Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company's U.S. Food and Drug Administration -cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a foundation for the development of the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake ...

Core Insights - Inspira Technologies has regained compliance with Nasdaq Listing Rule 5550(a)(2) regarding minimum bid price requirements, confirming the closing bid price was at or above $1.00 per share for 10 consecutive business days [1][2] Company Developments - The CEO of Inspira Technologies, Dagi Ben-Noon, highlighted that the compliance milestone reflects growing market confidence in the company's strategic direction, emphasizing a transformative shift marked by securing a large commercial order and establishing a government partnership for national adoption and global scaling [3] - Recent achievements include the clinical integration of the ART100 system in Tier-1 U.S. hospitals, expansion of manufacturing capabilities, and a significant $22.5 million purchase order, which are seen as catalysts for ongoing discussions with commercial and governmental entities worldwide [3] Product and Technology Focus - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with its INSPIRA™ ART100 system cleared by the U.S. FDA for cardiopulmonary bypass and ECMO procedures [4] - 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 [4] - With multiple cleared products and a growing intellectual property portfolio, Inspira Technologies is positioned as an attractive player in the life-support and MedTech landscape, aligning with industry trends such as consolidation and strategic partnerships [4]

Core Insights - Inspira Technologies experienced a transformative year in 2024, marked by significant technological advancements and regulatory milestones, including FDA clearance for the INSPIRA ART100 system [2][4] - The company aims to advance its flagship INSPIRA ART core technologies and plans to submit the HYLA blood monitoring sensor for FDA clearance in the second half of 2025 [2][5] Recent Business and Operational Highlights - The FDA-cleared INSPIRA ART100 system was deployed to Westchester Memorial Center, NY, for clinical evaluation [5] - A modular configuration for the VORTX blood oxygenation technology was unveiled, enhancing critical care practices [5] - The HYLA blood sensor achieved 96% accuracy in clinical studies, with plans for ongoing studies and FDA submission in 2025 [5] - A dedicated production line was established in partnership with Zriha Medical Ltd. to support the manufacturing of key components [5] - New support features for the INSPIRA ART100 system were introduced to improve efficiency for medical teams [5] - Positive initial results were reported from collaboration with Ennocure MedTech Ltd. for infection prevention technology [5] - Leadership was strengthened with the appointment of Mr. Tal Parnes as Chairman of the Board [5] Full Year 2024 Financial Highlights - Total operating expenses decreased to $11,267,000 in 2024 from $12,133,000 in 2023 [8] - R&D expenses decreased to $6,323,000 in 2024 from $7,320,000 in 2023, attributed to various factors including exchange rates and staffing changes [8] - G&A expenses increased to $4,185,000 in 2024 from $4,063,000 in 2023, primarily due to higher professional fees and compensation [8] - Net loss attributable to ordinary shareholders was $11,053,000 in 2024, compared to $11,286,000 in 2023 [8][10] - Cash position as of December 31, 2024, was $5,779,000, down from $7,361,000 in 2023, indicating financial stability for ongoing development [8] Balance Sheet Overview - Total assets decreased to $8,070,000 as of December 31, 2024, from $9,310,000 in 2023 [9] - Current assets included cash and cash equivalents of $5,111,000 and cash deposits of $668,000 [9] - Total liabilities increased slightly to $3,370,000 in current liabilities as of December 31, 2024, from $2,984,000 in 2023 [9]