Form 8-K

8-K — ClearPoint Neuro, Inc.

Accession: 0001193125-26-221596

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0001285550

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — clpt-20260513.htm (Primary)

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8-K

8-K (Primary)

Filename: clpt-20260513.htm · Sequence: 1

8-K

0001285550false00012855502026-05-132026-05-13

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 13, 2026

CLEARPOINT NEURO, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-34822

58-2394628

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

120 S. Sierra Ave., Suite 100

Solana Beach, California

92075

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 888 287-9109

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value per share

CLPT

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 13, 2026, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its financial results for the first fiscal quarter ended March 31, 2026. A copy of the press release is furnished herewith as Exhibit 99.1.

The information in Item 2.02 of this Form 8-K, as well as Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 7.01 Regulation FD Disclosure.

On May 13, 2026, the Company posted an updated investor presentation to its website at http://ir.stockpr.com/clearpointneuro/investor-presentations. A copy of the investor presentation is being furnished herewith as Exhibit 99.2. The Company may use the investor presentation from time to time in conversations with analysts, investors and others.

The information in Item 7.01 of this Form 8-K, as well as Exhibit 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished herewith:

Exhibit 99.1

Press Release dated May 13, 2026

Exhibit 99.2

Investor Presentation dated May 13, 2026

Exhibit 104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

CLEARPOINT NEURO, INC.

Date:

May 13, 2026

By:

/s/ Danilo D'Alessandro

Danilo D'Alessandro

Chief Financial Officer

EX-99.1

Filename: clpt-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

ClearPoint Neuro Reports First Quarter 2026 Results

Record Revenue Achieved Including 25% Organic Growth in Devices and 43% Overall Growth

SOLANA BEACH, CA, May 13, 2026 – ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced financial results for its first quarter ended March 31, 2026.

First Quarter 2026 Highlights

•

Reported first quarter revenue of $12.1 million, including $2.3 million of IRRAflow revenue, representing 43% overall growth and 16% year-over-year total organic growth compared with the first quarter of 2025;

•

The activated installed base across all ClearPoint technology including IRRAflow systems now includes over 175 global centers;

•

Achievement of measurable revenue and cost synergies through the continuing integration of the IRRAflow product portfolio and team;

•

Continued clinical trial and regulatory progress across more than 60 active biopharma partners;

•

FDA clearance and successful completion of the first clinical procedure utilizing the Velocity Alpha MR High Speed Surgical Drill System;

•

Received Medical Device License (MDL) from Health Canada for the ClearPoint Neuro Navigation System, covering both MRI-guidance and iCT guidance workflows with first cases now scheduled;

•

Completion of the first commercial drug delivery case utilizing ClearPoint technology in the Asia-Pacific region;

•

Gross margin expanded to 64%; and

•

Reported cash and cash equivalents totaling $35.6 million as of March 31, 2026.

“Our team is off to a strong start in 2026 with forward progress across our entire four-pillar growth strategy,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “While record revenue achievement and 25% organic devices growth made the headline, there is no shortage of meaningful strategic progress across the entire organization. This includes highlights from each pillar: multiple new drug routes-of-administration tested for the first time at the ClearPoint Advanced Laboratories, expansion of our navigation installed base globally, FDA clearance of the Velocity Alpha MR conditional drill that has now been used clinically for the first time, and the integration of the entire IRRAflow portfolio into the ClearPoint Neuro commercial and operations teams which will lead to meaningful revenue and cost synergies in the second half of 2026. We continue to believe that these four pillars will each contribute double digit growth in 2026, and represent a solid foundation on which to build our commercial cell and gene therapy delivery business in the future. Individual drug development programs of course come with inherent risk, however if you look across our entire portfolio of more than 60 partners and programs, every quarter we see partners getting funded or acquired, we see INDs being approved, we see more patients being recruited and enrolled in regulatory trials, and we see our partners getting closer and closer to pivotal data readouts. With more than 60 shots on goal across this portfolio, and having worked closely with the

amazing teams doing this drug development, we feel more than ever that global approvals are not a matter of if, but when.”

Business Outlook

The Company estimates revenue in 2026 to be between $52.0 million and $56.0 million.

Financial Results – Quarter Ended March 31, 2026

Total revenue was $12.1 million for the three months ended March 31, 2026, and $8.5 million for the three months ended March 31, 2025, which represents an increase of $3.6 million, or 43%.

Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased slightly to $4.8 million for the three months ended March 31, 2026 from $4.7 million for the three months ended March 31, 2025. Of note the construction of the new CAL facility (ClearPoint Advanced Laboratories) is continuing, which is designed to the bring the CAL's capacity to the level expected in the years ahead.

Neurosurgery navigation, therapy and access revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint and IRRAflow systems, increased 80% to $5.9 million for the three months ended March 31, 2026, from $3.3 million for the same period in 2025. The increase is driven by additional revenues from sales of the IRRAflow product of as well as the introduction of our 3.0 operating room navigation software, which has positively impacted procedural volumes in the operating room during the three months ended March 31, 2026, compared to the same period in 2025.

