# EDGAR Filing Document

**Accession Number:** 0001837493
**File Stem:** 0001213900-25-086686
**Filing Date:** 2025-9
**Character Count:** 10126
**Document Hash:** 684be351e4c6592d1d317e98c6092b42
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-086686.hdr.sgml**: 20250911

**ACCESSION NUMBER**: 0001213900-25-086686

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20250911

**FILED AS OF DATE**: 20250911

**DATE AS OF CHANGE**: 20250911

**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:** 251307366

**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 September 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 September 11, 2025, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled "Inspira Announces 97.35% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance," a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

The first four 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 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](http://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](http://www.sec.gov/Archives/edgar/data/1837493/000121390025020699/ea0233153-s8_inspira.htm) and [333-290162](https://www.sec.gov/Archives/edgar/data/1837493/000121390025086563/ea0254938-s8_inspira.htm)), 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 September 11, 2025, titled "Inspira Announces 97.35% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance."](ea025677301ex99-1_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.** |
| Date: September 11, 2025 | By: | /s/ Dagi Ben-Noon |
|  |  | Name: Dagi Ben-Noon |
|  |  | Title: Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Inspira Announces 97.3% Accuracy Results for HYLA™ Blood Sensor, Advancing Toward FDA Submission for Clearance**

RA'ANANA, Israel, September 11, 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 pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in its latest performance testing phase that will support its upcoming U.S. Food and Drug Administration ("FDA") submission. These results represent a significant advancement from the initial data obtained in a clinical study, as announced on March 4, 2025.

The clinical study from March, conducted at a medical center ranked among the world's leading hospitals, provided validation for HYLA's performance, while these latest test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe.

Key features of the HYLA Blood Sensor include:

● High Accuracy: Achieves 97.35% accuracy relative to standard blood gas analyzers.

● Continuous Monitoring: Provides second-by-second data, eliminating the need for intermittent blood draws.

● Non-invasive Technology: Utilizes optical measurement, operating without drawing blood from the patient.

● Versatility: Compatible with various medical procedures, including cardiopulmonary bypass, extracorporeal membrane oxygenation, continuous renal replacement therapy, and dialysis.

● Modular Design: Engineered to complement existing medical devices, targeting the two-million annual open-heart surgery patients globally.

While primarily designed for integration with Inspira's ART device line, the HYLA sensor is also being developed as a standalone device. This positions the HYLA platform to penetrate the broader disposables market, leveraging a planned razor-and-blade recurring revenue model.

Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: "HYLA was designed to solve one of the most urgent problems in operating rooms and critical care. A patient's condition can change in seconds, yet current blood tests provide delayed results. HYLA changes this reality by delivering continuous, second-by-second monitoring of key blood parameters, alerting medical teams instantly and enabling life-saving decisions in real time. Years of focused development across optics, software, hardware, and mechanics, supported by strong clinical results, have brought us to this point. The sensor's unique combination of simplicity and precision is already attracting significant interest from leading global medtech companies."

**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 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: its belief that the test results confirm the device's readiness for the regulatory pathway in the U.S. and Europe; the prospective size of the target demographic for the HYLA; the other prospective development uses for the HYLA sensor; the belief that the test results position the HYLA platform to penetrate the broader disposables market, leveraging a planned razor-and-blade recurring revenue model; the belief that the HYLA changes delivers continuous, second-by-second monitoring of key blood parameters, alerting medical teams instantly and enabling life-saving decisions in real time; and that the HYLA's features are attracting significant interest from leading global medtech companies. 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 – Media Relations<br> Email: info@inspirao2.com<br> Phone: +972-9-9664485