ClearPoint Neuro Announces Preliminary Unaudited Fourth Quarter and Full Year 2025 Revenue

Rhea-AI Summary

ClearPoint Neuro (Nasdaq:CLPT) reported preliminary unaudited Q4 2025 revenue of ~$10.4M, representing 20% comparable sales growth versus Q4 2024; IRRAflow product sales were only partially included after a recent acquisition. Full-year 2025 revenue was approximately $37M. Management expects 2026 total revenues of $54M–$60M, driven by organic growth and completion of IRRAflow integration. Segment trends in Q4 included functional neurosurgery disposables (+23%) and biologics/drug delivery (+26%). Results are preliminary and unaudited; audited financials and a Form 10-K will be filed in Q1 2026. Management will meet investors at the J.P. Morgan Healthcare Conference on January 12–13, 2026.

Positive

• Q4 2025 revenue of approximately $10.4M
• Comparable Q4 sales growth of 20% year-over-year
• Full-year 2025 revenue of approximately $37M
• Q4 segment growth: disposables +23% and biologics/drug delivery +26%
• 2026 revenue guidance of $54M–$60M indicating expected acceleration

Negative

• Results are preliminary unaudited estimates and subject to revision during audit
• Q4 comparable growth excludes IRRAflow because it was not in the portfolio a year ago
• 2026 guidance depends on successful integration of IRRAflow without quantified timing

News Market Reaction

+4.89%

43 alerts

+4.89% News Effect

-12.6% Trough in 27 hr 7 min

+$20M Valuation Impact

$427M Market Cap

1.1x Rel. Volume

On the day this news was published, CLPT gained 4.89%, reflecting a moderate positive market reaction. Argus tracked a trough of -12.6% from its starting point during tracking. Our momentum scanner triggered 43 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $20M to the company's valuation, bringing the market cap to $427M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q4 2025 revenue: $10.4 million Q4 2025 sales growth: 20% Neurosurgery disposables growth: 23% +5 more

8 metrics

Q4 2025 revenue $10.4 million Preliminary unaudited total revenue, Q4 2025

Q4 2025 sales growth 20% Comparable sales growth vs Q4 2024 (ex-IRRAflow)

Neurosurgery disposables growth 23% Functional neurosurgery disposables growth in Q4 2025

Biologics & drug delivery growth 26% Biologics and drug delivery growth in Q4 2025

Full-year 2025 revenue $37 million Preliminary unaudited total revenue for 2025

2026 revenue outlook (low) $54 million Company expectation for total 2026 revenue, low end

2026 revenue outlook (high) $60 million Company expectation for total 2026 revenue, high end

JPM conference dates January 12–13, 2026 Management meetings during J.P. Morgan Healthcare Conference

Market Reality Check

Price: $15.68 Vol: Volume 1,260,469 is above...

high vol

$15.68 Last Close

Volume Volume 1,260,469 is above the 20-day average of 694,270, indicating elevated trading ahead of this update. high

Technical Shares at $14.92 trade above the 200-day MA of $14.29 but sit 50.43% below the 52-week high of $30.0999.

Peers on Argus

CLPT declined 2.55% with higher volume, while key peers like SNWV, TCMD, NPCE, a...

1 Up

CLPT declined 2.55% with higher volume, while key peers like SNWV, TCMD, NPCE, and BFLY also showed negative price changes. Momentum scans flagged RXST with a strong 13.12% upside move, highlighting mixed action within Medical Devices rather than a uniform sector trend.

Common Catalyst Butterfly Network (BFLY) also reported preliminary unaudited Q4 2025 revenue growth, suggesting a wave of early revenue disclosures across Medical Devices around the same time.

Historical Context

5 past events · Latest: Nov 20 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 20	Acquisition completion	Positive	+2.3%	Closed IRRAS acquisition, adding IRRAflow system and >50 active customers.
Nov 06	Quarterly earnings	Positive	+7.4%	Q3 2025 revenue growth, strong gross margin, and reaffirmed 2025 guidance.
Nov 06	Acquisition agreement	Positive	+7.4%	Announced agreement to acquire IRRAS and outlined combined 2026 revenue view.
Nov 05	Investor conferences	Neutral	-3.1%	Planned participation in several global healthcare investor conferences.
Oct 07	Clinical data update	Positive	-0.8%	Promising Phase I–II brain tumor laser therapy results with no device-related events.

