IINN Inspira Technologies Oxy B H N Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of January 2024 (Report No. 2)

 

Commission File Number: 001-40303

 

Inspira Technologies Oxy B.H.N. Ltd.

(Translation of registrant’s name into English)

 

2 Ha-Tidhar St.

Ra’anana 4366504, Israel

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

☒  Form 20-F      ☐  Form 40-F

 

 

 

CONTENTS

 

On January 9, 2024, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for a New Disposable Perfusion Market Opportunity,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

 

The first and second paragraphs and the section titled “Forward-Looking Statements” in the press release are incorporated by reference into the Registrant’s Registration Statements on Form F-3 (Registration No. 333-266748) and Form S-8 (Registration No. 333-259057), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. 

 

Exhibit No.
99.1		Press Release issued by Inspira Technologies Oxy B.H.N. Ltd. on January 9, 2024, titled “Inspira™ Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for a New Disposable Perfusion Market Opportunity.”

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	Inspira Technologies Oxy B.H.N. Ltd.
Date: January 9, 2024	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

 

 

2

 

Exhibit 99.1 

 

Inspira™ Announces Plans to Launch and Target Single-Use Disposable Blood Oxygenation Kit for a New Disposable Perfusion Market Opportunity

 

The kit is being designed for the INSPIRA™ ART device series and is intended to be compatible with various life support machines sold in the market

 

RA’ANANA, Israel, January 9, 2024 – Inspira Technologies OXY B.H.N Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company” or “Inspira”), a pioneer in life support technology with a vision to supersede traditional mechanical ventilators, today announced its plan to launch a single-use disposable blood oxygenation kit (the “Kit”), currently in development, for its INSPIRA ART medical device series. The Kit is also intended to be compatible with various other life support machines, tapping into the disposable perfusion systems market.

 

The Kit, anticipated to be submitted for US Food & Drug Administration (FDA) authorization in 2025, is a single-use product designed for efficient blood oxygenation and carbon dioxide removal. The Kit represents a strategic move to enhance hospital budget spending by potentially reducing costs. The Company is focusing on making the Kit compatible with other medical devices such as certain types of cardio-pulmonary bypass machines.

 

Dagi Ben-Noon, CEO of Inspira Technologies, commented: “Introducing the Kit marks the potential expansion of our market presence and fast-tracks our goal to deploy our blood oxygenation devices, with potential revenue streams based on the disposable razorblade business model. We believe that this development, along with the anticipated FDA clearance of our INSPIRA™ ART100 device in the first half of 2024, solidifies our commitment to providing comprehensive and affordable solutions in life support technology.”

 

Inspira Technologies OXY B.H.N Ltd.

 

Inspira Technologies is leading the way in transforming life-support care. Its innovative solutions are paving the way for direct blood oxygenation, bypassing the lungs, and potentially reducing the need for traditional mechanical ventilation. Beyond this, the Company is committed to advancing blood circulation technology and incorporating AI-driven monitoring systems. These advancements are part of its strategy to offer more patient-focused, data-informed care. The integration of these technologies signifies the potential to enhance patient outcomes and streamline hospital operations, marking a new era in respiratory care.

 

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 under U.S. Federal securities laws. These forward-looking statements and their implications are based only on the current expectations of the management of the Company. They are subject to several factors and uncertainties that could cause results to differ materially from those described in the forward-looking statements. For example, the Company uses forward-looking statements when it discusses the prospective compatibility of the Kit with other life support machines, the anticipated FDA submission of the Kit in 2025, that the Kit represents a strategic move to potentially reduce costs, that the Kit fast-tracks the Company’s goal to deploy its blood oxygenation devices, and the belief that the Kits, along with the anticipated FDA clearance of its INSPIRA ART device in the first half of 2024, solidifies its commitment to providing comprehensive and affordable solutions in life support technology. 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 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, 2022, filed with 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.

MRK-ARS-082

 

 

 

 

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