Beyond Air® Announces LungFit® PH Receives Market Authorization in Australia
Beyond Air (NASDAQ: XAIR) has received market authorization from Australia's Therapeutic Goods Administration (TGA) for its LungFit® PH as a Class IIb medical device. The device generates nitric oxide (NO) from room air for delivery into ventilator breathing circuits at user-set concentrations.
The company plans to initiate shipments to Australia through its Asian Pacific partner, Getz Healthcare, in the coming months. This approval follows the recent CE Mark authorization in the European Union, with additional market approvals expected throughout 2025.
LungFit PH uses patented Ionizer® technology to generate unlimited on-demand NO from ambient air, delivering doses ranging from 0.5 ppm to 80 ppm. The system features a Smart Filter that lasts 12 hours and removes toxic nitrogen dioxide byproducts. Operating with the power equivalent of a 60-watt light bulb, the device eliminates the need for tanks or chemicals, supporting hospital sustainability initiatives by reducing carbon footprint.
Beyond Air (NASDAQ: XAIR) ha ricevuto l'autorizzazione di mercato dalla Therapeutic Goods Administration (TGA) dell'Australia per il suo LungFit® PH come dispositivo medico di Classe IIb. Il dispositivo genera ossido di azoto (NO) dall'aria ambiente per la somministrazione nei circuiti di ventilazione a concentrazioni impostate dall'utente.
La società prevede di avviare le spedizioni per l'Australia attraverso il suo partner Asia-Pacifico, Getz Healthcare, nei prossimi mesi. Questa approvazione segue l'autorizzazione recente del Marchio CE nell'Unione Europea, con ulteriori approvazioni di mercato previste per tutto il 2025.
LungFit PH utilizza la tecnologia brevettata Ionizer® per generare ossido di azoto illimitato su richiesta dall'aria ambiente, fornendo dosi che vanno da 0,5 ppm a 80 ppm. Il sistema dispone di un Filtro Smart che dura 12 ore e rimuove i sottoprodotti tossici di biossido di azoto. Operando con una potenza equivalente a quella di una lampadina da 60 watt, il dispositivo elimina la necessità di serbatoi o sostanze chimiche, supportando le iniziative di sostenibilità degli ospedali riducendo la propria impronta di carbonio.
Beyond Air (NASDAQ: XAIR) ha recibido la autorización de mercado de la Therapeutic Goods Administration (TGA) de Australia para su LungFit® PH como dispositivo médico de Clase IIb. El dispositivo genera óxido nítrico (NO) a partir del aire ambiente para su entrega en circuitos de ventilación a concentraciones establecidas por el usuario.
La empresa planea iniciar los envíos a Australia a través de su socio en Asia-Pacífico, Getz Healthcare, en los próximos meses. Esta aprobación sigue a la reciente autorización del Marcado CE en la Unión Europea, con más aprobaciones de mercado esperadas durante 2025.
LungFit PH utiliza la tecnología patentada Ionizer® para generar NO ilimitado bajo demanda a partir del aire ambiente, entregando dosis que varían de 0.5 ppm a 80 ppm. El sistema cuenta con un Filtro Inteligente que dura 12 horas y elimina los subproductos tóxicos de dióxido de nitrógeno. Funcionando con una potencia equivalente a la de una bombilla de 60 vatios, el dispositivo elimina la necesidad de tanques o productos químicos, apoyando las iniciativas de sostenibilidad de los hospitales al reducir su huella de carbono.
비욘드 에어 (NASDAQ: XAIR)는 호주의 의약품관리청(TGA)으로부터 LungFit® PH의 2b등급 의료기기로 시장 승인을 받았습니다. 이 장치는 실내 공기에서 질소 산화물(NO)을 생성하여 사용자가 설정한 농도로 인공호흡기 호흡 회로에 전달합니다.
회사는 향후 몇 달 내에 아시아 태평양 파트너인 게츠 헬스케어를 통해 호주로의 배송을 시작할 계획입니다. 이 승인은 유럽연합에서 최근에 CE 마크 승인을 받은 후 이루어진 것이며, 2025년까지 추가적인 시장 승인이 예상됩니다.
