Inspira wins Clalit approval for ART100 system

Inspira Technologies Oxy B.H.N.

Accepted by SEC EDGAR 02/09/2026 - 06:42 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Inspira Technologies Oxy B.H.N. Ltd. reports a major commercial step: its FDA-cleared INSPIRA ART100 system has received official vendor approval from Clalit Health Services, described as the world’s second-largest integrated HMO with $12 billion in revenue.

This approval allows immediate procurement and operational use of the ART100 for cardiopulmonary procedures across Clalit’s network of medical centers, subject to its supply-chain protocols. Management frames this as a “definitive commercial inflection point” that may support long-term, high-quality revenue and provide a strong reference site as the company pursues commercialization in the U.S. and other markets.

The ART100 is cleared in the U.S. for cardiopulmonary bypass and for ECMO procedures outside the U.S., and serves as the platform for the in-development ART500 system. The company is also advancing its HYLA blood sensor platform, positioning itself within the life-support and MedTech space.

Positive

• Clalit vendor approval enables immediate ART100 deployment, giving Inspira access to a large, $12 billion revenue integrated HMO network and creating a strong reference account for further commercialization.

Negative

• None.

Insights

MedTech commercial strategy analyst

Winning Clalit vendor status gives Inspira a powerful early commercial foothold.

Clalit Health Services, described as a $12 billion revenue HMO and the world’s second-largest integrated HMO, has approved INSPIRA ART100 for immediate procurement and use. That places Inspira’s system on a large, data-driven platform for cardiopulmonary procedures.

This decision signals clinical and operational acceptance of ART100 within a demanding health network, which management views as validating its suitability and safety profile. It also allows all Clalit medical centers to start purchases under existing supply-chain protocols, potentially supporting recurring procedure-related demand.

Management characterizes the milestone as a “definitive commercial inflection point” and a foundation for potentially long-term, high-quality revenue, as well as a reference case for commercialization in the U.S. and other markets. Actual revenue impact will depend on adoption levels and procedure volumes disclosed in future company filings.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Inspira Technologies (IINN) announce regarding Clalit Health Services?

Inspira Technologies announced that Clalit Health Services, described as the world’s second-largest integrated HMO, approved the INSPIRA ART100 system for vendor status. This enables immediate procurement and operational use of ART100 across Clalit’s medical centers under its supply-chain protocols.

Why is the Clalit vendor approval important for Inspira Technologies (IINN)?

The Clalit approval places the INSPIRA ART100 system inside a large, data-driven health network with about $12 billion in revenue. Management calls it a “definitive commercial inflection point,” viewing it as validation that can support long-term revenue and future commercialization in U.S. and global markets.

What is Inspira’s INSPIRA ART100 system used for?

The INSPIRA ART100 is a medical device system for advanced respiratory and cardiopulmonary support. It is FDA-cleared in the U.S. for cardiopulmonary bypass and approved for ECMO procedures outside the U.S., forming the technological basis for Inspira’s next-generation ART500 platform.

How does this 6-K filing relate to Inspira’s other SEC registrations?

The 6-K incorporates parts of the press release, including key highlights and forward-looking statements, into Inspira’s existing Form F-3 and Form S-8 registration statements. This means those disclosure sections now form part of the company’s broader SEC-registered offering and equity compensation documentation.

What other technologies is Inspira Technologies (IINN) developing besides ART100?

Inspira Technologies is developing the INSPIRA ART500, aimed at oxygenation while patients remain awake and breathing on their own, building on ART100’s platform. It is also advancing HYLA, a proprietary blood sensor offering continuous, non-invasive monitoring within its life-support and MedTech portfolio.

What forward-looking statements did Inspira make about the Clalit approval?

Inspira’s forward-looking statements discuss the potential commercial benefits of ART100 following Clalit’s approval, including possible long-term, high-quality revenue and accelerated commercialization in the U.S. and other markets. The company cautions that actual results may differ due to various risks and uncertainties outlined in its Form 20-F.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 February 2026 (Report No. 3)

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 February 9, 2026, Inspira Technologies Oxy B.H.N. Ltd. (the “Company”) issued a press release titled “ Inspira Secures Vendor Approval from $12 Billion Revenue HMO (World’s 2nd Largest), Enabling Immediate ART100 Deployment,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

The first paragraph, the bullet points under the section titled “Key Highlights” and the section titled “Forward-Looking Statements” of the press release attached hereto as Exhibit 99.1, is incorporated by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-284308 and 333-289324) and Form S-8 (Registration Nos. 333-259057, 333-277980, 333-285565, 333-290162 and 333-292592), 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 February 9, 2026, titled “Inspira Secures Vendor Approval from $12 Billion Revenue HMO (World’s 2nd Largest), Enabling Immediate ART100 Deployment.”

1

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: February 9, 2026	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

2

Exhibit 99.1

Inspira Secures Vendor Approval from $12 Billion Revenue HMO (World’s 2^nd Largest), Enabling Immediate ART100 Deployment

RA’ANANA, Israel, February 9, 2026 - Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN,IINNW) (“Inspira Technologies” or the “Company”), a pioneer in innovative life-support and diagnostic technologies, today announced a pivotal commercial advancement. The Company has received official approval from the Medical Equipment Committee of Clalit Health Services (“Clalit”), recognized as the second-largest integrated Health Maintenance Organization (HMO) globally. The approval enables the INSPIRA™ ART100 system for immediate procurement and operational use across Clalit’s extensive medical ecosystem.

Key Highlights:

● Commercial Activation: The approval transitions the ART100 from regulatory clearance to active commercial availability within a network serving approximately 4.9 million members.

● Tier-1 Network Scale: Clalit operates 14 major hospitals (including Rabin Medical Center and Soroka Medical Center, often ranked among Newsweek’s “World’s Best Smart Hospitals”) and over 1,600 clinics. This approval effectively opens the door to one of the most sophisticated healthcare supply chains in the world.

● Validation of Clinical Value: The approval follows a rigorous technical and clinical review by the Professional Committee for Medical Equipment regarding Thoracic and Cardiac Surgery, signaling strong validation of the ART100’s safety and efficacy profile to other global health systems.

“Securing vendor status with a health network of Clalit’s magnitude, comparable in scale to leading U.S. integrated systems like Kaiser Permanente, is a definitive commercial inflection point for Inspira,” stated Dagi Ben-Noon, CEO of Inspira Technologies.

“By securing this approval, we are laying the foundation for potentially long-term, high-quality revenue. This validation from a world-class, data-driven health ecosystem serves as a powerful reference case as we accelerate our commercialization efforts in the U.S. and other global markets.”

The Company views this approval as confirmation of the suitability of the INSPIRA ART100 for the organization’s specific clinical needs in cardiopulmonary procedures. It enables all medical centres within the Clalit network to initiate procurement processes in accordance with the organization’s supply chain protocols.

About Inspira Technologies

Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company’s FDA-cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a foundation for the development of the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the life-support and MedTech landscape. For more information, visit: 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 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 benefits and advantages of the ART100 system, the commercial potential of the ART100 system following Clalit’s approval for immediate procurement and operational use across its medical ecosystem, the validation of the ART100’s safety and efficacy profile, the belief that the Company is laying the foundation for long-term, high-quality revenue and accelerates its commercialization efforts in the U.S. and other global markets, and the suitability of the ART100 for Clalit’s specific clinical needs in cardiopulmonary procedures. 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, 2024, filed with the U.S. Securities and Exchange Commission (the “SEC”), which is available on the SEC’s website at www.sec.gov.

Company Contact

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