SPECIAL NOTE ABOUT FORWARD-LOOKING STATEMENTS
This prospectus and the other documents we incorporate by reference in this prospectus, may include forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend for such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Without limiting the foregoing, the words “aim,” “believe,” “may,” “will,” “should,” “expect,” “exploring,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these words. These forward-looking statements are not a guarantee of future results, performance, or achievements, and one should avoid placing undue reliance on such statements.
These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following:
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our ability to continue as a going concern;
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our ability to achieve or sustain profitability;
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our ability to obtain regulatory approval or other marketing authorizations from the U.S. Food and Drug Administration (“FDA”) and comparable foreign authorities for our products and product candidates, including our FDA 510(k) submission with respect to our CanGarooRM antibiotic-eluting biologic envelope;
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our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings;
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our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales;
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our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics Business;
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our ability to successfully execute or realize the anticipated benefits under our distribution arrangements with LeMaitre Vascular and Sientra;
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physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products;
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the continued and future acceptance of our products by the medical community;
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our dependence on a limited number of third-party suppliers;
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our ability to defend against the various lawsuits related to our recall of a single lot of Fiber Viable Bone Matrix (“FiberCel”) and avoid a material adverse financial consequence;
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our ability to defend ourselves against lawsuits and other claims related to our recall of a single lot of a certain viable bone matrix product and the market withdrawal of all of our viable bone matrix products;