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 Ventilator compatible |
In-Hospital use for PPHN and cardiac surgery | Final preparations for PMA | PMA filing 2H20 US Launch 2Q21 CE Mark 2H21 |
>$300M | >$600M |
| LungFit PRO | COVID-19 | Pilot studies in progress | Pilot study data 2H20 | N/A | N/A |
| LungFit PRO | Bronchiolitis | 3 Pilot studies complete Pivotal-ready |
Pivotal Starts 4Q21 (pandemic permitting) US Launch 2023 |
>$500M Beyond Air to commercialize |
>$1.2B |
| LungFit GO | Nontuberculous mycobacteria (NTM) lung infection | Pilot phase | Pilot study start 4Q20 Self-administration at home |
>$1B | >$2.5B |
| LungFit GO | Severe exacerbations due to lung infections in COPD patients | Pre-clinical | Pilot study start 2H21 | >$2.5B | >$6B |
| Solid Tumors | Multiple solid tumors | Pre-clinical | New in vivo data to be presented 4Q20 |
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