INDEX TO ANNUAL REPORT ON FORM 10-K
December 31, 2025
| Part I · Page |
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| Item 1 | Business | 1 |
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| Item 1A | Risk Factors | 9 |
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| Item 1B | Unresolved Staff Comments | 19 |
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| Item 1C | Cybersecurity | 20 |
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| Item 2 | Properties | 21 |
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| Item 3 | Legal Proceedings | 21 |
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| Item 4 | Mine Safety Disclosures | 21 |
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| Part II |
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| Item 5 | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 22 |
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| Item 6 | [Reserved] | 23 |
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| Item 7 | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 24 |
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| Item 7A | Quantitative and Qualitative Disclosures about Market Risk | 31 |
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| Item 8 | Financial Statements and Supplementary Data | 32 |
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| Item 9 | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 57 |
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| Item 9A | Controls and Procedures | 57 |
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| Item 9B | Other Information | 57 |
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| Item 9C | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 57 |
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| Part III |
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| Item 10 | Directors, Executive Officers and Corporate Governance | 58 |
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| Item 11 | Executive Compensation Discussion and Analysis | 64 |
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| Item 12 | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 76 |
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| Item 13 | Certain Relationships and Related Transactions and Director Independence | 79 |
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| Item 14 | Principal Accounting Fees and Services | 79 |
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| Part IV |
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| Item 15 | Exhibits and Financial Statement Schedules | 80 |
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| Signatures | | 82 |
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i
Cautionary Notes Regarding“Forward-Looking”** Statements**
We have included or incorporated by reference into this report, and from time to time may make in our public filings, press releases or other public statements, certain statements that may constitute forward-looking statements. These include without limitation those under “Business” in Part I, Item 1, “Risk Factors” in Part I, Item 1A, “Legal Proceedings” in Part I, Item 3 and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7. In addition, our management my make forward-looking statements to analysts, investors, representatives of the media and others. These forward-looking statements are not historical facts and represent only our beliefs regarding future events, many of which, by their nature, are inherently uncertain and beyond our control. We may, in some cases, use words such as “project”, “believe”, “anticipate”, “plan”, “expect”, “estimate”, “intend”, “should”, “would”, “could”, “potentially”, “may” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.
In connection with the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, we are identifying important factors that, individually or in the aggregate, could cause actual results to differ materially from those contained in any forward- looking statements made by us. Any such forward-looking statements are qualified by reference to the following cautionary statements.
Forward-looking statements in this report are subject to a number of risks and uncertainties, some of which are beyond our control, including, among other things:
| • | changes in general economic, business or demographic conditions or trends in the U.S. or throughout the world or changes in the political environment, including changes in GDP, military and trade wars, including tariffs, interest rates, economic recession and inflation; |
| • | our ability to maintain sufficient liquidity, meet current debt covenants, and preserve working capital in order to maintain operations; |
| • | our ability to conclude a sufficient number of attractive growth projects, make investments in amounts consistent with our objectives in the prosecution of those and achieve targeted risk-adjusted returns on any growth project, including the continued commercialization of our Helium Plasma Technology; |
| • | the regulatory environment, including our ability to gain requisite approval from the U.S. Food and Drug Administration (“FDA”) and other governmental and regulatory bodies; |
| • | our ability to estimate compliance costs, comply with any changes thereto, rates implemented by regulators, and our relationships and rights under, and contracts with, governmental agencies and authorities; |
| • | disruptions or other extraordinary or force majeure events and the ability to insure against losses resulting from such events or disruptions, including disruptions caused by global pandemics; |
| • | sudden or extreme volatility in commodity prices and availability, including supply chain disruptions; |
| • | changes in competitive dynamics affecting our business and the medical device industry as a whole including potential impact of GLP-1 medications used for weight-loss on the industry; |
| • | technological innovations leading to increased competition in the medical device industry; |
| • | changes in healthcare policy; |
| • | our ability to make alternate arrangements to account for any disruptions or shutdowns that may affect suppliers’ facilities or the operations upon which our business is dependent including technical and mechanical systems; |
| • | continued aggressive EPA state regulation of Ethylene oxide sterilization (EtO) commercial plants resulting in additional plant closures, leading to a reduced availability of our handpieces, which are commercially sterilized; |
| • | our ability to implement operating and internal growth strategies to achieve profitable operations; |
| • | environmental risks, including the impact of climate change and weather conditions; |
| • | the impact of weather events, including potentially hurricanes, tornadoes and/or seasonal extremes; |
| • | unplanned outages and/or failures of technical and mechanical systems; |
| • | existing or potential litigation related to our Helium Plasma Technology and our ability to resolve litigation within insurance limits; |
| • | cybersecurity breaches impacting critical systems or data; and |
| • | work interruptions or other labor stoppages. |
Our actual results, performance, prospects or opportunities could differ materially from those expressed in or implied by the forward-looking statements. A description of risks that could cause our actual results to differ appears under the caption “Risk Factors” in Part I, Item 1A and elsewhere in this report. It is not possible to predict or identify all risk factors and you should not consider that description to be a complete discussion of all potential risks or uncertainties that could cause actual results to differ.
In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements. The forward-looking events discussed in this report may not occur. These forward-looking statements are made as of the date of this report. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should, however, consult further disclosures we may make in future filings with the Securities and Exchange Commission. Past performance is not an indicator of future results.
ii
Part I
