# EDGAR Filing Document

**Accession Number:** 0001837493
**File Stem:** 0001213900-26-011104
**Filing Date:** 2026-2
**Character Count:** 10445
**Document Hash:** e4e5f74e021ad234528c286b78b14a54
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-26-011104.hdr.sgml**: 20260203

**ACCESSION NUMBER**: 0001213900-26-011104

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20260203

**FILED AS OF DATE**: 20260203

**DATE AS OF CHANGE**: 20260203

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Inspira Technologies OXY B.H.N. Ltd
- **CENTRAL INDEX KEY:** 0001837493
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **STATE OF INCORPORATION:** L3
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40303
- **FILM NUMBER:** 26590351

**BUSINESS ADDRESS:**
- **STREET 1:** HATIDHAR 2
- **STREET 2:** 11TH FLOOR
- **CITY:** RA'ANANA
- **STATE:** L3
- **ZIP:** 4366504
- **BUSINESS PHONE:** 972-9-9664488

**MAIL ADDRESS:**
- **STREET 1:** HATIDHAR 2
- **STREET 2:** 11TH FLOOR
- **CITY:** RA'ANANA
- **STATE:** L3
- **ZIP:** 4366504

**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

**<u>CONTENTS</u>**

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](https://www.sec.gov/Archives/edgar/data/1837493/000121390025004023/ea0227763-f3_inspira.htm) and [333-289324](https://www.sec.gov/Archives/edgar/data/1837493/000121390025072618/ea0251967-f3_inspira.htm)) and Form S-8 (Registration Nos. [333-259057](https://www.sec.gov/Archives/edgar/data/1837493/000121390021044780/ea146415-s8_inspiratech.htm), [333-277980](https://www.sec.gov/Archives/edgar/data/1837493/000121390024023044/ea0201791-s8_inspira.htm), [333-285565](https://www.sec.gov/Archives/edgar/data/1837493/000121390025020699/ea0233153-s8_inspira.htm), [333-290162](https://www.sec.gov/Archives/edgar/data/1837493/000121390025086563/ea0254938-s8_inspira.htm) and [333-292592](http://www.sec.gov/Archives/edgar/data/1837493/000121390026001862/ea0272007-s8_inspira.htm)), 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.

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| | |
|:---|:---|
| **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."](ea027527301ex99-1_inspira.htm) |

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**<u>SIGNATURES</u>**

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.** | **Inspira Technologies Oxy B.H.N. Ltd.** | **Inspira Technologies Oxy B.H.N. Ltd.** |
| Date: February 3, 2026 | By: | /s/ Dagi Ben-Noon | /s/ Dagi Ben-Noon |
|  |  | Name: | Dagi Ben-Noon |
|  |  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**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<br> Email: info@inspirao2.com<br> Phone: +972-9-9664485

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