Hey! We are PremieBreathe, a startup out of Yale University. We have designed and built a fully functional, low-cost prototype of a breathing support device for newborns. Our mission is to address and solve the widespread global health problem of newborn mortality due to breathing insufficiency.
Each year, 1.5 million infants die in the first month of life due to respiratory causes like pneumonia, respiratory distress syndrome, and complications from preterm birth. 99% of these deaths occur in low- and middle-income countries concentrated in Africa and South Asia. While the technology exists in high-income countries like the US to prevent these deaths, commercially available respiratory devices are prohibitively expensive (>$6,000/unit) and inappropriately designed for low-resource settings.
Over two years of prototyping, our team of student and alumni engineers has built a prototype of the gold standard for noninvasive newborn respiratory therapy for just $450, less than 10% of the US commercial price point. The device, a humidified high flow nasal cannula (HHFNC), delivers variable flows of warmed, humidified, and oxygenated air to provide respiratory support for premature and newborn infants. Our design improves upon expensive commercial alternatives by mitigating condensation or "rain-out" at the patient-end of the circuit, reducing complications for the infant. Our device also incorporates an ultraviolet water sterilization mechanism to kill waterborne bacteria.
By incorporating reusable, biofouling-resistant tubing rather than the disposable circuit used in the commercial technology, our breathing aid further reduces annual replacement costs by up to $13,000 per unit. The mobile, compact housing, designed to incorporate a rechargeable battery source, ensures that our device can provide portable oxygen therapy for critically ill newborns in need of undisrupted support, while in transport between hospitals and health centers. Bench-level testing has demonstrated performance and functionality consistent with commercially available HHFNC devices found in neonatal intensive care units across the US.
We have begun working with an industrial design company based in in California to make a few design tweaks to finalize our design for manufacturability. We have also been in contact with a number of international and US-based manufacturers to understand the process and costs associated with a first low-volume build. They have been able to provide for us pricing quotes based solely on the bill of materials and CAD designs our team has generated for our product.
In Ethiopia, where we plan to conduct clinical trials later this year, 29 out of every 1,000 live births do not survive beyond the first 28 days. We estimate PremieBreathe’s respiratory aid has the potential to save up to 10,400 newborn lives annually in that country alone. Globally, we believe our device can help to prevent thousands of newborn deaths associated with prematurity, respiratory distress, and pneumonia, lives that the WHO has stated can be saved with access to low-tech, low-cost care.