Beyond Air, Inc., a clinical-stage medical device and biopharmaceutical company, develops nitric oxide (NO) generator and delivery systems. The company is developing LungFit system, a NO generator and delivery system, which is in clinical trials for the treatment of persistent pulmonary hypertension of the newborn; acute viral pneumonia, including COVID-19; bronchiolitis and nontuberculous mycobacteria lung infections; and solid tumors. It operates in Israel, Ireland, Australia, and the European Union. The company was formerly known as AIT Therapeutics, Inc. and changed its name to Beyond Air, Inc. in June 2019. Beyond Air, Inc. is based in Garden City, New York.
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Here are 1-3 brief analogies for Beyond Air (XAIR):
- Intuitive Surgical for inhaled nitric oxide delivery: Like Intuitive Surgical's robotic platform for surgery, Beyond Air has developed a unique, high-tech system for generating and delivering therapeutic nitric oxide for respiratory conditions, with potential for broader applications.
- Edwards Lifesciences for critical inhaled therapies: Similar to Edwards Lifesciences' focus on critical care and cardiovascular devices, Beyond Air specializes in innovative medical devices that address life-threatening respiratory conditions requiring inhaled therapies.
- ResMed for therapeutic gas delivery: While ResMed is known for devices for sleep apnea and ventilation, Beyond Air is a respiratory medical device company specializing in the advanced delivery of therapeutic gases like nitric oxide.
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- LungFit PH System: A medical device designed to generate and deliver inhaled nitric oxide for the treatment of persistent pulmonary hypertension of the newborn (PPHN).
- LungFit PRO System: An investigational medical device developed to deliver high-concentration nitric oxide for the treatment of severe lung infections, such as non-tuberculous mycobacteria (NTM).
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Beyond Air (XAIR) primarily sells its products, such as the LungFit GO system, to other companies rather than directly to individuals.
Its major customers are:
- Hospitals: Specifically, hospitals that operate Neonatal Intensive Care Units (NICUs), as their flagship product is designed for the treatment of persistent pulmonary hypertension of the newborn (PPHN). The company also mentions selling through distributors.
According to Beyond Air's latest Form 10-K filing (for the fiscal year ended March 31, 2023), no single customer accounted for more than 10% of their total revenues. Therefore, specific names of major customer companies are not publicly disclosed. Furthermore, most hospitals are not publicly traded entities with stock symbols.
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Steve Lisi, Chief Executive Officer and Chairman of the Board
Steve Lisi was appointed CEO in June 2017. He has served on Beyond Air's Board since January 2017. Prior to his current role, Mr. Lisi was the Senior Vice President of Business and Corporate Development at Avadel Pharmaceuticals (AVDL), where he played a key role in restructuring the company, raising over $125 million, and increasing its enterprise value from $100 million to $1 billion in three years. Before his time at Avadel, he spent 18 years investing in the global healthcare industry at firms such as Deerfield Management, Millennium Management, and SAC Capital. Mr. Lisi also serves as Chairman of the Board of Beyond Cancer.
Douglas Larson, Chief Financial Officer
Douglas Larson was appointed Chief Financial Officer of Beyond Air, effective September 1, 2021. He brings over 20 years of international and operational financial leadership experience. Before joining Beyond Air, Mr. Larson served as Vice President, Finance and Head of Global Controlling at DBV Technologies, Inc. (NASDAQ: DBVT) from 2017 to 2020. From 2001 to 2015, he was the Chief Financial Officer of The Scotts Miracle-Gro Company's International division, based in Lyon, France.
Michael Gaul, Chief Operating Officer
Michael Gaul serves as the Chief Operating Officer of Beyond Air.
David Webster, Chief Commercial Officer
David Webster is listed as the Chief Commercial Officer.
Frederick Montgomery, PhD, Vice President, Medical Systems
Frederick Montgomery, PhD, holds the position of Vice President, Medical Systems at Beyond Air.
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The increasing adoption of preventative measures for Respiratory Syncytial Virus (RSV), particularly novel monoclonal antibodies like nirsevimab (Beyfortus) and approved RSV vaccines, represents a clear emerging threat. RSV is the primary cause of bronchiolitis, a condition for which Beyond Air is developing inhaled nitric oxide (iNO) therapy. Should these preventative therapies achieve widespread uptake and significantly reduce the incidence and severity of RSV-related bronchiolitis, it could substantially shrink the target patient population for Beyond Air's iNO treatment for this indication, thereby limiting its potential market opportunity.