Capital equipment and software revenue, consisting of sales of ClearPoint and IRRAflow reusable hardware and software and related services, increased 177% to $1.4 million for the three months ended March 31, 2026, from $0.5 million for the same period in 2025 due to an increase in placements of ClearPoint navigation capital and software, IRRAflow control units, and Prism laser units.

The Company achieved a gross margin of 64% on its sales for the three months ended March 31, 2026, and a gross margin of 60% in the same period in 2025. The increase in gross margin is primarily due to lower excess and obsolete inventory for the three months ended March 31, 2026, as compared to the same period in 2025.

Operating expenses were $16.2 million for the three months ended March 31, 2026, compared with $11.3 million for the same period in 2025, an increase of 44%. The increase was mainly driven by higher personnel costs as a result of the expanded team due to the acquisition of IRRAS which occurred in November 2025, as well as increased occupancy costs and travel costs.

At March 31, 2026, the Company had cash and cash equivalents totaling $35.6 million as compared to $45.9 million at December 31, 2025, with the decrease resulting from the use of $8.0 million in cash for operating activities and $2.0 million in cash paid for taxes related to the net share settlement of equity awards. The Company expects cost synergies resulting from the acquisition of IRRAS to contribute to a reduction in cash burn in the second half of 2026 and believes that the asset integration could potentially be cash neutral for the full year 2027.

Teleconference Information

Investors and analysts are invited to listen to a live broadcast review of the Company's first quarter 2026 results on Wednesday, May 13, 2026 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online

here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=IjzOoM7l. Investors and analysts who would like to participate in the conference call via telephone may do so at (877) 407-9034, or at (201) 493-6737 if calling from outside the U.S. or Canada.

For those who cannot access the live broadcast, a replay will be available shortly after the completion of the call until June 12, 2026, by calling (877) 660-6853 or (201) 612-7415 if calling from outside the U.S. or Canada, and then entering conference I.D. number 413671. An online archive of the broadcast will be available on the Company's Investor website at https://ir.clearpointneuro.com/.

About ClearPoint Neuro

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as preclinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct central nervous system delivery of therapeutics in preclinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit www.clearpointneuro.com.

Forward-Looking Statements

Statements in this press release and in the teleconference referenced above concerning the Company’s plans, growth and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the market opportunity and rate of sales and revenue growth for the Company’s products and services, including for the Company’s preclinical CRO facility and its products and services, the Company’s neuronavigational products, the IRRAflow Active Fluid Exchange System, and the PRISM Laser Therapy System; the Company’s expectations for achieving key growth drivers for its sales including its ability to expand its commercial organization, receive regulatory approval for its products in new geographies, activate additional customer sites, generate clinical and economic data to support and expand the adoption rate for its products, and its development of new products; the Company’s ability to successfully develop new products for gene and cell therapy delivery; the adoption of the Company’s products and services for use in the delivery of gene and cell therapies; the regulatory approval and commercialization of cell and gene therapies being developed by the Company’s biotech Partners; the Company's expectations regarding its four-pillar growth strategy, including its belief that each pillar will contribute double-digit growth in 2026; the Company's expectations regarding future revenue and cost synergies from the integration of the IRRAflow product portfolio and team, including the expectation that IRRAS integration could be cash neutral for the full year 2027; the Company's expectations for the ClearPoint Advanced Laboratories (CAL) facility, including anticipated future study capacity; the Company's expectations regarding international regulatory approvals, including the Medical Device License from Health Canada and the scheduling of future cases; the Company's expectations regarding the Velocity Alpha MR High Speed Surgical Drill System and the PRISM Laser Therapy System, including their clinical adoption and commercial potential; the Company's expectations that global regulatory approvals of cell and gene therapies by its biotech Partners are a matter of timing rather than outcome; and the Company’s expectations for revenues, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations

and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s biotech Partners’ risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners’ therapies; the limitation or modification of the FDA’s eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company’s biotech Partner’s continued use of the Company’s products and services in their delivery of gene and cell therapies; the Company’s ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company’s new products; the future market for preclinical services and products and the investment and timeline required to expand such services, which could divert resources from the Company’s other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company’s failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management’s attention on the integration of IRRAS into its business; the risk that the Company's four-pillar growth strategy may not achieve double-digit growth across each pillar as anticipated due to market, competitive, or operational factors; the risk that expected revenue and cost synergies from the IRRAS integration, including the expectation of cash neutrality for the full year 2027, may not be achieved on the anticipated timeline or at all; risks related to the construction, completion, and operational ramp up of the CAL facility, including the possibility that study capacity may not scale as expected; risks related to obtaining and maintaining international regulatory approvals, including approvals from Health Canada, and the Company's ability to successfully commercialize its products in new geographies; risks related to the clinical adoption and commercial success of the Velocity Alpha MR High Speed Surgical Drill System and other newly cleared products; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's business activity, including its research and development programs and the expansion of its commercial organization; the ability of the Company to manage the growth of its business; and the Company’s ability to attract and retain its key employees. For a detailed description of the Company’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contact:

Investor Relations:

Danilo D’Alessandro, Chief Financial Officer

(888) 287-9109 ext. 3

ir@clearpointneuro.com

CLEARPOINT NEURO, INC.

