RA'ANANA, Israel, Sept. 24, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW), ("Inspira Technologies", "Inspira", or the "Company") a breakthrough medical technology company, is poised to make a significant impact at the 34th Annual Extracorporeal Life Support Organization (ELSO) Conference in Detroit, Michigan, on the 29th to the 30th of September 2024. The Company will be presenting its latest and future technologies, underscoring its commitment to innovation and excellence ...

To date, a combined total of 32 claims have been deemed novel for the core technology of the INSPIRA™ ART device Targeting treatment for 20 million ICU patients with respiratory failure annually, with many relying on mechanical ventilators, in a $19 billion industry RA'ANANA, Israel, Sept. 13, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company targeting to supersede mechanical ventilat ...

Core Insights - Inspira Technologies OXY B.H.N. Ltd. is set to report clinical results for its new HYLA blood sensor, which is expected to align with the company's long-term growth plans in the medical industry [1] Company Overview - The HYLA blood sensor is a clip-on device designed to monitor vital blood parameters in real-time, alerting physicians to changes in a patient's condition without needing intermittent blood samples [2] - The clinical study results for the first configuration of the HYLA sensor are anticipated in Q4 2024, with a 510(k) submission to the FDA planned for early 2025 [3] - The development of the HYLA blood sensor involves in-house lab testing and collaborations with hospitals for clinical research [4] - Inspira aims to transform the respiratory and life-support sectors, targeting a market opportunity estimated at $59 billion annually [5] - The company is advancing its INSPIRA ART pipeline, which includes the HYLA blood sensor and other devices, although these have not yet been tested on humans or received regulatory approval [6] Regulatory and Market Position - The INSPIRA ART100 system has received FDA 510(k) clearance for use in cardiopulmonary bypass procedures and has also obtained Israeli AMAR certification [7] - The arterial blood gas (ABG) analyzers market is projected to grow from $3.5 million in 2023 to $88.5 million by 2030, with a CAGR of 7.1%, driven by the increasing use of minimally invasive diagnostic techniques [8] - The point-of-care diagnostics market was valued at $36.6 billion in 2022 and is expected to reach $74.8 billion by 2033, indicating strong growth potential for Inspira's HYLA sensor [9] Recent Developments - In August, Inspira received FDA listing for its INSPIRA CART, designed to enhance healthcare delivery during cardiopulmonary bypass procedures [10] - A recent evaluation showed that the integrated system of the INSPIRA ART100 exceeded 100% of the standard value for gas transfer at maximum flow, confirming its effectiveness in managing blood parameters [12] Financial Performance - Inspira's shares have increased by 1.9% this year, compared to a 10% growth in the industry [13]

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].

Exhibit 99.1 INSPIRA TECHNOLOGIES OXY B.H.N. LTD. INTERIM CONDENSED FINANCIAL STATEMENTS AS OF JUNE 30, 2024 UNAUDITED _______________________ ________________ ____________ INSPIRA TECHNOLOGIES OXY B.H.N. LTD. (UNAUDITED) The accompanying notes are an integral part of the financial statements. - 1 - INSPIRA TECHNOLOGIES OXY B.H.N. LTD. UNAUDITED INTERIM CONDENSED BALANCE SHEETS (U.S. dollars in thousands) TABLE OF CONTENTS | Interim condensed balance sheets | 1-2 | | --- | --- | | Interim condensed statemen ...

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]