ClearPoint Neuro Receives CE Mark for Velocity Alpha MR Surgical Drill System
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
ClearPoint Neuro announced that the Velocity Alpha MR High Speed Surgical Drill System has received CE Marking in addition to the existing FDA 510(k) clearance in the United States.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CLPT?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on CLPT
Wall Street analysts forecast CLPT stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 11.700
Low
28.00
Averages
29.00
High
30.00
Current: 11.700
Low
28.00
Averages
29.00
High
30.00
About CLPT
ClearPoint Neuro, Inc. is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. It provides both clinical products as well as pre-clinical development services for controlled drug and device delivery. Its flagship product is the ClearPoint Neuro Navigation System. It is engaged with healthcare and research centers in North America, Europe, Asia, and South America. Its primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software. Its ClearPoint Prism Neuro Laser Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy for neuro applications under 3.0T magnetic resonance imaging (MRI) guidance. It provides solutions for direct CNS delivery of therapeutics in preclinical studies and clinical trials worldwide. It also offers IRRAflow active fluid-exchange system.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
ClearPoint Neuro Reports Record Q1 2026 Revenue Amid Integration Progress
- Record Revenue: ClearPoint Neuro achieved a record revenue of $12.1 million in Q1 2026, representing a 43% year-over-year increase, with organic device growth of 25%, indicating strong performance in the neurosurgery navigation market and potential for increased market share.
- Acquisition Integration Progress: The majority of post-merger integration costs from the IRRAS acquisition were completed in Q1, with management stating that significant revenue and cost synergies will continue, and operational cash burn is expected to decrease in the coming quarters, enhancing financial stability.
- FDA New Product Approval: The company received FDA clearance for the Velocity Alpha MR high-speed surgical drill system and CE marking in Europe, marking an expansion of its product line and expected to provide strong support for future revenue growth.
- 2026 Outlook: Management expects revenue for 2026 to be in the range of $52 million to $56 million, with all four business segments anticipated to grow in double digits, reflecting confidence in future market demand.
See More
ClearPoint Neuro Q1 Earnings Beat Expectations Despite EPS Miss
- Earnings Highlights: ClearPoint Neuro reported a Q1 GAAP EPS of -$0.32, missing estimates by $0.05, yet revenue reached $12.13 million, a 42.9% year-over-year increase, surpassing expectations by $0.16 million, indicating strong growth potential in the market.
- Cash Flow Status: As of March 31, 2026, the company had cash and cash equivalents totaling $35.6 million, down from $45.9 million at December 31, 2025, primarily due to $8.0 million in cash used for operating activities and $2.0 million in tax payments related to equity awards, reflecting pressure on cash management.
- Acquisition Synergies: The company anticipates that cost synergies from the acquisition of IRRAS will contribute to a reduction in cash burn in the second half of 2026, believing that asset integration could potentially be cash neutral for the full year 2027, demonstrating confidence in future financial health.
- Business Outlook: ClearPoint Neuro estimates revenue for 2026 to be between $52.0 million and $56.0 million, below the analyst consensus of $53.3 million; nevertheless, the company's long-term outlook remains optimistic, showcasing its competitive position in the industry.
See More
ClearPoint Neuro Q1 Earnings Announcement Scheduled
- Earnings Announcement Date: ClearPoint Neuro, Inc. is set to announce its Q1 earnings on May 13th after market close, with a consensus EPS estimate of -$0.27 and a revenue estimate of $11.97 million, indicating challenges in profitability.
- Earnings Estimate Revisions: Over the past three months, there have been no upward revisions to EPS estimates, with two downward adjustments, while revenue estimates also saw no upward revisions and two downward changes, reflecting market caution regarding the company's short-term performance.
- Long-Term Outlook: Despite facing temporary headwinds, ClearPoint Neuro has outlined a revenue target of $52 million to $56 million for 2026, demonstrating the company's commitment to advancing its growth strategy and integrating the IRRAS acquisition.
- Market Reaction: The company's FY26 guidance fell below analysts' estimates, leading to a significant drop in stock price, highlighting investor concerns about the company's future performance.
See More
ClearPoint Neuro and UniQure Stocks Surge Following WSJ Report on Trump's Potential Plan to Dismiss FDA Commissioner Marty Makary
Company Overview: ClearPoint Neuro and Uniqure are involved in the biotechnology sector, focusing on innovative solutions in neurotechnology.