Consolidated Statements of Operations

(in thousands, except for share and per share data)

For the Three Months Ended March 31,

2026

2025

Revenue:

Product revenue

8,802

5,291

Service and other revenue

3,326

3,194

Total revenue

12,128

8,485

Cost of revenue

4,372

3,353

Gross profit

7,756

5,132

Research and development costs

4,522

3,379

Sales and marketing expenses

6,715

3,834

General and administrative expenses

4,997

4,082

Operating loss

(8,478

)

(6,163

)

Other income (expense):

Other (expense) income, net

(35

)

Interest income

351

151

Interest expense

(1,382

)

—

Net loss before income taxes

(9,544

)

(6,008

)

Income tax expense

Net loss

(9,552

)

(6,026

)

Net loss per share attributable to common stockholders:

Basic and diluted

(0.32

)

(0.22

)

Weighted average shares outstanding:

Basic and diluted

29,546,889

27,718,918

CLEARPOINT NEURO, INC.

Consolidated Balance Sheets

(in thousands, except for share and per share data)

March 31,

2026

December 31,

(Unaudited)

2025

ASSETS

Current assets:

Cash and cash equivalents

35,593

45,923

Accounts receivable, net

8,662

6,549

Inventory, net

8,573

8,359

Prepaid expenses and other current assets

2,049

2,769

Total current assets

54,877

63,600

Property and equipment, net

2,914

2,621

Operating lease, right-of-use assets

13,088

8,430

Goodwill

7,472

Intangible assets, net

13,419

13,922

Other assets

1,646

1,702

Total assets

93,416

97,747

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

2,330

1,256

Accrued compensation

2,977

4,360

Other accrued liabilities

2,125

2,786

Operating lease liabilities, current portion

234

694

Contract liabilities, current portion

1,814

1,669

Total current liabilities

9,480

10,765

Operating lease liabilities, net of current portion

13,710

8,461

Contract liabilities, net of current portion

608

581

Long-term notes payable, net

49,644

49,077

Deferred tax liabilities, net

354

Other long-term liabilities

779

489

Total liabilities

74,575

69,727

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at March 31, 2026 and December 31, 2025

—

Common stock, $0.01 par value; 90,000,000 shares authorized at March 31, 2026 and December 31, 2025; 29,986,639 and 29,368,760 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

300

294

Additional paid-in capital

239,468

238,995

Shares to be issued

5,535

5,641

Accumulated deficit

(226,462

)

(216,910

)

Total stockholders’ equity

18,841

28,020

Total liabilities and stockholders’ equity

93,416

97,747

CLEARPOINT NEURO, INC.

Consolidated Statements of Cash Flows

(in thousands)

Three Months Ended March 31,

2026

2025

Cash flows from operating activities:

Net loss

(9,552

)

(6,026

)

Adjustments to reconcile net loss to net cash flows from operating activities:

Allowance for credit losses (recoveries)

(95

)

217

Depreciation and amortization

103

Amortization of intangible assets

504

—

Share-based compensation

2,218

1,908

Payment-in-kind interest

525

—

Amortization of debt issuance costs and original issue discounts

—

Amortization of lease right of use assets, net of accretion in lease liabilities

523

231

Increase (decrease) in cash resulting from changes in:

Accounts receivable

(2,019

)

846

Inventory, net

(125

)

Prepaid expenses and other current assets

653

168

Other assets

(71

)

—

Accounts payable and accrued expenses

(437

)

(2,882

)

Lease liabilities

(391

)

(234

)

Contract liabilities

172

(581

)

Net cash flows from operating activities

(7,967

)

(6,172

)

Cash flows from investing activities:

Purchases of property and equipment

(645

)

(183

)

Net cash flows from investing activities

(645

)

(183

)

Cash flows from financing activities:

Payment of At-The-Market offering costs

—

(78

)

Proceeds from stock option exercises

148

Payments for taxes related to net share settlement of equity awards

(1,993

)

(1,305

)

Net cash flows from financing activities

(1,845

)

(1,362

)

Net change in cash, cash equivalents and restricted cash

(10,457

)

(7,717

)

Cash, cash equivalents and restricted cash, beginning of period

46,973

20,104

Cash, cash equivalents and restricted cash, end of period

36,516

12,387

Cash and cash equivalents

35,593

12,387

Restricted cash included in other current assets and other assets, non-current

923

—

Total cash, cash equivalents and restricted cash

36,516

12,387

SUPPLEMENTAL CASH FLOW INFORMATION

Cash paid for:

