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Beyond Air Announces Vanderbilt University Medical Center as First Luminary Site

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Beyond Air (NASDAQ: XAIR) has announced Vanderbilt University Medical Center (VUMC) as its first luminary site, marking a significant milestone in the company's mission to advance tankless nitric oxide delivery technology. LungFit PH, their innovative device, generates nitric oxide from room air without requiring traditional high-pressure cylinders.

Craig Rooks, Sr. Director of Respiratory Care at VUMC, highlighted how the device enhances workflow efficiency in ICU settings and enables anesthesiologists to manage it directly in operating rooms. This implementation is particularly important as VUMC prepares to expand its heart and lung transplant programs following a record year of heart transplants in 2024.

The collaboration aims to showcase the technology's benefits to potential customer hospitals, with VUMC serving as a demonstration site for respiratory therapists, anesthesiologists, and medical directors considering the cylinder-free, iNO delivery system.

Beyond Air (NASDAQ: XAIR) ha annunciato il Vanderbilt University Medical Center (VUMC) come il suo primo sito luminary, segnando un traguardo significativo nella missione dell'azienda di avanzare nella tecnologia di somministrazione di ossido nitrico senza serbatoi. LungFit PH, il loro dispositivo innovativo, genera ossido nitrico dall'aria ambiente senza richiedere tradizionali cilindri ad alta pressione.

Craig Rooks, Direttore Senior della Cura Respiratoria presso VUMC, ha evidenziato come il dispositivo migliori l'efficienza del flusso di lavoro nelle unità di terapia intensiva e consenta agli anestesisti di gestirlo direttamente nelle sale operatorie. Questa implementazione è particolarmente importante poiché VUMC si prepara ad espandere i suoi programmi di trapianto di cuore e polmoni dopo un anno record di trapianti di cuore nel 2024.

La collaborazione mira a mostrare i benefici della tecnologia agli ospedali clienti potenziali, con VUMC che funge da sito dimostrativo per terapisti respiratori, anestesisti e direttori medici che stanno considerando il sistema di somministrazione di iNO senza cilindri.

Beyond Air (NASDAQ: XAIR) ha anunciado el Vanderbilt University Medical Center (VUMC) como su primer sitio luminary, marcando un hito significativo en la misión de la empresa de avanzar en la tecnología de entrega de óxido nítrico sin tanques. LungFit PH, su dispositivo innovador, genera óxido nítrico a partir del aire ambiente sin necesidad de cilindros de alta presión tradicionales.

Craig Rooks, Director Senior de Cuidado Respiratorio en VUMC, destacó cómo el dispositivo mejora la eficiencia del flujo de trabajo en las UCI y permite a los anestesiólogos gestionarlo directamente en las salas de operaciones. Esta implementación es especialmente importante ya que VUMC se prepara para expandir sus programas de trasplante de corazón y pulmón tras un año récord de trasplantes de corazón en 2024.

La colaboración tiene como objetivo mostrar los beneficios de la tecnología a hospitales clientes potenciales, con VUMC sirviendo como un sitio de demostración para terapeutas respiratorios, anestesiólogos y directores médicos que consideran el sistema de entrega de iNO sin cilindros.

비욘드 에어 (NASDAQ: XAIR)는 밴더빌트 대학교 의료 센터 (VUMC)를 첫 번째 루미너리 사이트로 발표하며, 탱크 없는 질소 산화물 전달 기술을 발전시키려는 회사의 사명에서 중요한 이정표를 설정했습니다. 룽핏 PH, 그들의 혁신적인 장치는 전통적인 고압 실린더 없이 실내 공기에서 질소 산화물을 생성합니다.

VUMC의 호흡기 치료 수석 이사인 크레이그 룩스는 이 장치가 ICU 환경에서 작업 효율성을 향상시키고 마취과 의사들이 수술실에서 직접 관리할 수 있도록 한다고 강조했습니다. 이 구현은 VUMC가 2024년에 심장 이식의 기록적인 해를 맞이한 후 심장 및 폐 이식 프로그램을 확장할 준비를 하고 있기 때문에 특히 중요합니다.

이 협력은 잠재 고객 병원에 기술의 이점을 보여주는 것을 목표로 하며, VUMC는 실린더 없는 iNO 전달 시스템을 고려하는 호흡기 치료사, 마취과 의사 및 의료 이사들을 위한 시연 사이트로 기능합니다.

Beyond Air (NASDAQ: XAIR) a annoncé le Vanderbilt University Medical Center (VUMC) comme son premier site luminaire, marquant une étape importante dans la mission de l'entreprise d'avancer la technologie de livraison d'oxyde nitrique sans réservoir. LungFit PH, leur dispositif innovant, génère de l'oxyde nitrique à partir de l'air ambiant sans nécessiter de cylindres haute pression traditionnels.

Craig Rooks, Directeur Senior des Soins Respiratoires chez VUMC, a souligné comment le dispositif améliore l'efficacité du flux de travail dans les unités de soins intensifs et permet aux anesthésistes de le gérer directement dans les salles d'opération. Cette mise en œuvre est particulièrement importante alors que VUMC se prépare à étendre ses programmes de transplantation cardiaque et pulmonaire après une année record de transplantations cardiaques en 2024.

