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GARDEN CITY, N.Y. - Beyond Air, Inc. (NASDAQ: XAIR), a medical device and biopharmaceutical company with a market capitalization of $21.38 million, has broadened its international presence through new distribution agreements for its LungFit PH system in France, Turkey, Romania, and Morocco. With these additions, announced Today, Beyond Air’s distribution network now spans 18 countries. According to InvestingPro data, the company’s revenue reached $3.02 million in the last twelve months, with analysts forecasting significant sales growth ahead.
The company, which specializes in nitric oxide (NO) based treatments, has seen a surge in global interest for LungFit PH, especially after receiving CE Mark approval approximately 15 weeks prior. While the stock has experienced a significant decline of 86% over the past year and currently trades near its 52-week low of $0.24, InvestingPro analysis suggests the stock is currently undervalued. "Our international commercial footprint currently includes 18 countries, and we are rapidly moving towards signing additional agreements that will further expand our distribution network," stated Steve Lisi, Chairman and CEO of Beyond Air.
LungFit PH, a medical device cleared by the U.S. Food and Drug Administration (FDA) and holding CE Mark, generates nitric oxide from room air, offering a tankless alternative to traditional high-pressure cylinders. This innovation is designed to simplify operations and enhance efficiency in hospital settings.
The system is compatible with ventilators and can produce NO on demand for delivery to the lungs in concentrations ranging from 1 ppm to 80 ppm. It is intended to potentially replace large, high-pressure NO cylinders, reducing inventory and storage requirements, improving safety by eliminating NO2 purging steps, and offering other operational advantages.
Beyond Air’s LungFit PH is approved for commercial use in the United States, European Union, Australia, Thailand, and New Zealand. The company’s other LungFit systems are currently undergoing clinical trials for the treatment of severe lung infections, including COVID-19 and nontuberculous mycobacteria (NTM), and are not approved for commercial use.
The expansion into new markets follows positive feedback from a growing list of leading U.S. hospitals actively using the LungFit PH system. The company anticipates a more rapid commercial ramp-up internationally than experienced in the U.S., aided by distribution partners with established medical device infrastructure.
Beyond Air is also advancing a pre-clinical program for the treatment of autism spectrum disorder (ASD) and other neurological disorders, in partnership with The Hebrew University of Jerusalem. Furthermore, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO to target certain solid tumors in a pre-clinical setting.
This article is based on a press release statement from Beyond Air, Inc.
In other recent news, Beyond Air reported a significant increase in revenue for the third fiscal quarter of 2025, reaching $1.1 million, which represents a 175% year-over-year growth. This figure surpassed the consensus estimate and BTIG’s forecast, showcasing the company’s successful expansion and operational improvements. The company achieved a net loss improvement to $0.15 per share, down from $0.50 per share in the previous year. Beyond Air also announced an at-the-market equity offering agreement to potentially sell up to $35 million of its common stock, with BTIG, LLC acting as the sales agent. Additionally, Beyond Air received a reiterated Neutral rating from BTIG, indicating cautious optimism about the company’s future performance.
Beyond Air’s international expansion is progressing, with the company securing the CE Mark and Australian market authorization for its LungFit PH system. The company has also signed agreements with new distributors in the Middle East. Domestically, Beyond Air initiated six new hospital starts and renewed two hospital contracts, one of which extends for three years. The company projects continued double-digit sequential quarterly revenue growth and plans to provide further revenue guidance in June. Beyond Air concluded the quarter with $10.9 million in cash and has implemented cost-saving measures to reduce cash burn, which is expected to continue decreasing in the next quarter.
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