SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference herein 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 Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements include statements made regarding our commercialization strategy, future operations, cash requirements and liquidity, capital requirements, and other statements on our business plans and strategy, financial position, and market trends. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “should,” “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect,” and other similar expressions. These forward-looking statements are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements, including factors such as our ability to raise substantial additional capital to finance our planned operations and to continue as a going concern; our ability to execute our strategy and business plan; our ability to obtain regulatory approvals for our products, including the Neuro-Spinal Scaffold; our ability to successfully commercialize our current and future product candidates, including the Neuro-Spinal Scaffold; the progress and timing of our development programs; market acceptance of our products; our ability to retain management and other key personnel; our ability to promote, manufacture, and sell our products, either directly or through collaborative and other arrangements with third parties; and other factors detailed under “Risk Factors” in this prospectus and in the section entitled “Risk Factors” included in our most recent Annual Report on Form 10-K, as revised or supplemented by our subsequent Quarterly Reports on Form 10-Q, which are incorporated herein by reference, and other filings we make with the SEC from time to time, which are incorporated herein by reference. These forward-looking statements are only predictions, are uncertain, and involve substantial known and unknown risks, uncertainties, and other factors which may cause our actual results, levels of activity, or performance to be materially different from any future results, levels of activity, or performance expressed or implied by these forward-looking statements. Such factors include, among others, the following:
•
our limited operating history and history of net losses;
•
our ability to raise substantial additional capital to finance our planned operations and to continue as a going concern;
•
our ability to complete the INSPIRE 2.0 Study to support our existing Humanitarian Device Exemption application;
•
the impact of the COVID-19 pandemic on our business;
•
our ability to execute our strategy and business plan;
•
our ability to obtain regulatory approvals for our current and future product candidates, including our Neuro-Spinal Scaffold implant;
•
our ability to successfully commercialize our current and future product candidates, including our Neuro-Spinal Scaffold implant;
•
the progress and timing of our current and future development programs;
•
our ability to successfully open, enroll and complete clinical trials and obtain and maintain regulatory approval of our current and future product candidates;
•
our ability to protect and maintain our intellectual property and licensing arrangements;
•
our reliance on third parties to conduct testing and clinical trials;
•
market acceptance and adoption of our current and future technology and products;
•
our ability to promote, manufacture and sell our current and future products, either directly or through collaborative and other arrangements with third parties; and
•
our ability to attract and retain key personnel.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking