クリアポイントニューロの適時開示・決算・その他

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, 2025

    

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, 2025, ClearPoint Neuro, Inc. (the “Company”) issued a press release announcing its financial results for the first fiscal quarter ended March 31, 2025. 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, 2025, 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, 2025
Exhibit 99.2	Investor Presentation dated May 13, 2025
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, 2025	By:	/s/ Danilo D'Alessandro
			Danilo D'Alessandro Chief Financial Officer

EX-99.1 2 clpt-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

ClearPoint Neuro Reports First Quarter 2025 Results

Record Revenue Highlighted by 70% Growth in Single-Use Navigation and Therapy Products

SOLANA BEACH, CA, May 13, 2025 – 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, 2025.

First Quarter Highlights

•

Reported record quarterly revenue of $8.5 million, an 11% year-over-year increase compared with the first quarter of 2024;

•

Grew total consumable product revenue by $2.6 million year-over-year, or 104%, including biologics and drug delivery cannulas, SmartFrame® Family Navigation devices, and ClearPoint PRISM® Laser Therapy Applicators;

•

Received FDA Clearance for the ClearPoint 3.0 Software which includes both operating room navigation capability and enhanced laser therapy features. This software is now in Full Market Release and is contributing to meaningful revenue and case volume growth; and

•

Reported cash and cash equivalents totaling $12.4 million as of March 31, 2025 (balance does not include credit facility proceeds).

“Our 2025 fiscal year is off to a strong start as we enter the Fast Forward phase of the company, starting with a record revenue quarter and fueled by multiple new product launches that are delivering on our promise of fast, simple and predictable procedures,” commented Joe Burnett, President and CEO at ClearPoint Neuro. “The foundational investments that we have made over the past few years to grow our global biopharma partnerships, expand navigation into the operating room, and enter the laser therapy market are now paying off and are underlined by 104% growth in these single-use devices. It is especially exciting to see all three of these product lines contributing meaningfully to this growth.”

“In addition, despite recent volatility in the capital markets, we have now secured a long-term credit facility and an equity investment that gives us flexibility on our balance sheet to ensure we can achieve ClearPoint Neuro's strategic objectives. We are excited to see the confidence that Oberland Capital has in our future, as both a lender and a shareholder, and we look forward to this new partnership.”

Business Outlook

The Company reaffirms its full year 2025 revenue outlook between $36.0 million and $41.0 million.

Financial Results – Quarter Ended March 31, 2025

Total revenue was $8.5 million and $7.6 million for the three months ended March 31, 2025 and 2024, respectively, representing an increase of 11%.

Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 9% to $4.7 million for the three months ended March 31, 2025, from $4.3 million for the same period in 2024. This increase is attributable to a year-over-year increase of $1.2 million, or 222%, in product revenue resulting from higher demand for disposables as multiple partners progress in their trials, partially offset by a $0.8 million decrease in service and other revenue, due to less work performed in preclinical trials and consulting during the three months ended March 31, 2025, compared to the same period in 2024.

Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 70% to $3.3 million during the three months ended March 31, 2025, from $1.9 million for the same period in 2024. The increase is driven by higher sales for new product offerings as well as an increased customer base, during the three months ended March 31, 2025, compared to the same period in 2024.

Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 63% to $0.5 million for the three months ended March 31, 2025, from $1.4 million for the same period in 2024, due to a decrease in the placements of ClearPoint navigation capital equipment and software and Prism laser units, primarily driven by installation timing.

The Company achieved a gross margin of 60% on its sales for three months ended March 31, 2025, compared to a gross margin of 59% for the same period in 2024. The increase in gross margin was primarily due to lower excess and obsolete inventory for the three months ended March 31, 2025, as compared to the same period in 2024.

Operating expenses were $11.3 million for the three months ended March 31, 2025, compared with $8.7 million for same period in 2024, an increase of 29%. The increase was mainly driven by higher personnel-related expenses, including share-based compensation, as we increased headcount to fuel the expansion of the research and development, clinical, and support organizations, higher product development costs, an increase in the allowance for credit losses, and higher professional and regulatory fees.

At March 31, 2025, the Company had cash and cash equivalents totaling $12.4 million as compared to $20.1 million at December 31, 2024, with the decrease resulting from the use of $6.2 million in cash for operating activities, primarily driven by the payment of the employee annual incentive and $1.3 million for tax payments made related to the net share settlement of equity awards. The net share settlement of equity awards upon vesting results in the Company withholding from the shares issuable at vest a number of shares having a value equal to the employees' tax obligations and remitting a cash payment to the appropriate taxing authority.

