Beyond Air Secures EU CE Mark for LungFit PH, Expands Globally
Beyond Air, Inc. provided a comprehensive business update in its 10-K filing, highlighting significant progress across its nitric oxide (NO) platform. The company received European CE mark approval for its LungFit PH system in November 2024, leading to regulatory approvals in over 27 countries and distribution agreements in over 40 countries outside the U.S. Additionally, Beyond Air submitted a PMA supplement for its next-generation LungFit PH II to the FDA in June 2025, aiming to expand its addressable market. The filing also detailed positive clinical trial results for LungFit PRO in viral lung infections and bronchiolitis, and for LungFit GO in NTM lung disease, alongside progress in oncology and neurology programs through its subsidiaries. However, the auditor's report expressed substantial doubt about the company's ability to continue as a 'going concern'.
Key Highlights
- LungFit PH received European CE mark approval in November 2024.
- Regulatory approvals secured in over 27 countries outside the U.S. and EU.
- Distribution agreements signed covering over 40 countries outside the U.S.
- LungFit PH II PMA supplement submitted to FDA in June 2025.
- Estimated total addressable market for inhaled NO is $350 million in U.S., $700 million worldwide.
- LungFit PRO pilot trial for VCAP showed 1.8x shorter length of stay for NO group.
- LungFit PRO pilot studies for bronchiolitis showed 150-160 ppm NO shortened hospital LOS.
- Beyond Cancer completed a Phase 1 human clinical trial for UNO in solid tumors.
- Auditor's report contains an explanatory paragraph expressing substantial doubt about 'going concern'.
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