Our Pipeline and Its Potential
Beyond Air Pipeline & Market Size
| Product | Indication | Development Status |
Key Dates(1) | US Sales Potential(2) |
Worldwide Sales Potential(2) |
|---|---|---|---|---|---|
| LungFitPH (Pulmonary Hypertension) |
In-Hospital use for PPHN and cardiac surgery | Final preparations for PMA submission | FDA PMA filing 2Q20 US Launch 4Q20 |
>$300m | >$600m |
| LungFit | COVID-19 | Pre-Clinical | Initiate US COVID-19 treatment study pending FDA approvals | N/A | N/A |
| LungFit | Bronchiolitis | Pivotal Phase | Pivotal Starts 4Q21 US Launch 2023 |
>$500m Beyond Air to commercialize |
>$1.2b |
| LungFit Home | Nontuberculous mycobacteria (NTM) lung infection | Pilot phase | Q20 start for at-home pilot study with self-administration | >$1b | >$2.5b |
| LungFit Home | Severe exacerbations due to lung infections in COPD patients | Pre-clinical | Pilot study start 2021 | >$2.5b | >$6b |
| Solid Tumors | Multiple solid tumors | Pre-clinical | Initial data 2Q20 | TBD | TBD |
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.
(1) All dates are based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals
(2) All figures are Company estimates for peak year sales: Global sales potential includes US sales potential