Garden City, N.Y. – August 31, 2026
Beyond Air announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to LungFit® GO for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD). The designation recognizes the significant unmet medical need associated with NTM-PD and supports further development of LungFit GO, a portable system designed to deliver high-dose intermittent inhaled nitric oxide therapy. The FDA decision builds on clinical experience in patients with chronic refractory NTM lung disease, including findings from a pilot study in which adults were able to self-administer the therapy at home with high treatment compliance and a favorable safety profile. The study also reported signs of improvement across selected quality-of-life measures and a trend toward reduced mycobacterial burden, including one reported case of culture conversion. The Breakthrough Device designation provides Beyond Air with enhanced interactions with the FDA as the company works toward designing a future clinical study for LungFit GO in NTM-PD.
Beyond Air Advances LungFit GO for NTM-PD
The FDA Breakthrough Device Designation is the key development for Beyond Air’s LungFit GO program, reflecting the serious nature of NTM-PD and the need for new treatment approaches. NTM-PD is a chronic bacterial lung infection that can cause substantial morbidity and mortality and may be particularly difficult to manage in patients with refractory disease. Existing treatment can involve prolonged combinations of antibiotics, with treatment courses potentially extending for up to two years. These regimens can create significant tolerability challenges and may have limited effectiveness in difficult-to-treat infections such as Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC). Against this backdrop, LungFit GO is being developed as a potential home-based nitric oxide delivery platform that could provide patients with a more practical approach to prolonged inhaled therapy. Beyond Air said the designation strengthens the development pathway for the asset while the company evaluates the next steps for its NTM-PD program.
LungFit GO Builds on Home Nitric Oxide Data
The Breakthrough Device designation follows clinical data supporting the feasibility of home administration of inhaled nitric oxide with LungFit GO. In the company’s pilot study, adults with chronic refractory NTM lung disease were able to self-administer high-dose intermittent nitric oxide therapy at home, demonstrating high compliance and a favorable safety profile. The study also generated preliminary signals across several clinical measures, including improvements in selected quality-of-life domains and a trend toward lower mycobacterial burden. One patient achieved culture conversion, although the pilot study was not designed to establish efficacy or provide definitive evidence of clinical benefit. These findings provide the clinical foundation for further investigation while highlighting the potential of a portable system to move inhaled nitric oxide therapy beyond traditional hospital-based use. The company is now focused on determining the appropriate clinical development strategy for evaluating LungFit GO in a larger NTM-PD population.
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Beyond Air Plans Next Clinical Study for LungFit GO
With the FDA designation in place, Beyond Air plans to use the enhanced interactions available through the Breakthrough Devices Program as it finalizes the design of a future clinical study for LungFit GO in NTM-PD. The program is intended to facilitate more frequent engagement with the FDA and potentially support a more efficient development, assessment and review pathway for qualifying medical devices. Beyond Air said the designation enhances the value of LungFit GO as it considers the best path forward for the asset, including further regulatory discussions. The company continues to allocate its lead resources toward its commercial business, while the new designation provides an opportunity to advance LungFit GO through additional clinical development. LungFit GO forms part of Beyond Air’s broader nitric oxide platform, which is designed to harness nitric oxide for potential applications across respiratory and other serious diseases. The company already has FDA-approved and CE-marked LungFit PH for nitric oxide delivery in term and near-term neonates with hypoxic respiratory failure, providing an established foundation for its device technology platform.
Source: Beyond Air press relese
