ClearPoint Neuro, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>ClearPoint Neuro, Inc. has filed its 2023 10-K, detailing financial performance and corporate history, including a recent public offering.</b>

AI Summary

ClearPoint Neuro, Inc. (CLPT) filed a Annual Report (10-K) with the SEC on March 12, 2024. ClearPoint Neuro, Inc. filed its 2023 Form 10-K on March 12, 2024, reporting on the fiscal year ending December 31, 2023. The company was formerly known as MRI Interventions, Inc. and Surgivision Inc. The filing covers financial data for the fiscal years 2023, 2022, and 2021. Key financial statement elements like Common Stock, Additional Paid-In Capital, and Retained Earnings are detailed for the periods ending December 31, 2021, 2022, and 2023. A subsequent event noted is a public offering that occurred on March 4, 2024.

Why It Matters

For investors and stakeholders tracking ClearPoint Neuro, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of ClearPoint Neuro's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The inclusion of historical company names and details about past financing agreements (like the 2020 Secured Notes and Convertible Debt) offers context on the company's evolution and capital structure.

Risk Assessment

Risk Level: medium — ClearPoint Neuro, Inc. shows moderate risk based on this filing. The company's financial statements and risk factors are detailed in the 10-K, indicating potential risks inherent in the medical device industry and the company's specific market position.

Analyst Insight

Investors should review the detailed financial statements and risk factors within the 10-K to understand ClearPoint Neuro's current financial standing and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period end date)
• 2024-03-12 — Filing Date (Date the 10-K was filed)
• 2023 — Reporting Year (Primary fiscal year covered by the report)
• 2022 — Prior Year (Previous fiscal year data included)
• 2021 — Prior Year (Fiscal year data included)

Key Players & Entities

• ClearPoint Neuro, Inc. (company) — Filer name
• MRI Interventions, Inc. (company) — Former company name
• Surgivision Inc (company) — Former company name
• DE (jurisdiction) — State of incorporation
• 3841 (industry_code) — Standard Industrial Classification
• Solana Beach (location) — Business address city
• 9499006833 (phone_number) — Business phone
• March 4, 2024 (date) — Date of subsequent public offering

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-12: 10-K Filing Date — Official date the annual report was submitted to the SEC.
• 2024-03-04: Public Offering — A significant subsequent event occurring shortly after the fiscal year end.

Key Financial Figures

• $0.01 — Section 12(g) of the Act: Common Stock, $0.01 par value per share Title of each cla
• $7 billion — we estimate could have an approximately $7 billion market potential; however, our ability

Filing Documents

• clpt-20231231.htm (10-K) — 1347KB
• clpt-descriptionofsecuriti.htm (EX-4.4) — 28KB
• clearpointneuroinc-insid.htm (EX-10.1) — 53KB
• clpt-20231231x10kex21.htm (EX-21) — 4KB
• clpt-20231231x10kex231.htm (EX-23.1) — 3KB
• clpt-20231231x10kex311.htm (EX-31.1) — 10KB
• clpt-20231231x10kex312.htm (EX-31.2) — 10KB
• clpt-20231231x10kex32.htm (EX-32) — 5KB
• clpt-clawbackpolicy10323.htm (EX-97) — 43KB
• clearpointneuroinc-insid001.jpg (GRAPHIC) — 246KB
• clearpointneuroinc-insid002.jpg (GRAPHIC) — 229KB
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• clearpointneuroinc-insid011.jpg (GRAPHIC) — 253KB
• clearpointneuroinc-insid012.jpg (GRAPHIC) — 275KB
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• clearpointneuroinc-insid015.jpg (GRAPHIC) — 68KB
• clearpointneuroinc-insid016.jpg (GRAPHIC) — 29KB
• clearpointneuroinc-insid017.jpg (GRAPHIC) — 185KB
• picture2.jpg (GRAPHIC) — 21KB
• 0001285550-24-000031.txt (&nbsp;) — 11850KB
• clpt-20231231.xsd (EX-101.SCH) — 42KB
• clpt-20231231_cal.xml (EX-101.CAL) — 63KB
• clpt-20231231_def.xml (EX-101.DEF) — 229KB
• clpt-20231231_lab.xml (EX-101.LAB) — 635KB
• clpt-20231231_pre.xml (EX-101.PRE) — 450KB
• clpt-20231231_htm.xml (XML) — 637KB

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations. 45 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk. 53 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data. 53 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. 53 9A.

Controls and Procedures

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

Executive Compensation. 55 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

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. Table of Contents 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. Table of Contents PART I SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual

BUSINESS

ITEM 1. BUSINESS Overview We are a commercial-stage medical device company, incorporated in 1998 as a Delaware corporation, that develops and commercializes innovative platforms for performing minimally invasive surgical procedures in the brain. From our inception in 1998, we have deployed significant resources to fund our efforts to develop the foundational capabilities for enabling magnetic resonance imaging ("MRI") guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies we develop. In 2021, our efforts expanded beyond the MRI suite to encompass development and commercialization of neurosurgical device products for the operating room setting, as well as consulting services for pharmaceutical companies. Our products have been installed or used at over 75 centers globally. Since 2020, we have evolved to become a company comprised of two parts: (i) a business providing medical devices for neurosurgical applications, and (ii) a business focused on partnerships in the biologics and drug delivery space. Medical Devices for Neurosurgical Application The first foundational part of our business is focused on providing medical devices for neurosurgical applications. Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software. The primary applications for the ClearPoint system are to target and guide: (a) the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters; and (b) the infusion of pharmaceuticals into the brain. The ClearPoint system was originally designed for use in an MRI setting. In 2021, we launched the SmartFrame Array Neuro Navigation System and Software, which allows for operating room placement of the ClearPoint system and completion of the procedure in the MRI suite. In 2024, we commenced limited market release of the Smar

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View this 10-K filing on SEC EDGAR