Beyond Air seeks FDA OK for new LungFit PH 2 NO device
New model is a transport-ready version of the device approved in 2022
Beyond Air has submitted a supplement application to the U.S. Food and Drug Administration (FDA) for its LungFit PH 2, a second-generation device for administering nitric oxide (NO) to treat persistent pulmonary hypertension of the newborn (PPHN).
LungFit PH 2 is a smaller, lightweight, transport-ready version of the first-generation LungFit PH the FDA approved in 2022. Before the new device can be marketed, the company must ask the FDA to approve any changes that may affect the device’s safety or effectiveness.
“We are pleased to announce that development of our transport-ready LungFit PH II has resulted in a NO system which we believe is far superior to legacy systems currently available in the market,” Steve Lisi, chairman and CEO of Beyond Air, said in a company press release.
PH is characterized by high blood pressure, or hypertension, in the pulmonary arteries, the blood vessels that carry blood from the right side of the heart to the lungs to be oxygenated. In PPHN, a newborn’s pulmonary arteries fail to open sufficiently. This increases blood pressure, puts strain on the right side of the heart, and reduces oxygen delivery throughout the body, which can be life-threatening.
NO is a vasodilator gas for PPHN that lowers blood pressure by widening and relaxing blood vessels. It’s indicated for boosting oxygen and reducing the need for extracorporeal membrane oxygenation, or an artificial heart and lung machine, in term and near-term newborns with lung failure due to PH when combined with ventilation or other forms of support. NO has traditionally been administered to patients using large, bulky, pressurized cylinders, which take up a lot of space in hospitals.
How is the next-gen LungFit PH 2 better?
Leveraging Beyond Air’s patented Ionizer technology, the LungFit PH device is designed to generate NO from the surrounding air, making treatment more convenient. It also features a Smart Filter, which removes toxic nitrogen dioxide, or NO2, from the delivered gas.
Based upon feedback from respiratory therapists across the country, the next generation LungFit PH 2 is about half the weight of LungFit PH. It still has many of the same features, but the new system has simpler operations, longer service intervals, air and ground transport compatibility, and an automated backup system.
“While our first-generation system already delivers key advantages to hospitals, this next-generation device raises the bar with a reduced weight and footprint, simplified operation, longer service interval, and full compatibility with both air and ground transport,” Lisi said. “It also includes an automated backup system that retains most primary system capabilities.”
LungFit PH has been approved in Australia, Thailand, and New Zealand and received CE mark approval in the European Union, a certification that indicates a product meets safety, health, and environmental protection standards. The first-generation device was also recognized as an innovative technology by Vizient, a diverse group of medical providers that works to identify products that have the potential to improve healthcare.
“Once approved, we are confident that the introduction of LungFit PH 2 will play a pivotal role in accelerating our market expansion and advancing our position as a global leader in hospital-based NO delivery,” Lisi said.
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