Income taxes

—

Interest

525

—

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DISCLAIMER Statements in this presentation and discussion concerning ClearPoint Neuro’s (the “Company’s”) plans, growth, and strategies may include forward-looking statements within the context of the federal securities laws. Statements regarding the Company's future events, developments and future performance; the continued development, anticipated timing, and potential commercial opportunity of the Company’s pipeline of products and services under development, including its proprietary Robotic Neuro-Navigation platform System, cell and gene therapy delivery devices and routes of administration, software modeling and navigation tools, and preclinical service capabilities; the expected future role of the Company’s products and services in addressing unmet needs in neurological diseases and the potential market opportunity for therapies targeting those indications; the Company’s belief about the outcome of regulatory interactions with respect to its biotech Partners’ therapies, the benefits of regulatory expedited review with respect to accelerating the timing of commercialization of such therapies, and the market potential for such therapies; the size of total addressable markets or the market opportunity for the Company’s products and services, including for the PRISM Laser Therapy System; the Company’s preclinical CRO facility, the IRRAflow Active Fluid Exchange System, and the Company’s navigation technology; the anticipated adoption of the Company’s products and services for use in the delivery of gene and cell therapies; the Company’s ability to scale its operations, commercialization, and increase utilization of its products in neurosurgical centers; the Company's 4-Pillar Product pipeline; the Company’s future looking 4-phase strategy; the Company’s four and five pillar growth strategy for 2026 and beyond; the Company’s expectations for revenues, market share, operating expenses, and management's expectations, beliefs, plans, estimates or projections relating to the future, are forward-looking statements within the meaning of these laws. These forward-looking statements are based on management’s current expectations and are subject to the risks inherent in the business, which may cause the Company's actual results to differ materially from those expressed in or implied by forward-looking statements. Particular uncertainties and risks include those relating to: the Company’s biotech Partners’ risks related to the ongoing conduct of their clinical studies, including the risk that such trials will be unable to demonstrate data sufficient to support further clinical development or regulatory approval; the risk that more patient data becomes available that results in a different interpretation then the data already released for gene and cell therapies; risks related to interactions with regulatory authorities, which may affect the initiation, timing and progress of clinical trials and pathways to regulatory approval of the biotech Partners’ therapies; the limitation or modification of the FDA’s eligibility and criteria for its expedited review programs with respect to such therapies; the commercialization and acceptance of gene and cell therapies; the Company’s biotech Partner’s continued use of the Company’s products and services in their delivery of gene and cell therapies; the Company’s ability to maintain its current relationships with its biotech Partners or enter into relationships with new partners; the Company’s ability to continue to build and maintain the infrastructure and personnel needed to allow for widespread adoption of intracranial administration of gene and cell therapies; risks inherent in the research, development, and regulatory approval of the Company’s new pipeline products; the future market for preclinical services and the investment required to expand such services, which could divert resources from the Company’s other business operations; the possibility that the anticipated benefits of the IRRAS transaction are not realized when expected or at all; the Company’s failure to integrate IRRAS into its business in accordance with expectations; deviations from the expected market potential of the IRRAS products; diversion of management’s attention on the IRRAS proposed transaction; macroeconomic and inflationary conditions; regulatory and policy uncertainty; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as instability, protectionism and economic nationalism; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the availability of additional funding to support the Company's research and development programs and commercialization efforts; the ability of the Company to manage the growth of its business; and the Company’s ability to attract and retain its key employees. For a detailed description of the Company’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including the Company’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. © 2026 CLEARPOINT NEURO

Neuro Navigation and Robotics* Ablation Therapy and Access Neurocritical Management Biologics and Drug Delivery *Robotic product is in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. © 2026 CLEARPOINT NEURO OUR COMPANY We Enable Delivery of Both Drug and Device Therapies by Offering Precise Navigation to the Brain and Spine Our Unique Platform Includes Proven Clinical Products Used by Hospitals and Neurosurgeons, and Drug Development Services Used by BioPharma Partners

The Future of Neuro Biologics and Drug Delivery is Here Today Our Company Stroke Rehabilitation (7.0m) More than 30 Million people in the U.S. alone are estimated to suffer from severe and debilitating neurological disorders. Neurological diseases cost Americans nearly $800 Billion annually. To reduce these costs, we must improve both the therapies and the access to care. 30 Million Patients Indicated in the U.S. <300k treated to date with minimally-invasive neurosurgery <1% penetration 30 Million Patients U.S. prevalence pool Parkinson’s Disease & Movement Disorders (8.0m) Epilepsy (2.9m) Alzheimer's & Other Dementias (6.9m) Tumor & Glioblastoma (84k) Severe OCD (1.0m) Treatment Resistant Depression (2.9m) ALS & Spinal Cord Injury (300k) Neuropathic Pain (2.0m) Hemorrhagic Stroke, Subdural Hematoma, Infection (400k) Prevalence estimates are based on publicly available sources. Categories shown are representative and may not be mutually exclusive. ClearPoint Neuro believes that biologics and drug delivery, including cell and gene therapies, will be the answer and that our minimally invasive tools will make these therapies accessible. © 2026 CLEARPOINT NEURO

The Future of Neuro Biologics and Drug Delivery is Here Today Our Company Of those 30 million patients, 2.1 million in the U.S. alone have disorders where a ClearPoint BioPharma Partner has already been accepted for FDA expedited review. Importantly, this gene therapy is labeled as a combination product with the ClearPoint SmartFlow Neuro Cannula Parkinson’s Disease (1.0m) Drug Resistant Epilepsy (1.0m) Frontal Temporal Lobe Dementia (60k) Huntington’s Disease (41k) Glioblastoma (22k) Friedrich's Ataxia (5k) AADC Deficiency (rare) Hunter Syndrome (rare) © 2026 CLEARPOINT NEURO ClearPoint Neuro has 60+ Active Pharma Partners, with 10+ programs accepted for FDA expedited review. In 2024, the first gene therapy delivered directly to the brain was approved.

