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

GARDEN CITY, N.Y., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients' lives, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to LungFit GO for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD).

The Breakthrough Device Designation underscores the significant unmet need in NTM-PD and builds upon clinical data generated with LungFit GO within this patient population. Results from the Company's pilot study, which were published in the peer-reviewed journal Annals of the American Thoracic Society, showed that that adult subjects with chronic refractory NTM lung disease were able to safely self-administer high-dose intermittent inhaled nitric oxide therapy at home, with high treatment compliance and a favorable safety profile. The study also showed signs of meaningful improvement in a subset of patients across quality-of-life domains, along with a trend toward reduced mycobacterial burden, including one instance of culture conversion.

"LungFit GO has the potential to transform nitric oxide from a hospital-based therapy into a practical home-based treatment platform for chronic pulmonary disease and represents a valuable asset within Beyond Air’s broader nitric oxide platform," said Robert Goodman, Chief Executive Officer of Beyond Air. "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. Our focus and lead resource allocation remain firmly centered on our commercial business, however, this designation enhances the value of LungFit GO and expands the options available to us as we determine the best path forward for the asset, including through enhanced interactions with the FDA.”

"While inhaled nitric oxide has been used in medicine for many years, its use has largely been confined to the hospital setting," stated Kenneth Olivier, MD, MPH, Professor of Medicine and Director, Bronchiectasis/NTM Care and Research Center at the University of North Carolina – Chapel Hill. "The ability to deliver high-dose intermittent inhaled nitric oxide through a portable system in the home has the potential to address an important unmet need for patients with NTM-PD, who often require prolonged treatment. Breakthrough Device Designation is an encouraging step toward further evaluating this innovative approach in larger clinical studies."

Beyond Air plans to leverage the enhanced interactions available through the FDA's Breakthrough Devices Program as it finalizes the design of a future clinical study for LungFit GO in NTM-PD. The Company believes the designation has the potential to streamline the clinical development process and support more efficient advancement of the program toward potential regulatory approval.

FDA grants Breakthrough Device Designation when a device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. The Breakthrough Device Designation is designed to provide timely access to medical devices to speed up development, assessment, and review for FDA approval.

NTM-PD is a rare and serious chronic bacterial lung infection associated with substantial morbidity and mortality. The disease is considered an emerging global public health concern, as many infections are difficult to treat and often require prolonged multidrug antibiotic regimens that may continue for up to two years. These complex treatment courses can be difficult to tolerate, are associated with significant adverse events, and can have limited success in difficult-to-treat infections, including Mycobacterium abscessus complex (MABSC) and refractory Mycobacterium avium complex (MAC). As a result, NTM-PD remains a disease with significant unmet medical need, underscoring the need for novel therapeutic approaches.

About Beyond Air^®, Inc.

Beyond Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. For more information, visit www.beyondair.net.

About LungFit^®

Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator-compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders, providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety by eliminating NO2 purging steps, and offering other operational benefits.

LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g., COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g., NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

About LungFit GO

LungFit GO is an investigational device that has not been cleared or approved for commercial distribution by the FDA or any other regulatory authority. LungFit Go will be a portable device that weighs only ~20 lbs. and operates with a standard electrical outlet (120-240 volts). Since NO is generated from ambient air that flows through a reaction chamber, there is an unlimited supply. Beyond Air's proprietary NO2 filters are required for the system to generate and safely deliver NO. Toxic levels of NO2 can result from high concentrations of NO without proper filtration. The filters are equipped with an RFID chip which programs the system with respect to NO concentration, flow rate and duration of therapy. The Company believes this design provides maximum flexibility for NO administration. Filters are single use and there are no special requirements for disposal. Alarms monitor system performance.

*Beyond Air's LungFit PH is approved for commercial use in the United States, European Union, and many other countries around the world. Beyond Air's other LungFit systems are not approved for commercial use. Beyond Air is not suggesting or promoting NO use over 80 ppm, or use in the home setting, outside of an authorized investigational or clinical study setting.

About Nitric Oxide

Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential benefits of the Breakthrough Device Designation granted for LungFit GO, including its potential to accelerate the Company’s interactions with the FDA and to streamline clinical development and regulatory review; the design, timing, initiation, and completion of a future pivotal clinical study for LungFit GO in NTM-PD; and the Company’s ability to obtain regulatory approval for, and to ultimately commercialize, LungFit GO Forward-looking statements may be identified by words such as "anticipate," "believe," "expect," "intend," "plan," "potential," "will," "would," "could," "may," and similar expressions, or by the use of future tense.

Because forward-looking statements relate to future events, they are subject to inherent risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks related to the design, timing, initiation, and results of the Company’s planned future pivotal clinical study for LungFit GO in NTM-PD; whether Breakthrough Device Designation will result in a faster development, assessment, or review process, or in any expedited approval, for LungFit GO; the fact that Breakthrough Device Designation does not guarantee that LungFit GO will receive marketing authorization, or that any such authorization will be obtained on the timeline the Company anticipates, or at all; the Company’s ability to obtain the financial and other resources necessary to complete development of LungFit GO; and other risks described in the “Risk Factors” section of Beyond Air, Inc.’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.

CONTACTS:

Investor Relations contact
Corey Davis, Ph.D.
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com 
(212) 915-2577