LungFit PH는 특허 받은 아이오나이저(Ionizer®) 기술을 사용하여 주변 공기에서 무제한의 질소 산화물(NO)을 필요에 따라 생성하며, 0.5 ppm에서 80 ppm에 이르는 용량을 제공합니다. 이 시스템은 12시간 동안 지속되는 스마트 필터가 장착되어 있으며, 유독한 이산화질소(byproducts)를 제거합니다. 60와트 전구에 해당하는 전력으로 작동하여, 탱크나 화학물질의 필요성을 없애고 탄소 발자국을 줄임으로써 병원의 지속 가능한 발전 이니셔티브를 지원합니다.
Beyond Air (NASDAQ: XAIR) a reçu l'autorisation de mise sur le marché de la Therapeutic Goods Administration (TGA) d'Australie pour son LungFit® PH en tant que dispositif médical de classe IIb. Le dispositif génère de l'oxyde nitrique (NO) à partir de l'air ambiant pour être délivré dans des circuits de ventilation à des concentrations définies par l'utilisateur.
L'entreprise prévoit de commencer les expéditions vers l'Australie par l'intermédiaire de son partenaire Asie-Pacifique, Getz Healthcare, dans les mois à venir. Cette approbation fait suite à l'autorisation récente du marquage CE dans l'Union européenne, avec d'autres approbations de marché attendues tout au long de l'année 2025.
LungFit PH utilise la technologie brevetée Ionizer® pour générer de l'oxyde nitrique illimité à la demande à partir de l'air ambiant, avec des doses allant de 0,5 ppm à 80 ppm. Le système est doté d'un filtre intelligent qui dure 12 heures et élimine les sous-produits toxiques de dioxyde d'azote. Fonctionnant avec une puissance équivalente à celle d'une ampoule de 60 watts, le dispositif supprime le besoin de réservoirs ou de produits chimiques, soutenant les initiatives de durabilité des hôpitaux en réduisant leur empreinte carbone.
Beyond Air (NASDAQ: XAIR) hat die Marktgenehmigung der Therapeutic Goods Administration (TGA) Australiens für das LungFit® PH als medizinisches Gerät der Klasse IIb erhalten. Das Gerät erzeugt Distickstoffmonoxid (NO) aus Raumluft zur Abgabe in Beatmungszirkeln bei vom Benutzer festgelegten Konzentrationen.
Das Unternehmen plant, in den kommenden Monaten Lieferungen nach Australien über seinen Partner in Asien-Pazifik, Getz Healthcare, zu starten. Diese Genehmigung folgt der kürzlichen CE-Kennzeichnungsgenehmigung in der Europäischen Union, weitere Marktgenehmigungen werden für 2025 erwartet.
LungFit PH verwendet die patentierte Ionizer®-Technologie, um unbegrenztes, bedarfsgerechtes NO aus der Umgebungsluft zu erzeugen, mit Dosen von 0,5 ppm bis 80 ppm. Das System besitzt einen Smart Filter, der 12 Stunden hält und giftige Stickstoffdioxidnebenprodukte entfernt. Mit einer Leistung, die der einer 60-Watt-Glühbirne entspricht, beseitigt das Gerät die Notwendigkeit für Tanks oder Chemikalien und unterstützt die Nachhaltigkeitsinitiativen von Krankenhäusern, indem es den CO2-Fußabdruck reduziert.
- Received TGA market authorization in Australia for LungFit PH
- Recent CE Mark approval in European Union
- Additional market approvals expected throughout 2025
- Eliminates need for NO tanks and chemicals, reducing operational costs
- Supports hospital sustainability initiatives
- Shipments to Australia not yet initiated
- to 12-hour filter life requiring regular replacements
Insights
The Australian TGA authorization for LungFit PH marks a pivotal milestone in Beyond Air's commercialization strategy, particularly significant for a company with a
The device's innovative approach to generating nitric oxide from ambient air addresses several critical market pain points:
- Elimination of expensive compressed gas cylinders and associated logistics
- Reduced storage requirements and safety concerns in hospitals
- Lower environmental impact through elimination of cylinder transport and disposal
- Consistent 12-hour filter life regardless of usage, improving operational efficiency
The partnership with Getz Healthcare, a well-established distributor in the Asia-Pacific region, provides Beyond Air with an immediate distribution network and local market expertise. The Australian medical device market, valued at approximately
The company's strategic approach of securing approvals in major markets while simultaneously building distribution partnerships suggests a well-structured global rollout plan. With additional market approvals expected throughout 2025, Beyond Air is positioning itself for potential revenue acceleration. The technology's sustainability benefits, including minimal power consumption equivalent to a 60-watt bulb, align with increasing hospital focus on environmental initiatives, potentially driving adoption in environmentally conscious markets.
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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