Preterm birth is our focus because it is a major determinant of infant mortality and morbidity – this clear, unmet medical need deserves and requires safe and effective treatments

Preterm birth is a serious medical event with lifelong consequences for newborns

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 World 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. For some survivors, the consequences of preterm birth may continue throughout life, impairing neurodevelopmental functioning through increasing the risk of cerebral palsy, learning impairment and visual disorders and affecting long-term physical health with a higher disease burden. 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.

The high cost of pre-term infant care significantly increases the earlier a baby is born

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 compared to an average $5,000 for a non-PTB delivery. 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. Added to this is the life-long additional cost of chronic illness medical expenses and lost wages due to unfulfilled potential.

Safe and effective therapies that prolong gestation are greatly needed

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.