Our 4-Phase Strategy Positions ClearPoint for Decades of Growth Our Company 1 With more than $100m of capital invested over the past 5 years, our large commercial footprint, rapidly expanding installed base, high-capacity manufacturing, stress-tested quality system, global regulatory reach and expansive IP portfolio has given us a mature foundation on which to build GROW OUR ACTIVE INSTALLED BASE OF 150+ LEADING GLOBAL INSTITUTIONS AND ADD PROCEDURAL CAPACITY Our one-of-a-kind drug delivery platform including neuro navigation, predictive modeling, co-labeled delivery devices, infusion monitoring software and expert clinical case support has become the leading choice by biopharma developers EXTEND OUR LEAD WITH A UNIQUE DRUG DELIVERY ECOSYSTEM DESIGNED FOR CELL AND GENE THERAPY DESIGN. DISCOVERY. More than 10 of our partners have now been accepted for FDA expedited review and are leveraging our unique ecosystem, clinical trial experience, and proven global regulatory leadership Our next goal is to treat just 1% of patients with these indications under expedited review, generate another $300m in annual revenue BUILD A NEW $10B MARKET ALONGSIDE OUR 60+ BIOPHARMA PARTNERS AND DIVERSIFIED ACROSS 15+ INDICATIONS THAT INCLUDES DRUGS THAT ARE CO-LABELED WITH CLEARPOINT TECHNOLOGY Our current products and pipeline, combined with our growing commercial reach will continue to compete in these four existing markets; Biologics & drug delivery, Neuro navigation & robotics, Ablation therapy and access, Neurocritical management, Our next goal is to earn 20% share, generate $200m in annual revenue LEVERAGE OUR EXISTING PORTFOLIO TO PENETRATE A $1B EXISTING MARKET OPPORTUNITY TODAY 2 FUNDED. FOUNDATION. 3 FAST. FORWARD. 4 ESSENTIAL. EVERYWHERE. 2010 – 2019 2020 – 2025 2026+ 2026+ © 2026 CLEARPOINT NEURO

This Unique ClearPoint Ecosystem Has Been Years in the Making Design. Discovery. ClearPoint Neuro embraced the unmet need in neuro biologics and drug delivery and has invested more than $200m over the past 15 years to build a substantial headstart and leadership position. This expansive platform has been used in more than 10,000 procedures to date and has regulatory approvals across 34 countries and counting.* We are positioned to benefit from the expanded use of our delivery platform to include future cell and gene therapies, new DBS and BCI indications, second generation laser ablation therapy, and more advanced approaches to neurocritical fluid management. *Not all products cleared or approved in all territories. © 2026 CLEARPOINT NEURO Data on file ClearPoint Software v.3.x IRRAflow Active Fluid Exchange System ClearPoint Maestro Brain Model* SmartFrame XG SmartFrame OR with ClearPointer* SmartFrame Array* Inflexion Head Fixation Frame ClearPoint Prism Neuro Laser Fibers* ClearPoint Prism Neuro Laser Therapy System* Velocity MR Power Drill* SmartFlow Neuro Cannula IRRAflow Dual-Lumen Catheter and Tube Set CLEARED FDA MARKED

Active ClearPoint Installation (Additional Sites in Asia, EMEA, LATAM) Our Installed Base Has Grown to More than 175 Active Global Centers Funded. Foundation. © 2026 CLEARPOINT NEURO Over 170 employees worldwide focused exclusively on Neuro

~50% of the Top Ranked Neurosurgery Programs use ClearPoint Technology Funded. Foundation. https://health.usnews.com/best-hospitals/rankings/neurology-and-neurosurgery - Posted July 29, 2025 Methodology components and weights summarized from publicly described Best Hospitals specialty ranking methodology (2025–2026 cycle; specialty-specific adjustments may apply). UCSF Medical Center New York-Presbyterian Hospital-Columbia and Cornell Rush University Medical Center Northwestern Memorial Hospital Johns Hopkins Hospital Hospital of University Pennsylvania UT Southwestern Medical Ctr Massachusetts General Hospital Stanford Health Hospital Cleveland Clinic UCLA Medical Center Houston Methodist Hospital Brigham & Women’s Hospital Barnes-Jewish Hospital Cedars-Sinai Medical Center Mayo Clinic Arizona Mayo Clinic Florida Advent Health Orlando Keck Medical Center of USC Thomas Jefferson University UC Davis Medical Center UCSD Jacobs Medical Center University of Michigan Mount Sinai West University of Kansas Emory University Hospital Hackensack Meridian Health Corewell Beaumont University Yale University Hospital Ohio State University – Wexner University of Alabama at Birmingham University of Minnesota Barrow Institute Duke University Hospital University of Wisconsin, Madison Tampa General Hospital UC Irvine Medical Center Baptist Health Miami Hospital Ochsner Medical Center Penn State Health Milton Inova Fairfax Hospital Oregon Health & Science University University of Colorado Aurora Henry Ford Health University of North Carolina Froedtert Hospital Ohio Health Riverside University of Utah Georgetown University US News & World Report Best Neurology/Neurosurgery Hospitals 2025-2026 are recognized for excelling in the treatment of complex, high-risk neurological specialty cases. Evaluation Criteria Public Transparency 3% Patient Experience 5% Process / Expert Opinion 12% Structure 35% Outcomes 45% © 2026 CLEARPOINT NEURO

