As filed with the Securities and Exchange Commission on December 22, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INSPIRA TECHNOLOGIES OXY B.H.N.LTD. (Exact name of registrant as specified in its charter) State of Israel 3841 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Nu ...

Core Insights - Inspira Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accuracy in performance testing, which supports its upcoming FDA submission [1][2][6] - The HYLA sensor is designed for continuous, real-time monitoring of key blood parameters, addressing urgent needs in operating rooms and critical care [3][6] - The company is positioned to penetrate the broader disposables market with a planned razor-and-blade recurring revenue model [2][6] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system [4] - The company is advancing the HYLA platform, which offers continuous, non-invasive monitoring and is compatible with various medical procedures [4][6] - Recent internal shifts within the company may align with broader industry trends such as consolidation and potential strategic partnerships [4]

Core Company Vision - Inspira Technologies aims to radically transform life-support systems for patients facing mechanical ventilation challenges, with the INSPIRA ART500 system positioned as a breakthrough solution in respiratory care [2][4]. Product Development and Technological Innovations - The INSPIRA ART500 is designed to elevate oxygen levels for patients with Acute Respiratory Failure without invasive mechanical ventilation, targeting to replace a significant portion of the estimated 100,000 ventilators in the U.S. [4][12]. - The company is focusing its financial resources on accelerating the development of the INSPIRA ART500, which is expected to generate substantial value for the company and its shareholders [5]. - The INSPIRA ART100 has received FDA clearance and is being deployed in select U.S. centers for clinical evaluation, aiming to capture real-world performance data [7]. - The HYLA Blood Sensor, targeted for FDA submission in H2-2025, offers continuous, real-time blood monitoring, potentially replacing routine blood draws [8]. - A single-use patient kit is planned for FDA submissions in 2025/2026, designed to enhance patient safety and streamline workflows during procedures [9]. Market Opportunity and Revenue Forecast - The global mechanical ventilation market is estimated at $19 billion annually, with the INSPIRA ART500 expected to address this significant need with a safer, patient-friendly approach [11][12]. - The company anticipates receiving a prepayment from its U.S. distributor for INSPIRA ART100 systems, indicating near-term revenue potential [12]. Strategic Roadmap - The company is aligning key milestones to support sustained growth, including focusing on core technologies, scaling U.S. deployment, forming strategic alliances, and exploring global distribution agreements [17]. Future Vision - The integration of the INSPIRA ART500 with the HYLA blood sensor and the single-use patient kit aims to redefine patient-focused care, allowing patients to remain awake and involved in their recovery [13].

As filed with the Securities and Exchange Commission on May 20, 2024 Registration No. 333-279276 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 AMENDMENT NO. 1 TO FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INSPIRA TECHNOLOGIES OXY B.H.N. LTD. (Exact name of registrant as specified in its charter) If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the ex ...

As filed with the Securities and Exchange Commission on May 9, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INSPIRA TECHNOLOGIES OXY B.H.N. LTD. (Exact name of registrant as specified in its charter) State of Israel 3841 Not Applicable (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) ...