LungFit PH* is a portable ventilator-compatible system that utilizes an electric voltage to produce precise quantities of nitric oxide from the nitrogen and oxygen in air. Inhaled nitric oxide is a pulmonary vasodilator, which is approved in the United States for use as part of a regimen in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN). The currently available product, INOMAX®, is used in neonatal intensive care units and its delivery system administers nitric oxide from pressurized cylinders in conjunction with ventilator systems.
In early 2019, Circassia’s partner, BeyondAir, successfully completed a pre-submission meeting with the US Food and Drug Administration (FDA). BeyondAir anticipates submitting a Premarket Approval application in Q4 2019 for LungFit PH for use in the treatment of hypoxic respiratory failure associated with PPHN.*LungFit PH is not an approved name for the product and may not be the final name submitted for approval