Beyond Air Announces Agreements Expanding Global Distribution of LungFit® PH
Beyond Air (NASDAQ: XAIR) has announced significant expansion of its global distribution network for LungFit PH, a medical device that generates nitric oxide from room air. The company has signed new distribution agreements covering France, Turkey, Romania, and Morocco, bringing their total international presence to 18 countries.
The expansion comes approximately 15 weeks after receiving CE Mark approval. The company's tankless technology eliminates the need for traditional high-pressure cylinders, offering streamlined operations and enhanced efficiency in hospital settings. Initial international orders have already been received from four countries.
CEO Steve Lisi expressed confidence in a faster international market ramp-up compared to the U.S., citing positive feedback from U.S. hospitals and the advantage of working with established medical device distribution partners.
Beyond Air (NASDAQ: XAIR) ha annunciato un'importante espansione della sua rete di distribuzione globale per LungFit PH, un dispositivo medico che genera ossido nitrico dall'aria ambiente. L'azienda ha firmato nuovi accordi di distribuzione che coprono Francia, Turchia, Romania e Marocco, portando la loro presenza internazionale totale a 18 paesi.
L'espansione arriva circa 15 settimane dopo aver ricevuto l'approvazione del marchio CE. La tecnologia senza serbatoio dell'azienda elimina la necessità di tradizionali cilindri ad alta pressione, offrendo operazioni semplificate e una maggiore efficienza negli ambienti ospedalieri. Gli ordini internazionali iniziali sono già stati ricevuti da quattro paesi.
Il CEO Steve Lisi ha espresso fiducia in un'accelerazione più rapida del mercato internazionale rispetto agli Stati Uniti, citando feedback positivi da ospedali statunitensi e il vantaggio di lavorare con partner di distribuzione di dispositivi medici già affermati.
Beyond Air (NASDAQ: XAIR) ha anunciado una expansión significativa de 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 que cubren Francia, Turquía, Rumanía y Marruecos, llevando su presencia internacional total a 18 países.
La expansión se produce aproximadamente 15 semanas después de recibir la aprobación del Marcado CE. La tecnología sin tanque de la compañía elimina la necesidad de cilindros de alta presión tradicionales, ofreciendo operaciones simplificadas y una mayor eficiencia en los entornos hospitalarios. Ya se han recibido pedidos internacionales iniciales de cuatro países.
El CEO Steve Lisi expresó confianza en un aumento más rápido del mercado internacional en comparación con EE. UU., citando comentarios positivos de hospitales estadounidenses y la ventaja de trabajar con socios de distribución de dispositivos médicos establecidos.
비욘드 에어 (NASDAQ: XAIR)는 룸핏 PH의 글로벌 유통망을 대폭 확장한다고 발표했습니다. 룸핏 PH는 실내 공기로부터 질소 산화물을 생성하는 의료 기기입니다. 이 회사는 프랑스, 터키, 루마니아, 모로코를 포함하는 새로운 유통 계약을 체결하여 총 18개국으로 국제적 입지를 확대했습니다.
이번 확장은 CE 마크 승인을 받은 지 약 15주 만에 이루어졌습니다. 회사의 탱크 없는 기술은 전통적인 고압 실린더의 필요성을 없애고, 병원 환경에서 효율성을 높이며 운영을 간소화합니다. 초기 국제 주문은 이미 네 개 국가에서 접수되었습니다.
CEO 스티브 리시는 미국에 비해 국제 시장의 빠른 성장에 대한 확신을 표명하며, 미국 병원들로부터 긍정적인 피드백과 이미 확립된 의료 기기 유통 파트너와의 협력의 장점을 언급했습니다.
Beyond Air (NASDAQ: XAIR) a annoncé une expansion significative de son réseau de distribution mondial pour LungFit PH, un dispositif médical qui génère de l'oxyde nitrique à partir de l'air ambiant. L'entreprise a signé de nouveaux accords de distribution couvrant la France, la Turquie, la Roumanie et le Maroc, portant sa présence internationale totale à 18 pays.
Cette expansion intervient environ 15 semaines après avoir reçu l'approbation du marquage CE. La technologie sans réservoir de l'entreprise élimine le besoin de cylindres à haute pression traditionnels, offrant des opérations rationalisées et une efficacité accrue dans les environnements hospitaliers. Des commandes internationales initiales ont déjà été reçues de quatre pays.
Le PDG Steve Lisi a exprimé sa confiance dans une montée en puissance plus rapide du marché international par rapport aux États-Unis, citant des retours positifs des hôpitaux américains et l'avantage de travailler avec des partenaires de distribution de dispositifs médicaux bien établis.
Beyond Air (NASDAQ: XAIR) hat eine bedeutende Erweiterung seines globalen Vertriebsnetzes für LungFit PH angekündigt, ein Medizinprodukt, das aus Raumluft Stickstoffoxid erzeugt. Das Unternehmen hat neue Vertriebsvereinbarungen für Frankreich, die Türkei, Rumänien und Marokko unterzeichnet und damit seine internationale Präsenz auf insgesamt 18 Länder ausgeweitet.
