Beyond Air, Inc. (NASDAQ: XAIR) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its LungFit GO device for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD).

The designation applies to a portable device designed to deliver high-dose intermittent inhaled nitric oxide therapy in a home setting. NTM-PD is a rare chronic bacterial lung infection that often requires prolonged multidrug antibiotic regimens lasting up to two years.

The FDA grants Breakthrough Device Designation when a device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions, with the aim of speeding up development and review for approval.

Results from a pilot study published in the peer-reviewed journal Annals of the American Thoracic Society showed that adult subjects with chronic refractory NTM lung disease were able to safely self-administer the therapy at home, with high treatment compliance. The study also showed signs of improvement in quality-of-life measures in a subset of patients and a trend toward reduced mycobacterial burden, including one instance of culture conversion.

"We are excited to receive Breakthrough Device Designation, which validates both the significant unmet need facing patients with NTM-PD and the encouraging clinical experience generated to date with LungFit GO," said Robert Goodman, Chief Executive Officer of Beyond Air.

Beyond Air said it plans to use enhanced FDA interactions available through the Breakthrough Devices Program to finalize the design of a future clinical study for LungFit GO in NTM-PD.