Stress-Tested QMS and Operations Funded. Foundation. We have invested in our Research & Development, Quality and Manufacturing infrastructure to build confidence for both hospitals and biopharma partners We bring medical device expertise and regulatory combination product acumen to pharmaceutical companies ClearPoint Neuro assets available to our partners: HQ & training facility in Solana Beach, CA Advanced Research Laboratory in Torrey Pines, CA R&D and manufacturing facility in Carlsbad, CA ISO 13485 / MDSAP / EU MDR certified QMS Proven audit history with pharma partners, FDA and global regulatory body inspections © 2026 CLEARPOINT NEURO

Growth Continues Today While We Prepare for Commercial Drug Approvals Funded. Foundation. For the year ended December 31, 2025 Unaudited, as of, and for the quarter ended March 31, 2026 For the Trailing Twelve Months (TTM) Including owned and licensed patents Solana Beach, CA HEADQUARTERS $37.0m(A) 2025 REVENUE 130+(D) PATENTS ISSUED 170+ EMPLOYEES Carlsbad, CA R&D, MANUFACTURING $35.6m(B) CASH & CASH EQUIVALENTS 62%(B,C) GROSS MARGIN Torrey Pines, CA ADVANCED RESEARCH LABORATORIES 2026 2025 2024 2023 2022 2021 2020 2019 2018 $7.4 $11.2 $12.8 $16.3 $20.6 $24.0 $31.4 $37.0 $52-$56 (est) PRISM LASER THERAPY EXPANSION EU EXPANSION OPERATING ROOM EXPANSION PRECLINICAL EXPANSION IRRAflow ACQUISITION © 2026 CLEARPOINT NEURO *All Annual Totals in Millions

Experienced Leadership in Place Funded. Foundation. Joe Burnett President & Chief Executive Officer Megan Faulkenberry Senior Vice President of Quality Jeremy Stigall Chief Business Officer Mary McNamara-Cullinane Senior Vice President of Regulatory Affairs Danilo D’Alessandro Chief Financial Officer Rob Korn Senior Vice President of Sales Ernesto Salegio, PhD Vice President of Translational & Pre-Clinical Research Ellisa Cholapranee General Counsel Lyubomir Zagorchev, PhD Vice President of Clinical Science & Applications Paul Larson, MD Chief Medical Officer Mazin Sabra Chief Operating Officer Tim Orr Vice President of Software Development EXECUTIVE LEADERSHIP TEAM Proven industry operators with decades of experience in medical devices, biopharmaceuticals, and clinical research. © 2026 CLEARPOINT NEURO

Our 4-Pillar Growth Strategy Fast. Forward. Collective $1.0B Existing Market Opportunity Today *Not all products cleared or approved in all territories. Increasing Global Scale with Clearances in 34 Countries Worldwide* Pre-Commercial Biologics & Drug Delivery Neurosurgery Navigation & Robotics Laser Ablation Therapy & Access Neurocritical Care & Active CSF Exchange $300m+ Existing Market $125m+ Existing Market $75m+ Existing Market $500m+ Existing Market Our Fast. Forward. 4-Pillar Growth Strategy is to Win 20% of an Existing $1.0B Global Market Opportunity, Generate $200m in Annual Revenue, and to Achieve Cash Breakeven and Profitability Along the Way © 2026 CLEARPOINT NEURO FAST. FORWARD.

Pillar 1: Pre-Commercial Biologics & Drug Delivery Fast. Forward. Leverage Both Commercial and In-Development Delivery and Navigation Tools SmartFlow Software & Biophysical Modeling in Collaboration with NE Scientific $300m+ Existing Market ClearPoint Neuro currently offers a boutique, neuro-focused CRO complete with device co-development services, pre-clinical testing capabilities, and validated clinical trial products to support and de-risk our more than 60 active pharma partners and generate revenue before reaching the drug commercialization stage. Hardware Software Pre-Commercial Biologics & Drug Delivery Combining Services & Technology Benchtop Testing Preclinical Studies Device compatibility testing Custom device development Delivery system validation Performance assessment Running preclinical studies Surgical planning & strategy Dosing & surgical expertise Post-procedure analysis © 2026 CLEARPOINT NEURO

