Company Demonstrates Clinical Validation and Early Commercial Traction Toward 2026 Revenue ScaleRA'ANANA, Israel, March 26, 2026 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced its financial results for the full year ended December 31, 2025, and provided a corporate update. Dagi Ben-Noon, Chief Executive Officer of Inspira, commented: “2025 marked a pivotal year for Inspir ...

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, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR Securities registered or to be registered pursuant to Section 12(b) of the Act: | | | Name of each excha ...

Core Viewpoint - Inspira Technologies has received a notice from Nasdaq regarding non-compliance with the minimum market value requirement for publicly held shares, which is set at $35 million, and has until August 18, 2026, to regain compliance [1] Group 1: Compliance and Regulatory Information - The company is currently not in compliance with Nasdaq Listing Rule 5550(b)(2), which mandates a minimum market value of publicly held shares of $35 million [1] - The company has a 180-day period until August 18, 2026, to regain compliance by maintaining a market value of $35 million or more for at least 10 consecutive business days [1] - If compliance is not achieved by the deadline, Nasdaq may initiate delisting procedures, which the company can appeal [1] Group 2: Company Overview - Inspira Technologies is a commercial-stage medical device company focused on advanced respiratory support and real-time blood monitoring solutions [3] - The company’s FDA-cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S., with plans for a next-generation system, INSPIRA ART500 [3] - The company is also developing HYLA™, a proprietary blood sensor platform for continuous, non-invasive monitoring, and is positioned as an attractive player in the life-support and MedTech sectors [3]

Core Insights - Inspira Technologies has initiated a structured commercial evaluation of its FDA-cleared INSPIRA™ ART100 system at a leading U.S. academic medical center, expanding its presence in the Tier-1 U.S. hospital market [1][3] Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions [5] - The INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S., serving as a foundation for the development of the next-generation INSPIRA ART500 system [5] - The company is also advancing the HYLA™ platform, a proprietary blood sensor offering continuous, non-invasive monitoring [5] Market Positioning - The deployment of the ART100 system is part of the company's U.S. commercial strategy, aiming to convert high-profile evaluations into a sustainable commercial pipeline [4] - The partnering institution is ranked among New York State's top 10 hospitals, indicating the ART100's alignment with the operational and clinical demands of top-tier U.S. healthcare providers [2][4]

Core Insights - Inspira Technologies announced a strategic commercial showcase of its FDA-cleared INSPIRA™ ART100 system at the AmSECT 64th International Conference, scheduled for March 25–29, 2026, in Austin, Texas [1][4] Group 1: Commercial Strategy - The showcase aims to engage directly with decision-makers in hospitals, enhancing the company's U.S. commercial strategy and expanding clinical partnerships and distribution [3][7] - The ART100 system has received FDA 510(k) clearance, validating its readiness for clinical integration in cardiopulmonary bypass procedures [7] Group 2: Product Overview - The INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S., serving as a foundation for the development of the next-generation INSPIRA ART500 system [5] - The company is also advancing the HYLA™ blood sensor platform, which offers continuous, non-invasive monitoring [5] Group 3: Industry Context - The AmSECT International Conference is a key global event for perfusion technology, featuring cutting-edge medical technologies and expert-led sessions [4]

Core Viewpoint - Inspira Technologies has received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, as its ordinary shares have been trading below $1.00 for the last 30 consecutive business days [1][2]. Compliance and Trading Status - The notification does not immediately affect the listing or trading of the Company's ordinary shares, which will continue to trade under the symbol "IINN" on The Nasdaq Capital Market [2]. - The Company has a compliance period of 180 calendar days, until August 10, 2026, to regain compliance by ensuring the closing bid price is at least $1.00 for a minimum of ten consecutive business days [2][3]. Potential for Additional Compliance Period - If compliance is not regained by August 10, 2026, the Company may qualify for a second 180-calendar day compliance period, provided it meets other listing requirements and notifies Nasdaq of its intention to cure the deficiency [3]. Monitoring and Future Actions - The Company plans to monitor the closing bid price of its ordinary shares and will consider options to regain compliance within the compliance period [4]. Company Overview - Inspira Technologies is a commercial-stage medical device company focused on advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system and the upcoming INSPIRA ART500 system [5]. - The Company is also developing the HYLA™ blood sensor platform for continuous, non-invasive monitoring, positioning itself as a significant player in the life-support and MedTech sectors [5].

