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Fellowships in ECMO at the NHS, UK and cardiothoracic anesthesia at Harefield Hospital` Prof. Eddy Fan Intensivist & ECMO Advisor Medical director of the extracorporeal life support program at the Toronto General Hospital. Intensivist at the University Health Network/Mount Sinai Hospital Prof. Daniel Brodie Intensivist & ECMO Advisor President - elect of the Extracorporeal Life Support Organization (ELSO).
In addition, there is inherent risk and variability in the overall regulatory process. Approval by the FDA may not be granted, or the FDA may require different study parameters from those that are intended to be included in the submission. While the Company intends to execute on strategic distribution agreements, there is no guarantee any sales will occur pursuant to those existing agreements, and agreements that may be executed in the future. * The Distribution agreements are over a 7 - year period and subject to completion of development, and the required regulatory approvals or clearances.
The system is targeted to allow for treatmentof patients while awake and spontaneously breathing. Treatment setting: ICUs & Hospital Units FDA Pre - Submission H2 - 2023 A non - invasive blood sensor to be designed to perform real - time and continuous blood measurements, potentially minimizing the need for blood samples from patients. The HYLA's measurement shall be designed to assist physicians in the monitoring of a patient's clinical condition.
Treatment setting: Operating Theaters FDA Submission H2 - 2023, Planning FDA Class II 510(k) Inspira ART TM System HYLA TM Blood Sensor This respiratory support technology targeted to perform direct blood oxygenation and CO2 removal to boost patient saturation levels within minutes. The designed treatment is intended for longer than 6 hours, providing assisted extracorporeal circulation and physiologic gas exchange of the patient's bloodin adult patients with acute respiratory failure.
Clin Infect Dis. 2016;63:e61 - e111. MV requires intrusive intubation, coma induction, and can be very traumatic for patients: Potential Risks & Complications Ventilator - induced lung injury (VILI) Ventilator - associated pneumonia (VAP) Ventilator - induced diaphragmatic dysfunction Pneumothorax & tracheomalacia Increased Delirium Muscular atrophy Drug withdrawal symptoms High Cost of Treatment Prolonged duration of Ventilation Prolonged ICU stay Increased complication rate Patient re - admissions Requires weaning process Extended rehabilitation period Mechanical Ventilation (MV) Puts Patients at Risk 8 Copyright 2018 - 2022 Inspira Technologies OXY B.H.N.
Am J Respir Crit Care Med Vol. 196, P3 - 4, 2017. ATS Patient Education Series 2017 American Thoracic Society 2. Diling Wu et al. Frontiers in pharmacology MINI REVIEW published: 09 May 2019. doi: 10.3389/fphar.2019.00482 3. Kalil AC, Metersky ML, Klompas M, et al. Management of Adults With Hospital - acquired and Ventilator - associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society.
National Heart, Lung and Blood Institute website. https://www.nhlbi.nih.gov/health - topics/respiratory - failure 6 Global Market Expected to Grow (Based on invasive mechanical ventilation market) Increase in the prevalence of respiratory diseases Growing geriatric population Respiratory comorbidities following COVID - 19 Copyright 2018 - 2022 Inspira Technologies OXY B.H.N.
The Company assumes no obligation to update forward - looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward - looking information except to the extent required by applicable securities laws as well as subsequent filings with the SEC . If the Company does update one or more forward - looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward - looking statements . 2 * The Inspira ART and the ART presented in this presentation are both referring to the Inspira ART Copyright 2018 - 2022 Inspira Technologies OXY B.H.N.
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 , 2021 filed with the U . S . Securities and Exchange Commission (the "SEC"), which is available on the SEC's website, www . sec . govForward - looking statements speak only as of the date the statements are made .
However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed or indicated by the forward - looking statements . Forward - looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward - looking statements .
The presentation also contains estimates with respect to the Company's health economics model . Forward - looking statements are not historical facts, and are based upon management's current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain . Such expectations, beliefs and projections are expressed in good faith .
Words such as "expects," "intends," "plans," "believes," "seeks," "estimates," and similar expressions or variations of such words are intended to identify forward - looking statements . For example, the Company is using forward - looking statements when it discusses intended uses of its products and technology, its business model, its strategy for gaining market penetration and market share, the potential amounts to be derived from its distribution agreements, its go - to market strategy, potential strategic collaborations with third parties, its reimbursement strategy, regulatory submissions, market potential for its products, commercialization of its products, the potential to use its products together with mechanical ventilation, the regulatory approval process of its product candidates and the potential submission of approvals with such regulators, the benefits and uses of its product candidates for intended patient populations, lines of therapy, targeted major milestones for 2022 - 2023 and market milestones for 2022 - 2023 and its future growth .