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| PART I. FINANCIAL INFORMATION | 4 | |
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| Item 1. | Financial Statements (unaudited) | 4 |
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| | Condensed Consolidated Balance Sheets (unaudited) | 4 |
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| | Condensed Consolidated Statements of Operations (unaudited) | 5 |
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| | Condensed Consolidated Statements of Comprehensive Loss (unaudited) | 6 |
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| | Condensed Consolidated Statements of Shareholders’ Equity (unaudited) | 7 |
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| | Condensed Consolidated Statements of Cash Flows (unaudited) | 8 |
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| | Notes to Unaudited Condensed Consolidated Financial Statements | 9 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 18 |
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| Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 22 |
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| Item 4. | Controls and Procedures | 22 |
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| PART II. OTHER INFORMATION | 23 | |
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| Item 1. | Legal Proceedings | 23 |
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| Item 1A. | Risk Factors | 23 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 23 |
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| Item 3. | Defaults Upon Senior Securities | 23 |
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| Item 4. | Mine Safety Disclosures | 23 |
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| Item 5. | Other Information | 23 |
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| Item 6. | Exhibits | 24 |
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| SIGNATURES | 25 | |
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Cautionary STATEME****NT ON FORWARD-LOOKING INFORMATION
The statements contained in this Quarterly Report on Form 10-Q (this “Quarterly Report”) discuss our future expectations, contain projections of our results of operations or financial condition, and include other forward-looking statements which are made pursuant to the safe harbor provisions within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Our actual results may differ materially from those expressed in forward-looking statements made or incorporated by reference into this Quarterly Report.
All statements other than present and historical facts and conditions, including forward-looking statements expressing our beliefs, plans, objectives, business strategy, or future events, performance or results of operations and financial position, are forward-looking statements, which involve estimates, assumptions, risks and uncertainties. Therefore, our actual results and performance may differ materially from those expressed in the forward-looking statements. Forward-looking statements often, although not always, include words or phrases such as the following: “believe,” “plan,” “intend,” “should,” “estimate,” “expect” and “anticipate” or their negative or similar expressions, which reflect our views about future events and financial performance. Forward-looking statements involve inherent 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. 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 our financial position, indebtedness and our ability to raise capital; |
| ● | risks associated with the current worldwide inflationary environment, uncertain worldwide economic, political and financial environment, geopolitical instability, climate change impact, pandemic 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 the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and included in this Quarterly Report. Any forward-looking statement speaks only as of the date on which that statement is made. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. We qualify all of our forward-looking statements by these cautionary statements.
