Beyond Air Signs New International LungFit PH® Distribution Agreements, Most Notably in Japan
Beyond Air (NASDAQ: XAIR) has expanded its global distribution network for LungFit PH, a medical device that generates nitric oxide from ambient air. The company has signed new distribution agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 34 countries with a combined population of 2.7 billion people.
In Japan, Beyond Air partnered with AMCO Incorporated, a leading medical device distributor with over 70 years of experience. The LungFit PH system eliminates the need for traditional high-pressure cylinders, offering a more efficient and environmentally friendly solution for hospital settings. Hospital tender submissions are currently in progress in several regions while awaiting regulatory approvals in others.
Beyond Air (NASDAQ: XAIR) ha ampliato la sua rete di distribuzione globale per LungFit PH, un dispositivo medico che produce ossido nitrico dall'aria ambiente. L'azienda ha firmato nuovi accordi di distribuzione in Giappone, Corea del Sud, Costa Rica, Guatemala, Panama e El Salvador, portando la copertura internazionale a 34 paesi con una popolazione complessiva di 2,7 miliardi di persone.
In Giappone, Beyond Air ha stretto una partnership con AMCO Incorporated, un importante distributore di dispositivi medici con oltre 70 anni di esperienza. Il sistema LungFit PH elimina la necessità di bombole tradizionali ad alta pressione, offrendo una soluzione più efficiente e rispettosa dell'ambiente per gli ospedali. In diverse aree sono in corso le gare d'appalto ospedaliere, mentre in altre si attende l'approvazione normativa.
Beyond Air (NASDAQ: XAIR) ha ampliado su red de distribución global para LungFit PH, un dispositivo médico que genera óxido nítrico a partir del aire ambiente. La compañía ha firmado nuevos acuerdos de distribución en Japón, Corea del Sur, Costa Rica, Guatemala, Panamá y El Salvador, elevando su cobertura internacional a 34 países con una población combinada de 2,7 mil millones de personas.
En Japón, Beyond Air se asoció con AMCO Incorporated, un destacado distribuidor de dispositivos médicos con más de 70 años de experiencia. El sistema LungFit PH elimina la necesidad de cilindros tradicionales de alta presión, ofreciendo una solución más eficiente y respetuosa con el medio ambiente para entornos hospitalarios. En varias regiones ya se están presentando ofertas para licitaciones hospitalarias, mientras que en otras se esperan aprobaciones regulatorias.
Beyond Air (NASDAQ: XAIR)가 주변 공기에서 일산화질소를 생성하는 의료기기 LungFit PH의 글로벌 유통망을 확장했습니다. 회사는 일본, 대한민국, 코스타리카, 과테말라, 파나마, 엘살바도르에서 새로운 유통 계약을 체결해 국제적 커버리지를 총 34개국, 인구 합계 27억 명으로 확대했습니다.
일본에서는 Beyond Air가 70년 이상의 경험을 보유한 주요 의료기기 유통업체인 AMCO Incorporated와 협력했습니다. LungFit PH 시스템은 기존의 고압 실린더 필요성을 없애 병원 환경에서 보다 효율적이고 친환경적인 솔루션을 제공합니다. 일부 지역에서는 병원 입찰 제출이 진행 중이며, 다른 지역에서는 규제 승인 대기 중입니다.
Beyond Air (NASDAQ: XAIR) a étendu son réseau de distribution mondial pour LungFit PH, un dispositif médical qui génère du monoxyde d'azote à partir de l'air ambiant. La société a signé de nouveaux accords de distribution au Japon, en Corée du Sud, au Costa Rica, au Guatemala, au Panama et au Salvador, portant sa couverture internationale à 34 pays et une population combinée de 2,7 milliards de personnes.
Au Japon, Beyond Air s'est associé à AMCO Incorporated, un important distributeur de dispositifs médicaux fort de plus de 70 ans d'expérience. Le système LungFit PH supprime le besoin de bouteilles traditionnelles haute pression, offrant une solution plus efficace et respectueuse de l'environnement pour les établissements hospitaliers. Des soumissions pour des appels d'offres hospitaliers sont en cours dans plusieurs régions, tandis que d'autres attendent les autorisations réglementaires.
