SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein contain forward-looking statements. All statements other than statements of historical facts contained, or incorporated by reference, in this prospectus supplement and the accompanying prospectus are forward-looking statements. In some cases, you can identify forward- looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning:
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our history of operating losses and dependency on our Inspire system for revenues;
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commercial success and market acceptance of our Inspire therapy;
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our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize;
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competitive companies and technologies in our industry;
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the impact on our business, financial condition and results of operation from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease;
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our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire system;
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future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing;
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our ability to forecast customer demand for our Inspire system and manage our inventory;
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our dependence on third-party suppliers and contract manufacturers;
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risks related to consolidation in the healthcare industry;
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our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the United States;
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our ability to manage our growth;
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our ability to hire and retain our senior management and other highly qualified personnel;
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risks related to product liability claims and warranty claims;
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our ability to address quality issues that may arise with our Inspire system;
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our ability to successfully integrate any acquired business, products or technologies;
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changes in global macroeconomic conditions;
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any failure of key information technology systems, processes or sites or damage to or inability to access our physical facilities;
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our ability to commercialize or obtain regulatory approvals or certifications for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals or certifications;
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any violations of anti-bribery, anti-corruption and anti-money laundering laws;
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risks related to our indebtedness;
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our ability to use our net operating losses and research and development carryforwards;
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the risk that we may be deemed to be an investment company under the Investment Company Act of 1940;
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the U.S. Food and Drug Administration or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets;