CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, any applicable prospectus supplement and the documents incorporated by reference may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act, about us and our subsidiary. 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 the degree of market acceptance of our products;
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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;
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the full extent to which the pandemic resulting from the novel coronavirus and the disease it causes, or COVID-19, will continue to impact our business, results of operations and financial condition, including our revenue (resulting from deferrals of elective procedures using our products), expenses, manufacturing capability, supply chain integrity, research and development activities, and employee-related matters, including compensation;
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any future developments around COVID-19 and the uncertainty of COVID-19, including new information that may emerge, changes in the rate of COVID-19 transmission and infection, changes in the level of restrictions imposed by governmental authorities (and the resulting impact on the frequency of surgical procedures using our products), access to hospitals, and other actions taken to contain or treat COVID-19, as well as the economic impact on regional, national and international customers and markets;
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the performance of Aroa Biosurgery Ltd., or Aroa, in connection with the development and production of 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 to our current 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 attract 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 commercialize or obtain regulatory approvals for our products, or the effect of delays in commercializing or obtaining regulatory approvals;
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regulatory developments in the United States and internationally;
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our ability to develop and maintain our corporate infrastructure, including our internal controls;
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our ability to establish and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others;
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our expectations regarding the use of proceeds from our public offerings of common stock;