Core Insights - Inspira Technologies OXY B.H.N. Ltd. announced a conference call to discuss business targets and distribution agreements following FDA clearance for the INSPIRA ART100 system [1][2] Company Overview - Inspira Technologies is an innovative medical technology company focused on life support, with products designed to enhance patient care [3] - The INSPIRA ART (Gen 2), also known as INSPIRA ART500, utilizes Adaptive Blood Oxygenation technology to measure blood parameters in real-time and deliver oxygen directly into the blood [3] - This technology aims to elevate patient oxygen saturation levels quickly, potentially allowing patients to remain awake during treatment and reducing reliance on mechanical ventilation [3] Regulatory Milestones - The company received FDA 510(k) clearance for the INSPIRA ART100, a Cardiopulmonary Bypass System [4] - Other products, including the INSPIRA ART (Gen 2) and HYLA blood sensor, have not yet been tested in humans and lack regulatory approval [4]

With a prominent screen, 360-degree LED flow presentation and large digit display, the patient's information is easily viewed from a distance, making the INSPIRA ART100 ideal in both standard and challenging care situations, such as isolation or in-transit scenarios. Potential Application of INSPIRA ART100 Inspira Technologies OXY B.H.N. Ltd. (IINN) recently received the FDA 510(k) clearance for its INSPIRA ART100 — a Cardiopulmonary Bypass System. This approval is a significant milestone for the company, h ...

RA'ANANA, Israel, May 28, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System. Dagi Ben Noon, CEO of Inspira, said "This is a proud moment for all of us at Inspira Technologies. We would like ...

RA'ANANA, Israel, May 2, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, announced the start of production of the INSPIRA ART100 medical device. The INSPIRA ART100 device is being contract manufactured by a leading technology company that provides high-technology electronic assembly solutions for the medical, aero-space and aviation, communications and defense industries. The manufacturer has commenced ...

RA'ANANA, Israel, April 25, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, announced that it has received the Canadian Standards Association (CSA) Certification of Compliance to U.S. standards for the INSPIRA ART100 device. This is a positive recognition of our product's quality and safety standards. We believe, subject to U.S. Food and Drug Administration (FDA) regulatory clearance, that this ...

RA'ANANA, Israel, April 16, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, is proud to announce the signing of a collaboration term sheet (the "Term Sheet") with the Beilinson Hospital in Israel for the evaluation of its proprietary INSPIRA ART100 device (the "Device") in organ transplant procedures. This Term Sheet marks a significant advancement and opportunity for the Company in its technol ...

RA'ANANA, Israel, April 10, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, together with Ennocure MedTech Ltd. ("Ennocure"), announced results from their collaborative development of a proprietary bio-electronic treatment to prevent associated bloodstream infections in patients in intensive care units. Once developed, Inspira plans to integrate the bio-electronic novel physical stimulation tec ...

Exhibit 99.1 Inspira™ Technologies Reports Full Year 2023 Financial Results FDA Submission for approval of INSPIRA™ ART100 95% Accuracy Results for HYLA™ Blood Sensor Compared to Standard Blood Gas Analyzers Granted U.S. Patent for INSPIRA™ ART Medical Device Ra'anana, Israel, March 25, 2024 – Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31, 20 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission ...

Exhibit 1.1 INSPIRA TECHNOLOGIES OXY B.H.N. LTD. Ordinary Shares (no par value per share) Sales Agreement April 4, 2023 Roth Capital Partners, LLC 888 San Clemente Drive, Suite 400 Newport Beach, CA 92660 Ladies and Gentlemen: Inspira Technologies Oxy B.H.N., Ltd., an Israeli company (the "Company"), confirms its agreement (this "Agreement") with Roth Capital Partners, LLC (the "Agent"), as follows: 1. Issuance and Sale of Shares. The Company agrees that, from time to time during the term of this Agreement, ...