With a robust active pipeline of products that address respiratory therapeutic areas, cancer, and autism spectrum disorder, Beyond Air is the world’s leading nitric oxide company.
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Device Therapeutic Area | Preclinical | Pilot | Pivotal | PMA | Commercial | Next Milestone* | Partner |
|---|---|---|---|---|---|---|---|---|
Hospital NICU Setting
Low-concentration iNO (≤80 ppm) for pulmonary treatments1 |
Persistent pulmonary hypertension of the newborn (PPHN)2 Visit LungFitPH.com |
US FDA approved CE Mark 2H 2024 |
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Cardiac surgery3 |
PMA approval decision anticipated end of 2024 | |||||||
Hospital Setting
High-concentration iNO (150 to 400 ppm) for antimicrobial treatments |
Viral Community-Acquired Pneumonia (VCAP), including COVID-194,5; |
US VCAP pilot study on hold until further financing is available | ||||||
At-home Treatment
High-concentration iNO (80 to 400 ppm) for antimicrobial treatments |
Nontuberculous mycobacteria (NTM) lung infection8,9; Severe exacerbations due to lung infections in COPD patients10 |
Discuss pivotal trial design with FDA in 1H 2025 COPD pilot on hold |
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Drug Therapeutic Area | Preclinical | Ph1 | Ph2 | Ph3 | NDA | Commercial | Next Milestone* |
|---|---|---|---|---|---|---|---|---|
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Autism Spectrum Disorder (ASD)11 |
First-in human data anticipated in 2026 | |||||||
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Other nNOS related neurological disorders |
Visit BeyondCancer.com |
Drug Therapeutic Area | Preclinical | Ph1 | Ph2 | Ph3 | NDA | Commercial | Next Milestone* |
|---|---|---|---|---|---|---|---|---|
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Monotherapy
UNO: Ultrahigh concentration nitric oxide (>10,000 ppm) |
Cutaneous / near cutaneous tumors |
Phase 1a completed | ||||||
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Multiple solid tumors |
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Combination Therapy
UNO + anti-PD-1 |
Multiple solid tumors |
Human study initiation 2H24 | ||||||
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UNO + anti-CTLA-4 |
Multiple solid tumors |
*All dates are calendar year, and based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals.
Getz Healthcare is Beyond Air's commercial partner in 10 Asian countries (not including Japan) and is recognized as the leading distributor of medical equipment, devices, and consumables, in Asia Pacific.
The Cystic Fibrosis Foundation provided Beyond Air with a grant of up to $2.17 million to help fund the completed trial of LungFit GO to treat NTM pulmonary disease in Australia.
Demonstrated Safety with
High Concentration Nitric Oxide
Beyond Air has 10+ years of experience with high concentration NO, as high as 250 ppm have been tested with no SAEs. Currently, only 20 ppm NO is approved by FDA. Beyond Air has conducted multiple animal studies in 2 species that show intermittent dosing up to 400 ppm NO to be safe with no macroscopic or microscopic findings.
References: 1. Tripathi P, Tripathi P, Kashyap L, Singh V. The role of nitric oxide in inflammatory reactions [retracted in: FEMS Immunol Med Microbiol. 2012;66(3):449]. FEMS Immunol Med Microbiol. 2007;51(3):443-452. doi:10.1111/j.1574-695X.2007.00329.x 2. Lakshminrusimha S, Keszler M. Persistent pulmonary hypertension of the newborn. Neoreviews. 2015;16(12):e680-e692. doi:10.1542/neo.16-12-e680 3. Rosenkranz S, Gibbs JS, Wachter R, De Marco T, Vonk-Noordegraaf A, Vachiéry JL. Left ventricular heart failure and pulmonary hypertension. Eur Heart J. 2016;37(12):942-954. doi:10.1093/eurheartj/ehv512 4. Wolak T, Dicker D, Kalaora R, et al. Inhaled nitric oxide for the treatment of COVID-19 and other viral pneumonias in adults. Presented at: American Thoracic Society (ATS) 2021 International Conference; May 14-19, 2021. Accessed May 13, 2022. https://d1io3yog0oux5.cloudfront.net/beyondairinc/files/docs/2021.05.13+ATS2021-AVP-Final.mp4 5. Wolak T, Dicker D, Shifer Y, Hatan M, Tal A, et al. Treatment of COVID-19 with inhaled nitric oxide using a novel nitric oxide generator. Presented at: 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2022; April 23-26, 2022; Lisbon, Portugal. Accessed May 13, 2022. 6. Tal A, Kalaora R, Hatan M, et al. Efficacy and safety of inhaled nitric oxide for the treatment of acute bronchiolitis: an evaluation of three trials. Presented at: American Thoracic Society (ATS) 2021 International Conference; May 14-19, 2021. Accessed May 13, 2022. 7. Goldbart A, Lavie M, Lubetzky R, et al. Evaluation of two doses of nitric oxide (NO) given intermittently via inhalation to subjects with bronchiolitis – a multi-center double blind study. Poster presented at: CHEST Annual Meeting; October 16-19, 2020; Nashville, Tennessee. Accessed May 13, 2022. 8. Goldbart A, Gatt D, Golan Tripto I. Non-tuberculous mycobacteria infection treated with intermittently inhaled high-dose nitric oxide. BMJ Case Rep. 2021;14(10):e243979. doi:10.1136/bcr-2021-243979 9. Chau T, da Silva J, Ghaffari A, Zelazny A, Olivier KN. Synergistic effect of nitric oxide with antibiotics against mycobacterium abscessus in vitro. Am J Respir Crit Care Med. 2019;199:A2656. https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2019.199.1_MeetingAbstracts.A2656 10. McMullin BB, Chittock DR, Roscoe DL, Garcha H, Wang L, Miller CC. The antimicrobial effect of nitric oxide on the bacteria that cause nosocomial pneumonia in mechanically ventilated patients in the intensive care unit. Respir Care. 2005;50(11):1451-1456. 11. Tripathi, M. K., Ojha, S. K., Kartawy, M., Hamoudi, W., Choudhary, A., Stern, S., Aran, A., Amal, H., The NO Answer for Autism Spectrum Disorder. Adv. Sci. 2023, 2205783. https://doi.org/10.1002/advs.202205783.
Caution: LungFit®PRO and LungFit®GO are investigational devices, limited by federal (or United States) law to investigational use.