Teleconference Information

Investors and analysts are invited to listen to a live broadcast review of the Company's 2025 first quarter results on Tuesday, May 13, 2025 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=ZS0iBbgx. 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, 2025, 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 size of total addressable markets or the market opportunity for the Company’s products and services, the Company’s expectation for revenues, operating expenses, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, as well as 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: 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 protectionism and economic nationalism; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of the Company’s new products and the new products of its biologics and drug delivery partners. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, which the Company intends to file with the Securities and Exchange Commission on or before May 15, 2025.

The Company does not assume any obligation to update these forward-looking statements.

Contact:

Investor Relations:

Danilo D’Alessandro, Chief Financial Officer

(888) 287-9109 ext. 3

ir@clearpointneuro.com

CLEARPOINT NEURO, INC.

Consolidated Statements of Operations

(Unaudited)

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


	For the Three Months Ended March 31,
	2025			2024
Revenue:
Product revenue	$	5,291		$	3,635
Service and other revenue		3,194			4,004
Total revenue		8,485			7,639
Cost of revenue		3,353			3,114
Gross profit		5,132			4,525
Research and development costs		3,379			2,625
Sales and marketing expenses		3,834			3,290
General and administrative expenses		4,082			2,826
Operating loss		(6,163	)		(4,216	)
Other income (expense):
Other income (expense), net		4			(26	)
Interest income, net		151			111
Net loss before income taxes		(6,008	)		(4,131	)
Income tax expense		(18	)		(15	)
Net loss	$	(6,026	)	$	(4,146	)
Net loss per share attributable to common stockholders:
Basic and diluted	$	(0.22	)	$	(0.16	)
Weighted average shares outstanding:
Basic and diluted		27,718,918			25,452,096

CLEARPOINT NEURO, INC.

Consolidated Balance Sheets

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


	March 31,
	2025			December 31,
	(Unaudited)			2024
ASSETS
Current assets:
Cash and cash equivalents	$	12,387		$	20,104
Accounts receivable, net		3,651			4,713
Inventory, net		6,582			6,863
Prepaid expenses and other current assets		1,594			1,683
Total current assets		24,214			33,363
Property and equipment, net		2,183			2,005
Operating lease, right-of-use assets		2,960			3,086
Software license inventory		107			103
Licensing rights		458			484
Other assets		148			148
Total assets	$	30,070		$	39,189

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	1,216		$	1,340
Accrued compensation		1,944			4,885
Other accrued liabilities		1,510			1,450
Operating lease liabilities, current portion		578			557
Contract liabilities, current portion		1,618			2,121
Total current liabilities		6,866			10,353

Operating lease liabilities, net of current portion		2,860			3,011
Contract liabilities, net of current portion		357			436
Total liabilities		10,083			13,800
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.01 par value; 25,000,000 shares authorized; none issued and outstanding at March 31, 2025 and December 31, 2024		—			—
Common stock, $0.01 par value; 90,000,000 shares authorized at March 31, 2025 and December 31, 2024; 27,980,184 and 27,617,415 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively		280			276
Additional paid-in capital		217,103			216,483
Accumulated deficit		(197,396	)		(191,370	)
Total stockholders’ equity		19,987			25,389
Total liabilities and stockholders’ equity	$	30,070		$	39,189

CLEARPOINT NEURO, INC.

Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)


	For the Three Months Ended March 31,
	2025			2024
Cash flows from operating activities:
Net loss	$	(6,026	)	$	(4,146	)
Adjustments to reconcile net loss to net cash flows from operating activities:
Allowance for credit losses (recoveries)		217			(146	)
Depreciation and amortization		103			243
Share-based compensation		1,908			1,504
Amortization of debt issuance costs and original issue discounts		—			15
Amortization of lease right of use assets, net of accretion in lease liabilities		231			231
Increase (decrease) in cash resulting from changes in:
Accounts receivable		846			846
Inventory, net		78			53
Prepaid expenses and other current assets		168			165
Other assets		—			(39	)
Accounts payable and accrued expenses		(2,882	)		(931	)
Lease liabilities		(234	)		(171	)
Contract liabilities		(581	)		(1,464	)
Net cash flows from operating activities		(6,172	)		(3,840	)
Cash flows from investing activities:
Purchases of property and equipment		(183	)		—
Net cash flows from investing activities		(183	)		—
Cash flows from financing activities:
Proceeds from public offering of common stock, net of offering costs		—			16,183
Payment of At-The-Market offering costs		(78	)		—
Proceeds from stock option exercises		21			21
Payments for taxes related to net share settlement of equity awards		(1,305	)		(151	)
Net cash flows from financing activities		(1,362	)		16,053
Net change in cash and cash equivalents		(7,717	)		12,213
Cash and cash equivalents, beginning of period		20,104			23,140
Cash and cash equivalents, end of period	$	12,387		$	35,353
SUPPLEMENTAL CASH FLOW INFORMATION
Cash paid for:
Income taxes	$	—		$	—
Interest	$	—		$	185

