The clip-on HYLA™ blood sensor, designed to alert physicians of immediate signs of changes in a patient's clinical condition without the need for intermittent actual blood samples, targets a potential $2.5 billion Point of Care testing and Arterial Blood Gas (ABG) analyzer market. RA'ANANA, Israel, Aug. 28, 2024 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, has announced plans to report clinic ...

Inspira Technologies OXY B.H.N. Ltd. (IINN) recently announced the FDA listing of its INSPIRA CART. This medical cart, designed for use with the INSPIRA ART100 system, aims to enhance healthcare delivery in operating rooms during cardiopulmonary bypass procedures. The FDA classification as a Class I Medical Device and 510(K) Exempt highlights its compliance with rigorous safety and efficacy standards, paving the way for its introduction to the U.S. market. Significance of the Announcement The FDA listing of ...

Core Viewpoint - Inspira Technologies has received FDA listing for its INSPIRA™ CART, designed to enhance the INSPIRA™ ART100 system, aiming to improve healthcare delivery in various clinical settings [1][2]. Company Overview - Inspira Technologies focuses on life-support technology innovation, targeting a combined market opportunity of approximately $59 billion annually through its advanced blood oxygenation and monitoring technologies [3]. Product Development - The INSPIRA™ CART is classified as a Class I Medical Device and is 510(K) Exempt, facilitating its entry into the U.S. market for use in cardiopulmonary bypass procedures [2][7]. - The company is developing several products, including the HYLA™ blood sensor for continuous blood parameter monitoring and the INSPIRA™ Cardi-ART, a portable unit for brain oxygenation during cardiac arrest [4][5][6]. Regulatory Status - The INSPIRA™ ART100 system has received FDA 510(k) clearance for cardiopulmonary bypass procedures and AMAR certification for extra-corporeal membrane oxygenation [7].

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 ...