LungFit PH NO therapy device wins marketing approval in Australia
System approved in US, EU to treat newborns
LungFit PH, a device developed by Beyond Air for administering nitric oxide (NO) therapy, has received marketing approval from the Australian Therapeutic Goods Administration (TGA), which will allow the company to market the device as a Class IIb medical device.
NO causes blood vessels to relax and widen, lowering blood pressure. In the LungFit PH system, NO is indicated to improve oxygen levels and reduce the need for extracorporeal membrane oxygenation — which is a type of artificial life support used when the lungs and heart aren’t functioning correctly — in term and near-term newborns with respiratory failure associated with pulmonary hypertension in conjunction with ventilation or other forms of support.
“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,” Steve Lisi, chairman and CEO of Beyond Air, said in a company press release. “We expect to initiate shipments to Australia in a few months through Getz Healthcare, which is our partner in the Asian Pacific region.”
PH is a chronic disease where high blood pressure in the pulmonary arteries that supply the lungs restricts blood flow to them, limiting oxygen delivery to tissues. This causes the heart to work harder to pump blood, which can lead to heart failure. The disease’s main symptoms include shortness of breath, fatigue, dizziness, and chest pain.
A different approach to PH
Treatment with NO traditionally involves storing the gas in large pressurized cylinders, requiring lots of space. According to Beyond Air, LungFit PH works by generating an unlimited amount of NO from the surrounding air. NO is passed through a filter to remove the toxic substance nitrogen dioxide and is delivered to patients through a ventilator circuit at a low dosage of about 20 parts per million (ppm; ranging from 0.5-80 ppm), consistent with the current standard of care.
“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,” Lisi said.
The device was approved by the U.S. Food and Drug Administration in 2022 and received CE mark approval in the European Union (EU) last year to treat persistent pulmonary hypertension of the newborn (PPHN). In PPHN, a newborn’s pulmonary arteries don’t open up enough, which increases blood pressure, strains the right side of the heart, and reduces oxygen delivery to the body. The EU’s CE mark is a certification that indicates a product meets safety, health, and environmental protection standards.
“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,” Lisi said.
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