Inspira Technologies (NASDAQ: IINN) validates HYLA blood sensor for heart-lung surgery market

Rhea-AI Filing Summary

Inspira Technologies filed a Form 6-K highlighting new validation data for its next-generation standalone HYLA™ blood sensor system. In advanced lab testing, HYLA achieved 94.2% accuracy for continuous optical measurement of blood pCO₂, aligning with clinical needs within a 7 mmHg threshold versus blood gas analyzers.

The company has decoupled HYLA from its life-support hardware so it can operate as a standalone, “universally compatible” system that integrates into existing heart-lung machines and ICU workflows, aiming at an approximately $50 billion heart-lung surgery market and a recurring revenue model from disposable sensors and software upgrades.

Management states this validation supports a planned U.S. FDA regulatory submission process in 2026. The update fits into Inspira’s broader strategy around its FDA-cleared INSPIRA™ ART100 cardiopulmonary bypass system, development of the ART500 platform, and expansion into blood-based diagnostics, including a proposed liquid biopsy acquisition.

Insights

Medtech and diagnostics analyst

HYLA validation supports a standalone blood sensor strategy but commercial impact depends on future regulatory and market execution.

Inspira Technologies reports 94.2% accuracy for HYLA’s continuous optical pCO₂ measurement within a 7 mmHg threshold, which it says aligns with clinical needs. Positioning HYLA as a standalone system that can integrate with existing heart-lung machines targets an approximately $50 billion surgery market.

The company emphasizes a high-margin, recurring revenue model from disposable optical sensors and modular software. It also links HYLA to a broader roadmap that includes the FDA-cleared INSPIRA ART100 and development of ART500. Actual revenue impact will hinge on the planned FDA submission process in 2026 and subsequent adoption dynamics.

Management also frames HYLA as a step toward expansion into blood-based diagnostics, alongside a recently proposed potential acquisition of a liquid biopsy business. Future disclosures about regulatory milestones, commercial agreements, and any finalized acquisition terms will clarify how these elements translate into growth within the life-support and MedTech landscape.

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

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 3, 2026, Inspira Technologies Oxy B.H.N. Ltd. (the “Company”) issued a press release titled “Inspira™ Technologies Validates Next-Gen Standalone HYLA™ Blood Sensor with Clinical-Grade Accuracy, Targeting $48 Billion Heart-Lung Surgery Market,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

The first three and the fifth paragraphs 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 3, 2026, titled “Inspira Technologies Validates Next-Gen Standalone HYLA™ Blood Sensor with Clinical-Grade Accuracy, Targeting $48 Billion Heart-Lung Surgery Market.”

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 3, 2026	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

2

Exhibit 99.1

Inspira Technologies Validates Next-Gen Standalone HYLA™ Blood Sensor with Clinical-Grade Accuracy, Targeting $48 Billion Heart-Lung Surgery Market

Company’s validation confirms 94.2% accuracy for blood pCO₂ measurement, pivot to standalone configuration opens immediate commercial pathway to global installed base of heart-lung machines and extracorporeal procedures

RA’ANANA, Israel, February 3, 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 the successful validation in the Company’s advanced blood labs of its Next-Generation Standalone HYLA™ System. Designed to function independently of the Company’s respiratory support devices, this new configuration allows Inspira Technologies to penetrate the broader approximately $50 billion heart-lung surgery market immediately upon clearance. In advanced bench testing, the system demonstrated 94.2% accuracy for the continuous optical measurement of Partial Pressure of Carbon Dioxide (pCO₂), a performance level that aligns with clinical needs.

The validation data confirms that the HYLA™ optical sensor tracks real-time patient status with high fidelity. The observed 94.2% accuracy for pCO₂ is a critical achievement, demonstrating concordance with gold-standard blood gas analyzers within a tight 7 mmHg threshold. By providing continuous, non-invasive visibility into a patient’s metabolic status, HYLA™ eliminates the ‘blind spots’ associated with intermittent blood draws, potentially reducing complications during heart-lung machine and extracorporeal membrane oxygenation (ECMO) procedures.