Beyond Air (NASDAQ: XAIR) hat sein weltweites Vertriebsnetz für LungFit PH ausgeweitet, ein Medizinprodukt, das Stickstoffmonoxid aus der Umgebungsluft erzeugt. Das Unternehmen hat neue Vertriebsvereinbarungen in Japan, Südkorea, Costa Rica, Guatemala, Panama und El Salvador unterzeichnet und deckt damit insgesamt 34 Länder mit einer kombinierten Bevölkerung von 2,7 Milliarden Menschen ab.
In Japan ging Beyond Air eine Partnerschaft mit AMCO Incorporated ein, einem führenden Medizinprodukte-Distributeur mit über 70 Jahren Erfahrung. Das LungFit PH-System macht herkömmliche Hochdruckflaschen überflüssig und bietet eine effizientere sowie umweltfreundlichere Lösung für den Krankenhausbereich. In mehreren Regionen laufen derzeit Ausschreibungen für Krankenhäuser, während in anderen auf behördliche Zulassungen gewartet wird.
- Expansion into 6 new markets including major markets like Japan and South Korea
- Total reach extended to 34 countries with 2.7 billion population coverage
- Partnership with established distributor AMCO in Japan, with 70+ years experience
- Hospital tender submissions already in progress in several regions
- Pending regulatory approvals in various regions may delay market entry
- Revenue impact timeline uncertain as adoption depends on tender processes
Insights
Beyond Air significantly expands global distribution of its cylinder-free nitric oxide system, with important new agreements including Japan.
Beyond Air has strategically expanded its global distribution network for LungFit PH, its innovative nitric oxide delivery system. The addition of Japan, South Korea, and four Central American countries brings their international reach to 34 countries with a combined population of 2.7 billion.
The Japan partnership is particularly significant, as AMCO Incorporated brings over 70 years of experience in successfully distributing medical devices in this major healthcare market. Japan represents one of the world's largest and most advanced medical device markets, making it a crucial territory for Beyond Air's expansion strategy.
LungFit PH's key technological advantage is its ability to generate nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders that pose logistical challenges for hospitals. This cylinder-free approach offers multiple benefits: reduced storage requirements, elimination of cylinder delivery logistics, improved workflow efficiency, and lower environmental impact.
The company indicates it's already submitting hospital tenders in several regions while awaiting regulatory approvals in others. These regulatory milestones will be critical in determining the timeline for revenue generation from these new markets. The press release suggests these international distribution agreements represent a long-term growth strategy rather than immediate revenue, with significant adoption expected "in the coming years."
These recent LungFit PH international agreements bring the ex-U.S. total to 34 countries and a combined population of 2.7 billion people
GARDEN CITY, N.Y., Aug. 20, 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 patient lives, today announced the expansion of its global LungFit® PH distribution network. The Company has recently signed new distribution agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 34 countries, representing a combined population of 2.7 billion people.
The distribution partner in Japan is AMCO Incorporated, which, as a leading distributor of medical devices in the country, has been involved in successfully importing, marketing, and servicing medical and scientific products from the USA and Europe for over 70 years.
“These latest agreements build upon the Company’s rapidly growing international footprint, which now spans the globe,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “With distribution agreements in place for 34 countries and counting, we are well-positioned to capture opportunities in both developed and emerging healthcare markets. Hospital tender submissions are already underway in several regions, while we await regulatory approval in others. These efforts are expected to drive significant adoption and have a lasting impact in the coming years.”
Beyond Air’s LungFit PH generates nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders. This tankless technology streamlines hospital operations, enhances efficiency and reduces environmental impact within hospital settings.
Potential customers can visit the LungFit PH website, www.lungfitph.com, for additional information, including the product label, and to sign up for company updates.
About LungFit®*
Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system 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 by eliminating NO2 purging steps, and offering other operational 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, European Union and many other countries around the world. 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 (NO) 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-cardiac surgery, 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.
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 and CE Mark 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).
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.
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.
Contacts
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ
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