LungFit GO — FDA meeting
2026
We anticipate having discussions with the FDA in calendar 2026 to identify a path forward.Source filing
BEYOND AIR INC · Data as of 2026-09-08
2026
We anticipate having discussions with the FDA in calendar 2026 to identify a path forward.Source filing
2H CY2026
PMA supplement for second-generation LungFit PH system under FDA review; approval expected in 2H CY2026Source filing
Late 2026
We will continue to grow our business with LungFit PH as we prepare for the FDA clearance of our second-generation LungFit PH system, which we expect to receive before the end of calendar 2026, subject to regulatory review.Source filing
Late 2026
We expect this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.Source filing
in 2027
The Company is in preclinical development and expects to progress to a Phase 1 first-in-human clinical trial by the end of 2026, which could provide data in 2027.Source filing
2026
We anticipate having discussions with the FDA in calendar 2026 to identify a path forward.Source filing