EX-99.2 3 clpt-ex99_2.htm EX-99.2

DISCLAIMER This presentation and discussion contain forward-looking statements within the context of the federal securities laws, including the Company’s expectation for revenues, gross margin, the adequacy of cash and cash equivalent balances to support operations and meet future obligations, the future market of its products and services, and other performance and results. 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: macroeconomic and inflationary conditions; regulatory and policy uncertainty due to presidential administration change; the introduction of or changes in tariffs, sanctions, or trade barriers; changes in monetary policy; geopolitical trends, such as protectionism and economic nationalism; future revenue from sales of the Company’s products and services; the Company’s ability to market, commercialize and achieve broader market acceptance for new products and services offered by the Company; the ability of our biologics and drug delivery partners to achieve commercial success, including their use of the Company’s products and services in their delivery of therapies; the Company’s ability to maintain its current relationships with biologics and drug delivery partners or enter into new relationships with such partners; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its research and development programs; the ability of the Company to manage the growth of its business; the Company’s ability to attract and retain its key employees; and risks inherent in the research, development, and regulatory approval of new products and the new products of its biologics and drug delivery partners. More detailed information on these and additional factors that could affect the Company’s actual results are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024,which has been filed with the Securities and Exchange Commission, and the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, which the company intends to file with the Securities and Exchange Commission on or before May 15, 2025. The Company does not assume any obligation to update these forward-looking statements. © 2025 CLEARPOINT NEURO

OUR COMPANY We Enable Cell, Gene and Device Therapies by Offering Precise Navigation to the Brain and Spine Our Unique Platform Includes Both Proven Clinical Products Used by Neurosurgeons, and Drug Development Services Used by BioPharma Partners © 2025 CLEARPOINT NEURO

CLEARPOINT NEURO EXECUTIVE SUMMARY 15+ years building a complete drug delivery ecosystem including navigation solutions, predictive modeling, delivery devices, infusion monitoring software and clinical case support Combination device success, proprietary technology and deep FDA experience provide our BioPharma partners with a meaningful head start, and our investors with a Portfolio-like biotech strategy An expanding global installed base of regional treatment centers are scaling capacity to be ready for additional cell and gene therapy patients to be treated with a unified platform Evolved beyond the MRI and into operating room CT navigation, laser ablation therapy, surgical access tools and pre-clinical CRO services which fuel growth via new product launches and provide path to profitability Our dedicated team of engineers, scientists and clinical specialists wake up every morning focused on the future of neurosurgery and drug delivery. This is all that we do… A UNIQUE PLATFORM TECHNOLOGY USED FOR CELL AND GENE THERAPY DELIVERY CURRENT PORTFOLIO PROVIDES ACCESS TO A $500M MARKET OPPORTUNITY TODAY 100+ ACTIVE GLOBAL CENTERS A GROWING & PASSIONATE TEAM © 2025 CLEARPOINT NEURO A $10B POTENTIAL MARKET DIVERSIFIED ACROSS 60+ PARTNERS, 20+ INDICATIONS* *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies

Neurological diseases cost Americans nearly $800 Billion annually. The only way to decrease these costs is to improve treatment. Despite some available treatments, very few of these patients undergo a direct surgical intervention to improve their quality of life… © 2025 CLEARPOINT NEURO More than 30 Million People in the U.S. are estimated to suffer from severe and debilitating neurological disorders; Parkinson’s Disease (1,000,000) Essential Tremor (7,000,000) Epilepsy (2,900,000) Huntington’s Disease (41,000) Rare Childhood Genetic Disorders (25,000) Dementia and Alzheimer’s Disease (6,900,000) Tumor and Glioblastoma (280,000) Severe OCD (1,000,000) Treatment Resistant Depression (2,900,000) ALS and Spinal Cord Injury (300,000) Stroke Rehabilitation (7,000,000) Neuropathic Pain (2,000,000) The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAY Our Company Sources on file at ClearPoint Neuro

We will Enable fast, minimally-invasive, asleep procedures for a more comfortable and predictable patient experience… © 2025 CLEARPOINT NEURO We will partner to Develop Device, Cell and Gene Therapies that may cure the underlying disease and restore function… Our Goal is to Help More Patients by Addressing Two Primary Barriers to Treatment Our Company 1 2 The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAY

© 2025 CLEARPOINT NEURO Partners have programs selected for expedited review - the FDA recognizes the urgency The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAY Our Company 7 Partner has received FDA approval for a neuro gene therapy that is co-labeled with ClearPoint 1