Market Reaction: Shares of ClearPoint Neuro have seen a significant increase following reports from the Wall Street Journal regarding potential changes in leadership at the FDA.
Leadership Changes: The reports suggest that former President Trump is considering firing FDA Commissioner Marty Makary, which has implications for regulatory processes in the biotech industry.
Investor Sentiment: The news has sparked interest among investors, leading to a spike in ClearPoint Neuro's stock prices as market participants react to the potential shifts in FDA oversight.
See More
ClearPoint Neuro Completes First Clinical Procedure with New Surgical Drill
- Successful Clinical Procedure: ClearPoint Neuro has successfully completed its first clinical procedure utilizing the Velocity Alpha MR High Speed Surgical Drill System, marking the device's potential application in multi-trajectory clinical trials and enhancing the company's support capabilities for partnered biologics projects.
- Technological Innovation: Manufactured by Germany's adeor medical AG, the drill system is designed to optimize ClearPoint procedures' efficiency, capable of cutting and removing soft and hard tissue in magnetic fields of up to 3.0 Tesla, thereby improving operational efficiency in the operating room.
- Market Expansion Potential: The integration of the new system with ClearPoint's SmartFrame navigation platform is expected to reduce procedure times in neurosurgery, supporting complex therapeutic workflows and driving the company's growth in clinical trials and commercial applications.
- Strategic Partnership: The collaboration between ClearPoint and adeor medical AG is further solidified, as both companies are committed to enhancing surgical workflow efficiency, which is anticipated to drive market acceptance and commercialization of new products.
See More
ClearPoint Neuro's FY26 Revenue Guidance Falls Short of Expectations
- Significant Stock Decline: ClearPoint Neuro's stock plummeted 14.78% to $9.51 on Wednesday, primarily due to FY26 revenue guidance falling short of analysts' expectations, indicating market concerns about the company's future growth prospects.
- Strong Earnings but Dim Outlook: While the company reported fourth-quarter revenue of $10.4 million, exceeding analyst projections, and an 18% year-over-year revenue increase to $36.97 million, the FY26 revenue midpoint of $54 million was below the consensus of $55.50 million, highlighting uncertainty in future growth.
- Rising Costs Impacting Profitability: The company achieved a gross margin of 62% in the fourth quarter; however, operating expenses surged to $13.4 million, driven mainly by the acquisition of IRRAS and increased professional service fees, which may affect future profitability.
- Growth Strategy Amid Market Reaction: Despite ClearPoint's expectation for double-digit growth across all major product lines and capital equipment in FY26, investor confidence has waned due to concerns over the integration of IRRAS and the progress of FDA approvals.
See More
ClearPoint Neuro Reports Record Q1 2026 Revenue Amid Integration Progress
- Record Revenue: ClearPoint Neuro achieved a record revenue of $12.1 million in Q1 2026, representing a 43% year-over-year increase, with organic device growth of 25%, indicating strong performance in the neurosurgery navigation market and potential for increased market share.
- Acquisition Integration Progress: The majority of post-merger integration costs from the IRRAS acquisition were completed in Q1, with management stating that significant revenue and cost synergies will continue, and operational cash burn is expected to decrease in the coming quarters, enhancing financial stability.
- FDA New Product Approval: The company received FDA clearance for the Velocity Alpha MR high-speed surgical drill system and CE marking in Europe, marking an expansion of its product line and expected to provide strong support for future revenue growth.
- 2026 Outlook: Management expects revenue for 2026 to be in the range of $52 million to $56 million, with all four business segments anticipated to grow in double digits, reflecting confidence in future market demand.
See More
ClearPoint Neuro Q1 Earnings Beat Expectations Despite EPS Miss
- Earnings Highlights: ClearPoint Neuro reported a Q1 GAAP EPS of -$0.32, missing estimates by $0.05, yet revenue reached $12.13 million, a 42.9% year-over-year increase, surpassing expectations by $0.16 million, indicating strong growth potential in the market.
- Cash Flow Status: As of March 31, 2026, the company had cash and cash equivalents totaling $35.6 million, down from $45.9 million at December 31, 2025, primarily due to $8.0 million in cash used for operating activities and $2.0 million in tax payments related to equity awards, reflecting pressure on cash management.