Die Expansion erfolgt etwa 15 Wochen nach Erhalt der CE-Kennzeichnung. Die tanklose Technologie des Unternehmens beseitigt die Notwendigkeit traditioneller Hochdruckzylinder und bietet optimierte Abläufe sowie erhöhte Effizienz in Krankenhausumgebungen. Erste internationale Bestellungen wurden bereits aus vier Ländern erhalten.
CEO Steve Lisi äußerte sich zuversichtlich, dass der internationale Markt schneller wachsen wird als in den USA, und verwies auf positives Feedback von US-Krankenhäusern sowie den Vorteil der Zusammenarbeit mit etablierten Vertriebspartnern für Medizinprodukte.
- Expansion to 18 countries demonstrates strong market penetration
- Initial orders already received from four countries
- CE Mark approval enables European market access
- Established distribution partners with existing medical device infrastructure
- None.
Insights
Beyond Air's expansion of distribution agreements for its LungFit PH system across France, Turkey, Romania, and Morocco represents a meaningful commercial development for this micro-cap medical device company. With their global footprint now encompassing 18 countries after receiving CE Mark approval just 15 weeks ago, the company is executing on its international commercialization strategy at an encouraging pace.
The announcement of initial international orders from four countries provides tangible evidence of early market traction. For a company with a market capitalization of only
The LungFit PH technology offers a compelling value proposition by generating nitric oxide from ambient air, eliminating the logistical challenges and safety concerns associated with traditional high-pressure cylinders. This innovation addresses real operational pain points for hospitals seeking more efficient and sustainable solutions.
Management's expectation of a faster international commercial ramp compared to the US experience suggests confidence in their go-to-market strategy. Leveraging established distribution partners with existing medical device infrastructure represents a capital-efficient approach that could accelerate market penetration while conserving resources.
However, investors should recognize that while distribution agreements are an essential first step, the path to meaningful revenue will depend on the company's ability to support these partners with training, marketing, and ongoing technical support. For a company of Beyond Air's size, execution across multiple international markets simultaneously will present operational challenges that require disciplined resource allocation.
Beyond Air's expansion of LungFit PH distribution to 18 countries, including recent agreements in France, Turkey, Romania, and Morocco, represents a significant advancement in nitric oxide delivery technology access. The system's ability to generate nitric oxide from room air addresses critical challenges in the management of persistent pulmonary hypertension of the newborn (PPHN), a condition requiring precise and reliable NO therapy.
The traditional cylinder-based NO delivery systems create substantial operational burdens for hospitals: they require dedicated storage space, specialized handling protocols, regular supply chain management, and carry safety concerns associated with high-pressure cylinders. LungFit PH elegantly eliminates these pain points while maintaining therapeutic efficacy.
For hospitals in international markets, particularly those with less robust medical gas infrastructure, the tankless approach offers compelling advantages beyond convenience. It reduces dependency on complex supply chains for specialty medical gases, minimizes risk of therapy interruption due to cylinder depletion, and aligns with growing sustainability initiatives in healthcare.
The company's strategy to partner with distributors who have established medical device infrastructure is particularly astute. These partners bring existing relationships with neonatal intensive care units, understanding of local regulatory nuances, and technical support capabilities—critical factors for successful implementation of respiratory care technologies.
The rapid expansion following CE Mark approval suggests considerable market interest, likely driven by the recognition of LungFit PH's potential to streamline clinical workflows while maintaining the therapeutic benefits of nitric oxide therapy. For neonatologists and respiratory therapists, a system that eliminates the logistical complications of cylinders while delivering consistent therapy represents a meaningful advance in patient care capabilities.
Distribution agreements recently signed for France, Turkey, Romania and Morocco
LungFit PH international distribution network now includes 18 countries
Initial international orders for LungFit PH systems have been received for four countries
GARDEN CITY, N.Y., March 11, 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, announced the expansion of its global distribution channels for LungFit PH with several new distribution agreements that will cover four countries, including France, Romania, Turkey and Morocco.
"Global interest for our LungFit PH system, which only just received CE Mark about 15 weeks ago is very strong. With the addition of these latest agreements, our international commercial footprint currently includes 18 countries, and we are rapidly moving towards signing additional agreements that will further expand our distribution network," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “Considering the commercial experience we have gained over the past couple of years, and positive feedback from a rapidly growing list of leading U.S. hospitals actively using the LungFit PH system, we anticipate a more rapid commercial ramp-up in the international market than seen in the U.S. We also will have the advantage of distribution partners that have established medical device infrastructure to help generate positive early momentum.”
Below is a list of the current LungFit PH partnerships.
| Partner | Countries |
| Getz Healthcare | Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam |
| Saudi Health Services CO | Saudi Arabia |
| MDC Care Medical Trading | United Arab Emirates, Oman, Qatar |
| EUROCARE | France |
| Medelart Healthcare | Turkey |
| Abb Neopuls | Romania |
| OXYPLUS | Morocco |
Beyond Air’s LungFit PH generates nitric oxide from room air, eliminating the need for traditional high-pressure cylinders. This tankless technology streamlines operations, enhances efficiency, and supports sustainability efforts 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, Australia, Thailand 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 (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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