7 Active Clinical-Stage Partners have been selected for expedited review including: AADC Deficiency Huntington's’ Disease Parkinson’s Disease Epilepsy (MTLE) Parkinson’s Disease Parkinson’s Disease Frontotemporal Dementia RMAT - June 2024 May 2024 February 2025 June 2024 - - Indication Fast Track Designation - - - - June 2024 November 2023 Clinical Strategy Approved Confirmed Confirmed Confirmed Source: Lake Street Capital Markets analyst coverage of uniQure, Bluerock, Neurona, AskBio, Aspen Neuroscience, and AviadoBio - TBD TBD TBD The Future of Cell and Gene Therapy is Not Coming… It is HERE TODAY Our Company

In 2025 Our Journey Enters the NEXT CHAPTER Our Company © 2025 CLEARPOINT NEURO Discovery. Design. Neurosurgeon Led Ideation Unique MRI Navigation Initial FDA Clearance and Product Revenue Accumulation of Clinical Trial Experience Using SmartFlow® Maestro A.I. Software Development Initial IP Generation and Licenses NASDAQ Listed Funded. Foundation. ≈ 100 Activated Customers 60+ Biopharma Partners 20+ Potential Disease Indications* Pre-Clinical Team Creation Operating Room Product Launch Laser Therapy Product Launch 100+ Owned & Licensed Patents EU MDR Certification Expanded, Audit-Ready Manufacturing in California Leadership Team Complete Fast. Forward. Grow into an estimated, existing $500m Market Opportunity 150 Activated Customers First Commercial CGT Launched GLP Pre-Clinical Capability Operating Room Nav Growth Laser Therapy Growth MR Drill and Access Growth ‘Harmony’ Software Launch New Routes of Administration Operational Cash Breakeven Essential. Everywhere. $10b Potential Revenue Opportunity ‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development One Unified Platform with both MRI and Operating Room Capability and Workflows Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies

Our Start: Unique Neurosurgery Navigation Guided by Live MRI Discovery. Design. © 2025 CLEARPOINT NEURO Neurosurgery has traditionally been done via open craniotomy or by using CT guidance in the operating room The historical limitations of CT accuracy would often require patients to remain awake for hours-long brain surgery to confirm the location and impact of technologies like DBS ClearPoint believed that building a navigation system that could harness the power of live MRI would be accurate enough that the patient could be comfortably asleep for this minimally-invasive procedure The ClearPoint SmartFrame® family of products use MRI-safe materials and enable surgeons to Decide, Guide & Confirm using live MR Imaging to achieve sub-millimetric accuracy

Our Start: Decide, Guide & Confirm Discovery. Design. © 2025 CLEARPOINT NEURO Three Primary Use Cases demonstrated the value of the ClearPoint MRI Navigation System: Functional Neurosurgeons could confidently place DBS electrodes with the patient comfortably asleep Neuro-Oncologists could perform entire Tumor Laser Ablations in one room instead of having to transport the patient from the OR to the MRI BioPharma researchers could confirm that cell and gene therapies are not only delivered to a precise location, but could also confirm proper coverage of the target structure before closing the patient

Our Start: Assemble the Building Blocks Discovery. Design. © 2025 CLEARPOINT NEURO Leveraging our unique platform and dedicated team, we developed and acquired essential technologies necessary to complete the entire ecosystem for MRI Guided Navigation, and with a focus on cell and gene therapy delivery SmartFlow® Cannula (FDA and CE Mark, more than 8,000 cannulas sold to date) Radial Branching Cell Therapy Devices and Spinal Infusion Anchors (Investigational Use Only) ClearPoint Maestro® Brain Model Segmentation and Image Fusion Biophysical Modeling of patient specific drug infusions (Investigational Use Only) SmartFrame® XG and Surgical Accessory Kit 3D Peri-procedural Infusion Monitoring Software (Investigational Use Only)

Building the Business Funded. Foundation. © 2025 CLEARPOINT NEURO ClearPoint Neuro Navigation Software v.2.2.1 ClearPoint Array Software v.1.2 ClearPoint Maestro Brain Model SmartFrame XG Kit Components SmartFrame OR with ClearPointer Inflexion Head Fixation Frame SmartFrame Array Kit Components ClearPoint Prism Neuro Laser Fibers ClearPoint Prism Neuro Laser Therapy System Velocity Power Drill SmartFlow Cannula Radial Branching Cell Therapy Devices & Spinal Infusion Anchors (Investigational Use Only) ClearPoint built a complete and unique ecosystem of clinical and pre-clinical products and has achieved regulatory approvals in multiple geographies This proven technology has more than 10 years of experience and been used in more than 7,000 procedures to date Demand for our platform has grown driven by the promise of cell and gene therapies, new DBS indications, and expansion of laser therapy ClearPoint activated a record 25 new Global Customers in 2024 alone