Pillar 2: Neuro Navigation & Robotics Fast. Forward. ClearPoint will provide unmatched flexibility by having a single pre-planning software offering several workflows deployed via either MRI, iCT and eventually Robotics. This strategy balances the consistency of delivery that biopharma partners desire with the optionality and adaptability for surgeons to choose their desired technique. $125m+ Existing Market SmartFrame XG and Accessory Kit ClearPoint Robotic Platform using the KUKA LBR Robotic Arm SmartFrame OR and ClearPointer Optical Wand *Robotic product is in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. Pre-Planning & Navigation Software Select Optimal Delivery Method Neurosurgery Navigation & Robotics © 2026 CLEARPOINT NEURO

Pillar 3: Laser Therapy & Access Fast. Forward. $75m+ Existing Market VelocityALPHA MRI Conditional Power Drill With Optional ClearPoint Navigation Synergies A Versatile Power Solution for SmartFrame in the MRI and OR ClearPoint Prism is a mobile laser therapy system featuring innovative non‑cooled applicator technology that simplifies setup, reduces power and potentially ablation time, and enables efficient workflows. Surgeons can capitalize on workflow efficiency and total system accuracy when Prism is combined with ClearPoint Navigation. Laser Ablation Therapy & Access © 2026 CLEARPOINT NEURO The VelocityALPHA MR High Speed Surgical Drill System is a versatile cutter system designed to reduce procedure times in both the MRI suite and the operating room. One System One Team One Room

Pillar 4: Neurocritical Management Fast. Forward. ClearPoint’s recent acquisition of IRRAS expands the portfolio with a unique and disruptive solution for neurocritical care and intracranial fluid management. IRRAflow enables active irrigation and controlled drainage of hemorrhage, toxins, and clots to therapeutically treat intracranial pathologies. $500m+ Existing Market Active Fluid Exchange System Components IRRAflow Tube Set & Intelligent Digital Cassette IRRAflow Control Unit & Drainage Collection Bag IRRAflow Dual-Lumen Catheter Neurocritical Care & Active CSF Exchange © 2026 CLEARPOINT NEURO

Clear and Continued Investment in ClearPoint’s 4-Pillar Product Pipeline Fast. Forward. 1H 2026 2H 2026 1H 2027 2H 2027 2028+ 1 CAL Facility Operational Radiopharma Formulation MRI/CT Imaging Live GLP Study Capable Cell Culture Capability PET/SPECT Imaging Live Radiolabeling Active Histopathology Active Bioanalytic Lab Active Pathology Lab Active Hot Cell F-18 Radiochemistry Translational Models for tumor, stroke and spinal cord injury 2 CE Mark for 3.x Software Global Installed Base with OR iCT capability SmartFrame Accessory Kit Pre-Clinical Robotic System Active at the CAL Harmony 1.0 Software Sub-Nuclei Segmentation SmartFrame Duet Maestro CT Harmony 2.0 Software Robotic System DBS/BCI Area of Activation Non-Rigid Fusion 3 1.5T Compatibility Velocity MRI Power Drill Philips MRI Compatibility Interoperable 3D Damage Model CE Mark Prism System 3D Thermal Modeling Study Initiated Predictive Ablation Software Spine LITT Data Readout 4 Shoreline Software Cranial Access Bolt IRRAflow Dart Cranial Access Bolt Kit ARCH RCT Data Readout Next Gen IRRAflow Catheter Subdural Indication IRRAflow Rapid Evacuation System VASH Trial Data Readout CRYSTAL Registry Readout Bedside Navigation System © 2026 CLEARPOINT NEURO

3 2 2026+ LASER ABLATION THERAPY & ACCESS Add Ablation Coverage & AI Predictive Thermal Modeling Software Launch MRI Conditional Power Drill for Faster Procedure Times 4 NEUROCRITICAL CARE & ACTIVE CSF EXCHANGE Expand Existing Portfolio Into Multiple New Indications Launch Shoreline Software, Cranial Bolt, IRRAflow Dart, Next-Gen IRRAflow Catheter and a Subdural Hemorrhage Catheter Kit 1 PRE-COMMERCIAL BIOLOGICS & DRUG DELIVERY Expand Neuro Pre-Clinical CRO Services Portfolio and Capacity including larger GLP Study Capability Expand Partnerships to Include Co-Development, Commercial Pricing, Drug Clinical Milestones & Royalty Based Agreements Execute on Development Pipeline for Drug Infusion Monitoring/Modeling, Cell Therapy Actuation, Indwelling Catheters and Spinal Routes of Administration NEUROSURGERY NAVIGATION AND ROBOTICS Expand into the Operating Room w/ 3.0 Software, ClearPoint Duet, and Robotics Launch Maestro CT, sub-nuclei segmentation, Non-Rigid Fusion, Area-of-Activation Harmony Software © 2026 CLEARPOINT NEURO Our Fast. Forward. 4-Pillar Growth Strategy is to Win 20% of an Existing $1.0B Global Market Opportunity, Generate $200m in Annual Revenue, and to Achieve Cash Breakeven and Profitability Along the Way

