SANARA MEDTECH INC.
Form 10-K
For the Year Ended December 31, 2024
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| PART I. |
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| ITEM 1 | BUSINESS | 4 |
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| ITEM 1A | RISK FACTORS | 18 |
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| ITEM 1B | UNRESOLVED STAFF COMMENTS | 39 |
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| ITEM 1C | CYBERSECURITY | 40 |
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| ITEM 2 | PROPERTIES | 40 |
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| ITEM 3 | LEGAL PROCEEDINGS | 40 |
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| ITEM 4 | MINE SAFETY DISCLOSURES | 40 |
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| PART II. |
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| ITEM 5 | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | 41 |
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| ITEM 6 | RESERVED | 41 |
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| ITEM 7 | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 42 |
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| ITEM 7A | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 55 |
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| ITEM 8 | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | F-1 |
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| ITEM 9 | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | 56 |
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| ITEM 9A | CONTROLS AND PROCEDURES | 56 |
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| ITEM 9B | OTHER INFORMATION | 56 |
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| ITEM 9C | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | 56 |
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| PART III. |
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| ITEM 10 | DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE | 57 |
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| ITEM 11 | EXECUTIVE COMPENSATION | 57 |
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| ITEM 12 | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | 57 |
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| ITEM 13 | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | 57 |
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| ITEM 14 | PRINCIPAL ACCOUNTING FEES AND SERVICES | 57 |
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| PART IV. |
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| ITEM 15 | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | 58 |
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Sanara, Sanara MedTech, our logo and our other trademarks or service marks appearing in this report are the property of Sanara MedTech Inc. Trade names, trademarks and service marks of other companies appearing in this report are the property of their respective owners. Solely for convenience, the trademarks, service marks and trade names included in this report are without the ®, ™ or other applicable symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names.
Unless otherwise indicated, “Sanara MedTech,” “Sanara,” the “Company,” “our,” “us,” or “we,” refer to Sanara MedTech Inc. and its consolidated subsidiaries.
** CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS**
This report contains forward-looking statements within the meaning of the federal securities laws. Forward-looking statements generally relate to future events or our future financial or operating performance, including topics such as our value-based wound and skincare services and Tissue Health Plus platforms. In some cases, you can identify forward-looking statements because they contain words such as “aims,” “anticipates,” “believes,” “contemplates,” “continue,” “could,” “estimates,” “expects,” “forecast,” “guidance,” “intends,” “may,” “plans,” “possible,” “potential,” “predicts,” “preliminary,” “projects,” “seeks,” “should,” “target,” “will” or “would” or the negative of these words, variations of these words or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. Such forward-looking statements are subject to certain risks, uncertainties and assumptions relating to factors that could cause actual results to differ materially from those anticipated in such statements, including, without limitation, the following:
| ● | shortfalls in forecasted revenue growth; |
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| ● | our ability to implement our value-based wound and skincare strategy through acquisitions and investments and our ability to realize the anticipated benefits of such acquisitions and investments; |
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| ● | our ability to meet our future capital requirements; |
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| ● | our ability to maintain compliance with our debt obligations; |
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| ● | our ability to develop and commercialize new products and products under development, including the manufacturing, distribution, marketing and sale of such products; |
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| ● | our ability to retain and recruit key personnel; |
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| ● | the intense competition in the markets in which we operate and our ability to compete within our markets; |
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| ● | the failure of our products to obtain market acceptance; |
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| ● | the effect of security breaches and other disruptions; |
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| ● | our ability to maintain effective internal controls over financial reporting; |
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| ● | our ability to maintain and further grow clinical acceptance and adoption of our products; |
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| ● | the impact of competitors inventing products that are superior to ours; |
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| ● | disruptions of, or changes in, our distribution model, consumer base or the supply of our products; |
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| ● | the failure of third-party assessments to demonstrate desired outcomes in proposed endpoints; |
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| ● | our ability to successfully expand into value-based wound, skincare and other services; |
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| ● | our ability and the ability of our research and development partners to protect the proprietary rights to technologies used in certain of our products and the impact of any claim that we have infringed on intellectual property rights of others; |
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| ● | our dependence on technologies and products that we license from third parties; |
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| ● | the effects of current and future laws, rules, regulations and reimbursement policies relating to the labeling, marketing and sale of our products, and our planned launch of value-based wound, skincare and other services and our ability to comply with the various laws, rules and regulations applicable to our business; and |
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| ● | the effect of defects, failures or quality issues associated with our products. |
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All forward-looking statements speak only as of the date on which they are made. For a more detailed discussion of these and other factors that may affect our business, see the discussion in “Item 1A. Risk Factors” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. We caution that the foregoing list of factors is not exclusive, and new factors may emerge, or changes to the foregoing factors may occur, that could impact our business. We do not undertake any obligation to update any forward-looking statement, whether written or oral, relating to the matters discussed in this report, except to the extent required by applicable securities laws.
