Inspira™ Receives Israeli Regulatory Approval for the INSPIRA™ ART100 System

Rhea-AI Summary

Inspira Technologies has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This approval follows the FDA clearance announced on May 28, 2024.

Both approvals are critical milestones, enhancing the company's market opportunities in the U.S. and Israel. The INSPIRA™ ART100, equipped with Adaptive Blood Oxygenation technology, measures blood parameters in real-time to deliver oxygen directly into the blood.

CEO Dagi Ben-Noon and Dr. Dekel Stavi highlight the significance of these approvals for business expansion and local adoption. The company aims to revolutionize respiratory and life-support technologies with further product development, although some products like the INSPIRA™ ART (Gen 2) and HYLA™ blood sensor remain untested and unapproved by any regulatory bodies.

Positive

• Israeli Ministry of Health approval for INSPIRA™ ART100.
• FDA clearance for INSPIRA™ ART100 on May 28, 2024.
• Opens market opportunities in the U.S. and Israel.
• Features Adaptive Blood Oxygenation technology for real-time blood parameter monitoring.

Negative

• INSPIRA™ ART (Gen 2) and HYLA™ blood sensor remain untested and unapproved.

Insights

Medical Research Analyst

Inspira Technologies' approval from the Israeli Ministry of Health for the INSPIRA™ ART100 system is a significant step in their journey. This technology, which includes Extra-Corporeal Membrane Oxygenation (ECMO) and Cardiopulmonary Bypass capabilities, is designed to elevate patient oxygen levels rapidly, potentially allowing patients to remain conscious during treatment. This can offer a revolutionary shift in how critical respiratory care is administered.

From a research perspective, the real-time blood parameter monitoring embedded in the ART100 system is particularly noteworthy. This feature provides continuous data, which can lead to better patient outcomes through timely interventions. However, the system's efficacy and safety in real-world settings remain to be fully validated, especially beyond controlled environments like intensive care units.

For investors, it's important to note that while the ART100 has received regulatory clearance, other products in Inspira's pipeline, such as the INSPIRA™ ART500 and HYLA™ blood sensor, are still in the early stages. These products have not yet undergone human testing or received regulatory approval, representing both an opportunity and a risk, depending on future clinical outcomes.

Financial Analyst

The recent approval by the Israeli Ministry of Health for the INSPIRA™ ART100 system follows the earlier FDA clearance, positioning Inspira Technologies for potential market expansion. This regulatory milestone can drive revenue growth, primarily from institutional sales to hospitals and healthcare facilities in Israel and potentially other regions.

From a financial perspective, this approval underpins the company's strategy to enter new markets. However, investors should weigh this against the company's current stage. Early-stage companies like Inspira, especially in the medical technology sector, face inherent risks such as prolonged commercialization timelines and the necessity for substantial capital expenditure to scale production and distribution.

Short-term, this approval might boost investor sentiment and share price valuation. In the long-term, sustained profitability will depend on the successful commercialization of their broader product portfolio, which is still under development and unapproved for human use.

Market Research Analyst

The AMAR approval for the INSPIRA™ ART100 system marks a important step for Inspira Technologies in establishing its footprint in the Israeli medical devices market. The ECMO and Cardiopulmonary Bypass technologies embedded in the ART100 address a critical need in respiratory and cardiac care, which can potentially drive high adoption rates among hospitals.

However, the competitive landscape in the medical devices market is intense. Inspira's success will largely depend on their ability to differentiate their products from existing solutions. Their real-time blood monitoring feature is a potential differentiator, but the market's response will be the ultimate test. Additionally, strategic alliances and partnerships could play a pivotal role in accelerating market penetration and ensuring sustained growth.

Long-term market success will require ongoing innovation and robust post-market surveillance to ensure the technology meets clinical expectations and addresses any safety concerns that may arise.

Approval follows the FDA clearance announced on May 28, 2024 

RA'ANANA, Israel, July 11, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is excited to announce the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval for the INSPIRA™ ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This is a pivotal milestone in Inspira's strategy to conduct business development activities to bring its innovative products and technologies to the market.

The Company believes that receiving Israeli regulatory approval marks an important step towards growing local support and adoption for the INSPIRA™ ART100 and demonstrates Inspira's capabilities in obtaining regulatory approvals for its products.

Dr. Dekel Stavi, head of the Israeli Extra-Corporeal Membrane Oxygenation ("ECMO") Society and Inspira's Medical Director, commented, "As a physician and the head of the Israeli ECMO Society, I am delighted to witness this exciting milestone where hospitals will have the opportunity to acquire and use the innovative and technologically cutting-edge INSPIRA™ ART100."

Dagi Ben-Noon, CEO of Inspira Technologies, stated, "After we received FDA approval for the INSPIRA ART100 that will allow us to establish our presence in the U.S., receiving AMAR approval will facilitate the creation of business opportunities in new regions and emerging markets."

Inspira Technologies OXY B.H.N. Ltd.

Inspira™ Technologies targets to reshape the respiratory and life-support landscape. We are developing novel expanding life support technologies and solutions to prolong life and improve the quality of life for patients. Inspira is on a quest to become the leading ground-breaking medical device company in our field with business alliances around the world.

The INSPIRA™ ART (Gen 2), also known as the INSPIRA™ ART500, will include 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 require intubation and medically induced coma.

The Company's INSPIRA™ ART100 system received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

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 AMAR approval is a pivotal milestone in its strategy to conduct business development activities to bring its innovative products and technologies to the market, that it believes that receiving this approval marks an important step towards increasing local support and adoption for the INSPIRA™ ART100 and demonstrates its capabilities in obtaining regulatory approvals for its products, that hospitals will have the opportunity to acquire and use the INSPIRA™ ART100, and that receiving this approval may allow the Company to establish its presence in the U.S. and facilitate the creation of business opportunities in new regions and emerging markets . 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, 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 approvals has Inspira Technologies received for the INSPIRA™ ART100?

Inspira Technologies has received Israeli Ministry of Health approval and FDA clearance for the INSPIRA™ ART100 system.

What is the INSPIRA™ ART100 system?

The INSPIRA™ ART100 is an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system designed to measure blood parameters in real-time and deliver oxygen directly into the blood.

When did the INSPIRA™ ART100 receive FDA clearance?

The INSPIRA™ ART100 received FDA clearance on May 28, 2024.

How will the INSPIRA™ ART100 system affect business opportunities for Inspira Technologies?

The approval of the INSPIRA™ ART100 system in both the U.S. and Israel opens new market opportunities and facilitates business expansion in these regions.

What other products is Inspira Technologies developing?

Inspira Technologies is developing the INSPIRA™ ART (Gen 2) and the HYLA™ blood sensor, both of which have not yet been tested or approved by any regulatory entities.