What Does it Mean to be Essential to Future of Cell and Gene Therapy? Essential. Everywhere. It starts by being unique. Our Essential. Everywhere. Strategy is to build a new market from the ground up where our unique ecosystem plays an essential role and enables 20,000 annual Cell & Gene Therapy procedures. Our Goal is to create the capacity for 20,000 CGT patients per year and generate an additional $300m annually. *Not all products cleared or approved in all territories. ESSENTIAL. EVERYWHERE. © 2026 CLEARPOINT NEURO 20 © 2026 CLEARPOINT NEURO Increasing Global Scale with Clearances in 34 Countries Worldwide* 60+ Active Pharma Partners Exclusively co-labeled with: Pre-Commercial Biologics & Drug Delivery Neurosurgery Navigation & Robotics Laser Ablation Therapy & Access Neurocritical Care & Active CSF Exchange 25+ Active Clinical Trials 15+ Neuro-Focused Indications 10+ Under Regulatory Expedited Review 1 Approved Combination Device

Our Unique Ecosystem Will Play An Essential Role for Cell and Gene Therapy Essential. Everywhere. Comprehensive Pre-Planning Navigation Software Modules Flexible Options for Surgeon Selected Navigation Including Frames, Robotics Multiple Biologic Specific & Co-Labeled Routes-of-Administration Every Step Fully Supported by a Team of 30+ Expert Field-Based Clinical Specialists Confirmatory Volumetric Dosing Data for Quality of Delivery Documentation A.I. Derived Patient and Tissue Specific Segmentation Therapy and Patient Specific Biophysics Modeling Tools All products in development phase. Commercialization is subject to successful development, testing, and applicable regulatory clearance. © 2026 CLEARPOINT NEURO

Indication Parkinson’s Disease Epilepsy Huntington’s Rare Genetic Dementias Gliomas Neuromuscular Stroke …and more than 15 additional programs that are undisclosed and in preclinical development. © 2026 CLEARPOINT NEURO ClearPoint Neuro Has 60+ Active Pharma Partners, 25+ Active Clinical Trials Essential. Everywhere. Preclinical Phase 1/2 Phase 3 Commercialization

Parkinson's (Kenai) – RNDP-001 Parkinson's (Aspen) – ANPD001 Frontotemporal Dementia (AviadoBio) – AVB-101 Friedreich's Ataxia – (Undisclosed) Huntington's (uniQure) – AMT-130 AADC Deficiency (PTC) – KEBILIDI / Upstaza Parkinson's (AskBio) – AB-1005 Parkinson's (BlueRock) – BRT-DA01 Hunter Syndrome (REGENXBIO) – RGX121 Glioma (Siren) – SRN-101 Parkinson’s – (Undisclosed) Parkinson’s – (Undisclosed) Epilepsy (MTLE) (Neurona) – NRTX-1001 10+ Programs Are Already Under FDA Expedited Review and Enrolling Essential. Everywhere. Indication © 2026 CLEARPOINT NEURO Preclinical Phase 1/2 Phase 3 Commercialization

Building Surgical Experience and Capacity to Prepare for Drug Commercialization Essential. Everywhere. © 2026 CLEARPOINT NEURO Existing CLPT Navigation Site Experienced CLPT Navigation Site and Participant in Active CGT Trial

5 COMMERCIAL DRUG DELIVERY Add Capacity for 5,000 cell & gene therapy procedures Launch Co-Labeled Products with 10+ partners that are already under FDA Expedited Review across 8 Indications 3 2 2026+ LASER ABLATION THERAPY & ACCESS Add Ablation Coverage & AI Predictive Thermal Modeling Software Launch MRI Conditional Power Drill for Faster Procedure Times 4 NEUROCRITICAL CARE & ACTIVE CSF EXCHANGE Expand Existing Portfolio Into Multiple New Indications Launch Shoreline Software, Cranial Bolt, IRRAflow Dart, Next-Gen IRRAflow Catheter and a Subdural Hemorrhage Catheter Kit 1 PRE-COMMERCIAL BIOLOGICS & DRUG DELIVERY Expand Neuro Pre-Clinical CRO Services Portfolio and Capacity including larger GLP Study Capability Expand Partnerships to Include Co-Development, Commercial Pricing, Drug Clinical Milestones & Royalty Based Agreements Execute on Development Pipeline for Drug Infusion Monitoring/Modeling, Cell Therapy Actuation, Indwelling Catheters and Spinal Routes of Administration NEUROSURGERY NAVIGATION AND ROBOTICS Expand into the Operating Room w/ 3.0 Software, ClearPoint Duet, and Robotics Launch Maestro CT, sub-nuclei segmentation, Non-Rigid Fusion, Area-of-Activation Harmony Software © 2026 CLEARPOINT NEURO Our Essential. Everywhere. Strategy Expands Our Vision into a 5-Pillar Growth Strategy Which Will Include Commercial Drug Delivery and Highlights Our Path to Achieving $500m in Revenue

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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