Inspira™ Receives First Ever Purchase Order for INSPIRA™ ART100 Systems in the U.S.

Rhea-AI Summary

Inspira Technologies has announced its first purchase order for the INSPIRA ART100 systems from Glo-Med Networks. This order includes five units expected to ship in Q4 2024, with a potential for 20 additional units pending further agreements. This milestone follows the recent FDA clearance of the INSPIRA ART100 and marks a significant step in Inspira's growth strategy. The INSPIRA ART100, part of a new generation of devices targeting the $19 billion mechanical ventilator market, aims to reduce the need for traditional mechanical ventilation. The company also plans to offer hospitals special terms for the integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) devices, pending regulatory approvals and product development.

Positive

• Received first purchase order for INSPIRA ART100 systems.
• FDA clearance for INSPIRA ART100 obtained.
• Potential for additional 20 units in future purchase orders.
• Targets $19 billion mechanical ventilator market.
• Special terms planned for integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) devices.

Negative

• Shipment of first units not expected until Q4 2024.
• Additional units' purchase dependent on further agreements.
• Integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) still require regulatory approvals.

Insights

Financial Analyst

The announcement of the first purchase order for INSPIRA™ ART100 systems is a significant milestone for Inspira Technologies. It's an indicator of market acceptance and readiness to enter a competitive $19 billion mechanical ventilator market. This purchase order, particularly being the initial order, implies potential future revenue growth which is critical for investor confidence. The future agreement for an additional 20 systems could mean an exponential growth in revenue if successful. Financially, this could enhance the company's balance sheet and improve its market valuation.

However, investors should also consider the timeline. The units are due for shipment in the fourth quarter of 2024, meaning the financial impact won’t be immediate. Also, the company's future success largely hinges on the development and approval of the INSPIRA™ ART Gen 2 and HYLA™ Blood Sensor, which introduces an element of uncertainty.

Medical Research Analyst

From a clinical perspective, the INSPIRA™ ART100 system's FDA clearance and subsequent purchase order underscore its potential utility and effectiveness in a clinical setting. This technology aims to provide an alternative to traditional mechanical ventilation, a market that has seen little innovation over recent years. The pivot to next-generation technology shows a forward-thinking approach, potentially positioning Inspira as a disruptor in the life support systems space.

Nevertheless, the success of these systems in real-world settings will be critical. Clinical validation through widespread use will determine if the INSPIRA™ ART100 can indeed perform as expected and be a preferable alternative to current mechanical ventilators. Thus, while the initial order is promising, it remains to be seen how the market will respond after deployment.

First units expected to be shipped in Q4 2024. The Purchase Order follows the recent FDA Clearance of the INSPIRA™ ART100.

RA'ANANA, Israel, June 13, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, today announced that is has received the first purchase order from Glo-Med Networks, Inc. ("Glo-Med") for its INSPIRA™ ART100 systems, with the five product units expected to be shipped in the fourth quarter of 2024. The purchase order also provides for the potential purchase of  an additional 20 systems, the timing of which is subject to further agreement between Inspira and Glo-Med.

The planned shipment and potential additional sales of the INSPIRA™ ART100 systems is a pivotal step in the Company's growth model, which is primarily based on the INSPIRA™ ART (Gen 2) that is currently in development and is expected to target the $19 billion mechanical ventilator market, with its next generation cutting-edge technology designed to replace the need for mechanical ventilation. The Company plans to offer hospitals receiving the INSPIRA™ ART100 an option with special terms for the integrated HYLA™ Blood Sensor and INSPIRA™ ART (Gen 2) devices, subject to the completion of the development of those products, which are also subject to approval by regulatory entities.

Joe Hayon, Director, President and co-founder of Inspira stated: "We continue to develop the breakthrough technologies of tomorrow. The INSPIRA™ ART100, is our first and important step in building the INSPIRA market presence and position in preparation for the INSPIRA™ ART (Gen 2), which we believe has the potential to provide a new clinical solution with a potentially different intent of use for the mega life support and mechanical ventilation market."

The Company already began the commercial manufacturing of the INSPIRA™ ART100 with the first five units planned for shipment to Glo-Med, a distributor for Inspira products in the U.S., with the devices planned for deployment in U.S. hospitals.

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, shall 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 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 the expected timing of the delivery of the ART100 systems, the potential for future orders, the belief that the planned shipment and potential additional sales of ART100 systems is a pivotal step in the Company's growth model, that it expects its ART100 systems to be deployed in U.S. hospitals and that it began the commercial manufacturing of the INSPIRA ART100 with the first five units planned for shipment to U.S. hospitals. 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 did Inspira Technologies announce on June 13, 2024?

Inspira Technologies announced its first purchase order for the INSPIRA ART100 systems from Glo-Med Networks.

When will the INSPIRA ART100 units be shipped?

The first units are expected to be shipped in Q4 2024.

How many INSPIRA ART100 units were ordered by Glo-Med Networks?

Glo-Med Networks ordered five units, with a potential for an additional 20 units.

What is the market target for the INSPIRA ART100?

The INSPIRA ART100 targets the $19 billion mechanical ventilator market.

What regulatory status does the INSPIRA ART100 have?

The INSPIRA ART100 has received FDA clearance.

What conditions apply to the additional 20 INSPIRA ART100 units?

The purchase of the additional 20 units is subject to further agreement between Inspira and Glo-Med.

What future plans does Inspira have for the INSPIRA ART100 buyers?

Inspira plans to offer special terms for the integrated HYLA Blood Sensor and INSPIRA ART (Gen 2) devices to hospitals receiving the INSPIRA ART100, pending regulatory approvals and product development.