Beyond Air® Secures Australian Market Authorization for LungFit® PH

Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, announced that the LungFit^® PH has received market authorization from the Australian Therapeutic Goods Administration (TGA) for sale as a Class IIb medical device to deliver nitric oxide, a vasodilator, generated by the device into the inspiratory limb of the patient breathing circuit of a ventilator in a way that provides a constant concentration of nitric oxide, as set by the user, to the patient throughout the inspired breath.

“We are excited to have the opportunity to introduce our revolutionary LungFit PH system to hospitals in Australia following this market authorization 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,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The global LungFit PH story begins now, as we begin to ramp up our commercial activities outside the U.S. 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.”

LungFit PH, the first device in the LungFit therapeutic platform of nitric oxide generators, leverages the company’s patented Ionizer^® technology and has already received FDA clearance in the United States and European CE Mark approval.

LungFit PH uses Ionizer technology to generate unlimited on-demand NO from ambient air and deliver it to a ventilator circuit, regardless of dose or flow. The device uses a compressor to drive room air through a plasma chamber where pulses of electrical discharge are created between two electrodes. The LungFit PH system ionizes the nitrogen and oxygen molecules, forming NO with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas is then passed through a Smart Filter, which removes toxic NO2 from the internal circuit.

LungFit PH represents a significant step forward in sustainable healthcare solutions. Since the device generates NO conveniently and cleanly from ambient air, without the need for tanks or chemicals, it is highly energy-efficient, using only the power equivalent to a 60-watt light bulb. By eliminating the emissions associated with truck transport and cylinder refills, LungFit PH supports hospital sustainability initiatives, helping facilities reduce their carbon footprint while delivering critical care to patients.

For the approved indications, the novel LungFit PH system is designed to deliver a dosage of NO to the lungs that is consistent with the current standard of care for delivery of 20 ppm NO, with a range of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients. Each Smart Filter will last 12 hours regardless of ventilator demands, and replacing a filter only takes seconds.