Index to Annual Report on Form 10-K
| PART I | 1 | |
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| Item 1. | Business. | 1 |
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| Item 1A. | Risk Factors. | 11 |
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| Item 1B. | Unresolved Staff Comments. | 11 |
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| Item 1C. | Cybersecurity. | 11 |
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| Item 2. | Properties. | 12 |
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| Item 3. | Legal Proceedings. | 12 |
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| Item 4. | Mine Safety Disclosures. | 12 |
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| PART II | 12 | |
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| Item 5. | Market For Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. | 12 |
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| Item 6. | [Reserved]. | 13 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 14 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk. | 19 |
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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. | 20 |
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| Item 9A. | Controls and Procedures. | 20 |
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| Item 9B. | Other Information. | 21 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. | 21 |
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| PART III | 21 | |
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| Item 10. | Directors, Executive Officers and Corporate Governance. | 21 |
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| Item 11. | Executive Compensation. | 22 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. | 22 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence. | 22 |
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| Item 14. | Principal Accountant Fees and Services. | 22 |
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| PART IV | 22 | |
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| Item 15. | Exhibits and Financial Statement Schedules. | 22 |
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INFORMATION REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this Annual Report on Form 10-K that are not statements of historical fact should be considered forward-looking statements within the meaning of the safe harbor provisions 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”). Forward-looking statements include, but are not limited to, statements regarding: our business strategy, including our intended level of investment in research and development and marketing activities; our expectations with respect to earnings, gross margins and sales growth, industry relationships, marketing strategies and international sales; estimated sizes of markets into which our products are or may be sold; our business strengths and competitive advantages; our ability to grow additional sales distribution channels; our intent to retain any earnings for use in operations rather than paying dividends; our expectation that our products will continue to qualify for reimbursement and payment under government and private insurance programs; our intellectual property plans and practices; the expected impact of applicable regulations on our business; our beliefs about our manufacturing processes; our expectations and beliefs with respect to our employees and our relationships with them; our belief that our current facilities are adequate to support our growth plans; our expectations with respect to ongoing compliance with the terms of our credit facility; our expectations regarding the ongoing availability of credit and our ability to renew our line of credit; enhancements to our products and services; expected excise tax exemption for the SmartVest System; and our anticipated revenues, expenses, capital requirements and liquidity. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “ongoing,” “plan,” “potential,” “project,” “target,” “should,” “will,” “would,” and similar expressions, including the negative of these terms, are intended to identify forward-looking statements but are not the exclusive means of identifying such statements. Although we believe these forward-looking statements are reasonable, they involve risks and uncertainties that may cause actual results to differ materially from those projected by such statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results or our industry’s actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by the forward-looking statements.
Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to, the following:
| ● | ability to obtain and maintain reimbursement from Medicare, Medicaid, or private insurance payers for our products; |
| ● | component or raw material shortages, changes to lead times or significant price increases and changes to trade regulations (including, but not limited to, changes to tariffs); |
| ● | adverse changes to state and federal health care regulations; |
| ● | our ability to maintain regulatory compliance and to gain future regulatory approvals and clearances; |
| ● | entry of new competitors including new drug or pharmaceutical discoveries; |
| ● | adverse economic and business conditions or intense competition; |
| ● | technical problems with our research and products; |
| ● | the risks associated with cyberattacks, data breaches, computer viruses and other similar security threats; |
| ● | changes affecting the medical device industry; |
| ● | our ability to develop new sales channels for our products such as the hospital or homecare distributor channels; |
| ● | adverse international health care regulation impacting current international business; |
| ● | our ability to renew our line of credit or obtain additional credit as necessary; and |
| ● | our ability to protect and expand our intellectual property portfolio. |
This list of factors is not exhaustive, however, and these or other factors, many of which are outside of our control, could have a material adverse effect on us and the results of our operations. Therefore, you should consider these risk factors with caution and form your own critical and independent conclusions about the likely effect of these risk factors on our future performance. Forward-looking statements speak only as of the date on which the statements are made, and we undertake no obligation, and expressly disclaim any such obligation, to update any forward-looking statement for any reason other than as required by law, even if new information becomes available or other events occur in the future. You should carefully review the disclosures and the risk factors described in this and other documents we file from time to time with the Securities and Exchange Commission (the “SEC”). All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth herein.
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