0001213900-23-059209.txt : 20230724 0001213900-23-059209.hdr.sgml : 20230724 20230724160502 ACCESSION NUMBER: 0001213900-23-059209 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20230724 FILED AS OF DATE: 20230724 DATE AS OF CHANGE: 20230724 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] IRS NUMBER: 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: 231105087 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 6-K 1 ea182250-6k_inspiratech.htm REPORT OF FOREIGN PRIVATE ISSUER

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 July 2023 (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 July 24, 2023, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

The first and third paragraphs in the press release are incorporated by reference into the Registrant’s Registration Statements on Form F-3 (Registration No. 333-266748) and Form S-8 (Registration No. 333-259057), 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

Exhibit No.
99.1		Press Release issued by Inspira Technologies Oxy B.H.N. Ltd. on July 24, 2023, titled “Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval.”

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: July 24, 2023	By:	/s/ Dagi Ben-Noon
		Name:	Dagi Ben-Noon
		Title:	Chief Executive Officer

EX-99.1 2 ea182250ex99-1_inspiratech.htm PRESS RELEASE ISSUED BY INSPIRA TECHNOLOGIES OXY B.H.N. LTD. ON JULY 24, 2023, TITLED "INSPIRA TECHNOLOGIES RECEIVES CERTIFICATION OF MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS, ANOTHER STEP TOWARDS EU REGULATORY APPROVAL."

Exhibit 99.1

Inspira™ Technologies Receives Certification of Medical Devices Quality Management Systems, Another Step Towards EU Regulatory Approval

Ra’anana, Israel, July 24, 2023 – Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company aiming to revolutionize acute respiratory care, is proud to announce it has received International Organization for Standardization (ISO) 13485:2016 Standard Certification, which is the international standard for quality management systems within the medical device industry, and a requirement for EU regulatory approval.

Dagi Ben Noon, Inspira Technologies’ Chief Executive Officer, stated: “By successfully obtaining this ISO certification, Inspira Technologies has demonstrated adherence of our quality management system to the highest standards, which comply with industry best practices”.

The ISO certification encompasses key aspects, including design, development, manufacturing, distribution and sales of extracorporeal and blood monitoring devices and respiratory care devices. The ISO certification process also involved a comprehensive evaluation of the Company’s quality management system, including documentation, risk management and continuous improvement practices. The assessment was conducted by the British Standards Institution Group, an independent, third-party auditing firm specializing in medical device quality management systems.

About ISO 13485: https://www.iso.org/standard/59752.html

About Inspira Technologies OXY B.H.N. Ltd.

Inspira Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA^TM ART), targeting hyper-personalization care, supported by INSPIRA AI that is designed to rebalance patient oxygen saturation levels within minutes, aiming to significantly improve patient outcomes. This technology potentially allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The Company’s products have not yet been tested or used in humans and has not been approved by any regulatory entity.

For more information, please visit our corporate website: https://inspira-technologies.com

For more details:

Public Relations Manager
Adi Shmueli

Inspira Technologies
infor@inspirao2.com