ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation 'Easy to Digest' Infant Formula

January 16, 2022

ByHeart's Randomized, Controlled and Double-Blind Clinical Trial Proved Both Easy Digestion and More Efficient Growth Driven by the formula's Patented Protein Blend, Which Comes Closest to Breast Milk of Any in the Infant Formula Market

NEW YORK, June 16, 2022 /PRNewswire/ -- ByHeart, the next-generation baby nutrition company dedicated to setting a new standard for infant nutrition, today announced the publication of an article in the Journal of Pediatric Gastroenterology and Nutrition entitled, "Effects of a novel high-quality protein infant formula on energetic efficiency and tolerance: a randomized trial." The article highlights data that ByHeart's formula closes the gap between infant formula and breast milk on important outcomes in both growth and easy digestion - a significant and historic breakthrough within this category.

"Breast milk is the gold standard of infant nutrition, and we are better equipped than ever before to leverage the tremendous advancements in breast milk research to create infant formulas that come closer to breast milk, and offer babies both functional nutrition and highest quality, cleanest ingredients," said ByHeart Co-Founder and CEO Ron Belldegrun. "It is incumbent upon infant formula manufacturers to ensure that product innovation and research keeps up with science – for the benefit of babies' future health."

ByHeart, which launched to the commercial market in March 2022, began development of its first infant formula in 2016 and identified the biggest gap between breast milk and other infant formulas on shelf: the protein blend. ByHeart's formula recipe was informed by breast milk research and pediatric nutrition science that demonstrates protein's role in driving all-in-one benefits including easy digestion, immune support, brain and gut health, less spit up, and softer stools. ByHeart recognized the necessity of rewriting the infant formula recipe to develop a first of its kind high-quality protein blend that includes the two key proteins in breast milk – alpha-lactalbumin and lactoferrin – and features an 80:20 whey to casein ratio (incorporating partially hydrolyzed whey), as well as being the first in the US to include organic, grass-fed whole milk (versus skim milk used by other formulas on shelf). ByHeart's protein blend gets closest to breast milk of any formula in the market and drives easy digestion benefits to baby without the use of 'filler' ingredients like corn syrup, maltodextrin, palm oil or soy like so many other "gentle" formulas on shelf.

The company's randomized, double-blind controlled clinical trial, the only one run by a new infant formula entrant in recent years, and the largest by a new infant formula brand in over 25 years, assessed the impact of this protein blend, and evaluated infant growth, safety and tolerance, including healthy, singleton, term infants, enrollment age ≤ 14 days. The national, multi-site clinical trial, which ran for 6 months with over 300 babies, compared ByHeart's formula to both commercial infant formula and a human breast milk reference arm.

 "I am extremely proud of the thoroughness of design and execution of this study, as we went well above the industry standard," explained Dr. Bruce German, an author of the study and a distinguished professor of Food Science and Technology at the University of California, Davis. "The fact that the study was done at all – let alone by a new brand - is also notable, as almost all changes to infant formula these days are done through ingredient additions, thus avoiding a comprehensive trial such as this one."

ByHeart's clinical data demonstrated improved parent-reported gastrointestinal tolerance and more efficient growth with less daily formula and protein intake, supporting that their novel formula may reduce the metabolic burden of protein overfeeding associated with infant formula. ByHeart's trial showed that the formula's composition resulted in more efficient growth, demonstrating the high-quality of the ingredients:

• Mean daily weight gain velocity (g/d) between trial enrollment and 24 weeks was 26.7 (SD = 5.2) in the ByHeart (SF) group and 26.1 (SD = 4.7) in the Commercial Formula (CF)  group.
• Formula intake by weight (oz/kg/d) was estimated to be lower in the SF group (-0.33 oz/kg/d, 95 CI: -0.66, -0.01, p=0.05) than in the CF group, for a decreased protein intake in the SF group of -0.13 g/kg/d (95 CI: -0.26, 0.00, p= 0.05) compared to the CF group
• Energetic efficiency per oz/mL of formula was 14.0% (95 CI: 8.3%, 19.7%), 13.0% (95 CI: 6.0%, 20.0%), and 18.1% (95 CI: 9.4%, 26.8%) higher for weight, length, and HC, respectively, in SF group compared to CF group.
• The combination of the essential and conditionally essential amino acids was greater in the SF group compared to the CF group (p = 0.048)

ByHeart's formula also demonstrated better tolerance (easy digestion) with less spit-up and softer stools, with significantly fewer mean number of spit-ups over time in the SF group compared to the CF group (p= 0.01), and a mean stool consistency softer in the SF group compared to the CF group (mean score difference 0.39, 95 CI 0.27, 0.52, p<0.001). This clinical data shows that infants fed ByHeart's formula exhibit similar outcomes to breastfed infants compared to those fed a commercial formula, with ByHeart's formula offering significant benefit to both digestion and efficient growth in healthy term infants.

Dr. Devon Kuehn, ByHeart's Chief Medical Officer and a neonatologist whose team oversaw the trial's analysis and the development of the published manuscript, explained, "ByHeart was bold in rewriting the recipe for infant formula, and even more progressive as the only new entrant in years to run our own clinical trial in order to provide the reassurance that parents deserve when choosing a product to feed their babies. Infant formula needs real innovation, and it's vital that the category is held to a standard of new research – for every formula on the market – so that we can effectively evolve infant nutrition. We were proud to be awarded publication of this data by the Journal of Pediatric  Gastroenterology and Nutrition, as it represents a significant leap forward for the nutrition provided by easy to digest infant formula."