Apnea of Prematurity - AOP
Breakthrough therapy for preterm newborns suffering from apnea of prematurity (AOP)
Improving Treatment
AOP is treated with caffeine citrate and supplemental oxygen support. Off-label dosing of caffeine (higher than FDA-recommended levels) is common, and supplemental oxygen increases risk.
FDA Breakthrough Designation
On November 4, 2022 the FDA awarded Prapela's Incubator pad and Radiant Warmer with Breakthrough Device Designation. As an adjunctive therapy our device is designed to reduce apneic episodes and improve oxygenation in preterm newborns.
What's Next
* CAUTION— For AOP , the Prapela pad is an investigational device. Limited by Federal law to investigational use. We're conducting a clinical trial to prove the effectiveness and safety of our SVS therapy in preterm newborns with AOP. We are enrolling patients and expect to report our results in 2026.