Preterm birth (PTB), defined as birth before 37 weeks, is a serious medical event with potential life-long or lethal consequences for the newborn, especially children born before 32 weeks. The Worldwide Health Organization (WHO) has identified PTB as the leading cause of death among children less than 5 years of age. Globally, over 1 million deaths are attributed to PTB every year. The incidence of PTB varies between 7-12% of all births in advanced economies, with approximately 400,000 premature births every year in the United States.

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Preterm infants are among the most expensive of all pediatric patients since early gestational age correlates with increased neonatal mortality, prematurity-associated medical complications, hospital length of stay, and per individual medical expenditures. According to the March of Dimes, the average cost of a preterm birth in the United States was $65,000 in 2016. See the report here.

These costs become more significant the earlier a baby is born. The average cost of a preterm baby less than 28 weeks approaches $300,000 due to lengthy hospital stays in the NICU and programs to manage potentially debilitating consequences to the newborn.

PTB remains a critical unmet need in obstetrics due to the lack of safe and effective treatments that significantly extend gestation. While available medications (e.g., tocolytics) may delay birth for a few days, such medications have little impact on improving newborn outcomes.