smallTalk

smallTalk® is a seed stage technology startup developing the first intervention to improve brain development in preterm infants. Each year, nearly 400,000 U.S. infants are born preterm, with millions more worldwide. These children face heightened risks of neurodevelopmental outcomes. Many of the neurodevelopmental issues stem from the neonatal intensive care unit (NICU) environment itself. A key element that is compromised in the NICU is “infant-directed speech”. Such speech is vital for brain development, with preterm infants showing better neurobehavioral and language outcomes with increasing levels of exposure. Yet fewer than 20% of parents can interact daily with their NICU infant due to socioeconomic and other barriers, making reliance on parental visits insufficient. With the support of a $2.5M NIH grant, smallTalk has developed the first medical device designed to improve brain development in preterm infants. Our ACTIVE Egg System includes our voice recording app, the NICU Egg speaker (designed specifically for use in the NICU) and the Paci™ sensor, which fits into a NICU pacifier to communicate suck strength data to the speaker. During a therapy session, the sensor equipped pacifier is used by the baby to enable active interaction with the recorded voice. The speaker sets and adjusts an individualized threshold of suck strength, communicating wirelessly with the sensor. When the threshold is met, the baby is rewarded with ten seconds of maternal voice. In published feasibility studies, this active learning therapy has resulted in significant improvement in speech sound processing, a biomarker associated with speech, language and neurodevelopmental outcomes. Sessions are conducted once daily for two weeks by a nurse or therapist, making it simple to implement in NICU’s from Level II to Level IV. The Active Egg will be available when cleared for sale by the FDA.