Core Viewpoint - Inspira Technologies announced positive initial results from its collaboration with Ennocure MedTech to develop a novel bio-electronic treatment aimed at preventing bloodstream infections in critical patients [1][3] Group 1: Technology and Testing Results - The bio-electronic patch demonstrated a 95% reduction in bacterial presence within 4 hours during ex-vivo porcine skin model testing, with continued effectiveness observed over a 24-hour period [2] - The technology utilizes physical electric stimulation instead of chemical agents, showing promising results in preventing pathogen growth on treated surfaces [2][8] - Testing followed standardized protocols, including the AATCC TM100 standard for antimicrobial performance, showing consistent bacterial reduction under active patches compared to controls [3] Group 2: Market Potential and Company Overview - There are an estimated 250,000 bloodstream infections related to intravenous lines occurring worldwide each year, indicating a significant market opportunity for the new technology in critical care settings [3] - Inspira Technologies is focused on innovative medical technology in life support and respiratory treatment, with its INSPIRA™ ART system targeting the $19 billion mechanical ventilation market [5] - The company has developed the HYLA™ blood sensor technology for continuous, real-time blood monitoring, targeting the $2.5 billion blood gas analyzer market [5]

Core Viewpoint - Inspira Technologies has developed an innovative AI-powered blood sensor technology, HYLA, which enables continuous monitoring of tissue oxygenation and early detection of hypoxia, with preliminary clinical results expected soon [1][3]. Group 1: Technology and Innovation - The integration of a next-generation oxygenation indicator into the HYLA blood sensor represents a significant enhancement in critical care monitoring, allowing for real-time and continuous monitoring of oxygenation therapy [2][4]. - The HYLA technology positions itself as a potential game-changer in the $2.5 billion point-of-care testing and arterial blood gas analyzer market [2]. - The non-invasive technology utilizes advanced optical sensors and machine-learning algorithms for continuous monitoring of blood parameters and oxygen levels [3]. Group 2: Clinical Validation and Regulatory Path - Clinical validation of the enhanced HYLA blood sensor is currently underway at Sheba Medical Center, which is recognized as one of the world's top smart hospitals [3]. - The company anticipates submitting for FDA regulatory clearance in the second half of 2025 [3]. Group 3: Market Potential and Applications - Inspira Technologies has developed the Augmented Respiration Technology (INSPIRA ART), which aims to revolutionize the $19 billion mechanical ventilation market by stabilizing oxygen saturation levels without the use of a ventilator [5]. - The INSPIRA ART, combined with the HYLA blood sensor, aims to provide a comprehensive approach to patient care by enabling continuous, non-invasive monitoring while patients remain conscious during treatment [4][5].

Core Insights - Inspira Technologies OXY B.H.N. Ltd. has introduced new support features to its INSPIRA™ ART100 system, enhancing efficiency and reducing staff overhead in medical procedures [1][4] - The INSPIRA ART100 system is designed to integrate with hospital procedures and includes advanced software for real-time monitoring and troubleshooting during critical care situations [2][3] Company Overview - Inspira Technologies is focused on innovative medical technology, particularly in life support and respiratory treatment, with the INSPIRA ART100 system positioned to potentially replace the $19 billion mechanical ventilation market [5] - The company aims to assist medical professionals in treating patients effectively, with the INSPIRA ART100 capable of enriching blood with oxygen and removing carbon dioxide, thus supporting critical care patients [4][5] Product Features - The INSPIRA ART100 system features a small footprint design, up to four hours of uptime in emergencies, and compatibility with various disposable equipment [4] - New features include system-activated alarm troubleshooting and a prominent screen for displaying critical information during complex care situations [2][3] Regulatory Status - The INSPIRA ART100 system has received FDA 510(k) clearance for use in Cardiopulmonary Bypass procedures and Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation [6]

