Inspira™ Receives CSA Certification of Compliance to U.S. Standards for the INSPIRA™ ART100

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Inspira™ Technologies OXY B.H.N. (Nasdaq: IINN) has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device. This certification marks a significant step towards market access for their medical device, showcasing adherence to strict safety and performance requirements.

Positive

• Inspira™ received CSA Certification of Compliance to U.S. standards for the INSPIRA ART100 device.
• The certification allows the INSPIRA ART100 System to bear the CSA Mark for Medical Electrical Equipment/Systems.
• The certification signifies the company's dedication to product quality and safety standards.

Negative

• None.

Medical Device Analyst

The CSA Certification of Compliance is an indicator of the INSPIRA ART100 device's adherence to safety and performance standards, which is an essential step before entering the U.S. market. This certification can often streamline the process for FDA clearance, as it demonstrates a commitment to regulatory requirements. The presence of the CSA Mark, akin to a seal of approval, may improve buyer confidence and could potentially expedite partnerships or agreements with healthcare providers looking for externally validated equipment.

Market Analyst

In light of this certification, investors may anticipate an increase in market readiness for Inspira's product. It's a forward step for the company's operational presence in the U.S. and may act as a catalyst for stock valuation. Investors should observe the company's next steps towards FDA approval, as it will be a significant determinant of the product's commercial success. The timing of market entry is also key, as delays can affect investor sentiment. Moreover, being able to bear the CSA Mark could enhance the company's reputation, giving it a competitive edge in the medical device market.

RA'ANANA, Israel, April 25, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: 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 and safety."

About CSA

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, https://www.sec.gov.

MRK-ARS-100
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD. All rights reserved.

Logo: https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg

For more details:
Adi Shmueli
Public Relations Manager
Inspira Technologies
info@inspirao2.com
+972-9-9664485

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SOURCE Inspira Technologies

FAQ

What certification did Inspira™ Technologies OXY B.H.N. receive for the INSPIRA ART100 device?

Inspira™ Technologies OXY B.H.N. received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device.

What does the CSA Certification of Compliance mean for the INSPIRA ART100 System?

The Certification of Compliance allows for the INSPIRA ART100 System to bear the CSA Mark for Medical Electrical Equipment/Systems.

Who stated that the certification showcases unwavering commitment to product quality and safety?

Inspira Chief Operations Officer Mr. Avi Shabtay stated that the certification is a sign of their unwavering commitment to the highest standards of product quality and safety.