Beyond Air, a commercial-stage medical device and biopharmaceutical company focused on nitric oxide (NO) therapies, announced that its LungFit PH device has received market authorisation from the Australian Therapeutic Goods Administration (TGA).
The device is classified as a Class IIb medical device and is designed to deliver NO, a vasodilator, to patients through the inspiratory limb of a ventilator circuit.
LungFit PH is the first device within Beyond Air’s LungFit therapeutic platform and utilises the company’s proprietary Ionizer technology.
The device has previously obtained regulatory clearance from the US Food and Drug Administration (FDA) and the European CE Mark, enabling its availability in other key markets.
Beyond Air chairman and CEO Steve Lisi said: “The global LungFit PH story begins now, as we begin to ramp up our commercial activities outside the US so that patients and medical staff in countries around the world will benefit from nitric oxide generated from room air.
“CE Mark in the European Union was granted just two months ago and now approval in Australia has come.
“We expect additional market approvals to be granted throughout 2025 and to add to our global partner network.”
The LungFit PH system generates on-demand NO directly from ambient air, eliminating the need for tanks or chemicals.
The device operates by driving room air through a plasma chamber, where nitrogen and oxygen molecules are ionised to produce NO, with minimal levels of nitrogen dioxide (NO2) as a byproduct. A Smart Filter within the system removes NO2, ensuring safe delivery of NO to ventilated patients.
The device is said to be energy-efficient, requiring power equivalent to a 60W light bulb. By generating NO onsite and avoiding the emissions associated with transportation and cylinder refills, LungFit PH aligns with sustainability initiatives in healthcare.
Designed to deliver low concentrations of NO, LungFit PH offers dosage ranges of 0.5 ppm to 80 ppm, consistent with the current standard of care for ventilated patients. Each Smart Filter lasts 12 hours, and replacing the filter is said to be a quick process, requiring only seconds.
Last month, Beyond Air’s oncology-focused subsidiary, Beyond Cancer, secured approval from the Israeli Ministry of Health to conduct a Phase 1b clinical trial. The trial will assess Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in combination with anti-PD-1 therapy. Patient screening for the trial is scheduled to begin in Q1 2025 across four sites in Israel.