Building the Business: Our Four-Pillar Growth Strategy Remains Our Foundation Funded. Foundation. © 2025 CLEARPOINT NEURO BIOLOGICS & DRUG DELIVERY 1 NEURSURGERY NAVIGATION 2 VISUALASE LASER THERAPY & ACCESS 3 CLEARPOINT NAVIGATION IS COMPATIBLE WITH MAJOR DIAGNOSTIC AND INTRAOPERATIVE MRI AND CT SCANNERS GLOBAL SCALE 4 100+ GLOBAL CENTERS 60+ INDUSTRY & ACADEMIC PARTNERS

Banner Health Tucson Baptist Memorial Hospital-Memphis Barnes-Jewish Hospital Barrow Neurological Institute/St. Joseph's Hospital Benioff Children's Hospital Beth Israel Deaconess Boston Children's Hospital Brigham & Women's Hospital Brown University / Rhode Island Hospital Carilion Clinic Children's Hospital of Alabama Children’s Mercy Hospital Children's National Hospital CHOA Scottish Rite Cincinnati Children's Hospital Cincinnati Jewish Hospital Cleveland Clinic Hospital Cook Children's Hospital Corewell Health Dallas Presbyterian Hospital Dartmouth-Hitchcock Duke University Emory University Froedtert Hospital Hackensack University Medical Center Henry Ford Health Henry Ford West Bloomfield Hospital Hospital of University Pennsylvania Houston Methodist Hospital INOVA Fairfax JFK University Medical Center Johns Hopkins University Kaleida Health Kettering Health Loma Linda University Health Lucile Packard Children's Hospital Massachusetts General Hospital Mayo Clinic in Arizona Mayo Clinic in Florida MD Anderson Cancer Center MedStar Georgetown University Hospital Memorial Sloan-Kettering Cancer Center Methodist Hospital San Antonio Mt. Sinai West Nationwide Children's Northwestern Central DuPage Ochsner Medical Center Ohio State University Oregon Health & Science University Orlando Health Arnold Palmer Hospital for Children Prisma Health Riverside Methodist Hospital Rutgers/Robert Wood Johnson San Francisco VA Health Care System Southern Arizona VA Health Care System Stanford University Sunnyside Kaiser Permanente Tampa General Hospital Texas Children's Hospital University of Alabama at Birmingham University of California Los Angeles University of California San Diego University of California San Francisco University of Colorado University of Florida Jacksonville University of Kansas Medical Center University of Maryland Medical Center University of Michigan University of Minnesota University of North Carolina (UNC) Health University of Oklahoma Medical Center University of Utah University of Wisconsin USC Keck Hospital UT Southwestern Medical Center Wolfson Children’s Hospital Yale University Charité – Universitätsmedizin Berlin (Berlin, Germany) Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (Milan, Italy) Great Ormond Street Hospital (London, UK) Hôpital Fondation Rothschild (Paris, France) Hospital Israelita Albert Einstein (São Paulo, Brazil) Hospital Santa Joana (Recife, Brazil) Mazowiecki Szpital Bródnowski (Warsaw, Poland) Meyer Children’s Hospital (Florence, Italy) Policlinico Umberto I (Rome, Italy) Rigshospitalet (Copenhagen, Denmark) Sahlgrenska Universitetssjukhuset (Gothenburg, Sweden) Skänes Universitetssjukhus Lund (Lund, Sweden) Santobono Children’s Hospital (Naples, Italy) Universitätsklinikum Tübingen (Tübingen, Germany) Universitätsklinikum Düsseldorf (Düsseldorf, Germany) Universitätsklinikum Freiburg (Freiburg, Germany) University Hospital of Wales (Cardiff, UK) Charles River Labs (Laval, Canada) Charles River Labs (Lyon, France) Charles River Labs (Mattawan, Michigan) Children's Hospital of Philadelphia Envol Biomedical (Florida) Labcorp (Madison, Wisconsin) Prisys Biotechnologies (Shanghai, China) TIDU GENOV - Institut du Cerveau (Paris, France) University of Pennsylvania Gene Therapy United States Centers International Centers Preclinical Centers 100+ GLOBAL CENTERS NOW ACTIVATED © 2025 CLEARPOINT NEURO