Core Viewpoint - Inspira Technologies has successfully delivered its INSPIRA™ ART100 systems to Glo-Med Networks Inc. for deployment in a leading U.S. hospital, marking a significant step in introducing its innovative respiratory support technology to the market [1][2]. Company Overview - Inspira Technologies is focused on revolutionizing life support and respiratory treatment with its Augmented Respiration Technology (INSPIRA™ ART), which aims to potentially replace the $19 billion mechanical ventilation market [4]. - The company targets the 20 million intensive care unit patients with acute respiratory failure annually, offering a non-ventilator solution that stabilizes oxygen saturation levels quickly while allowing patients to remain awake during treatment [4]. Product Development and Regulatory Approvals - The INSPIRA™ ART100 system has received FDA 510(k) clearance for use in cardiopulmonary bypass (CBP) procedures and has also obtained Israeli AMAR certification for both Extra-Corporeal Membrane Oxygenation and CBP procedures [5]. - The INSPIRA™ ART100 is designed in collaboration with leading U.S. clinicians and is set to integrate with the HYLA™ continuous blood monitoring technology, which is currently undergoing clinical evaluations [3]. Market Strategy - The initial deployment of the INSPIRA™ ART100 systems will target hospitals on the U.S. east coast, specifically a top-ranked New York hospital's cardiothoracic surgery division, to facilitate collaboration and brand introduction [2]. - The company aims to leverage these deployments to familiarize physicians and perfusionists with its technologies and brand [2].

Core Viewpoint - Inspira Technologies OXY B.H.N. Ltd. has appointed Mr. Tal Parnes as the new chairman of the board of directors, effective February 1, 2025, aiming to enhance the company's leadership and strategic vision in the medical technology sector [1][4]. Company Leadership - Mr. Tal Parnes brings over three decades of experience in the technology sector, particularly in medical technology and pharmaceuticals, and has served as an independent director of the company since July 2021 [1][2]. - His previous roles include co-founding and serving as CEO of Zuta-Core Ltd. and HQL Pharmaceuticals Ltd., as well as holding executive positions at Silynx Communications Inc., Wavion Inc., Atrica Ltd., and Printlife Ltd. [3]. Strategic Impact - Mr. Parnes' leadership is expected to refine the company's strategic vision and bolster its competitive advantage in the market, positioning the company for sustainable success [4]. - The company expresses gratitude to Prof. Benad Goldwasser for his contributions as chairman since 2021, highlighting his support during the company's Nasdaq listing [5]. Product Innovation - Inspira Technologies is focused on life-support technology, having developed the Augmented Respiration Technology (INSPIRA™ ART), which aims to revolutionize the $19 billion mechanical ventilation market [6]. - The INSPIRA ART provides an alternative for patients with acute respiratory failure, stabilizing oxygen saturation levels without the need for a ventilator, allowing patients to remain awake during treatment [6]. Regulatory Approvals - The INSPIRA™ ART100 system has received FDA 510(k) clearance for use in cardiopulmonary bypass procedures and has also obtained Israeli AMAR certification for similar applications [7]. Future Developments - The company is in the process of designing and developing additional products, including the INSPIRA™ ART500, INSPIRA™ Cardi-ART, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, which are not yet tested or approved for human use [8].

Company Collaboration and Production - Inspira Technologies is establishing a dedicated production line for a crucial component of its respiratory support system in collaboration with Zriha Medical Ltd, a leading international manufacturer specializing in medical device production [1] - The collaboration involves the manufacture of a flow mechanism integrated into Inspira's products for use in extracorporeal circulation of blood during oxygenation [1] - Zriha Medical's capabilities in precision assembly and clean room environments are well-suited for this collaboration, potentially enabling Inspira to scale up production and accelerate market entry [2] - Zriha Medical brings over 50 years of experience in advanced plastic and silicone injection, metal processing technologies, and ISO 13485-certified clean room facilities [2] Inspira Technologies' Products and Market - Inspira Technologies is an innovative medical technology company focused on life support and respiratory treatment, with a breakthrough Augmented Respiration Technology (INSPIRA™ ART) targeting the $19 billion mechanical ventilation market [3] - The INSPIRA ART offers a potential alternative to mechanical ventilators by stabilizing oxygen saturation levels in minutes without requiring patients to be sedated, with 20 million ICU patients suffering from acute respiratory failure annually [3] - The INSPIRA ART is equipped with a clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology designed to alert physicians of changes in patient conditions without intermittent blood sampling [3] - The INSPIRA™ ART100 system has obtained FDA 510(k) clearance for use in CBP procedures and Israeli AMAR certification for ECMO and Cardiopulmonary Bypass procedures [4] Product Development and Regulatory Status - Inspira's other products, including the INSPIRA™ ART500 (Gen 2), INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor, are currently in the design and development phase and have not yet been tested in humans or approved by regulatory entities [5]

