Beyond Air® Signs New International LungFit PH® Distribution Agreements, Most Notably in Germany and Brazil
Rhea-AI Summary
Beyond Air (NASDAQ: XAIR) announced new international distribution agreements for LungFit PH adding Germany, Brazil, Austria, the Netherlands and Sri Lanka and expanding its network to 39 countries.
The agreements cover a combined population of more than three billion people. Beyond Air said some markets will require regulatory approvals that may take time, while others are expected to begin benefiting from LungFit PH in calendar 2026. LungFit PH generates nitric oxide from ambient air, providing a tankless alternative to high‑pressure cylinders intended to streamline hospital operations, improve efficiency and reduce environmental impact.
Positive
- International coverage expanded to 39 countries
- New distribution agreements include Germany and Brazil
- Combined population reachable exceeds 3 billion
- Tankless nitric oxide technology removes need for high‑pressure cylinders
Negative
- Regulatory approvals in some countries will take time
- Commercial benefits in certain markets are likely delayed until calendar 2026
News Market Reaction – XAIR
On the day this news was published, XAIR gained 2.71%, reflecting a moderate positive market reaction. Argus tracked a trough of -11.0% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $199K to the company's valuation, bringing the market cap to $8M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
While XAIR was down 8.86% pre-news, sector peers like NVNO (+5.16%), SINT (+3.48%) and AIMD (+1.9%) were positive, suggesting XAIR’s weakness was stock-specific rather than a Medical Devices sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 26 | CFO transition | Neutral | +1.5% | CFO resignation with interim replacement and continued advisory role. |
| Nov 10 | Earnings update | Positive | -1.1% | Q2 FY2026 results, strong revenue growth and updated guidance. |
| Nov 05 | Financing agreements | Positive | +1.1% | Up to $32M in financing to support growth and LungFit PH rollout. |
| Oct 23 | Earnings call setup | Neutral | +4.0% | Scheduling Q2 FY2026 results call and providing dial-in details. |
| Sep 22 | Conference participation | Positive | +5.4% | Participation in ROTH healthcare conference and investor meetings. |
Recent news has mostly seen price moves align with event tone, with one divergence on earnings where positive operational updates coincided with a modest decline.
Over the last few months, Beyond Air reported fiscal Q2 2026 results with revenue of $1.8M and guidance of $8–$10M, alongside financing facilities of up to $32M and a pro forma cash balance of $22.9M. The company has been expanding LungFit PH internationally, reaching 35 countries before this release, and engaging investors via conferences and earnings calls. Leadership changes include a CFO transition. Today’s news about new LungFit PH distribution in additional countries extends this commercial expansion narrative.
Regulatory & Risk Context
The company has an active S-3/A shelf registration dated 2025-09-30, expiring 2028-09-30. It is noted as not yet effective and shows 0 instances of reported usage, but could provide a mechanism for future capital raises once effective.
Market Pulse Summary
This announcement expands LungFit PH distribution to Germany, Brazil, Austria, the Netherlands and Sri Lanka, bringing total coverage to 39 countries and a population exceeding three billion. It builds on prior updates highlighting international growth and financing to support commercialization. Investors may focus on how quickly these agreements translate into revenue, the timing of country-level regulatory approvals, and how the company balances growth initiatives with potential use of its existing S-3/A shelf.
Key Terms
nitric oxide medical
AI-generated analysis. Not financial advice.
Distribution network coverage expanded to a total of 39 countries
GARDEN CITY, N.Y., Dec. 17, 2025 (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 the lives of patients, today announced the recent signing of several key international distribution agreements for LungFit® PH, expanding its network to include Germany, Brazil, Austria, the Netherlands and Sri Lanka. These agreements bring the total international coverage to 39 countries, representing a combined population of more than three billion people.
"We are encouraged by the rapid expansion of LungFit PH’s international footprint over the past nine months. With access to 39 countries outside of the United States, including key markets such as Japan, Brazil, Mexico, Germany and France, the foundation for significant market share gains is in place. While regulatory approvals in some countries will take time, others will begin to benefit from the unique features of LungFit PH in calendar 2026. We look forward to bringing the benefits of LungFit PH to the majority of the world’s hospitals over the next several years," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.
Beyond Air's LungFit PH generates nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders. This tankless technology streamlines hospital operations, enhances efficiency and reduces environmental impact within hospital settings.
Potential customers can visit the LungFit PH website, www.lungfitph.com, for additional information, including the product label, and to sign up for company updates.
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. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM).
The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. 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.
*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 and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.
Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “appears,” “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ
What countries did Beyond Air add in the December 17, 2025 LungFit PH distribution update?
How many countries does LungFit PH cover after the new agreements for XAIR?
What population size do Beyond Air's international agreements cover after the expansion?
When will some countries begin using LungFit PH according to Beyond Air (XAIR)?
What is the key technical advantage of LungFit PH highlighted by Beyond Air?
Does Beyond Air say regulatory approvals are required for LungFit PH in new markets?
