the 4th fully-integrated, FDA-registered, US-based infant formula brand in the country.  Backed by an impressive Scientific Advisory Board and the industry's leading breast milk researchers, nutrition scientists and pediatricians, ByHeart is the first new infant formula company in decades to build its manufacturing facility. Their clinical study meets FDA's rigorous requirements for Infant formula, but also studies how nutrition impacts baby's holistic health and development as an extended arm of the trial - results will be released in the coming months. This fall, bolstered by a team that includes quality and regulatory experts that have spent their careers in infant formula, ByHeart expects to launch its small batch recipe infant formula, which uses breast milk as a blueprint to offer next-generation baby nutrition.

ByHeart was founded by Ron Belldegrun and Mia Funt, siblings dedicated to transforming the baby nutrition category. Together they formed a team of the world's foremost experts at the forefront of immune, microbiome, cognitive and digestive health. Belldegrun and Funt, as parents of young children, were inspired by modern advancements in nutrition science and decades of breast milk research, both of which have outpaced innovation in the infant formula space. Using this advanced research, the team developed a proprietary blend of the highest quality ingredients designed to deliver the holistic health benefits of breast milk.

"Breast milk is the most natural and most functional first food - it is nature's gold standard, but it doesn't always work for all parents, or at least not all the time. We developed a proprietary protein blend because we believe proteins are the key to most closely mirroring breast milk in order to support a strong immune system, a healthy gut microbiome and easy digestion," says Belldegrun. "Nutrition science has meaningfully developed to support the importance of good fats in early development, and we are expected to be the first US formula made with grass-fed, organic whole milk from farms that strive for regenerative practices.  We hand-pick every ingredient because innovating in this category doesn't just mean incremental improvements. We are actually changing the standard of what an infant formula recipe should be."

There is currently a limited supply chain in the infant formula space, as only four companies in the US produce infant formula - three of which own approximately 90% of the market. New companies wanting to enter the space have had to go through a single contract manufacturer who manages the process from start to finish. Belldegrun and Funt chose to forego this traditional route, and instead acquired and upgraded a US manufacturing facility in Reading, PA to accommodate full in-house R&D capabilities, direct highest quality sourcing, and ensure complete oversight of rigorous preventative safety measures. By controlling ingredients and process, ByHeart can evolve their formulas more quickly and effectively to meet babies' needs.

The ByHeart team also cultivates more direct and dynamic relationships: they work directly with their suppliers to carefully consider and hand-select every ingredient. Their proprietary small batch blending process  ensures the integrity and functional benefits of the ingredients are maintained at highest quality levels.

"Ron and I are both parents and have faced the struggles that come with feeding firsthand – as every parent does. Our goal has always been to marry our personal experience with scientific leadership to change the landscape and provide better feeding options. Our team is dedicated to transforming a category by building something truly new, and more importantly, something that gives parents confidence in the food they are giving their babies – in every ingredient," says Funt. "We will be rolling out programs and initiatives that provide health and wellness education and empower all parents by giving them access to resources and experts who can support them through each and every feeding moment."

ByHeart's infant formula is expected to be available exclusively on byheart.com later this year.