Core Insights - Inspira Technologies has developed a modular configuration for its VORTX blood oxygenation delivery technology, which aims to significantly advance extracorporeal oxygenation and transform critical care practices globally [1][4] - The INSPIRA ART system targets the $19 billion mechanical ventilation market, designed to stabilize declining oxygen saturation levels in patients while they are awake and without the use of a ventilator [2][5] - The VORTX system represents a potential paradigm shift in blood oxygenation technology, maintaining a more natural blood flow and reducing harmful effects on blood components, supported by 32 novel patent claims [3] Company Overview - Inspira Technologies is an innovative medical technology company focused on life support and respiratory treatment, with its flagship product, the INSPIRA ART, offering a potential alternative to mechanical ventilators for the 20 million ICU patients with acute respiratory failure annually [5] - The INSPIRA ART is equipped with a HYLA blood sensor for real-time continuous blood monitoring, allowing physicians to make informed decisions without the need for intermittent blood samples [5] - The INSPIRA ART100 system has received FDA 510(k) clearance and Israeli AMAR certification for use in cardiopulmonary bypass procedures [6] Product Development - The modular configuration of the VORTX technology is expected to enhance its versatility and applicability across various medical scenarios [4] - Other products in development include the INSPIRA ART500, Cardi-ART portable modular device, and VORTX Oxygen Delivery System, which have not yet been tested in humans or approved by regulatory entities [7]

Regulatory Approvals and Certifications - The INSPIRA™ ART100 system received FDA 510(k) clearance for use in CBP procedures in June and July 2024 [1] - The system also obtained Israeli AMAR certification for Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass procedures [1] Production and Market Readiness - The company is preparing for a potential production ramp-up of the INSPIRA™ ART100 device due to the recent hMPV outbreak in China [2] - Discussions are ongoing with leading providers in affected regions to evaluate demand for advanced respiratory solutions [3] - The company is working closely with suppliers to secure raw materials and components to meet potential demand spikes [4] - Production plans are being adjusted based on the evolving hMPV situation globally [4] Company Preparedness and Strategy - The company believes it is well-positioned to meet potential increased demand for advanced respiratory support systems [4] - Increased production capacity is aimed at ensuring healthcare providers have access to vital respiratory care equipment [5] - Preparedness measures are precautionary and align with the company's commitment to global health readiness [5] Product Development and Innovation - The company is developing other products and technologies, including the INSPIRA ART (INSPIRA™ ART500 or Gen 2), INSPIRA™ Cardi-ART portable modular device, VORTX™ Oxygen Delivery System, and HYLA™ blood sensor [6] - These products are currently in the design and development phase and have not yet been tested or used in humans nor approved by any regulatory entity [6] Market Potential and Technology Impact - The INSPIRA™ ART is a groundbreaking device aimed at revolutionizing the $19 billion mechanical ventilation market [7] - The technology offers a potential alternative to mechanical ventilators by elevating and stabilizing decreasing oxygen saturation levels in minutes without a ventilator, with patients being awake during treatment [7] - The INSPIRA ART is equipped with a clip-on HYLA™ blood sensor, a real-time continuous blood monitoring technology, aiming to alert physicians of changes in a patient's condition without the need for intermittent actual blood samples [7]

Visitors at Glo-Med Network Inc's booth can explore Inspira's cutting-edge respiratory solutions, with the FDA-cleared INSPIRA™ ART100, showcasing the future of respiratory careRA'ANANA, Israel, Jan. 7, 2025 /PRNewswire/ -- Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN) (NASDAQ: IINNW), ("Inspira Technologies," "Inspira" or the "Company"), a groundbreaking respiratory support technology company, is pleased to announce that the INSPIRA™ ART100, a cardiopulmonary bypass system will be showcased at Arab H ...

RA'ANANA, Israel, Dec. 27, 2024 /PRNewswire/ -- Inspira Technologies Oxy B.H.N. Ltd. (NASDAQ: IINN), (NASDAQ: IINNW), ("Inspira Technologies," "Inspira" or the "Company"), a groundbreaking respiratory support technology company, a pioneer in life-support technology, today announced the pricing of a private placement offering consisting of the issuance and sale of 4,608,715 ordinary shares, no par value per share (or pre-funded warrants in lieu thereof) and ordinary warrants to purchase up to 4,608,715 ordin ...