This validation marks a strategic evolution for the HYLA™ platform. By decoupling the sensor from Inspira Technologies’ life-support hardware, the Company is advancing a standalone system capable of integrating into any existing operating room or ICU workflow. This ‘universal compatibility’ strategy significantly expands Inspira Technologies’s total addressable market and activates a high-margin, recurring revenue model based on the sale of disposable optical sensors and modular software upgrades.

Dagi Ben-Noon, CEO stated: “This validation confirms our technology operates at a clinical grade. By offering HYLA as a standalone solution, we can enter the market faster and serve a massive global installed base of perfusion systems, independent of our ART™ system rollout. We are moving rapidly toward our planned U.S. Food and Drug Administration (“FDA”) regulatory submission process in 2026.”

Inspira Technologies is advancing this standalone direction based on extensive industry engagement identifying extracorporeal procedures as an immediate commercial opportunity. The Company’s approach supports recurring revenue through modular sensor and software upgrades and aligns with Inspira Technologies’ long-term expansion into blood-based diagnostics, including its recently proposed potential acquisition of an advanced liquid biopsy business.

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 HYLA system and its core technology, this new configuration allows Inspira Technologies to penetrate the broader heart-lung surgery market immediately upon clearance, the size of the heart-lung surgery market, that HYLA’s ‘universal compatibility’ strategy significantly expands the Company’s total addressable market , regulatory submission process for HYLA system and the timing thereof, extensive industry engagement and an immediate commercial opportunity, , the Company’s recurring revenue model, its long-term expansion into blood-based diagnostics and potential acquisition of an advanced liquid biopsy. 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

FAQ

What did Inspira Technologies (IINN) validate in its HYLA blood sensor?

Inspira Technologies validated its next-generation standalone HYLA blood sensor system, demonstrating 94.2% accuracy for continuous optical pCO₂ measurement within a 7 mmHg threshold versus blood gas analyzers. The company states this performance aligns with clinical needs for real-time monitoring during extracorporeal procedures.

How large is the target market for Inspira Technologies (IINN) HYLA system?

The HYLA standalone blood sensor targets the broader heart-lung surgery market, which Inspira Technologies describes as approximately $50 billion. By integrating with existing heart-lung machines and extracorporeal procedures, the system is positioned to access a global installed base after appropriate regulatory clearances.

How does the HYLA standalone configuration support Inspira Technologies (IINN) business model?

The standalone HYLA configuration is designed to integrate into any operating room or ICU workflow, independent of Inspira’s life-support hardware. The company highlights a high-margin, recurring revenue model based on sales of disposable optical sensors and modular software upgrades to existing perfusion systems worldwide.

What regulatory plans did Inspira Technologies (IINN) disclose for HYLA?

Inspira Technologies stated it is moving rapidly toward a planned U.S. Food and Drug Administration regulatory submission process for the HYLA system in 2026. This planned submission is positioned as a key step toward commercializing the standalone blood sensor in heart-lung surgery and extracorporeal procedures.

How does HYLA relate to Inspira Technologies (IINN) existing ART systems?

HYLA builds on Inspira Technologies’ respiratory and blood monitoring platforms, which include the FDA-cleared INSPIRA ART100 system for cardiopulmonary bypass in the U.S. and ECMO outside the U.S. The company is also developing the INSPIRA ART500 as a next-generation oxygenation system for awake, spontaneously breathing patients.

What strategic direction did Inspira Technologies (IINN) outline beyond HYLA?

Beyond HYLA, Inspira Technologies described a long-term expansion into blood-based diagnostics, referencing a recently proposed potential acquisition of an advanced liquid biopsy business. It also cited multiple cleared products, a growing IP portfolio, and streamlined operations as elements supporting its positioning in the life-support and MedTech space.