According to Beyond Air, the FDA has approved the company’s LungFit PH inhaled nitric oxide (iNO) generation and delivery system for the treatment of babies with persistent pulmonary hypertension of the newborn (PPHN). The approval is the first for the company, which is also developing LungFit iNO systems for the treatment of COVID-19 pneumonia, bronchiolitis, and NTM lung infections.
The LungFit technology generates NO for inhalation from ambient air without the need for a gas cylinder, and the version of the system approved for the treatment of PPHN delivers low concentrations of iNO in the range of 0.5 ppm – 80 ppm. According to the company, LungFit PH will be launched broadly next year, but “select hospitals” will have access to the system as of July 2022.
Beyond Air Chairman and CEO Steve Lisi said, “The FDA approval of LungFit PH enables a new era of nitric oxide therapy and marks a pivotal event for Beyond Air as we officially enter the US market. As the first and only approved nitric oxide generator and delivery system, LungFit PH empowers healthcare providers to maximize the efficiency of a hospital when treating PPHN by moving beyond their reliance on traditional, inefficient delivery systems and the associated burdensome logistics and safety requirements.”
Lisi added, “I am immensely proud of the Beyond Air team for navigating a multitude of obstacles over the past five years, especially the last 27 months during the global pandemic, to bring this revolutionary device to market. The approval of LungFit PH validates our patented Ionizer technology and lays out a premarket approval model for our other LungFit platform devices, including LungFit PRO and LungFit GO. We believe that LungFit PH is just the first in a series of our medical devices that, if approved, will become available for treating a wide variety of respiratory diseases as we remain dedicated to our mission of harnessing the power of nitric oxide for all who can benefit from this transformational therapy.”
Read the Beyond Air press release.
