INSPIRA™ ART100 Receives FDA 510(k) Clearance

Rhea-AI Summary

Inspira Technologies OXY announced that its INSPIRA™ ART100 Cardiopulmonary Bypass System has received 510(k) class II clearance from the FDA.

The FDA clearance is a significant milestone for the company, suggesting technological and innovative advancements.

CEO Dagi Ben Noon and Chairman Professor Benad Goldwasser expressed their appreciation for investors and partners and highlighted the strategic importance of this clearance.

Positive

• FDA 510(k) class II clearance for INSPIRA™ ART100 signifies regulatory approval and potential market entry.
• The clearance is indicative of the company's technological and innovative capabilities.
• Leadership's appreciation for investors and partners may bolster investor confidence.

Negative

• The press release lacks specific financial data or immediate revenue projections tied to the FDA clearance.
• There is no mention of current or anticipated production timelines for the INSPIRA™ ART100.
• Unspecified potential risks or challenges in the commercialization phase post-clearance.

Insights

Medical Research Analyst

The FDA 510(k) clearance for Inspira Technologies' INSPIRA™ ART100 is a significant milestone, indicating that the product is substantially equivalent to a legally marketed device. This clearance allows the company to market and sell the ART100 in the U.S. Cardiopulmonary bypass systems are critical during heart surgeries, temporarily taking over the function of the heart and lungs. The clearance reflects well on the safety and effectiveness of the ART100.

For investors, the FDA's decision represents a potential for revenue growth. The U.S. market for cardiopulmonary bypass systems is competitive but also substantial. However, it's essential to monitor how quickly Inspira can scale up production and secure hospital contracts.

Given the positive nature of this news, the rating is 1.

Financial Analyst

From a financial perspective, FDA 510(k) clearance can be a pivotal event for a company's stock. This approval potentially opens up a new revenue stream and enhances the company’s market position. Investors should watch for subsequent financial reports to assess the impact on revenue and profitability. Additionally, it's vital to consider the costs associated with ramping up production and marketing efforts.

This clearance may also attract investor confidence, leading to possible short-term stock price appreciation. However, the true financial impact will become clearer over the next few quarters as the company begins to commercialize the ART100.

Given the financial implications, the rating is 1.

RA'ANANA, Israel, May 28, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System.

Dagi Ben Noon, CEO of Inspira, said "This is a proud moment for all of us at Inspira Technologies. We would like to thank all our investors and partners who have been with us on this journey to get here."

Professor Benad Goldwasser, the Chairman of the Board of Inspira, stated: "We believe that the FDA clearance marks a clear example of the Company's technological and innovative advancements."

About Inspira Technologies OXY B.H.N. Ltd.

Inspira™ Technologies is an innovative medical technology company in the life support arena. The INSPIRA™ ART (Gen 2), also known as the INSPIRA™ ART500, includes the Company's Adaptive Blood Oxygenation technology and is being designed to continuously measure the patient's blood parameters in real-time, delivering needed oxygen volume straight into the blood. By elevating patient oxygen saturation levels in minutes, this technology potentially allows patients to remain awake during treatment and therefore may enable patients to be treated in and beyond intensive care units, reducing the need for mechanical ventilation systems that requires intubation and medically induced coma.

The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary Bypass System.

The Company's other products, including the INSPIRA ART (Gen 2) and HYLA™ blood sensor, have not yet been tested or used in humans and have 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 discusses that the Company believes the FDA clearance is an example of its technological and innovative advancements and the potential benefits of its products and technologies. 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

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

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

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SOURCE Inspira Technologies

FAQ

What recent FDA approval did Inspira Technologies receive?

Inspira Technologies received FDA 510(k) class II clearance for its INSPIRA™ ART100 Cardiopulmonary Bypass System.

What is the significance of FDA 510(k) clearance for IINN?

The FDA 510(k) clearance indicates regulatory approval, allowing Inspira Technologies to market the INSPIRA™ ART100 in the U.S.

When did Inspira Technologies announce the FDA clearance for INSPIRA™ ART100?

Inspira Technologies announced the FDA clearance on May 28, 2024.

What is the INSPIRA™ ART100?

The INSPIRA™ ART100 is a Cardiopulmonary Bypass System developed by Inspira Technologies.

How did Inspira Technologies' leadership respond to the FDA clearance?

CEO Dagi Ben Noon and Chairman Professor Benad Goldwasser expressed pride and appreciation for investors and partners, emphasizing the strategic importance of the clearance.