INVEST Pitch Perfect Spotlight: How One Company Aims To Change Neonatal Feeding

About one in 10 babies in the U.S. are born preterm. And because they have immature organs, they cannot process large volumes of milk. This requires milk to be fortified, often done with cow’s milk, so preterm babies can have nutrient-rich feedings in low volumes. But when Beth Schinkel, co-founder and CEO of Mother’s Milk Is Best, was working in a neonatal intensive care unit (NICU), she saw first-hand the effect cow’s milk had on preterm babies. Human breast milk is recommended for preterm infants.

“I was taking care of babies that were extremely premature,” she said in an interview. “They were born 16 weeks early and they would often get really sick when they were fed cow milk formula. My first career was as a clinical dietitian, and I’ve worked in nutrition and I knew a lot about what we were feeding babies. I didn’t really understand why we were feeding them cow milk fortifiers.”

She started interviewing NICUs across the country and realized there wasn’t a better option. So she began developing one and eventually launched Mother’s Milk Is Best with Co-founder and CTO Elizabeth Nelson in 2014. Last month, judges selected the Tyngsborough, Massachusetts-based company as the winner of the consumer/employer track of MedCity News’ INVEST Pitch Perfect contest. In total, five startups — which all address women’s health — competed in the contest.

Mother’s Milk Is Best has a medical device that increases the ability to use a mother’s milk or a donor’s milk versus other fortification processes. After the mother or donor’s milk is pumped, the device (which looks like a small packet) is put into the milk. It then draws water into the device like a sponge and is removed from the milk. The milk that is remaining has higher nutrients and higher bioactives.

“It leaves everything that’s really good about the milk on the outside. … It’s taking some of the water out of the milk so that instead of adding things to the milk that can make babies potentially sick, we’re going to give them as high of nutrient feedings so that they can grow and thrive,” Schinkel said.

The name Mother’s Milk Is Best comes from the idea that human milk is the best option for preterm babies. However, Schinkel and Nelson noted that there is still a place for alternatives when it comes to term babies.

“For preterm infants, human milk is best and human milk is life-saving,” Schinkel said. “We are not at all focused on term babies. There will always be a need for alternatives for mothers.”

The company is looking to apply for breakthrough designation with the Food and Drug Administration. The FDA’s Breakthrough Devices Program provides patients and healthcare providers with “timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization,” according to the agency’s website. Mother’s Milk Is Best plans to sell its device directly to NICUs and is looking at partnerships with hospital systems, Schinkel said.

The startup is also planning to undergo clinical trials for its device.

“As we go through and develop the product and test the product, we really want to make sure that we see that it’s clinically relevant and evidence-based,” Nelson said.

Mother’s Milk Is Best has received support from investors as well. It has over $2.5 million in grant funding, including from the National Institutes of Health. It also has $111,000 from friends and family.

Samir Batra, managing partner of Health Innovation Pitch and one of the judges of the Pitch Perfect Contest, said Mother’s Milk Is Best was crowned winner because “of the clinical validation from the team that sees the issue daily and the simplicity of the solution.”