ClearPoint Neuro, Inc. operates as a medical device company primarily in the United States. The company develops and commercializes platforms for performing minimally invasive surgical procedures in the brain under direct, and intra-procedural magnetic resonance imaging (MRI) guidance. It offers ClearPoint system for the insertion of deep brain stimulation electrodes and biopsy needles, and the infusion of pharmaceuticals and laser catheters into the brain; and ClearPoint Neuro Navigation System, an MRI suite. It has license and collaboration agreements with Boston Scientific Corporation, The Johns Hopkins University, Clinical Laserthermia Systems Americas Inc, Koninklijke Philips N.V., Blackrock Neurotech, and University of California and San Francisco. The company was formerly known as MRI Interventions, Inc. and changed its name to ClearPoint Neuro, Inc. in February 2020. ClearPoint Neuro, Inc. was incorporated in 1998 and is headquartered in Solana Beach, California.
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Here are 1-3 brief analogies for ClearPoint Neuro (CLPT):
- Intuitive Surgical for brain interventions.
- The 'Intel Inside' for targeted brain therapies.
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- ClearPoint® Neuro Navigation System: An MRI-guided platform providing real-time visualization and precise trajectory guidance for minimally invasive neurosurgical procedures.
- SmartFrame® Array: A complementary stereotactic device designed for accurate instrument placement during deep brain procedures using the ClearPoint System.
- ClearPoint Prism™ System: Their next-generation MRI-guided neuro-navigation platform, offering advanced imaging and software features for improved procedural control.
- Drug Delivery Cannulas and Catheters: Specialized devices enabling precise, targeted delivery of biologics and gene therapies directly to specific regions within the brain.
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ClearPoint Neuro (CLPT) primarily sells its products and services to other companies and institutions, not directly to individuals.
According to its SEC filings (e.g., 2023 Form 10-K), ClearPoint Neuro does not have any single customer that accounts for 10% or more of its total revenue. Therefore, it does not have individually named "major customers" that dominate its sales. Instead, its customer base is diversified across several categories of institutions:
- Hospitals and Medical Centers: These institutions purchase ClearPoint's neuro-navigation systems (e.g., ClearPoint Neuro Navigation System, SmartFrame®) and related disposable products for use in advanced neurosurgical procedures, including functional neurosurgery, tumor biopsy, and gene/cell therapy delivery.
- University Research Institutions: These academic centers utilize ClearPoint's platforms for clinical research and development, particularly in the field of novel neurological therapies and advanced brain mapping.
- Pharmaceutical and Biotechnology Companies: ClearPoint Neuro collaborates with and sells its therapy delivery platforms and services to pharmaceutical and biotechnology companies. These companies leverage ClearPoint's technology for the precise, MRI-guided delivery of their investigational gene therapies, cell therapies, and other biologics into the brain during clinical trials for various neurological disorders. While specific names are not disclosed as major individual customers due to revenue diversification, ClearPoint Neuro has announced partnerships and collaborations with several publicly traded companies in this sector, which are their customers for these platforms. Examples of such companies include Sarepta Therapeutics (SRPT), Voyager Therapeutics (VYGR), uniQure (QURE), and Regeneron (REGN).
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Joseph M. Burnett, President & CEO
Joseph M. Burnett joined ClearPoint Neuro as President and Chief Executive Officer and became a member of its Board of Directors in November 2017. Before joining ClearPoint Neuro, Mr. Burnett served as Vice President and General Manager of Neuro Diagnostics and Therapy at Royal Philips, a publicly-traded global health technology company, since March 2016. Prior to that, he was the Senior Vice President and Business Leader of Image Guided Therapy Devices at Royal Philips and General Manager of Volcano Corporation (a Royal Philips company) from February 2015 to March 2016. Before Royal Philips' acquisition of Volcano in February 2015, he held various positions at Volcano from November 2004 to February 2015, most recently as Executive Vice President and General Manager of its Coronary & Systems Business Unit. Mr. Burnett also served as an R&D Engineer and Product Manager at Guidant Corporation from August 1999 to November 2004. He holds an MBA from The Fuqua School of Business at Duke University and a B.S.E. degree in Biomedical Engineering from Duke University.
Danilo D'Alessandro, Chief Financial Officer
Danilo D'Alessandro joined ClearPoint Neuro as Vice President of Finance in September 2020 and assumed the Chief Financial Officer position on January 1, 2021. Prior to joining ClearPoint Neuro, from April 2015 he served as the global Head of Finance for the Image Guided Therapy Devices Division at Royal Philips, a business unit representing cumulative inorganic investments of approximately $4 billion and more than 3,000 employees. From July 2011 to April 2015, Mr. D'Alessandro was part of the Corporate Mergers & Acquisitions function at Royal Philips, focusing on its Healthcare division. He has an extensive background in global corporate finance, financial planning and growth, and mergers & acquisitions (M&A). Mr. D'Alessandro completed an Undergraduate degree in Institutions and Financial Markets Management at Università Bocconi and a Master of Science in Accounting and Finance from the University of Bath.
