GlobeNewswire·Aug 31, 2026, 8:00 AM ET

Beyond Air® Receives FDA Breakthrough Device Designation for LungFit® GO to Treat Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

Beyond Air received FDA Breakthrough Device Designation for LungFit GO to treat nontuberculous mycobacterial pulmonary disease (NTM-PD).
Pilot study results published in the Annals of the American Thoracic Society showed adult subjects could safely self-administer high-dose inhaled nitric oxide therapy at home with high compliance.
Clinical data indicated favorable safety profiles, potential quality-of-life improvements, reduced mycobacterial burden, and one instance of culture conversion.
The designation aims to streamline clinical development, enhance FDA interactions, and support the advancement of LungFit GO toward regulatory approval.
Beyond Air plans to leverage the Breakthrough Devices Program to finalize the design of a future pivotal clinical study for the device.
LungFit GO is an investigational portable device weighing approximately 20 lbs that generates nitric oxide from ambient air without cylinders.
NTM-PD is a rare, chronic bacterial lung infection often requiring prolonged multidrug antibiotic regimens with significant adverse events and limited success rates.
Beyond Air's existing LungFit PH system holds FDA approval for neonatal hypoxic respiratory failure, while LungFit GO remains unapproved for commercial distribution.