The US Food and Drug Administration (FDA) has approved the LungFit PH system from Beyond Air for the treatment of hypoxic respiratory failure in term and near-term neonates.
The device uses the company’s Ionizer technology to generate unlimited, on-demand nitric oxide using ambient air.
This allows nitric oxide to be provided for the treatment of persistent pulmonary hypertension of the newborn (PPHN) at a dosage strength that is consistent with the current standard of care.
LungFit PH is the first device from Beyond Air’s LungFit therapeutic platform of nitric oxide generators.
It is said to be the company’s first FDA-approved product and eliminates the need for traditional nitric oxide tanks in hospitals.
Nitric oxide gas is a vasodilator that is approved in many countries worldwide to improve oxygenation and reduce the extracorporeal membrane oxygenation (ECMO) needs in neonates.
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LungFit PH uses a compressor to drive air in the room through a plasma chamber where electrical discharge pulses are generated between two electrodes.
It uses power equivalent to a 60W lightbulb to ionise nitrogen and oxygen molecules, generating nitric oxide with low levels of nitrogen dioxide (NO₂) as a by-product.
The gas generated is passed through a Smart Filter to remove the toxic NO₂ from the internal circuit.
The company stated that no matter the ventilator demands, the Smart Filter will last for 12 hours.
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.”