Pattern Detected

Recent earnings and IRRAS acquisition headlines tended to align with positive share reactions, while clinical data and conference participation saw flat-to-negative moves, indicating investors have rewarded financial and strategic updates more than scientific or IR events.

Recent Company History

Over the last few months, ClearPoint Neuro has focused on both growth and strategic expansion. On November 6, 2025, it reported Q3 revenue of $8.9M with 63% gross margin and reaffirmed $36.0M–$38.0M 2025 revenue guidance, plus a combined $54.0M–$60.0M 2026 revenue outlook with IRRAS. The company then agreed to acquire, and later completed the acquisition of, IRRAS, adding the IRRAflow intracranial fluid management platform. Earlier, positive laser therapy study results and multiple conference participations supported its neurosurgery and neuro-oncology positioning. Today’s preliminary 2025 revenue update builds directly on that guidance and integration narrative.

Market Pulse Summary

This announcement highlights preliminary unaudited Q4 2025 revenue of about $10.4 million, represent...

Analysis

This announcement highlights preliminary unaudited Q4 2025 revenue of about $10.4 million, representing 20% comparable sales growth, and full-year 2025 revenue near $37 million. Management also reiterated expectations for 2026 revenue between $54 and $60 million, supported by functional neurosurgery disposables and biologics and drug delivery growth of 23% and 26%, respectively. Investors may track the audited 2025 results, IRRAflow integration progress, and whether double-digit growth materializes across all four targeted neuro markets.

Key Terms

cell and gene therapy, biologics, neurosurgery navigation, laser therapy, +4 more

8 terms

cell and gene therapy medical

"a global device, cell, and gene therapy-enabling company offering precise navigation"

Therapies that use living cells or altered genes to treat or cure disease by repairing, replacing or reprogramming parts of the body; think of it as swapping or reprogramming malfunctioning hardware or software inside the body. Investors watch these treatments closely because they can command high prices and offer one-time or long-lasting benefits, but they also carry big development costs, complex manufacturing and regulatory risks that can cause large swings in a company’s value.

biologics medical

"functional neurosurgery disposables and biologics and drug delivery coming in at 23% and 26%"

Biologics are medicines made from living cells or their components rather than from simple chemical recipes, more like a handcrafted product than a mass-produced pill. They matter to investors because they often command higher prices and longer patent protection but also carry greater manufacturing, regulatory and supply risks—so a successful biologic can boost a company’s revenue significantly, while setbacks can quickly affect its stock.

neurosurgery navigation medical

"neurosurgery navigation, (3) laser therapy and access, and (4) intracranial fluid"

A neurosurgery navigation system is an image-guided technology that helps surgeons pinpoint structures in the brain and spine during operations, functioning much like a GPS that shows exact location and planned pathways. For investors it matters because these systems can improve surgical accuracy, reduce complications and time in the operating room, and therefore influence hospitals’ buying decisions, reimbursement rates, regulatory hurdles and the commercial prospects of companies that make or supply the technology.

laser therapy medical

"neurosurgery navigation, (3) laser therapy and access, and (4) intracranial fluid"

Laser therapy uses focused beams of light to treat or image tissue by heating, stimulating, or cutting in a controlled way, often with minimal incision or downtime. Investors track it because new or improved laser treatments can change patient demand, regulatory approval and reimbursement patterns, and competitive dynamics—similar to how a faster, cheaper tool can reshape an industry’s sales and profit outlook.

intracranial fluid management medical

"(4) intracranial fluid management. In 2026 we expect double-digit growth"

Intracranial fluid management means controlling the amount and pressure of fluids inside the skull, including brain tissue, blood and cerebrospinal fluid, to prevent damage or restore normal function. Think of it like regulating water levels and pressure in a closed plumbing system: proper control keeps fragile structures safe, while failure can cause swelling, reduced blood flow or neurological harm. For investors, advances, devices or drugs in this area can affect patient outcomes, regulatory approval risk, market size and clinical trial prospects for companies working on brain injury, stroke or neurosurgical care.

preclinical development services medical

"provides both established clinical products as well as preclinical development services for controlled"

Preclinical development services are the laboratory and animal studies that test a drug or medical product’s safety, how it works, and whether it’s worth trying in humans. Think of it as building and test-driving a prototype before mass production: these services reduce scientific and regulatory risk, help set timelines and costs, and can make a project more or less attractive to investors by affecting the likelihood and speed of eventual revenue.

FDA clearance regulatory

"The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked."

