IINNW 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 December 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 December 10, 2024, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Expands HYLA Blood Sensor Technology into Personalized Blood Lab Testing for Rapid Detection of Serious Medical Conditions,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

 

The first three 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 Nos. 333-259057 and 333-277980), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this Report of Foreign Private Issuer on Form 6-K is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 December 10, 2024, titled “Inspira™ Expands HYLA Blood Sensor Technology into Personalized Blood Lab Testing for Rapid Detection of Serious Medical Conditions.”

 

 

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: December 10, 2024	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

 

 

2

Exhibit 99.1

 

Inspira™ Expands HYLA™ Blood Sensor Technology into Personalized Blood Lab Testing for Rapid Detection of Serious Medical Conditions

 

RA’ANANA, Israel– December 10, 2024 – Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN, IINNW), (“Inspira Technologies” or the “Company”), a groundbreaking life support technology company, revealed the expansion of its HYLA blood sensor technology (“HYLA”) into an immediate personalized Blood Lab Test, aimed at performing real-time patient blood work for the rapid detection in minutes of the potential development of an underlying life-threatening medical condition.

 

The HYLA business model is designed to replace the need for nurses to take intermittent physical blood samples from patients undergoing extracorporeal procedures by providing patient blood work with pre-determined setup options, or alternatively, supporting physical immediate intermittent blood work testing and analysis. The HYLA is expected to be used near a patient’s bed in ER’s, ICU’s, Medical Units and in operating rooms, with the potential to replace expensive equipment, eliminate the need for blood cartridges and dependency on central labs and reduce the burden on hospital staff. The HYLA technology could also potentially reduce countless tests performed each year where valuable time is often lost between the time of ordering a blood test and when test results are received, which can impact patient treatment and outcomes.

 

The HYLA is undergoing clinical evaluations in Sheba Hospital (Ranked 9^th in the world by Newsweek™ magazine) 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.

 

“Our plans to use HYLA to perform blood work without the need to take physical blood samples is part of a broader business strategy,” said Dagi Ben-Noon, CEO of Inspira Technologies. “The core technologies of the INSPIRA ART are progressing, with the Company currently performing a clinical evaluation of the HYLA blood technology at Sheba hospital, with results expected to be revealed in the near future.”

 

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 potential use and design of its products and technologies, the expected timing of its FDA submission and the potential size of its target market and that its development of innovative life support technology could disrupt the $19 billion mechanical ventilation market. 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
 

MRK-ARS-124

 

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