Inspira™ Technologies Delivers Systems to Leading Distributor for U.S. Deployment

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) has delivered its INSPIRA™ ART100 systems to U.S. distributor Glo-Med Networks for deployment in east coast hospitals, including a leading New York cardiothoracic surgery division ranked in the top 15% nationally. The ART100, designed with U.S. clinicians, is FDA 510(k) cleared for Cardiopulmonary Bypass procedures and will be integrated with the HYLA™ blood monitoring technology, currently under clinical evaluation at Sheba Hospital.

The HYLA™ system is preparing for FDA submission in 2025, aiming to provide real-time patient condition monitoring without requiring blood samples. The company's broader technology portfolio includes the INSPIRA ART500, Cardi-ART portable device, and VORTX system, all still in development and pending regulatory approvals.

Positive

• FDA 510(k) clearance obtained for INSPIRA™ ART100 system
• Initial delivery of systems to U.S. market achieved
• Distribution agreement with major hospital in top 15% of U.S. cardiothoracic programs
• HYLA™ blood monitoring technology undergoing clinical evaluations at globally ranked Sheba Hospital

Negative

• Most products still in development phase without regulatory approval
• HYLA™ FDA submission not planned until 2025
• No revenue figures or financial terms disclosed for the distribution agreement

Insights

Medical Device Analyst

The delivery of INSPIRA™ ART100 systems marks a significant milestone in Inspira's commercialization strategy. The initial deployment to a top-tier cardiothoracic program in New York provides a strategic entry point for market penetration. The FDA 510(k) clearance for cardiopulmonary bypass procedures adds credibility, though revenue impact may be initially. The planned integration with HYLA™ blood monitoring technology could provide a competitive edge, pending successful clinical evaluations and FDA approval. However, investors should note that key products like the INSPIRA ART500 and HYLA™ are still in development phases, with FDA submission for HYLA™ targeted for 2025.

Market Research Analyst

The $19 billion mechanical ventilation market represents a substantial opportunity, with 20 million ICU patients annually needing respiratory support. The strategic distribution through Glo-Med Networks positions Inspira to target the lucrative U.S. East Coast market. The collaboration with a leading New York hospital could enhance brand credibility and facilitate market acceptance. However, with a market cap of just $22.1 million, the company faces significant competition from established players. The success of this initial deployment and subsequent market expansion will be important for long-term growth prospects.

RA'ANANA, Israel, Dec. 16, 2024 /PRNewswire/ -- Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN, IINNW), ("Inspira Technologies," "Inspira" or the "Company"), a groundbreaking respiratory support technology company, announced the delivery of INSPIRA™ ART100 systems to its U.S. distributor, Glo-Med Networks Inc ("Glo-Med"). The systems were shipped in fulfilment of a purchase order issued by Glo-Med to Inspira.

The delivered INSPIRA™ ART100 systems 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 9^th 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. 

Dagi Ben-Noon, CEO of Inspira Technologies stated: "We see this as merely the first deployment step in Inspira's quest to revolutionize acute respiratory care with our groundbreaking technology and superior products that we believe will follow this initial distribution."

 

Inspira™ Technologies OXY B.H.N. Ltd.

Inspira Technologies is an innovative medical technology company in the life support and respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA™ ART), a groundbreaking device poised to revolutionize 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 ventilators, with patient being awake during treatment. The INSPIRA ART is being equipped with the HYLA™ blood sensor technology, 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, and potentially supporting physicians in making informed decisions.

The Company's INSPIRA^™ ART100 system has obtained FDA 510(k) clearance for use in Cardiopulmonary Bypass 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 orbiting Oxygen Delivery System and HYLA™ blood sensor, are currently being designed and developed, and 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 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 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™, and that its sees these distribution lines as the first deployment step in Inspira's quest to revolutionize acute respiratory care with its groundbreaking technology and superior products that may follow. 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:
For more information, contact:

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

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

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SOURCE Inspira Technologies

FAQ

When will Inspira Technologies (IINN) submit the HYLA blood monitoring system to FDA?

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

What regulatory approvals has IINN's INSPIRA ART100 system received?

The INSPIRA ART100 system has received FDA 510(k) clearance for Cardiopulmonary Bypass procedures and Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures.

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

The systems are being deployed to hospitals on the U.S. east coast, including a leading New York hospital's cardiothoracic surgery division ranked among the top 15% of cardiothoracic programs in the U.S.

Which distributor is handling IINN's INSPIRA ART100 systems in the United States?

Glo-Med Networks Inc. is the U.S. distributor handling the INSPIRA ART100 systems.

Where is IINN conducting clinical evaluations for the HYLA blood monitoring technology?

The HYLA blood monitoring technology is undergoing clinical evaluations at Sheba Hospital, which is ranked 9th in the world by Newsweek.