Core Insights - Inspira Technologies has received official approval from Clalit Health Services for the INSPIRA™ ART100 system, marking a significant commercial advancement for the company [1][4]. Commercial Activation - The approval allows the ART100 to transition from regulatory clearance to active commercial availability within Clalit, which serves approximately 4.9 million members [7]. - Clalit operates 14 major hospitals and over 1,600 clinics, providing access to one of the most sophisticated healthcare supply chains globally [7]. Validation of Clinical Value - The approval follows a rigorous technical and clinical review by the Professional Committee for Medical Equipment, confirming the ART100's safety and efficacy profile [7]. - This validation serves as a powerful reference case for Inspira Technologies as it accelerates commercialization efforts in the U.S. and other global markets [4]. Strategic Positioning - The CEO of Inspira Technologies emphasized that securing vendor status with Clalit is a definitive commercial inflection point, comparable to leading U.S. integrated systems like Kaiser Permanente [3]. - The company views this approval as a foundation for potentially long-term, high-quality revenue [4]. Product Overview - The INSPIRA™ ART100 system is FDA-cleared for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [5]. - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake and breathing spontaneously [5].

Core Viewpoint - Inspira Technologies has announced a registered direct offering of 6,785,715 ordinary shares at a price of $0.70 per share, expected to raise approximately $4.75 million before expenses [1][2]. Group 1: Offering Details - The offering is set to close on or about February 6, 2026, pending customary closing conditions [2]. - The net proceeds from the offering will be utilized for working capital and general corporate purposes [2]. - A.G.P./Alliance Global Partners is acting as the sole placement agent for this offering [2]. Group 2: Securities and Registration - The ordinary shares are being offered under a prospectus supplement to be filed with the SEC, linked to the Company's effective shelf registration statement [3]. - The warrants issued in a concurrent private placement will have an exercise price of $0.70 per share and will be exercisable six months after issuance, expiring in 5.5 years [1][3]. Group 3: Existing Warrants Amendment - Existing warrants issued to the investor in December 2023, originally priced at $1.28, will be amended to a reduced exercise price of $0.70 per share, expiring five years from the closing date [5]. Group 4: Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA™ ART100 system [6]. - The company is developing the INSPIRA ART500 system for oxygenation while patients remain awake and is advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [6]. - With a growing IP portfolio and strategic operational streamlining, Inspira Technologies is positioned as an attractive player in the life-support and MedTech sectors [6].

Core Insights - Inspira Technologies has successfully validated its Next-Generation Standalone HYLA™ System, which is designed to operate independently of its existing respiratory support devices, allowing entry into the $50 billion heart-lung surgery market upon clearance [1][4] Group 1: Product Validation and Performance - The HYLA™ optical sensor achieved a 94.2% accuracy in tracking the Partial Pressure of Carbon Dioxide (pCO₂), aligning with clinical needs and demonstrating concordance with gold-standard blood gas analyzers within a 7 mmHg threshold [2][3] - This system provides continuous, non-invasive monitoring of a patient's metabolic status, potentially reducing complications during heart-lung machine and ECMO procedures by eliminating the need for intermittent blood draws [2][3] Group 2: Strategic Market Positioning - By decoupling the HYLA™ sensor from existing life-support hardware, Inspira Technologies is advancing a standalone system that can integrate into any operating room or ICU workflow, significantly expanding its total addressable market [3] - The company is pursuing a high-margin, recurring revenue model through the sale of disposable optical sensors and modular software upgrades, enhancing its long-term growth prospects [3][4] Group 3: Future Plans and Industry Engagement - The CEO of Inspira Technologies indicated that the validation confirms the technology operates at a clinical grade, enabling faster market entry and serving a large global installed base of perfusion systems [4] - The company is moving towards a planned FDA regulatory submission process in 2026, focusing on extracorporeal procedures as an immediate commercial opportunity [4]

Core Insights - Inspira Technologies has successfully completed the clinical evaluation of its FDA-cleared INSPIRA™ ART100 system, which is now moving to a budgeted procurement process at a leading U.S. academic medical center [1][3] Group 1: Clinical Evaluation and Procurement - The ART100 system is the first of its kind at this institution to transition from pilot use to standard clinical workflow after treating approximately 30 patients across various medical indications, including life-saving procedures, surgeries, and transplants [2][3] - Following the completion of the clinical phase, the medical center has initiated an internal procurement process for multiple ART100 systems, which is now subject to budget release [3] Group 2: Company Positioning and Technology Validation - The CEO of Inspira Technologies highlighted that reaching this milestone at a top academic medical center validates the clinical value and reliability of the ART100 technology, which has been integrated into routine workflow due to positive feedback from medical staff [4] - The completion of the clinical phase and the advancement to procurement is seen as a significant strengthening of the company's U.S. commercial positioning and supports broader adoption of the ART100 platform across leading healthcare institutions [4] Group 3: Company Overview - Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions, with the ART100 system approved for cardiopulmonary bypass in the U.S. and ECMO procedures outside the U.S. [5] - The company is also developing the INSPIRA ART500, a next-generation system designed for oxygenation while patients remain awake, and advancing the HYLA™ blood sensor platform for continuous, non-invasive monitoring [5]