RA'ANANA, Israel, July 30, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a trailblazer in life-support technology, proudly introduces the INSPIRA Cardi-ART, a portable modular device, currently in development, to provide oxygen to the brain during cardiac arrest (the "Device" or "INSPIRA Cardi-ART"). Inspira™ Technologies targets to reshape the respiratory and life-support landscape. We are developing novel exp ...

Core Viewpoint - Inspira Technologies OXY B.H.N. Ltd. has received approval from the Israeli Ministry of Health for its INSPIRA™ ART100 system, marking a significant milestone in the company's strategy to expand its market presence and develop innovative medical technologies [1][7]. Group 1: Product Approval and Features - The INSPIRA™ ART100 system is an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system that has received both Israeli AMAR approval and FDA 510(k) clearance [9]. - The INSPIRA™ ART (Gen 2), also known as INSPIRA™ ART500, features Adaptive Blood Oxygenation technology, designed to continuously measure blood parameters in real-time and deliver oxygen directly into the bloodstream, potentially allowing patients to remain awake during treatment [2][3]. - The approval of the INSPIRA™ ART100 is expected to facilitate hospitals' acquisition and use of this innovative technology, enhancing patient care [2][7]. Group 2: Strategic Implications - The receipt of Israeli regulatory approval is seen as a crucial step towards increasing local support and adoption of the INSPIRA™ ART100, showcasing the company's ability to secure regulatory approvals [7]. - The CEO of Inspira Technologies emphasized that the AMAR approval will help create business opportunities in new regions and emerging markets, following the earlier FDA approval [8]. - The company aims to reshape the respiratory and life-support landscape by developing novel technologies to prolong and improve the quality of life for patients [8].

Company Overview - Inspira Technologies OXY B.H.N. Ltd. (IINN) has disclosed a new business plan focusing on next-generation technologies, particularly its core blood oxygenation technology, the INSPIRA ART (Gen 2) [1][3] - The company aims to strengthen its position in the mechanical ventilation market with the INSPIRA ART (Gen 2) device, targeting a share of the global mechanical ventilation market projected to reach $19 billion by 2030 [8][7] Product Development - The INSPIRA ART (Gen 2) device allows for direct blood oxygenation, enabling patients to potentially remain awake without intubation, utilizing adaptive oxygenation technology [3] - The INSPIRA ART100, a cardiopulmonary support device, is set to be deployed in the U.S. and internationally, with the first purchase order received from Glo-Med Networks, Inc., and shipment scheduled for Q4 2024 [2][4] Business Goals - The company has outlined business goals for 2024-2025, focusing on the distribution of the INSPIRA ART100 system and the integration of the HYLA blood sensor into the next generation of the INSPIRA ART100 device [5][11] - Inspira is on track with phase 2 research and development for its VORTX blood delivery system and phase 3 verification and validation testing of the HYLA blood sensor [11] Market Insights - The cardiopulmonary bypass equipment market was valued at $437.8 million in 2023 and is expected to grow at a CAGR of more than 1% by 2033, driven by the increased prevalence of chronic diseases and technological advancements [12] - Inspira's business plan is well-timed to capitalize on the growth opportunities within this market [13] Recent Developments - In May 2024, production of the ART100 commenced, and it received CSA certification for product quality and safety [14] - The company has made significant technological advancements, satisfying 100% of regulatory guideline requirements for its VORTX blood delivery system [15] Stock Performance - Year-to-date, shares of IINN have surged 32.1%, outperforming the industry growth of 5.6% [16]

RA'ANANA, Israel, June 20, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN), (Nasdaq: IINNW) (the "Company" or "Inspira"), a breakthrough medical technology company, announced today that the Company's President and co-founder, Mr. Joe Hayon, presented a business plan with targets for the Company's next-generation technologies on a Company conference call today. Key Highlights from the Presentation: The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary B ...

RA'ANANA, Israel, June 17, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, is proud to announce today that the Company will present at the annual iECOs Conference in Herzliya, Israel on June 18th, 2024. About iECOs About Inspira Technologies OXY B.H.N. Ltd. The Company received FDA 510(k) clearance for its INSPIRA ART100, a Cardiopulmonary Bypass System. For more information, pleas ...

The planned shipment and potential additional sales of the INSPIRA™ ART100 systems is a pivotal step in the Company's growth model, which is primarily based on the INSPIRA™ ART (Gen 2) that is currently in development and is expected to target the $19 billion mechanical ventilator market, with its next generation cutting-edge technology designed to replace the need for mechanical ventilation. The Company plans to offer hospitals receiving the INSPIRA™ ART100 an option with special terms for the integrated H ...

The event is an opportunity to present and demonstrate new products and technologies to potential customers and strategic partners RA'ANANA, Israel, June 5, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, is proud to announce plans to exhibit the INSPIRA™ ART100 System, recently cleared by the U.S. Food and Drug Administration ("FDA"), at the Extracorporeal Life Support Organizatio ...

Core Insights - Inspira Technologies OXY B.H.N. Ltd. announced a conference call to discuss business targets and distribution agreements following FDA clearance for the INSPIRA ART100 system [1][2] Company Overview - Inspira Technologies is an innovative medical technology company focused on life support, with products designed to enhance patient care [3] - The INSPIRA ART (Gen 2), also known as INSPIRA ART500, utilizes Adaptive Blood Oxygenation technology to measure blood parameters in real-time and deliver oxygen directly into the blood [3] - This technology aims to elevate patient oxygen saturation levels quickly, potentially allowing patients to remain awake during treatment and reducing reliance on mechanical ventilation [3] Regulatory Milestones - The company received FDA 510(k) clearance for the INSPIRA ART100, a Cardiopulmonary Bypass System [4] - Other products, including the INSPIRA ART (Gen 2) and HYLA blood sensor, have not yet been tested in humans and lack regulatory approval [4]

With a prominent screen, 360-degree LED flow presentation and large digit display, the patient's information is easily viewed from a distance, making the INSPIRA ART100 ideal in both standard and challenging care situations, such as isolation or in-transit scenarios. Potential Application of INSPIRA ART100 Inspira Technologies OXY B.H.N. Ltd. (IINN) recently received the FDA 510(k) clearance for its INSPIRA ART100 — a Cardiopulmonary Bypass System. This approval is a significant milestone for the company, h ...

RA'ANANA, Israel, May 28, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company", "Inspira", or "Inspira Technologies"), a breakthrough medical technology company, today announced that it has received notification of 510(k) class II clearance from the U.S. Food and Drug Administration (FDA) for its INSPIRA™ ART100, a Cardiopulmonary Bypass System. Dagi Ben Noon, CEO of Inspira, said "This is a proud moment for all of us at Inspira Technologies. We would like ...