[6-K] Inspira Technologies OXY B.H.N. Ltd Current Report (Foreign Issuer)

Rhea-AI Filing Summary

Inspira Technologies Oxy B.H.N. Ltd. submitted a Form 6-K that incorporates by reference previously filed registration statements and furnishes a press release dated September 18, 2025. The press release announces that Inspira will unveil its HYLA™ real-time blood sensor at the U.S. ELSO conference and states the device has 97.35% accuracy confirmed. The filing is signed by Chief Executive Officer Dagi Ben-Noon. The document provides an event announcement and a specific accuracy figure for the product but does not include financial results, commercialization details, regulatory approvals, or timelines.

Positive

• HYLA™ product unveiled at a relevant industry event (U.S. ELSO), increasing visibility
• Specific performance metric provided: the press release states 97.35% accuracy

Negative

• No financial data or revenue/earnings impact disclosed in this filing
• Key validation details missing: study design, sample size, independent review, and comparator not provided
• No regulatory or commercialization information such as approvals, timelines, or manufacturing plans

Insights

Medical Device Analyst

TL;DR: Product announcement with a specific performance metric but no commercial, regulatory, or financial details to assess immediate market impact.

The filing supplies a clear product claim: the HYLA real-time blood sensor achieved 97.35% accuracy and will be presented at U.S. ELSO. For a medical device, an accuracy metric is relevant but insufficient alone. Critical information missing includes the study design, sample size, comparator methods, regulatory status (e.g., CE mark or FDA clearance), intended use population, and plans for manufacturing or distribution. Without those details, investors cannot quantify clinical robustness, market opportunity, reimbursement likelihood, or timing of revenue realization. This is a promotional disclosure rather than a substantive operational update.

Corporate Communications / Investor Relations Specialist

TL;DR: This Form 6-K communicates a product launch event and a verified accuracy claim, useful for awareness but lacking material commercial context.

From a communications standpoint, announcing an unveiling at a relevant industry conference (U.S. ELSO) and citing a precise accuracy percentage is effective for generating interest among clinicians and potential partners. The filing correctly links the press release into the company's SEC disclosure. However, the absence of accompanying information such as independent validation details, commercialization milestones, or guidance means the announcement is unlikely to be material for valuation models. The company should follow up with substantiating data and commercialization plans to convert interest into measurable investor impact.

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. 4)

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 18, 2025, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira to Unveil HYLA™ Real-Time Blood Sensor at U.S. ELSO; 97.35% Accuracy Confirmed” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

The first, second, third and fifth 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 18, 2025, titled “Inspira to Unveil HYLA™ Real-Time Blood Sensor at U.S. ELSO; 97.35% Accuracy Confirmed.”

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 18, 2025	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

2

FAQ

What did Inspira Technologies (IINNW) disclose in this Form 6-K?

The company furnished a press release stating it will unveil the HYLA™ real-time blood sensor at U.S. ELSO and reported a confirmed 97.35% accuracy figure.

When and where will Inspira present the HYLA sensor?

The press release is dated September 18, 2025 and states the device will be unveiled at the U.S. ELSO conference.

Does the filing include financial results or commercial guidance for IINNW?

No. The filing contains an event announcement and product accuracy claim but does not include financial results or guidance.

Is there information on regulatory approval or market launch in the filing?

No. The document does not mention regulatory status, approvals, or a timeline for commercialization.

Who signed the Form 6-K for Inspira Technologies?

The filing is signed by Dagi Ben-Noon, identified as Chief Executive Officer.