Sources
- All dates are based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals
- Label expected to include cardiac surgery and PPHN
Product/Indication | Preclinical | Pilot Trials | Pivotal | PMA | Commercial | Next Milestone1 |
---|---|---|---|---|---|---|
LungFit PH ventilator compatible | ||||||
Persistent Pulmonary Hypertension of the Newborn (PPHN) worldwide, and cardiac surgery outside US where indicated | Preclinical completed | Pilot Trials completed | Pivotal completed | PMA started | Commercial not started | PMA pending |
LungFit PRO | ||||||
Community-Acquired Viral Pneumonia (CAVP), including COVID-19 | Preclinical completed | Pilot Trials started | Pivotal not started | PMA not started | Commercial not started | Safety & efficacy CAVP |
Bronchiolitis | Preclinical completed | Pilot Trials started | Pivotal not started | PMA not started | Commercial not started | Initiate US study in 4Q22; |
LungFit GO | ||||||
Nontuberculous mycobacteria (NTM) lung infection | Preclinical completed | Pilot Trials started | Pivotal not started | PMA not started | Commercial not started | Safety & efficacy data at |
Severe exacerbations due to lung infections in COPD patients | Preclinical started | Pilot Trials not started | Pivotal not started | PMA not started | Commercial not started | Pilot study start 2022/23 |
Solid Tumor Program (through Beyond Cancer) | ||||||
Multiple Solid Tumors | Preclinical started | Pilot Trials not started | Pivotal not started | PMA not started | Commercial not started | First in human trial start in 1H22 |
Sources
Sources
†Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.