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Beyond Air (XAIR) focuses on developing and commercializing nitric oxide (NO) generator and delivery systems for various respiratory conditions and other diseases. The addressable markets for their main products are as follows:
- LungFit PH System (for Inhaled Nitric Oxide Delivery): This system is approved for Persistent Pulmonary Hypertension of the Newborn (PPHN) in neonates and has received European CE mark approval for pulmonary hypertension in infants and adults. The global market size for inhaled nitric oxide delivery systems is estimated to be approximately $700 million. Within the United States, this market is valued at around $300 million. Other estimates for the global inhaled nitric oxide delivery systems market size vary, including approximately USD 377.19 million in 2025, projected to reach USD 562.47 million by 2034. The U.S. market specifically for inhaled nitric oxide delivery systems was about USD 101.03 million in 2024, with projections to reach around USD 160.60 million by 2034.
- LungFit PRO System (for Acute Bronchiolitis): Beyond Air estimates the global market size for bronchiolitis to be over $2 billion. In the U.S., there are approximately 150,000 infant hospitalizations per year due to bronchiolitis.
- LungFit GO System (for Non-Tuberculous Mycobacteria (NTM) Lung Infections): While NTM infection is described as a rare and serious bacterial infection, specific addressable market size in dollar figures for Beyond Air's product was not identified in the available information.
- Beyond Cancer Program (for Solid Tumors) and NeuroNOS Program (for Autism Spectrum Disorder): These programs are in earlier stages of clinical development, and specific addressable market sizes were not identified in the available information.
(I have presented the available information. Since specific market sizes in dollar figures for NTM, solid tumors, and autism spectrum disorder were not found for Beyond Air's specific products, I did not include "null" as an overall return, but rather clarified that the market sizes were not identified for those particular products within the HTML output, as per the user's instructions to clarify within the answer if unable to size. This approach provides the most complete information based on the available data.)
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Expected Drivers of Future Revenue Growth for Beyond Air (XAIR)
Beyond Air (XAIR) is positioned for future revenue growth over the next 2-3 years, driven by several key factors:
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Global Commercial Expansion of LungFit PH: Beyond Air is actively expanding its international distribution network for the LungFit PH system. The company has secured new distribution partnerships in numerous countries, including Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, El Salvador, France, India, Israel, Italy, Poland, Romania, Saudi Arabia, and Turkey, significantly broadening its geographic reach and market penetration. This expansion has already led to the first international commercial placements of LungFit PH outside the United States.
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Launch of the Next-Generation LungFit PH (Gen II): The anticipated commercial launch of the second-generation LungFit PH system in the U.S. market by late calendar year 2026, pending FDA approval, is a significant growth driver. This updated system is designed to be smaller, lighter, and suitable for both air and ground transportation, while retaining the features of the first generation. It is expected to enable the company to penetrate larger hospitals and health systems, thereby accelerating adoption and strengthening LungFit's market position.
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Expansion of U.S. Market Presence and Flexible Sales Models: Beyond Air is enhancing its presence in the U.S. market by increasing its hospital customer base, partly due to device upgrades and new commercial leadership. The company has also entered into national group purchasing agreements, such as with Premier, Inc., providing access to a vast network of hospitals. Furthermore, the introduction of a capital purchase model, which allows hospitals to buy LungFit PH systems outright in addition to the existing recurring revenue from disposables and service agreements, offers greater flexibility and is expected to accelerate product adoption.
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Advancement of Pipeline Products and New Indications: Beyond the current LungFit PH system, Beyond Air is progressing its pipeline with other LungFit systems and programs targeting new indications. This includes LungFit PRO for severe lung infections (such as viral community-acquired pneumonia, including COVID-19, bronchiolitis, and nontuberculous mycobacteria) and the Beyond Cancer program, which is in Phase 1 human clinical trials using nitric oxide to target solid tumors. Additionally, the NeuroNOS program, focused on neurological conditions, is expected to advance to a Phase 1 clinical trial by the end of 2026. These represent potential new revenue streams as they move through clinical development and regulatory approval.
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Share Issuance
- In September 2024, Beyond Air completed a private equity offering, raising approximately $20.6 million in gross proceeds through the sale of common stock and warrants.
- The company entered into an Equity Line of Credit (ELOC) agreement in November 2025, providing the right to sell up to $20 million of newly issued common stock to Streeterville Capital over a 24-month period.
- A 1-for-20 reverse stock split was implemented effective July 14, 2025, with the aim of raising the per-share bid price above $1.00 and regaining compliance with Nasdaq listing rules.
Inbound Investments
- Beyond Air secured financing agreements with Streeterville Capital in November 2025, providing up to $32 million in total potential proceeds, including a $12 million promissory note and a $20 million Equity Line of Credit.
- An $11.5 million royalty funding agreement, led by certain Beyond Air Board members, was entered into in November 2024.
- Avenue Capital invested $3.35 million in Beyond Air through a private equity offering in September 2024.
Capital Expenditures
- Capital expenditures were approximately $5.88 million for the fiscal year ended March 31, 2025.
- For the fiscal year ended March 31, 2024, capital expenditures amounted to approximately $5.75 million.
- The primary focus of capital expenditures has been on investments in supply chain infrastructure and LungFit devices to support future revenue growth.