LungFit PH

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.

Product progress

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 Q1 2020 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