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| · PART I—FINANCIAL INFORMATION · |
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| Item 1. | | Financial Statements | | 4 |
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| Item 2. | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 24 |
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| Item 3. | | Quantitative and Qualitative Disclosures About Market Risk | | 34 |
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| Item 4. | | Controls and Procedures | | 34 |
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| · · |
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| | PART II—OTHER INFORMATION | | |
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| · · |
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| Item 1. | | Legal Proceedings | | 34 |
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| Item 1A. | | Risk Factors | | 34 |
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| Item 2. | | Unregistered Sales of Equity Securities and Use of Proceeds | | 34 |
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| Item 3. | | Defaults Upon Senior Securities | | 34 |
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| Item 4. | | Mine Safety Disclosures | | 35 |
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| Item 5. | | Other Information | | 35 |
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| Item 6. | | Exhibits | | 35 |
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Forward-Looking Information
All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business, operations and financial performance and condition, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "ongoing," "plan," "potential," "predict," "project," "should," "target," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this Quarterly Report on Form 10-Q. These risks, uncertainties and other factors include, but are not limited to:
| ● | our ability to obtain reimbursement from third-party payers for our products; |
| ● | the impact of inflation, rising interest rates or recession; |
| ● | the adequacy of our liquidity to pursue our business objectives; |
| ● | adverse economic conditions or intense competition; |
| ● | price increases for supplies and components; |
| ● | wage and component price inflation; |
| ● | entry of new competitors and products; |
| ● | compliance with and changes in federal, state and local government regulation; |
| ● | loss or retirement of key executives, including transition matters related to our recent Chief Executive Officer change; |
| ● | technological obsolescence of our products; |
| ● | technical problems with our research and products; |
| ● | our ability to expand our business through strategic acquisitions; |
| ● | our ability to integrate acquisitions and related businesses; |
| ● | the effects of current and future U.S. and foreign trade policy and tariff actions; and |
| ● | the inability to carry out research, development and commercialization plans. |
You should read the matters described in "Risk Factors" and the other cautionary statements made in our Annual Report on Form 10-K for the year ended December 31, 2023, and in subsequent Quarterly Reports on Form 10-Q. We cannot assure you that the forward-looking statements in this report will prove to be accurate and therefore you are encouraged not to place undue reliance on forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. You are urged to carefully review and consider the various disclosures made by us in this report and in other filings with the Securities and Exchange Commission (the “SEC”) that advise of the risks and factors that may affect our business. Other than as required by law, we undertake no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.
