HYLA™ blood sensor
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Inspira Technologies Reports First Half 2025 Financial Results and Issues Business Update
Globenewswire· 2025-10-01 12:00
Core Insights - Inspira Technologies has transitioned from a development-stage company to commercial execution, achieving significant milestones including $49.5 million in binding purchase orders and clinical validation in leading hospitals [2][4] - The HYLA blood sensor has demonstrated a 97.35% accuracy rate, positioning the company favorably for FDA submission and enhancing its growth outlook [2][5] - The company is targeting an annual revenue run rate of at least $70 million in 2026, driven by confirmed global demand and an expanding product pipeline [2][5] Recent Business and Operational Updates - The company secured binding purchase orders totaling $49.5 million for the INSPIRA™ ART100 system, including a $22.5 million order and a $27 million order from a national ministry of health in Africa [5] - The first human treatment using the ART100 system was successfully completed at Westchester Medical Center in April 2025, validating the technology's performance [5] - The ART100 system has been expanded for use in lung transplantation procedures at a top U.S. hospital [5] - U.S. patent approval was received for the INSPIRA™ ART500 core technology, providing protection until at least 2043 [5] - The company engaged a strategic consulting firm to accelerate growth initiatives and maximize enterprise value [5] Financial Results for the Six Months Ended June 30, 2025 - Revenues recognized were $289,000, with a gross profit of $2,000 after accounting for costs of $287,000 [4][15] - Total operating expenses increased to $7,235,000 compared to $5,806,000 in the same period in 2024, primarily due to increases in general and administrative expenses [9][15] - Research and development expenses rose to $3,638,000 from $3,270,000 in the same period in 2024 [9][15] - The net loss for the period was $6,398,000, slightly higher than the net loss of $6,240,000 for the same period in 2024 [9][15] Cash Position and Financial Liabilities - As of June 30, 2025, the company had cash and cash equivalents of $2,126,000, down from $5,779,000 as of December 31, 2024 [9][12] - Financial liabilities at fair value totaled $886,000, a decrease from $1,575,000 as of December 31, 2024 [9][12]
CORRECTION - Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
Globenewswire· 2025-06-05 15:15
Core Insights - Inspira Technologies is scaling up production capabilities for its FDA-cleared INSPIRA™ ART100 system in response to anticipated demand from a European governmental authority, with advanced-stage procurement negotiations underway [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 cross-sector collaboration [5]
Inspira Scales Up ART100 Production Capabilities Amid Advanced Negotiation with European Government Authority
Globenewswire· 2025-06-05 13:15
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]
Inspira Technologies Initiates Global Commercial Rollout of FDA-Cleared ART100 System
Globenewswire· 2025-05-29 13:15
Core Insights - Inspira Technologies is accelerating the commercialization of its INSPIRA ART100 system following successful clinical implementations in the U.S. [1][2] - The company is engaged in discussions with governmental health departments and private organizations to structure rollouts that align with clinical priorities [3] - Deliveries of the ART100 are expected to begin in the second half of 2025, contingent on logistical and regulatory alignment [3] Company Overview - Inspira Technologies specializes in advanced respiratory support and real-time blood monitoring solutions, with the ART100 system cleared by the U.S. FDA for cardiopulmonary bypass and ECMO procedures [5] - The company is also developing the next-generation INSPIRA ART500 and the HYLA blood sensor, aiming to support its innovation pipeline while focusing on near-term revenue from the ART100 [4] - Inspira is positioned as an attractive platform within the critical care and MedTech landscape, reflecting broader industry trends such as consolidation and cross-sector collaboration [5]