Full Press Release Details
Benad Goldwasser, MD, MBA Executive Chairman Urologic surgeon, inventor & entrepreneur. Multiple well - known industry exits Dr. Dekel Stavi , MD Medical Director Senior Intensive Care physician at Tel Aviv Sourasky Medical Center. Chairman of the Israeli ECMO Society INSPIRED TEAM See Disclaimers on slides 1 - 16 . Copyright 2018 - 2024 Inspira Technologies OXY B.H.N.
The timelines assume certain approvals by regulatory and or other authorizing authorities and are subject to change. There i s i nherent risk and variability in the overall regulatory process and no guarantee as to the success of any device or the approval or clearance of such devices by any regulatory authorities and or other authorizing authorities.
Disclaimers Source: $19 Billion Predicted Global Mechanical Ventilation Market By 2030 Source: Perfusion S ystems M arket Source: $ 2.5 Billion ABG Market By 2030 Source: $ 39.4 Billion Cardiac Arrest Treatment Market By 2029 Source: Extracorporeal Membrane Oxygenation Machine Market Size by 2036 Source: After Out - of - Hospital Cardiac Arrest Source: inspira - technologies.com/news/ Source: High Mortality Rate Source : 20M Patients/Year on MV Source: > 50 % Mortality Rate Source: Washington Post The Dark Side of Ventilators Source: CNBC Why Some Doctors Are Moving Away From Ventilators Source: CNN When Life Support is Really Death Support Source: Forbes Millions May Soon Breath Better Source: WhitePaper_Oxygenators V 11 _ 5.1.2023 See Disclaimers on slides 2 - 3 Copyright 2018 - 2024 Inspira Technologies OXY B.H.N.
In addition, there is inherent risk and variability in the overall regulatory process and no guarantee as to the success of any trial or regulatory approval or clearance. Some or all the clinical studies may be conducted outside of the U.S. INSPIRA TM Cardi - ART, INSPIRA TM ART 500 , INSPIRA TM ART or HYLA TM may either have embedded or integrated INSPIRA TM AI or other software with selective levels or functionality, yet to be decided by the Company.
Product intent of uses and regulatory pathways are yet to be defined or finalized. The products have not been cleared or approved by the FDA or any other regulatory or authorizing authority. The estimated date/time of regulatory clearance or approval may be subject to change. Approval or clearance by the FD A, CE or any other authorizing entity may not be granted or may require different study parameters or data or validation from those that are intended or were included in the submission.
The INSPIRA ART 100 System is FDA 510 (k) cleared for use in an extracorporeal perfusion circuit to pump blood during short - duration cardiopulmonary bypass procedures lasting 6 hours or less. INSPIRA ART 100 and INSPIRA ART are different devices The Augmented Respiration Technology, Adaptive Blood Oxygenation Technology, INSPIRA TM AI, HYLA TM , INSPIRA TM ART 500 , INSPIRA TM ART, INSPIRA TM Cardi - ART, VORTX TM and any other Inspira products, devices, disposables, components, software or technologies are still in development and have not been tested or used on humans.
The use of the term INSPIRA TM ART can refer to the INSPIRA TM ART 500 or INSPIRA TM ART Gen 2 . Mechanical Ventilation refers to Invasive Mechanical Ventilation. Planned timelines, milestones, estimates or assumptions are subject to change. The INSPIRA ART 100 system has FDA 510 (k) clearance and Israeli AMAR certification for Cardiopulmonary Bypass and ECMO procedures.
Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward - looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events . More detailed information about the risks and uncertainties affecting the Company is contained under the heading " Risk Factors " in the Company ' s annual report on Form 20 - F for the fiscal year ended December 31 , 2023 filed with the U .
This presentation also contains estimates of the Company ' s health economics model . These forward - looking statements and their implications are based solely on the current expectations of the Company ' s management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward - looking statements .
For example, the Company is using forward - looking statements when it discusses the prospective commercialization of its products, prospective U . S . Food and Drug Administration (FDA) regulatory submissions and clearances for its products the projected size of the mechanical ventilation market and perfusion systems market, the projected size of any other markets the Company may operate, the potential market sizes of its future products, the intended outcomes of the use of its products, including the HYLA Blood Sensor, INSPIRA ART 100 , INSPIRA ART, and INSPIRA Cardi - ART, and the intended uses and potential benefits of its products and technology .