Full Press Release Details
Receives CSA Certification of Compliance to U.S. Standards for the INSPIRA ART100
Ra'anana, Israel, April 25,
2024 - Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira"),
a breakthrough medical technology company, announced that it has received the Canadian Standards Association (CSA) Certification
of Compliance to U.S. standards for the INSPIRA ART100 device.
This is a positive recognition of our product's quality and
safety standards. We believe, subject to U.S. Food and Drug Administration (FDA) regulatory clearance, that
this is an important milestone on the path towards attaining market access for our medical device, with the INSPIRA ART100 having undergone
advanced testing and certification to evaluate compliance with safety and performance requirements defined by the CSA.
The Certification of Compliance allows for the INSPIRA ART100 System
to bear the CSA Mark; C878081 MEDICAL ELECTRICAL EQUIPMENT/SYSTEMS - Certified to U.S. Standards.
Inspira Chief Operations Officer, Mr. Avi Shabtay stated: "This
certification is more than just a mark of compliance. It is a sign of our unwavering commitment to the highest standards of product quality
CSA Group is an independent, not-for-profit and impartial organization
that develops standards and codes serving industry, government, consumers and other interested parties in Canada and the global marketplace.
CSA Group works to develop standards that address real needs, such as enhancing public safety and health, advancing the quality of life,
helping to preserve the environment and facilitating trade. Accredited by the Standards Council of Canada, CSA Group has developed more
than 3,000 standards, codes and related products for the safety, design or performance of a wide range of products and services.
About Inspira Technologies OXY B.H.N. Ltd.
Inspira Technologies is an innovative medical technology company
in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA ART), designed
to rebalance patient oxygen saturation levels. This technology potentially allows patients to remain awake during treatment while reducing
the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The
Company's products have not yet been tested or used in humans and has not been approved by any regulatory entity.
For more information, please visit our corporate website: https://inspira-technologies.com
Forward-Looking Statement Disclaimer
This press release contains express or
implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are
based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that
could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using
forward-looking statements when it states that the receipt of the CSA mark is an important milestone on the path towards attaining
market access for the INSPIRA ART100 , subject to FDA regulatory clearance or when it states that the receipt
of the mark is a sign of its unwavering commitment to the highest standards of product quality and safety. These forward-looking statements
and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors
and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except
as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements
to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information
about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's
annual report on Form 20-F for the fiscal year ended December 31, 2023 filed with the U.S. Securities and Exchange Commission (the "SEC"),
which is available on the SEC's website, http://www.sec.gov
Public Relations Manager
Inspira Technologies
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