ClearPoint Neuro Inc

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K, or Annual Report, contains “forward-looking statements” as defined under the U.S. federal securities laws. The forward-looking statements relate to our expectations for performance, revenues and costs, and the adequacy of cash and cash equivalent balances and short-term investments to support operations and meet future obligations. These statements involve known and unknown risks, uncertainties and other 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.

In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these words. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain.

In evaluating forward-looking statements, you should refer to (i) the section of this Annual Report entitled “Risk Factors” and (ii) Item 2 of this Annual Report, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Factors Which May Influence Future Results of Operations.” As a result of these risk factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake to update any of the forward-looking statements after the date of this Annual Report, except to the extent required by applicable securities laws.

Our business faces many risks and uncertainties. These risks and uncertainties could lead to events or circumstances that have a material adverse effect on our business, financial condition, results of operations and prospects. You should carefully review and consider the full discussion of our risk factors described under Item 1A, Risk Factors of this Annual Report together with other information in this Annual Report and our other filings with the Securities and Exchange Commission (“SEC”), before making an investment decision regarding our common stock.

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Our business, financial condition, and results of operations may be adversely affected by general economic and financial market conditions, and current and future social and geopolitical instability.

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Revenue can be meaningfully impacted if we cannot maintain current relationships or programs or enter into new relationships or programs with drug delivery customers.

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The size of the markets for our current and future products and services may be smaller than we estimate.

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Our ClearPoint system may not achieve broad market adoption and our future business growth is dependent upon marketing and selling our ClearPoint system, and other new products, in the operating room.

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Our long-term growth depends on our ability to compete effectively in the neurosurgery market by developing and commercializing new products and services through our research and development efforts.

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If coverage and reimbursement from third-party payors for procedures utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability will suffer.

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We currently have significant customer concentration, so economic difficulties or changes in the purchasing policies or patterns of our key customers could have a significant impact on our business.

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Our internal manufacturing operations are generally conducted at a single location, which may limit our ability to provide an adequate supply of our products, and any disruption at our manufacturing facility could render us unable to produce our products, increase our expenses and decrease our revenue.

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Our reliance on single-source suppliers could harm our ability to meet demand for our products.

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To the extent we seek a new indication for use of, or new claims for, our products, the FDA may not grant 510(k) clearance or premarket approval application approval of such new use or claims.

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If we fail to obtain the necessary clearances, certifications or approvals for our new products, our ability to grow our business globally could be harmed.

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The results of our clinical trials may not support our product candidate claims or additional claims we may seek for our products and may result in the discovery of adverse side effects.

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The markets for medical devices are highly competitive, and we may not be able to compete effectively against larger, well-established as well as emerging small innovative competitors.

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We sell our products outside of the U.S., and are subject to various economic, political, regulatory and other risks relating to international operations.

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Disruptions of critical information systems or material breaches in the security of our systems could harm us.

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We may acquire other businesses, form joint ventures, or make investments in other companies or technologies that may not result in commercial success and could lead to significant losses.

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We need to hire and retain additional qualified personnel to grow and manage our business.

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We have incurred losses since our inception, and we may continue to do so. We may never achieve or sustain profitability.

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We may need additional funding for our business, and we may not be able to raise capital when needed or on terms that are acceptable to us, and raising additional funds may cause dilution, restrict our operations or require us to relinquish proprietary rights.

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Our cash, cash equivalents, and short-term marketable securities are subject to economic risk.

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We hold assets at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), which could negatively affect our operations or liquidity.

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If we, or the third parties from whom we license intellectual property, are unable to secure and maintain patent or other intellectual property protection for the intellectual property covering our marketed products or our product candidates, our ability to compete will be harmed.

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If we are subject to third-party claims of intellectual property infringement, we may become engaged in costly disputes.

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If our intellectual property is inadequately protected, our ability to successfully commercialize our marketed products and product candidates will be harmed.

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Patent terms may be inadequate to protect our competitive position for an adequate amount of time and we may not be able to protect our intellectual property rights throughout the world.

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If we lose access to third-party software that is integrated into our products, our costs could increase and new installations of our products could be delayed.

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Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others.

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We operate in a highly regulated industry and any failure to comply with the extensive government regulations may subject us to fines, injunctions and other penalties.

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Federal legislation and other payment and policy changes may have a material adverse effect on our business.

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Our products may be subject to product recalls that could harm our reputation, business operating results and financial condition.

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If our products cause or contribute to a death or a serious injury, or malfunction, we will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

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We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the U.S. or elsewhere.

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If we or our third-party suppliers fail to comply with the FDA’s Quality Management System Regulation (“QMSR”) or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer.

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We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.

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We are subject to various laws protecting the confidentiality and security of certain personal information, and our failure to comply could result in penalties and reputational damage.

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Our Fourth Amended and Restated Bylaws include exclusive forum provisions for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

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The market price of our common stock may be volatile, and stockholders may not be able to resell shares at or above the purchase price.

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Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.

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We have not paid dividends in the past and do not expect to pay dividends in the future.

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Anti-takeover provisions in our certificate of incorporation, bylaws and Delaware law could prevent or delay a change in control.

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We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price.

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Securities analysts may not continue coverage for our common stock or may issue negative reports.

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We are subject to certain general risks, including, but not limited to, risks related to damage to our reputation, natural disasters, product and professional liability claims or other lawsuits, and the requirements of being a public company.