Core Insights - Inspira Technologies has scaled up production capabilities for its FDA-cleared INSPIRA ART100 system in anticipation of demand from a European governmental authority, with advanced-stage procurement negotiations ongoing [1][2][3] - The ART100 system is already in clinical use in the U.S. and is recognized as a reliable device for critical care and emergency preparedness [2][3] - The company aims to fast-track revenue generation from the ART100 system while continuing to develop next-generation platforms, including the ART500 and HYLA blood sensor [3][4] Company Overview - Inspira Technologies specializes 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 ART500 is a next-generation system designed to provide oxygenation while patients remain awake and spontaneously breathing, and the HYLA platform offers continuous, non-invasive blood monitoring [5] - The company is positioned as an attractive platform within the critical care and MedTech landscape, reflecting broader industry trends such as consolidation and potential strategic partnerships [5]

Company Overview - Inspira Technologies OXY B.H.N. Ltd. is a pioneering company in advanced respiratory support and diagnostic systems, recently announcing changes in its executive structure to align with long-term strategic goals [1][4] - The company specializes in advanced respiratory support and real-time blood monitoring solutions, with FDA-cleared products including the INSPIRA ART100 system for cardiopulmonary bypass and ECMO procedures [5][6] Leadership Changes - Joe Hayon, Co-Founder and President, will step down from his operational role but remain an active Board member, indicating a streamlined leadership framework [2][3] - The decision not to appoint a successor for the President role aims to enhance operational clarity and strategic flexibility as the company enters a new phase [2][3] Strategic Positioning - The company is advancing its portfolio of proprietary respiratory technologies, focusing on innovation and addressing unmet global needs [4][6] - Recent internal shifts reflect alignment with industry trends such as consolidation and cross-sector collaboration, positioning Inspira as an attractive platform within the critical care and MedTech landscape [6]

Core Insights - Inspira Technologies has received approval from Israel's largest healthcare provider to validate its INSPIRA ART100 system for organ transplant procedures, marking a significant advancement in its clinical applications [1][2][4] - The INSPIRA ART100 system is designed to maintain organ viability through advanced blood oxygenation, providing out-of-body blood oxygenation during transplant procedures and recovery [2][3] - The clinical validation will generate valuable data to support the development of the INSPIRA ART500 system, which aims to revolutionize respiratory care by enabling direct blood oxygenation without mechanical ventilation [3][4] Company Overview - Inspira Technologies specializes in innovative respiratory support and diagnostic technologies, with its flagship product, the INSPIRA ART500 system, currently under development [5] - The INSPIRA ART100 system has received FDA 510(k) clearance for cardiopulmonary bypass procedures and Israeli AMAR certification for both cardiopulmonary bypass and ECMO procedures [4][5] - The company is also developing the HYLA blood sensor technology for continuous, real-time blood monitoring without blood draws, along with other pipeline products [5]

Core Insights - The company has achieved a significant milestone by generating initial revenues from its FDA-cleared life support technology, specifically the INSPIRA™ ART100 systems, deployed in a leading U.S. healthcare facility [1][2][3] - The revenue generated is in the low hundreds of thousands of dollars, marking a successful step in the company's strategy to expand its presence in the U.S. healthcare market [2][3] - The CEO emphasized that this achievement validates the company's innovative technology and its ability to collaborate with top-tier medical institutions, which is crucial for advancing the adoption of its life-support systems [3] Company Overview - Inspira Technologies is focused on developing innovative respiratory support and diagnostic technologies, with its flagship product, the INSPIRA ART500 system, designed to allow patients to remain awake during treatment while stabilizing oxygen levels without mechanical ventilation [4] - The INSPIRA ART100 system is FDA-cleared for cardiopulmonary bypass procedures and has also received regulatory approvals in Israel for similar applications [4] - The company is also developing the HYLA blood sensor technology for continuous, real-time blood monitoring without the need for blood draws, along with other pipeline products [4] Market Context - The INSPIRA ART500 aims to revolutionize the $19 billion mechanical ventilation market by providing a safer alternative that allows patients to avoid mechanical ventilation during treatment [3] - The company plans to install additional INSPIRA ART100 systems at a second leading academic medical center, further expanding its clinical footprint [2][3]

Core Viewpoint - Inspira Technologies has received a notice from Nasdaq indicating non-compliance with the minimum bid price requirement, as its ordinary shares have been trading below $1.00 for 30 consecutive business days [1][2]. Compliance Period and Requirements - The company has been granted a 180-calendar day compliance period until September 8, 2025, to regain compliance by ensuring the closing bid price meets or exceeds $1.00 for at least 10 consecutive business days [2]. - If compliance is not achieved by the deadline, 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 specified period [4]. - Despite the notice, the company's ordinary shares will continue to be listed and traded on the Nasdaq Capital Market during this compliance period [4]. Company Overview - Inspira Technologies is focused on developing innovative respiratory support and diagnostic technologies, with its flagship product, the INSPIRA ART system, designed to improve critical care by stabilizing oxygen levels without mechanical ventilation [6]. - The INSPIRA ART100 system has received regulatory approvals for use in cardiopulmonary bypass procedures in both the U.S. and Israel [6]. - The company is also developing the HYLA™ blood sensor technology for continuous, real-time blood monitoring without blood draws, along with other pipeline products that are currently in development [6].

Significant progress in HYLA blood sensor and INSPIRA ART core technologies RA'ANANA, Israel, March 11, 2025 /PRNewswire/ -- 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, 2024, and provided a corporate update.Dagi Ben-Noon, Chief Executive Officer of Inspira, commented: "2024 was a transformative year for Inspira, marked by signific ...