CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, any applicable prospectus supplement and the documents incorporated by reference herein and therein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act, about us and our subsidiaries. These forward-looking statements are intended to be covered by the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact, and can be identified by the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “could,” “should,” “projects,” “plans,” “goal,” “targets,” “potential,” “estimates,” “seeks,” “intends” or “anticipates” or the negative thereof or comparable terminology. Forward-looking statements include, but are not limited to, statements concerning:
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estimates regarding future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing;
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the commercial success and degree of market acceptance of our products;
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the introduction of new products or product enhancements by us or others in our industry, including new products which may be perceived to negatively impact the demand for our products now or in the future;
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our ability to expand, manage and maintain our direct sales and marketing organization and to market and sell our products in the United States, or U.S., and Europe;
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the performance of our exclusive contract manufacturer for our OviTex and OviTex PRS products, Aroa, in connection with the supply of product and in the development of additional products and product configurations within these products;
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our ability to maintain our supply chain integrity and expand our supply chain to manage increased demand for our products;
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our ability to compete successfully with larger competitors in our highly competitive industry;
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our ability to achieve and maintain adequate levels of coverage or reimbursement for our current products and any future products we may seek to commercialize;
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our ability to enhance our products, expand our indications and develop and commercialize additional products;
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the development, regulatory approval, efficacy and commercialization of competing products;
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our business model and strategic plans for our products, technologies and business, including our implementation thereof;
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the size of the markets for our current and future products;
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our ability to recruit and retain senior management and other highly qualified personnel;
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our ability to obtain additional capital to finance our planned operations;
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our ability to maintain regulatory approval for our products;
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our ability to commercialize or obtain regulatory approvals for our future products, or the effect of delays in commercializing or obtaining regulatory approvals;
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decreasing selling prices and pricing pressures;
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regulatory developments in the U.S., including regulatory developments due to changes in the U.S. presidential administration and European markets;
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the potential impact of healthcare reform in the U.S., including the Inflation Reduction Act of 2022, and measures being taken worldwide designed to reduce healthcare costs;
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any decrease in frequency of surgical procedures using our products, whether through outbreak of illness or disease, cybersecurity events impacting hospital operations, potential hospital closures, labor