MADELYN'S
MILK
Madelyn's Milk is working to advance the future of neonatal nutrition through High Pressure Processing (HPP) of donor milk. Our goal is to develop and validate a process specifically suited to the unique, fragile needs of NICU environments — built on rigorous safety and nutritional standards for the most vulnerable infants.
The Opportunity
The neonatal nutrition field is increasingly focused on the long-term outcomes of human milk diets for preterm babies. Several research groups have explored high-pressure approaches to pasteurizing human milk, with promising but incomplete results — no published study has yet tested the leading candidate approaches against a full pathogen panel alongside comprehensive nutrient retention data. We believe closing that gap is a meaningful opportunity, and we're building the research to do it.
The Problem
NICUs face a critical, ongoing challenge: ensuring donor milk is both safe and nutritionally complete. Traditional heat-based pasteurization methods are understood to reduce some of milk's beneficial bioactive components, while ensuring a consistent, sterile supply remains a complex logistical and clinical hurdle for clinicians.
The Solution
Madelyn's Milk is developing a validated High Pressure Processing (HPP) protocol for human donor milk, building on and extending previously published and patented research in this space. Unlike heat treatment, HPP applies pressure rather than temperature to inactivate pathogens — and published research suggests certain approaches may better preserve immunoglobulins, enzymes, and other bioactive components essential for infant development. Rigorously validating the most effective approach, against a full pathogen panel and nutrient retention profile, is the core of our current work.
Why Now?
Advancements in neonatal medicine and a growing appreciation for the value of human milk have created real momentum for better donor milk solutions. Hospitals are increasingly interested in alternatives that could improve on traditional milk bank protocols — and we're working to build the evidence base that could bring HPP technology to that conversation. Advancements in neonatal medicine and a growing appreciation for the value of human milk have created real momentum for better donor milk solutions. Hospitals are increasingly interested in alternatives that could improve on traditional milk bank protocols — and we're working to build the evidence base that could bring HPP technology to that conversation. A review of the patent landscape indicates that prior attempts to protect specific high-pressure processing parameters for human milk were not maintained in the U.S. market, suggesting this remains an open space for rigorous, validated innovation.
Path to Validation
We are currently in Phase I.
01
Phase I
Initial comparative study of leading HPP protocol candidates, testing pathogen log-reduction across a full safety-relevant pathogen panel alongside nutrient and bioactive-protein retention.
02
Phase II
Scalability and standardization of HPP protocols.
03
Phase III
Clinical trials and multi-site pilot programs.
04
Phase IV
Regulatory approval and broad-scale NICU integration.
The Ask
We're seeking research partners, clinical collaborators, and institutions interested in helping validate and advance this work. If you're exploring better solutions for donor milk in your NICU or research program, we'd welcome the conversation.
About the Founder
My daughter Madelyn spent her first 30 days in the NICU after being born at 34 weeks. That experience, and the difficulty we later had finding safe donor milk once we brought her home, is what continues to drive this work — I want to help make sure every family facing a similar situation has access to a safe, well-validated donor milk option.