Building the Business Funded. Foundation. © 2025 CLEARPOINT NEURO We have invested in the Development, Quality and Supply infrastructure to build confidence for both Hospitals and BioPharma partners We are not a start-up company but an experienced and sophisticated medical device extension for any cell and gene therapy company ClearPoint assets available to our partners; HQ & Training Facility in Solana Beach Research Laboratory in San Diego Manufacturing Facility in Carlsbad ISO 13485 / MDSAP / EU MDR Certified QMS Significant and positive experience with BioPharma Audits, FDA and Global Notified Body inspections

Building the Business Funded. Foundation. © 2025 CLEARPOINT NEURO Key Products: Marked Platforms EMPLOYEES 100+ 2024 REVENUE $31.4m(A) CASH & CASH EQUIVALENTS $12.1 m(B,C) HEADQUARTERS Solana Beach, CA GROSS MARGIN 61%(B,E) MANUFACTURING Carlsbad, CA For the year ended December 31, 2024 Unaudited, as of, and for the quarter ended March 31, 2025 Excludes Gross Proceeds of $33.5m received on May 12, 2025 Including owned and licensed patents For the Trailing Twelve Months (TTM) PATENTS ISSUED 100+(D) 2024 Operational Cash Burn ($9.0m) (A) Hostius polibu atus patiaedi, esct lorestimo conduces 2018 2019 2020 2021 2022 2023 2024 23.8% CAGR $7.4 $11.2 $12.8 $16.3 $20.6 $24.0 $31.4 27% CAGR 2025 (est.) $36 - $41 (est.)

Building the Business Funded. Foundation. © 2025 CLEARPOINT NEURO Joe Burnett President & Chief Executive Officer Danilo D’Alessandro Chief Financial Officer Jeremy Stigall Chief Business Officer Mazin Sabra Chief Operating Officer Ellisa Cholapranee General Counsel Megan Faulkenberry Vice President of Quality Mary McNamara-Cullinane Vice President of Regulatory Affairs Rob Korn Vice President U.S. Commercial Sales Lyubomir Zagorchev, PhD Vice President of Clinical Science & Applications Ernesto Salegio, PhD Vice President of Translational & Pre-Clinical Research EXECUTIVE LEADERSHIP TEAM Experienced leadership team with decades of leadership in medical devices, pharmaceuticals, and clinical research.

In 2025 Our Journey Enters the NEXT CHAPTER Our Company © 2025 CLEARPOINT NEURO Discovery. Design. Neurosurgeon Led Ideation Unique MRI Navigation Initial FDA Clearance and Product Revenue Accumulation of Clinical Trial Experience Using SmartFlow® Maestro A.I. Software Development Initial IP Generation and Licenses NASDAQ Listed Funded. Foundation. ≈ 100 Activated Customers 60+ Biopharma Partners 20+ Potential Disease Indications* Pre-Clinical Team Creation Operating Room Product Launch Laser Therapy Product Launch 100+ Owned & Licensed Patents EU MDR Certification Expanded, Audit-Ready Manufacturing in California Leadership Team Complete Fast. Forward. Grow into an Estimated, Existing $500m Market Opportunity 150 Activated Customers First Commercial CGT Launched GLP Pre-Clinical Capability Operating Room Nav Growth Laser Therapy Growth MR Drill and Access Growth ‘Harmony’ Software Launch New Routes of Administration Operational Cash Breakeven Essential. Everywhere. $10b Potential Revenue Opportunity ‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development One Unified Platform with both MRI and Operating Room Capability and Workflows Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies

We are Pointing the Way for a Cell and Gene Therapy Future: Fast. Forward. Fast. Forward. Our Commitment to Hospitals & BioPharma Partners is to help prepare for tens-of-thousands of anticipated new patients who will be seeking these restorative therapies Extend Our Lead in Neuro Drug Delivery by leveraging our complete and unique ecosystem of both products and drug development services Evolve our Portfolio to focus on fast, simple, predictable procedures in both the MRI and Operating Room to increase hospital throughput Expand our Base of global, activated centers to increase capacity and ensure access of these new-to-world cell and gene therapies © 2025 CLEARPOINT NEURO

3 LASER THERAPY & ACCESS 2 NEUROSURGERY NAVIGATION BIOLOGICS & DRUG DELIVERY 2027 2025 COMPLETE PRISM LASER & VELOCITY DRILL LAUNCHES 4 GLOBAL SCALE ACTIVATE 150 CENTERS & GROW REVENUE FASTER THAN OPEX © 2025 CLEARPOINT NEURO 1 ADD PRE-CLINICAL GLP SERVICES & NEW ROUTES OF ADMINISTRATION EXPAND INTO THE OPERATING ROOM & CREATE A UNIFIED SOFTWARE PLATFORM Fast. Forward. OUR 4 PILLAR GROWTH STRATEGY CONTINUES 2025-2027

