Incubator Pad for 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 to improve the treatment of AOP. As an adjunctive therapy our device is intended to be the first improvement in the treatment of AOP in over twenty years.
What's Next
* CAUTION—Investigational device. Limited by Federal law to investigational use. We're conducting a clinical trial to prove the effectiveness and safety of our incubator pad with SVS therapy in preterm newborns with AOP. We are enrolling patients and expect to report our results in 2026.