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Beyond Air Announces Agreements Expanding Global Distribution of LungFit PH Distribution agreements recently signed for France, Turkey, Romania and Morocco LungFit PH international distribution network now includes 18 co

Key Takeaway: Beyond Air has announced new distribution agreements for its LungFit PH system in France, Turkey, Romania, and Morocco, expanding its international market presence to 18 countries. The company anticipates a quicker commercial ramp-up in international markets compared to the U.S., aided by established distribution partners. This product allows for on-demand nitric oxide generation, enhancing hospital efficiency and reducing safety risks associated with traditional high-pressure cylinders. The LungFit PH system has recently received CE Mark approval and is already being utilized by leading hospitals in the U.S.

Market Sentiment Analysis

POSITIVE FACTORS

  • Expansion of global distribution indicates strong international interest.
  • Strong feedback from U.S. hospitals suggests effective product performance.
  • LungFit PH simplifies operations by eliminating high-pressure cylinder needs.

Full Press Release Details

Air Announces Agreements Expanding Global Distribution of LungFit PH
agreements recently signed for France, Turkey, Romania and Morocco
PH international distribution network now includes 18 countries
international orders for LungFit PH systems have been received for four countries
CITY, N.Y., March 11, 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, announced the expansion of its global distribution channels for LungFit PH with several new distribution agreements that
will cover four countries, including France, Romania, Turkey and Morocco.
interest for our LungFit PH system, which only just received CE Mark about 15 weeks ago is very strong. With the addition of these latest
agreements, our international commercial footprint currently includes 18 countries, and we are rapidly moving towards signing additional
agreements that will further expand our distribution network," said Steve Lisi, Chairman and Chief Executive Officer of Beyond
Air. "Considering the commercial experience we have gained over the past couple of years, and positive feedback from a rapidly
growing list of leading U.S. hospitals actively using the LungFit PH system, we anticipate a more rapid commercial ramp-up in the international
market than seen in the U.S. We also will have the advantage of distribution partners that have established medical device infrastructure
to help generate positive early momentum."
is a list of the current LungFit PH partnerships.
Partner Countries
Getz Healthcare Australia, Hong Kong, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Taiwan, Thailand, Vietnam
Saudi Health Services CO Saudi Arabia
MDC Care Medical Trading United Arab Emirates, Oman, Qatar
EUROCARE France
Medelart Healthcare Turkey
Abb Neopuls Romania
OXYPLUS Morocco
Air's LungFit PH generates nitric oxide from room air, eliminating the need for traditional high-pressure cylinders. This tankless
technology streamlines operations, enhances efficiency, and supports sustainability efforts within hospital settings.
customers can visit the LungFit PH website, www.lungfitph.com for additional information, including the product label, and to
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.
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.
Air's LungFit PH is approved for commercial use in the United States, European Union, Australia, Thailand and New Zealand. 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.
Oxide (NO) is a powerful 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-cardiac surgery, and persistent pulmonary hypertension of the
newborn to treat hypoxemia.
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,
including mycobacteria, viruses, fungi, yeast, and parasites, and has the potential to eliminate multi-drug-resistant strains.
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).
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.
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.
LifeSci Advisors, LLC

Frequently Asked Questions

What countries are included in the new distribution agreements?

The new distribution agreements cover France, Romania, Turkey, and Morocco.

How many countries does the LungFit PH network cover now?

The LungFit PH international distribution network currently includes 18 countries.

What advantage does LungFit PH provide over traditional systems?

LungFit PH generates nitric oxide from room air, eliminating the need for high-pressure cylinders.

In which countries is LungFit PH approved for commercial use?

LungFit PH is approved for use in the United States, EU, Australia, Thailand, and New Zealand.

What is the main benefit of using nitric oxide in treatments?

Nitric oxide is critical for treating respiratory illnesses and has antimicrobial properties.

Last updated: Mar 11, 2025