clpt-20231231

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________

FORM 10-K

___________________________


þ			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2023


¨			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______.

Commission File Number: 001-34822

CLEARPOINT NEURO, INC.

(Exact name of registrant as specified in its charter)


Delaware			58-2394628
(State or other jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)


120 S. Sierra Ave., Suite 100			92075
Solana Beach, California			(Zip Code)
(Address of principal executive offices)

(888) 287-9109

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(g) of the Act: Common Stock, $0.01 par value per share


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.01 par value per share	CLPT	Nasdaq Capital Market

Securities registered pursuant to Section 12(b) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ¨Yes þ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. ¨Yes þ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.þ Yes ¨ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). þ Yes ¨ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ¨

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ¨

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b)¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). ¨ Yes þ No

As of June 30, 2023, the aggregate market value of the registrant’s common stock held by non-affiliates of the registrant was approximately $155 million based on the closing sale price as reported on the Nasdaq Capital Market.

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:


Class			Outstanding at March 5, 2024
Common Stock, $.01 par value per share			26,976,289 shares

DOCUMENTS INCORPORATED BY REFERENCE

The information required by Part III is incorporated by reference from portions of the definitive proxy statement to be filed within 120 days after December 31, 2023, pursuant to Regulation 14A under the Securities Exchange Act of 1934 in connection with the 2024 annual meeting of stockholders.

Table of Contents

CLEARPOINT NEURO, INC.

TABLE OF CONTENTS


Item		Page
	PART I

1.	Business.	3
1A.	Risk Factors.	19
1B.	Unresolved Staff Comments.	43
1 C .	Cybersecurity .	43
2.	Properties.	44
3.	Legal Proceedings.	44
4.	Mine Safety Disclosures.	44

	PART II

5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.	45
6.	Reserved.	45
7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	45
7A.	Quantitative and Qualitative Disclosures About Market Risk.	53
8.	Financial Statements and Supplementary Data.	53
9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.	53
9A.	Controls and Procedures.	53
9B.	Other Information.	54
9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspection	54

	PART III

10.	Directors, Executive Officers and Corporate Governance.	55
11.	Executive Compensation.	55
12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.	55
13.	Certain Relationships and Related Transactions, and Director Independence.	56
14.	Principal Accounting Fees and Services.	56

	PART IV

15.	Exhibits, Financial Statement Schedules.	57

Trademarks, Trade Names and Service Marks

ClearPoint Neuro®, ClearPoint®, SmartFlow®, SmartFrame®, SmartGrid®, Inflexion™, SmartTwist™, SmartTip™, ClearPoint Maestro®, SmartFrame Array®, SmartFrame OR™, ClearPoint Neuro Orchestra™, ClearPoint Prism®, SmartFlow Flex™, ClearPointer™, When Your Path is Unclear, We Point The Way®, and MRI Interventions® are all trademarks of ClearPoint Neuro, Inc. Any other trademarks, trade names or service marks referred to in this Annual Report are the property of their respective owners.

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Company Names Used in this Annual Report

As used in this Annual Report, we, us, our, the Company or ClearPoint Neuro refer to ClearPoint Neuro, Inc. and its affiliates; Siemens refers to Siemens Healthineers AG and its affiliates; Boston Scientific refers to Boston Scientific Corporation and its affiliates; Brainlab refers to Brainlab AG and its affiliates; UCB refers to UCB Biopharma SRL and its affiliates; CLS refers to Clinical Laserthermia Systems AB and its affiliates; IMRIS refers to IMRIS, Deerfield Imaging, Inc. and its affiliates; PTC refers to PTC Therapeutics, Inc. and its affiliates; Philips refers to Koninklijke Philips N.V. and its affiliates; Abbott refers to Abbott Laboratories and its affiliates; Elekta refers to Elekta AB and its affiliates; NE Scientific refers to NE Scientific, LLC and its affiliates; NeuroPace refers to NeuroPace, Inc. and its affiliates; Medtronic refers to Medtronic plc and its affiliates; UCSF refers to the University of California, San Francisco; and Johns Hopkins refers to Johns Hopkins University.

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PART I

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.

RISK FACTOR SUMMARY

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.

•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.

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

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

•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.

•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.

•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.

•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.

•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.

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

•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.

•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.

•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.

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

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

•We may acquire other businesses, form joint ventures, or make investments in other co

SEC Form 10-K filed by ClearPoint Neuro Inc.