# EDGAR Filing Document

**Accession Number:** 0001837493
**File Stem:** 0001213900-25-109624
**Filing Date:** 2025-11
**Character Count:** 9195
**Document Hash:** 16d27c2fde9f24c319bb070d3bcd1f32
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-109624.hdr.sgml**: 20251113

**ACCESSION NUMBER**: 0001213900-25-109624

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20251113

**FILED AS OF DATE**: 20251113

**DATE AS OF CHANGE**: 20251113

**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:** 251475770

**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 November 2025 (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

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

On November 13, 2025, Inspira Technologies Oxy B.H.N. Ltd. (the "Company") issued a press release titled "Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission," 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" in the press release are incorporated by reference into the Company's Registration Statements on Form F-3 (Registration Nos. [333-266748](https://www.sec.gov/Archives/edgar/data/1837493/000121390022046430/ea164081-f3_inspiratech.htm), [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) and 333-290162), 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 November 13, 2025, titled "Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission."](ea026551201ex99-1_inspira.htm) |

---

**<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: November 13, 2025 | By: | /s/ Dagi Ben-Noon | /s/ Dagi Ben-Noon |
|  |  | Name: | Dagi Ben-Noon |
|  |  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Inspira Completes Clinical Study for HYLA™ Blood Sensor - Ahead of Regulatory Submission**

RA'ANANA, Israel, November 13, 2025 -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("**Inspira,**" **"Inspira Technologies**," or the "**Company**"), a pioneer in innovative life-support and diagnostic technologies, today announced the completion of the clinical study for its HYLA, non-invasive blood sensor, toward regulatory submission and future commercialization.

Based on the clinical trial results and ongoing lab tests, showing between 95% to 99% accuracy across measured parameters, Inspira is soon entering the final validation and verification stage ahead of planned regulatory submission.

Inspira is leveraging its proprietary non-invasive platform and integrating advanced Machine Learning algorithms to further extend the HYLA sensor's capabilities beyond its core parameters. This development focuses on adding critical physiological parameters currently unavailable through existing non-invasive monitoring systems.

**Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated:**

"The system is performing at exceptional accuracy levels in our testing - between 95 and 99 percent across the board. These results reinforce HYLA's position as a disruptive, non-invasive solution for real-time blood monitoring. We are now entering the final phase before submitting for regulatory approval."

**About the HYLA Blood Sensor**

**The HYLA is a smart, non-invasive blood sensor designed to deliver continuous, real-time blood data without the need for blood draws. Developed for use in operating rooms, ICUs, ECMO/CRRT/dialysis settings, and cardiac care units, HYLA provides clinicians with immediate access to critical physiological information. By enabling seamless, real-time monitoring, the system is engineered to enhance patient safety, improve workflow efficiency, and support more informed decision-making in demanding critical-care environments.**

**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 U.S. Food and Drug Administration-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. The Company's recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: https://inspira-technologies.com

**Forward-Looking Statement Disclaimer**

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 regulatory submission for HYLA and potential future commercialization, that the Company is soon entering the final validation and verification stage ahead of planned regulatory submission, HYLA's benefits and advantages and that the Company is adding critical physiological parameters currently unavailable through existing non-invasive monitoring systems, and that results reinforce HYLA's position as a breakthrough, non-invasive solution for real-time blood monitoring . 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**<br> Inspira Technologies – Media Relations<br> Email: info@inspirao2.com<br> Phone: +972-9-9664485