FDA clearance is the U.S. Food and Drug Administration’s official permission to market certain medical devices or diagnostic tests after reviewing evidence that they are as safe and effective as similar products already on the market. For investors, it’s like a product passing a required safety inspection — it reduces regulatory uncertainty, speeds commercial rollout, and can directly affect sales prospects, valuation, and partnership opportunities.

CE-marked regulatory

"ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked."

CE-marked indicates a product meets European Union requirements for safety, performance and legal compliance, allowing it to be sold across the European Economic Area. For investors, a CE mark is like a passport or safety stamp — it reduces regulatory and market-entry risk, can speed sales and adoption across many countries, and signals the maker completed required testing and documentation, which can affect revenue forecasts and valuation.

AI-generated analysis. Not financial advice.

The Company Achieved 20% Comparable Sales Growth in the Fourth Quarter of 2025 at $10.4 Million

SOLANA BEACH, CALIFORNIA / ACCESS Newswire / January 12, 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 preliminary unaudited revenue growth for its fourth quarter of 2025. These preliminary unaudited financial results are management's estimates, are subject to revision in the course of completing annual audit processes, and do not represent a comprehensive statement of the Company's financial results for the period. Audited results for the fourth quarter and full year 2025 will be publicly reported by the Company later in the first quarter of 2026, prior to a Form 10-K filing for the year with full financial statements.

Preliminary unaudited financial results demonstrated total revenue in the fourth quarter of 2025 of approximately $10.4 million, which is 20% comparable sales growth versus the fourth quarter of 2024. This sales growth does not include the impact of IRRAflow product sales which was not a part of the Company product portfolio a year ago and was only included partially in the fourth quarter of 2025 after the closing of the IRRAS Holdings, Inc. acquisition.

"Preliminary unaudited results from the fourth quarter showed a strong end of the year, with overall growth returning to 20%, and functional neurosurgery disposables and biologics and drug delivery coming in at 23% and 26% respectively," commented Joe Burnett, President and CEO at ClearPoint Neuro. "We believe this indicates excellent momentum headed into 2026 where we have the team, the portafolio and the pipeline of new products to continue our penetration of the four existing markets that we participate in today: 1) pre-commercial biologics and drug delivery, (2) neurosurgery navigation, (3) laser therapy and access, and (4) intracranial fluid management. In 2026 we expect double-digit growth in all four of these growth markets which will continue to grow our installed base and fund the necessary infrastructure as we prepare for the commercial launch of neuro cell and gene therapies in the years ahead."

Preliminary unaudited revenue for the full year 2025 was approximately $37 million. The Company continues to expect total revenues in 2026 between $54 and $60 million driven by the combination of organic growth and the completion of integration activities for the IRRAflow product line.

The Company's management team will be available for meetings in San Francisco, CA during the J.P. Morgan Healthcare Conference from January 12-13, 2026.

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

This press release contains forward-looking statements within the context of the federal securities laws, including statements regarding the Company's preliminary unaudited financial results, projections for future growth in its four existing markets, and 2026 revenue outlook. Preliminary unaudited financial results are subject to adjustment upon completion of the Company's financial closing processes and review. 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 ability to market, commercialize and achieve broader market acceptance for the products and services offered by the Company; 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; the future market for the Company's preclinical services; 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; and deviations from the expected market potential of the IRRAS products. 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

SOURCE: ClearPoint Neuro, Inc.

View the original press release on ACCESS Newswire

FAQ

What were ClearPoint Neuro (CLPT) preliminary Q4 2025 revenues?

Preliminary unaudited Q4 2025 revenue was approximately $10.4M, a 20% comparable increase versus Q4 2024.

How much revenue did ClearPoint Neuro (CLPT) report for full-year 2025?

Preliminary unaudited full-year 2025 revenue was approximately $37M.

What is ClearPoint Neuro's (CLPT) revenue guidance for 2026?

The company expects total revenues between $54M and $60M for 2026, driven by organic growth and IRRAflow integration.

How did ClearPoint Neuro's product segments perform in Q4 2025 for CLPT?

Management reported Q4 growth of +23% in functional neurosurgery disposables and +26% in biologics/drug delivery.

Why do ClearPoint Neuro (CLPT) comparable sales exclude IRRAflow in the year-over-year comparison?

IRRAflow was not part of the company product portfolio a year earlier and was only partially included in Q4 2025 after closing the acquisition.

When will ClearPoint Neuro (CLPT) release audited 2025 financial results?

Audited fourth quarter and full-year 2025 results will be publicly reported in Q1 2026 prior to the Form 10-K filing.