HYLA Blood Sensor Hits 97.35% Accuracy; Inspira Seeks FDA Clearance

Rhea-AI Filing Summary

Inspira Technologies Oxy B.H.N. Ltd. disclosed a press release announcing that its HYLA™ blood sensor achieved 97.35% accuracy. The company states this result as an advance toward a planned FDA submission for clearance, signaling progress in regulatory milestones for the device. The filing incorporates that press release into the Form 6-K report.

The information provided is limited to the accuracy result and the intended regulatory step; no financial results, timelines, trial sizes, or additional performance metrics are included in the filing.

Positive

• HYLA sensor reported 97.35% accuracy, indicating strong device performance on the metric disclosed
• Company is advancing toward an FDA submission for clearance, showing progress on a regulatory pathway

Negative

• None.

Insights

Financial Analyst

TL;DR: Strong device accuracy reported; regulatory submission progress could be value-driving if supported by clinical detail.

The announced 97.35% accuracy for the HYLA blood sensor is a clear positive data point that may increase the commercial potential of the product. As reported, the item is limited to the accuracy metric and an intention to move toward an FDA submission for clearance. From a valuation perspective, the development reduces technical risk if independently validated and if regulatory pathways proceed, but the filing lacks sample size, study design, or timing details that are necessary to assess reliability and near-term commercial impact.

Regulatory Specialist

TL;DR: Reported accuracy supports a regulatory filing narrative but critical submission details are not disclosed.

The press release incorporated into the Form 6-K highlights a specific performance metric—97.35% accuracy—and states advancement toward an FDA submission for clearance. Regulatory reviewers will require complete clinical data, validation protocols, and manufacturing controls; none of these elements are present in the filing. The announcement is a preliminary regulatory milestone communication rather than evidence of an accepted or filed submission.

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

CONTENTS

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, 333-284308, and 333-289324) and Form S-8 (Registration Nos. 333-259057, 333-277980, 333-285565 and 333-290162), 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.”

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: September 11, 2025	By:	/s/ Dagi Ben-Noon
		Name: Dagi Ben-Noon
		Title:   Chief Executive Officer

2

FAQ

What accuracy did Inspira Technologies (IINNW) report for the HYLA blood sensor?

The company reported 97.35% accuracy for the HYLA blood sensor in the incorporated press release.

Does the Form 6-K state that Inspira has submitted to the FDA?

No. The filing states the company is advancing toward an FDA submission for clearance but does not say a submission has been made.

Are there clinical trial details or sample sizes in the filing?

No. The filing does not provide clinical trial size, study design, or additional performance metrics.

When was the press release issued that is included in the 6-K?

The press release was issued on September 11, 2025 as stated in the filing.

Does the filing include any financial results related to the HYLA sensor?

No. The filing contains no financial data, revenue figures, or cost information.