3 LASER THERAPY & ACCESS 2 NEUROSURGERY NAVIGATION BIOLOGICS & DRUG DELIVERY 2027 2025 Add 1.5 Tesla PRISM for full market access Add Ablation Coverage & Predictive Thermal Modeling Launch MRI Conditional Power Drill to reduce procedure time 4 GLOBAL SCALE Expand Global Footprint to 150+ Centers Perform Procedures w/ Remote Clinical Support Show path to 70%+ Margins & Cashflow Breakeven © 2025 CLEARPOINT NEURO 1 Expand Neuro Pre-Clinical CRO Services and Capacity to include 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/Modelling, Intracranial Cell Therapy and Spinal Routes of Administration Show Compatibility with Existing Third-Party Navigation w/ SmartFrame OR Expand into the Operating Room w/ ClearPoint Duet™ and 3.0 Software Launch Maestro CT, Non-Rigid Fusion, Area-of-Activation and DTI Harmony Software Fast. Forward. OUR 4 PILLAR GROWTH STRATEGY CONTINUES 2025-2027

GLP Services & New Routes of Administration Fast. Forward. Market Growth Drivers: Improved BioPharma Funding Environment Additional cell and gene therapies entering the ‘funnel’ Partner progression into larger spend GLP studies and clinical trials Successful implementation of FDA ‘Expedited Review’ pathways including RMAT offering faster clinical trials and less capital required Market Share Drivers: Addition of GLP capability and increased study capacity Expansion to ClearPoint Advanced Laboratories (aka ‘the CAL’) Product portfolio expansion including new routes of administration Increased custom-development strategic partnerships w/ BioPharma © 2025 CLEARPOINT NEURO GLP Pre-Clinical Services and Image Analysis Lab (Expected 2H 2025) New Routes of Administration (Investigational Use Only) Coverage Estimation and Biophysical modeling (Investigational Use Only) Assumptions: 150 active cell and gene therapy programs globally 7.5 years average program duration 200 patients studied clinically on average as part of trials Estimated Market Size, Growth Drivers, and Share Drivers are based on internal estimates and assumptions, market trends, and customer insights. Assumptions may not reflect actual future performance.

Market Growth Drivers: Asleep DBS FDA Clearance and Patient Awareness New DBS Indications including Epilepsy, OCD, Depression, BCI Increased hospital throughput of laser therapy compared to open surgery Improved laser insurance decisions and awareness Additional global approvals in EU and APAC Market Share Drivers: 3.0 Software for proficient, mirrored CLPT workflow in the MRI and OR Asleep, Simultaneous workflows for fast procedures, low radiation 1.5 Tesla PRISM Laser approval for full market access Velocity® Alpha MR Drill for faster cranial access times Neuro Navigation, Therapy and Access Product Growth Fast. Forward. © 2025 CLEARPOINT NEURO SmartFrame OR and ClearPointer™ ClearPoint 3.0 Software w/ CT Functionality (FDA Cleared January 2025) SmartFrame DUET™ w/ flexile MRI & CT workflows (Expected 2026) 1.5 Tesla PRISM (Expected 2H 2025) Adeor Velocity® MRI Conditional Power Drill Estimated Market Size, Growth Drivers, and Share Drivers are based on internal estimates and assumptions, market trends, and customer insights. Assumptions may not reflect actual future performance.

In 2025 Our Journey Enters the NEXT CHAPTER Our Company © 2025 CLEARPOINT NEURO Discovery. Design. Neurosurgeon Led Ideation Unique MRI Navigation Initial FDA Clearance and Product Revenue Accumulation of Clinical Trial Experience Using SmartFlow® Maestro A.I. Software Development Initial IP Generation and Licenses NASDAQ Listed Funded. Foundation. ≈ 100 Activated Customers 60+ Biopharma Partners 20+ Potential Disease Indications* Pre-Clinical Team Creation Operating Room Product Launch Laser Therapy Product Launch 100+ Owned & Licensed Patents EU MDR Certification Expanded, Audit-Ready Manufacturing in California Leadership Team Complete Fast. Forward. Grow into an Estimated, Existing $500m Market Opportunity 150 Activated Customers First Commercial CGT Launched GLP Pre-Clinical Capability Operating Room Nav Growth Laser Therapy Growth MR Drill and Access Growth ‘Harmony’ Software Launch New Routes of Administration Operational Cash Breakeven Essential. Everywhere. $10b B Potential Revenue Opportunity ‘Combination Product’ Regulatory Designation for multiple cell and gene therapy indications Meaningful Revenue from Sophisticated BioPharma Deal Structures beyond product sales including royalty and milestone payments, co-development One Unified Platform with both MRI and Operating Room Capability and Workflows Global Regulatory Approvals Beyond the U.S. and E.U. 2010 - 2020 2021 - 2024 2025 - 2027 2028+ *Including indications for all cell, gene, and device therapies enabled by ClearPoint Neuro technologies

