Certain information included or incorporated by reference in this annual report on Form 20-F may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “predict,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified.
| ● | Our planned level of revenues, capital expenditures and liquidity; |
| ● | Our available cash and our ability to obtain additional funding; |
| ● | Our financial statements for the period ended December 31, 2025, contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms, if at all; |
| ● | Our expectation regarding the sufficiency of our existing cash and cash equivalents to fund our current operations; |
| ● | Our ability to advance the development of our products and future potential product candidates; |
| ● | Our ability to commercialize and sell our products and future potential products and future sales of our product or any other future potential products; |
| ● | Our assessment of the potential of our products and future potential product candidates; |
| ● | Our planned level of capital expenditures and liquidity; |
| ● | Our plans to continue to invest in research and development to develop technology for new products; |
| ● | Our ability to maintain our relationships with suppliers, manufacturers, distributors and other partners; |
| ● | Anticipated actions of the FDA, state regulators, if any, or other similar foreign regulatory agencies, including approval to conduct clinical trials, the timing and scope of those trials and the prospects for regulatory approval or clearance of, or other regulatory action with respect to our products or services; |
| ● | The regulatory environment and changes in the health policies and regimes in the countries in which we intend to operate, including the impact of any changes in regulation and legislation that could affect the medical device industry; |
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| ● | Our ability to meet our expectations regarding the commercial supply of our products and future product candidates; |
| ● | Our ability to retain key executive members; |
| ● | Our ability to internally develop new inventions and intellectual property; |
| ● | The overall global economic environment; |
| ● | The impact of competition and new technologies; |
| ● | The possible impacts of cybersecurity incidents on our business and operations; |
| ● | Our ability to comply with continued listing requirements and standards of Nasdaq; |
| ● | General market, political and economic conditions in the countries in which we operate, including those related to recent unrest and actual or potential armed conflict in Israel and other parts of the Middle East; |
| ● | The impact of competition and new technologies; |
| ● | Our ability to internally develop new inventions and intellectual property; |
| ● | Changes in our strategy; and |
Readers are urged to carefully review and consider the various disclosures made throughout this annual report on Form 20-F which are designed to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
You should not put undue reliance on any forward-looking statements. Any forward-looking statements in this annual report on Form 20-F are made as of the date hereof, and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
In addition, the sections of this annual report on Form 20-F entitled “Introduction” and “Item 4. Information on the Company” contain information obtained from independent industry sources and other sources that we have not independently verified.
Unless otherwise indicated, all references to the “Company,” “we,” “our” and “Inspira” refer to Inspira Technologies Oxy B.H.N. Ltd. References to “U.S. dollars, “dollars,” and “$” are to currency of the United States of America, and references to “NIS” are to New Israeli Shekels.
Beginning with the year ended December 31, 2023, we transitioned from preparing and reporting our financial statements in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB, to preparing and reporting our financial statements in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, which may cause our financial results to differ from results, or impact the comparability to our financial statements, prepared in accordance with IFRS.
Notwithstanding the foregoing, we have retroactively converted the historical financial statements that were prepared in accordance with IFRS and included in this report to present such financial statements in accordance with U.S. GAAP.
All trademarks or trade names referred to in this Form 20-F are the property of their respective owners. Solely for convenience, the trademarks and trade names in this annual report on Form 20-F are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
This Form 20-F contains various depictions and illustrations of the various products we are developing. These illustrations are representative of the current expected designs for our products and are subject to change.
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