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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 U.S.; |
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the performance of Aroa Biosurgery Ltd. (“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 U.S. and internationally; |
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the effect of events for which we have no control, including, global pandemics including the Coronavirus Disease 2019 (“COVID-19”) and economic uncertainty; |
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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 initial public offering (“IPO”); and |
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other risks and uncertainties, including those listed under the caption “Risk Factors.” |