Beyond Air has received the US Food and Drug Administration (FDA) approval for its LungFit PH device to treat a type of hypoxic respiratory failure in neonates.

The prescription-only device is indicated for neonates with hypoxic respiratory failure, commonly called persistent pulmonary hypertension of the newborn (PPHN).

PPHN is a severe condition characterised by elevated pulmonary vascular resistance (PVR) leading to labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood.

LungFit PH, part of the company’s LungFit therapeutic platform of nitric oxide (NO) generators, uses  Beyond Air’s patented Ionizer technology.

It is the company’s first FDA-approved product that generates on-demand NO from ambient air for the treatment of term and near-term neonates with hypoxic respiratory failure.

NO gas is a vasodilator approved in many countries worldwide to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in neonates.

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 maximise 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.

“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.”

LungFit PH leverages a compressor to drive the room air through a plasma chamber and generates pulses of electrical discharge between two electrodes.

The system uses power equivalent to a 60W lightbulb to ionize the nitrogen and oxygen molecules, to generate NO with low levels of nitrogen dioxide (NO2) as a by-product.

When the gas generated is passed through a Smart Filter, the toxic NO2 constituent is removed from the internal circuit. A Smart Filter lasts 12 hours despite ventilator demands.

Beyond Air said that its LungFit PH system is designed to deliver NO to the lungs to treat PPHN, at a dosage strength consistent with the current standard of care.

“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.”