Inspira™ Technologies Prepares its First Life-Support Systems for Deployment at a Leading U.S. Hospital

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) has delivered its INSPIRA™ ART100 systems to Glo-Med Networks for deployment at a leading U.S. hospital. The systems will be distributed to hospitals on the U.S. east coast, including a top-ranking cardiothoracic surgery division in New York.

The INSPIRA™ ART100, which received FDA 510(k) clearance for cardiopulmonary bypass procedures in May 2024, will be integrated with the HYLA™ blood monitoring technology. The HYLA™ is currently undergoing clinical evaluations at Sheba Hospital in preparation for FDA submission in 2025.

The company is developing breakthrough respiratory support technologies, including the INSPIRA ART, aimed at potentially replacing the $19 billion mechanical ventilation market. This technology is designed to stabilize decreasing oxygen levels without requiring ventilation, allowing patients to remain awake during treatment.

Positive

• FDA 510(k) clearance obtained for INSPIRA™ ART100 system in May 2024
• Initial deployment at top 15% ranked U.S. cardiothoracic program
• HYLA™ blood monitoring technology in clinical evaluation phase at globally ranked hospital

Negative

• Core products (INSPIRA ART500, Cardi-ART, VORTX, HYLA) still in development phase
• No human testing or regulatory approval yet for main product pipeline

Insights

Medical Technology Analyst

The deployment of INSPIRA™ ART100 systems at a leading U.S. hospital marks a important commercialization milestone for Inspira Technologies. This strategic entry into the $19 billion mechanical ventilation market through a top-tier cardiothoracic program demonstrates calculated market penetration.

The company's two-pronged approach is noteworthy: First, targeting high-ranking hospitals builds credibility and facilitates wider adoption. Second, the integration of HYLA™ blood monitoring technology could create a compelling competitive advantage in the critical care space.

For investors, several key factors warrant attention:

• Market Positioning: Initial deployment in a top 15% cardiothoracic program provides valuable clinical validation and potential reference site
• Regulatory Progress: FDA 510(k) clearance for CPB procedures and Israeli AMAR certification strengthen market access
• Development Pipeline: The planned FDA submission for HYLA™ in 2025 indicates continued innovation momentum

However, investors should consider that while this deployment represents progress, substantial risks remain. The company's $26 million market cap suggests early-stage status and successful commercialization will require significant resources for market education, clinical adoption and sales infrastructure development. Additionally, the transition from initial deployment to meaningful revenue generation typically involves a lengthy adoption cycle in medical devices.

RA'ANANA, Israel, Jan. 22, 2025 /PRNewswire/ -- Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW), ("Inspira Technologies," "Inspira" or the "Company"), a groundbreaking respiratory support technology company, announced that its INSPIRA™ ART100 systems have been delivered to Glo-Med Networks Inc. ("Glo-Med") and are now being prepared for their first planned deployment at a leading U.S. hospital. The deployment will include direct support from Inspira's team alongside Glo-Med's experts, ensuring a seamless integration of the revolutionary life-support technology into clinical use.

The delivered INSPIRA™ ART100 systems, as previously announced on December 16, 2024, will be distributed to sales targets across hospitals on the U.S. east coast and distributed to a cardiothoracic surgery division at a leading New York hospital, ranked among the top 15 percent of cardiothoracic programs in the U.S., with a view to collaborating with such hospital. The Company believes that the delivery of the INSPIRA™ ART100 to the U.S. market serves the Company's goal well to introduce physicians and perfusionists to Inspira's technologies and brand via initial deployments at leading hospitals.

Designed in collaboration with leading U.S. clinicians, the INSPIRA™ ART100 cardiopulmonary bypass system revolutionizes extracorporeal blood circulation by combining cutting-edge technology with intuitive design to optimize patient care during crucial times. The INSPIRA™ ART100 is planned to be integrated with the HYLA™, a continuous blood monitoring technology designed to potentially detect real-time changes in patient condition. The HYLA™ is undergoing clinical evaluations at Sheba Hospital, ranked the 9th in the world by Newsweek™, in patients undergoing open-heart procedures, in preparation of the Company's planned U.S. Food and Drug Administration ("FDA") submission of the first configuration of the HYLA™ in 2025.

Inspira™ Technologies OXY B.H.N. Ltd.

Inspira Technologies is an innovative medical technology company targeting to better the life support and respiratory treatment arena. The Company is developing a breakthrough Augmented Respiration Technology (INSPIRA™ ART), a groundbreaking device poised to revolutionize and potentially replace the $19 billion mechanical ventilation market. With 20 million intensive care unit patients with acute respiratory failure each year, many of whom rely on mechanical ventilators, the INSPIRA ART offers a potential alternative by elevating and stabilizing decreasing oxygen saturation levels in minutes without a ventilator, with patients being awake during treatment. The INSPIRA ART is being designed to include the clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology, aiming to alert physicians of changes in a patient's condition without the need for intermittent actual blood samples, aiming to support physicians in making informed decisions.

In May and July 2024, respectively, the Company's INSPIRA^™ ART100 system has obtained FDA 510(k) clearance for use in CBP procedures, along with the Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

The Company's other products and technologies, including the INSPIRA ART also known as the INSPIRA™ ART500 or Gen 2, the INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, are currently being designed and developed, and have not yet been tested or used in humans nor approved by any regulatory entity.

For more information, please visit our corporate website at https://inspira-technologies.com

Forward-Looking Statements

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 the prospective preparation and deployment of the INSPIRA™ ART100 systems,  the prospective distribution lines for the INSPIRA™ ART100 systems, the belief that the delivery of the INSPIRA™ ART100 to the U.S. market serves the Company's goal well to introduce physicians and perfusionists to Inspira's technologies and brand via initial deployments at leading hospitals, the benefits of the INSPIRA™ ART100 , its plan to combine the INSPIRA™ ART100 with the HYLA™, the expected timing of the planned FDA submission of the first configuration of the HYLA™. 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.

Contact: Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485

Copyright © 2018-2025 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

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SOURCE Inspira Technologies

FAQ

When did IINN receive FDA 510(k) clearance for the INSPIRA™ ART100 system?

Inspira Technologies received FDA 510(k) clearance for the INSPIRA™ ART100 system in May 2024 for use in cardiopulmonary bypass procedures.

What is the market potential for IINN's INSPIRA ART technology?

The INSPIRA ART technology targets the $19 billion mechanical ventilation market, with potential application to 20 million intensive care unit patients with acute respiratory failure annually.

When is IINN planning to submit the HYLA™ blood sensor for FDA approval?

Inspira Technologies plans to submit the first configuration of the HYLA™ blood sensor to the FDA in 2025.

Where is IINN deploying its first INSPIRA™ ART100 systems in the US?

The first INSPIRA™ ART100 systems are being deployed at a leading cardiothoracic surgery division in New York, ranked among the top 15% of cardiothoracic programs in the U.S.

Which regulatory approvals has IINN received for its INSPIRA™ ART100 system?

IINN has received FDA 510(k) clearance and Israeli AMAR certification for the INSPIRA™ ART100 system for use in Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.