© 2025 CLEARPOINT NEURO Partners have programs selected for expediated review - the FDA recognizes the urgency The FDA & Global Notified Bodies Recognize the Urgency Essential. Everywhere. 7 Partner has received FDA approval for a neuro gene therapy that is co-labeled with ClearPoint 1

ClearPoint has 60+ Active BioPharma Programs across 20+ indications including DBS, LiTT Essential. Everywhere. © 2025 CLEARPOINT NEURO BENCHTOP TESTING PRECLINICAL STUDIES Device Compatibility Testing Infusion Pump Testing Custom Device Development Performance Assessment Device Comparisons / Bridging Running Pre-Clinical studies Surgical Planning & Guidance Writing IACUC / Study Protocols Dosing and Surgical Support Post-Infusion Reporting Surgical Guidance + Site Intros Procedure Pre-Planning On-Site Clinical Support Inventory Management Data / Infusion Reporting CLINICAL TRIALS

Sophisticated Partnerships are Enabled by the ClearPoint Ecosystem of Products & Services Essential. Everywhere. © 2025 CLEARPOINT NEURO ClearPoint May Provide to BioPharma; Assurance of Supply Access to FDA Device Dossier Redundant Global Manufacturing Contracted Commercial Pricing Licenses to Key Intellectual Property Custom Device Development Clinical Specialist Procedural Support Dedicated Inventory Locations Extensive Audit Access & Experience Supply Continuity and Reliability We provide the creative flexibility to structure agreements as an essential and long-term supplier ClearPoint May Secure from BioPharma; Demand Planning Purchasing Commitments Minimum Device Purchases Co-Development Design Fees Strategic Retainer Agreements Clinical Milestone Payments Premium Commercial Pricing Royalties on Drug Revenue Pre-Clinical Service Purchases Multiple Program Collaborations

More than 30 Million People in the U.S. alone suffer from severe and debilitating neurological disorders; Parkinson’s Disease (1.0m) Essential Tremor (7.0m) Epilepsy (2.9m) Huntington’s Disease (41k) Rare Childhood Genetic Disorders (25k) Dementia and Alzheimer’s Disease (6.9m) Tumor and Glioblastoma (280k) Severe OCD (1.0m) Treatment Resistant Depression (2.8m) ALS and Spinal Cord Injury (300k) Stroke Rehabilitation (7.0m) Neuropathic Pain (2.0m) ClearPoint is Diversified Across; 60+ BioPharma Partners 20+ Indications including device, cell and gene therapies Redundant Partners for multiple indications Many Partners with multiple programs Additional Device treatments including DBS, Laser, BCI Many ‘Shots on Goal’ with a path to operational cash breakeven; If just 1% of patients with diseases under expedited review are treated each year, at current ASP’s that would yield more than $250m in additional CLPT revenue © 2025 CLEARPOINT NEURO CLPT is like a Portfolio of BioPharma without drug development costs or binary outcomes Essential. Everywhere.

Sources © 2025 CLEARPOINT NEURO Sources Alzheimer's Association 2024 Alzheimer's Disease Facts and Figures How Many People in the USA Have Essential Tremor? Deriving a Population Estimate Based on Epidemiological Data - PMC Parkinson's Disease: Challenges, Progress, and Promise | National Institute of Neurological Disorders and Stroke Epilepsy Facts and Stats | Epilepsy | CDC Prevalence of Huntington’s Disease in the US (954) | Neurology What is Friedreich's ataxia? - Friedreich's Ataxia Research Alliance Angelman syndrome | About the Disease | GARD Brain Tumor Facts https://pmc.ncbi.nlm.nih.gov/articles/PMC3250269/#Abs1 Amyotrophic lateral sclerosis estimated prevalence cases from 2022 to 2030, data from the National ALS Registry | National ALS Registry | CDC Spinal Cord Injury Prevalence In The U.S. | Reeve Foundation Abbott Initiates Clinical Study to Evaluate the Use of Its Deep Brain Stimulation System to Manage Severe Depression - Sep 4, 2024 The prevalence of neuropathic pain: Clinical evaluation compared with screening tools in a community population - PMC Deep brain stimulation for obsessive-compulsive disorder: A systematic review of worldwide experience after 20 years - PMC How common is OCD? Burden of Neurological Disorders Across the US From 1990-2017: A Global Burden of Disease Study | Dementia and Cognitive Impairment | JAMA Neurology | JAMA Network