Beyond Air previously gained clearance from the US FDA and European CE Mark approval for the system. Credit: MacroEcon/Shutterstock.

The Australian Therapeutic Goods Administration (TGA) has granted authorisation to market Beyond Air’s LungFit PH as a Class IIb medical device.

This device delivers a steady concentration of nitric oxide (NO), a vasodilator, into the inspiratory limb of the patient’s ventilator circuit.

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Reputed to be the first device in the LungFit therapeutic platform, the system utilises the company’s patented Ionizer technology.

The technology behind the device involves a compressor that drives room air through a plasma chamber, where electrical discharge pulses create ionisation of nitrogen and oxygen molecules to form NO.

A Smart Filter is also included in the system that removes nitrogen dioxide from the internal circuit. Lasting 12 hours, the Smart Filter can be replaced rapidly.

The sustainable aspect of LungFit PH is notable as it produces NO from ambient air without the need for tanks or chemicals, making it energy efficient and environmentally friendly.

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It supports hospital sustainability initiatives by minimising emissions associated with transport and cylinder refills.

For the approved indications, the device delivers NO dosages in line with the current standard of care, offering a range of 0.5 parts per million (ppm) to 80ppm for ventilated patients.

Beyond Air CEO and chairman Steve Lisi said: “We are excited to have the opportunity to introduce our revolutionary LungFit PH system to hospitals in Australia following this market authorisation by the TGA. We expect to initiate shipments to Australia in a few months through Getz Healthcare, which is our partner in the Asian-Pacific region.

“We expect additional market approvals to be granted throughout 2025 and to add to our global partner network.”

Previously, the device gained clearance from the US Food and Drug Administration (FDA) and European CE Mark approval.