This annual report includes certain forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934 (the “Exchange Act”), which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “aim”, “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Forward-looking statements involve inherent known and unknown risks and uncertainties including matters not yet known to us or not currently considered material by us. Actual events or results may differ materially from those expressed or implied in such forward-looking statements as a result of various factors that may be beyond our control. Factors that could affect future results or cause actual events or results to differ materially from those expressed or implied in forward-looking statements include, but are not limited to:
| - | risks associated with the current worldwide inflationary environment, uncertain worldwide economic, political and financial environment, geopolitical instability, climate change impact, pandemics and each of their related impacts on our business operations; |
| - | the success of our High Intensity Focused Ultrasound (“HIFU”) technology; |
| - | the uncertainty of market acceptance for our HIFU devices; |
| - | the clinical and regulatory status of our devices in various geographical territories; |
| - | the uncertainty in the regulatory agencies review and approval process for any of our devices and changes in their recommendations and guidance; |
| - | the impact of government regulation, particularly relating to public healthcare systems and the commercial distribution of medical devices; |
| - | effects of intense competition in the markets in which we operate; |
| - | the uncertainty of reimbursement status of procedures performed with our products and their level of reimbursement; |
| - | the market potential for our HIFU devices; |
| - | dependence on our strategic suppliers and distribution partners; |
| - | difficulties to attract and recruit high-level experts in software, design, and development of high technology devices such as our HIFU products |
| - | any event or other occurrence that would interrupt operations at our primary production facility; |
| - | reliance on patents, licenses and key proprietary technologies; |
| - | cybersecurity risks and incidents, |
| - | risk of exchange rate fluctuations, particularly between the euro and the U.S. dollar and between the euro and the Japanese yen; |
| - | fluctuations in results of operations due to the cyclical nature of demand for medical devices; |
| - | risks relating to ownership of our securities; and |
| - | risks relating to securities litigations involving class actions. |
You should also consider the information contained in Item 3, “Key Information—Risk Factors” and Item 5, “Operating and Financial Review and Prospects,” or further discussion of the risks and uncertainties that may cause such differences to occur. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. Moreover, forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this annual report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