La collaboration vise à mettre en avant les avantages de la technologie pour les hôpitaux clients potentiels, VUMC servant de site de démonstration pour les thérapeutes respiratoires, anesthésistes et directeurs médicaux envisageant le système de livraison iNO sans cylindres.

Beyond Air (NASDAQ: XAIR) hat das Vanderbilt University Medical Center (VUMC) als seinen ersten Luminary-Standort bekannt gegeben, was einen bedeutenden Meilenstein in der Mission des Unternehmens darstellt, die Technologie zur Lieferung von stickstoffmonoxid ohne Tanks voranzutreiben. LungFit PH, ihr innovatives Gerät, erzeugt stickstoffmonoxid aus Raumluft, ohne traditionelle Hochdruckzylinder zu benötigen.

Craig Rooks, Senior Director of Respiratory Care bei VUMC, hob hervor, wie das Gerät die Effizienz des Arbeitsablaufs in Intensivstationen verbessert und es Anästhesisten ermöglicht, es direkt in den Operationssälen zu steuern. Diese Implementierung ist besonders wichtig, da VUMC sich darauf vorbereitet, seine Herz- und Lungentransplantationsprogramme nach einem Rekordjahr für Herztransplantationen im Jahr 2024 auszubauen.

Die Zusammenarbeit zielt darauf ab, die Vorteile der Technologie potenziellen Kundenkrankenhäusern zu demonstrieren, wobei VUMC als Demonstrationsstandort für Atemtherapeuten, Anästhesisten und medizinische Direktoren dient, die das zylinderfreie iNO-Liefersystem in Betracht ziehen.

Positive
  • Partnership with major academic medical center VUMC enhances product credibility
  • Technology eliminates need for costly high-pressure cylinders, reducing operational expenses
  • System improves workflow efficiency and reduces staffing requirements
  • Strategic timing with VUMC's expansion of transplant programs could drive adoption
Negative
  • Success depends on convincing other hospitals to adopt the technology
  • Requires changes to established hospital protocols and procedures

As the first Beyond Air luminary site, Vanderbilt will help evaluate and showcase the clinical and operational benefits of LungFit® PH, supporting broader awareness and adoption of tankless iNO technology

GARDEN CITY, N.Y., March 31, 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 Vanderbilt University Medical Center (VUMC) has become the Company’s first luminary site. This collaboration marks a major milestone in Beyond Air’s mission to redefine tankless nitric oxide (iNO) delivery and drive continued innovation in respiratory care.

As one of the nation’s leading academic medical centers, VUMC is at the forefront of advancing healthcare through cutting-edge research and clinical excellence. Through the luminary program with VUMC, Beyond Air aims to further optimize its LungFit products and explore new opportunities to enhance hospital-based nitric oxide therapy.

“The introduction of this advanced nitric oxide delivery device marks a transformative step for respiratory therapists at Vanderbilt University Medical Center,” says Craig Rooks, Sr. Director, Respiratory Care and Acute Rehabilitation Services at VUMC. “By streamlining setup and management processes, the LungFit PH significantly enhances workflow efficiency, allowing therapists to focus more on patient care and outcomes within the ICU. The device empowers anesthesiologists to manage it directly in the operating room, reducing reliance on additional staff and ensuring seamless integration into OR workflows. As we prepare to expand both our heart and lung transplant programs — following a record year of heart transplants in 2024 — implementing simple, innovative technology that works across multiple settings will be critical. This innovation is a testament to our commitment to equipping healthcare professionals with tools that make a real difference.”

"Establishing our first luminary site with Vanderbilt University Medical Center is an important step forward for Beyond Air as it will allow us to showcase the full utility of the LungFit PH technology to respiratory therapists, anesthesiologists, medical directors and other relevant clinicians at hospitals considering adopting our cylinder-free, iNO delivery system. There is no stronger endorsement for a medical device than a hospital that has fully integrated it into patient care. We look forward to welcoming representatives from potential customer hospitals to Vanderbilt University Medical Center to experience firsthand the benefits that LungFit PH can offer both hospitals and their patients," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "Vanderbilt’s commitment to medical innovation makes them an ideal partner as we continue to push the boundaries of what’s possible in iNO technology and delivery."

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. The collaboration with Vanderbilt reinforces Beyond Air’s dedication to advancing next-generation iNO solutions.

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 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.

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.

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

What is the significance of VUMC becoming Beyond Air's first luminary site for XAIR?

VUMC will showcase LungFit PH's clinical benefits and help drive broader adoption of tankless iNO technology, serving as a demonstration site for potential hospital customers.

How does Beyond Air's LungFit PH technology differ from traditional nitric oxide delivery systems?

LungFit PH generates nitric oxide from room air, eliminating the need for high-pressure cylinders, which streamlines operations and enhances hospital efficiency.

What operational benefits does LungFit PH offer to VUMC's medical staff?

It streamlines setup processes, improves ICU workflow efficiency, and allows anesthesiologists to manage it directly in operating rooms without additional staff.

Why is the timing of LungFit PH implementation significant for VUMC in 2025?

It aligns with VUMC's expansion of heart and lung transplant programs, following their record year of heart transplants in 2024.
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