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.

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