Beyond Air® Announces LungFit® PH Receives Market Authorization in Australia
GARDEN CITY, N.Y., Jan. 24, 2025 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today 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.
Potential customers can visit the LungFit PH website, www.lungfitph.com, for additional information, including the product label, and to sign up for updates.
About Beyond Air®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM) among others. Also, the Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
About LungFit®*
Beyond Air’s LungFit is a cylinder-free, phasic flow generator and delivery system and has been designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.
* Beyond Air’s LungFit PH is approved for commercial use in the United States of America, European Union, Australia and New Zealand. Beyond Air’s other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.
About Nitric Oxide
Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
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