- Acquisition Synergies: The company anticipates that cost synergies from the acquisition of IRRAS will contribute to a reduction in cash burn in the second half of 2026, believing that asset integration could potentially be cash neutral for the full year 2027, demonstrating confidence in future financial health.
- Business Outlook: ClearPoint Neuro estimates revenue for 2026 to be between $52.0 million and $56.0 million, below the analyst consensus of $53.3 million; nevertheless, the company's long-term outlook remains optimistic, showcasing its competitive position in the industry.
See More
ClearPoint Neuro Q1 Earnings Announcement Scheduled
- Earnings Announcement Date: ClearPoint Neuro, Inc. is set to announce its Q1 earnings on May 13th after market close, with a consensus EPS estimate of -$0.27 and a revenue estimate of $11.97 million, indicating challenges in profitability.
- Earnings Estimate Revisions: Over the past three months, there have been no upward revisions to EPS estimates, with two downward adjustments, while revenue estimates also saw no upward revisions and two downward changes, reflecting market caution regarding the company's short-term performance.
- Long-Term Outlook: Despite facing temporary headwinds, ClearPoint Neuro has outlined a revenue target of $52 million to $56 million for 2026, demonstrating the company's commitment to advancing its growth strategy and integrating the IRRAS acquisition.
- Market Reaction: The company's FY26 guidance fell below analysts' estimates, leading to a significant drop in stock price, highlighting investor concerns about the company's future performance.
See More
ClearPoint Neuro and UniQure Stocks Surge Following WSJ Report on Trump's Potential Plan to Dismiss FDA Commissioner Marty Makary
Company Overview: ClearPoint Neuro and Uniqure are involved in the biotechnology sector, focusing on innovative solutions in neurotechnology.
Market Reaction: Shares of ClearPoint Neuro have seen a significant increase following reports from the Wall Street Journal regarding potential changes in leadership at the FDA.
Leadership Changes: The reports suggest that former President Trump is considering firing FDA Commissioner Marty Makary, which has implications for regulatory processes in the biotech industry.
Investor Sentiment: The news has sparked interest among investors, leading to a spike in ClearPoint Neuro's stock prices as market participants react to the potential shifts in FDA oversight.
See More
ClearPoint Neuro Completes First Clinical Procedure with New Surgical Drill
- Successful Clinical Procedure: ClearPoint Neuro has successfully completed its first clinical procedure utilizing the Velocity Alpha MR High Speed Surgical Drill System, marking the device's potential application in multi-trajectory clinical trials and enhancing the company's support capabilities for partnered biologics projects.
- Technological Innovation: Manufactured by Germany's adeor medical AG, the drill system is designed to optimize ClearPoint procedures' efficiency, capable of cutting and removing soft and hard tissue in magnetic fields of up to 3.0 Tesla, thereby improving operational efficiency in the operating room.
- Market Expansion Potential: The integration of the new system with ClearPoint's SmartFrame navigation platform is expected to reduce procedure times in neurosurgery, supporting complex therapeutic workflows and driving the company's growth in clinical trials and commercial applications.
- Strategic Partnership: The collaboration between ClearPoint and adeor medical AG is further solidified, as both companies are committed to enhancing surgical workflow efficiency, which is anticipated to drive market acceptance and commercialization of new products.
See More
ClearPoint Neuro's FY26 Revenue Guidance Falls Short of Expectations
- Significant Stock Decline: ClearPoint Neuro's stock plummeted 14.78% to $9.51 on Wednesday, primarily due to FY26 revenue guidance falling short of analysts' expectations, indicating market concerns about the company's future growth prospects.
- Strong Earnings but Dim Outlook: While the company reported fourth-quarter revenue of $10.4 million, exceeding analyst projections, and an 18% year-over-year revenue increase to $36.97 million, the FY26 revenue midpoint of $54 million was below the consensus of $55.50 million, highlighting uncertainty in future growth.
- Rising Costs Impacting Profitability: The company achieved a gross margin of 62% in the fourth quarter; however, operating expenses surged to $13.4 million, driven mainly by the acquisition of IRRAS and increased professional service fees, which may affect future profitability.
- Growth Strategy Amid Market Reaction: Despite ClearPoint's expectation for double-digit growth across all major product lines and capital equipment in FY26, investor confidence has waned due to concerns over the integration of IRRAS and the progress of FDA approvals.
See More