Jeremy Stigall, Chief Business Officer
Jeremy L. Stigall joined ClearPoint Neuro in July 2020 as Vice President, Biologics and Drug Delivery, assumed the role of Executive Vice President and General Manager of Biologics & Drug Delivery in December 2022, and became Chief Business Officer in February 2024. He has over 20 years of experience in the medical device industry, starting his career at Guidant Corporation and Abbott Vascular, holding various positions within R&D, Engineering, and Operations. Mr. Stigall was responsible for the development and commercialization of several key stent delivery systems and drug-eluting stent platforms. He has also managed cross-functional groups at Volcano Corporation and Philips. Mr. Stigall played a key role in the acquisition of several companies which were integrated into the Philips strategic plan. He currently holds over 60 granted patents in the US.
Mazin Sabra, Chief Operations Officer
Mazin Sabra joined ClearPoint Neuro in October 2022. He has served as Vice President of Supplier Quality Engineering for Philips, a multinational health technology company, since April 2021, where he led a global team.
Ellisa Cholapranee, General Counsel
Ellisa Cholapranee serves as the General Counsel of ClearPoint Neuro.
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One clear emerging threat for ClearPoint Neuro (CLPT) is the increasing adoption and expansion of **Focused Ultrasound (FUS)** as a non-invasive treatment option for neurological disorders such as essential tremor and Parkinson's disease. FUS offers a non-surgical alternative for ablating targeted brain tissue, achieving similar therapeutic effects to some procedures currently guided by ClearPoint's system (e.g., lesioning or deep brain stimulation lead placement) but without the need for an incision or direct brain intervention. This technology, exemplified by devices like InSightec's Exablate Neuro, is gaining regulatory approvals, expanding its indications, and increasing its presence in treatment centers, potentially diverting patients from invasive or minimally invasive surgical procedures that would utilize ClearPoint's technology.
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ClearPoint Neuro (CLPT) operates in several key markets related to neurosurgical navigation and targeted drug delivery. The addressable market sizes for their main products and services are as follows:
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Neurosurgery Navigation Systems: The global surgical navigation systems market size is valued at approximately $9.53 billion in 2025 and is projected to reach $18.51 billion by 2030, with neurosurgery accounting for a significant share. Another estimate places the global neuro-navigation systems market at $3.13 billion in 2025, growing to $4.53 billion in 2029. North America holds a substantial portion of this market, with a 38.2% share in 2024.
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Biologics and Drug Delivery (including Cell and Gene Therapy): ClearPoint Neuro is positioned in the biological therapeutics delivery market. The company is targeting a substantial addressable market of over 30 million Americans suffering from neurological disorders, with an estimated market opportunity of $500 million by 2027, potentially growing to $10 billion by 2028 and beyond. The preclinical and clinical trial opportunity for drug delivery is estimated at approximately $300 million USD annually. The global image-guided drug delivery market is projected to reach $983 million by 2035, with neurology as the fastest-growing segment across North America, Europe, and Asia-Pacific.
- For Huntington's Disease (related to partner uniQure's AMT-130), a basic estimate for ClearPoint disposables per infusion, if uniQure targets 6,000 HD patients at launch, could represent a $90 million total addressable market (TAM). Approximately 41,000 Americans are symptomatic with Huntington's Disease.
- For Kebilidi (AADC deficiency gene therapy), the total addressable market has muted peak annual sales estimates of almost $275 million.
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IRRAflow System (Neurocritical Care for Intracranial Fluid Management): Through its acquisition of IRRAS Holdings, ClearPoint Neuro gains access to an existing market estimated at $0.5 billion globally, with approximately 400,000 procedures annually in the United States alone for conditions such as intracerebral hemorrhage and chronic subdural hematoma.
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Neuromodulation: While ClearPoint Neuro's systems are used in neuromodulation procedures like deep brain stimulation (DBS), the broader global neuromodulation market was valued at approximately $6.81 billion in 2025 and is projected to reach $10.68 billion by 2030. The U.S. neuromodulation market was estimated at $2.60 billion in 2024 and is projected to reach around $8.36 billion by 2034. ClearPoint estimates 120,000 Parkinson's disease and essential tremor patients per year are potential candidates for DBS utilizing their system.
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PRISM Laser Therapy System: The ClearPoint PRISM Neuro Laser Therapy System's recent FDA clearance for 1.5T MRI compatibility significantly expands its addressable market, opening up approximately 50% of the neuro-Laser Interstitial Thermal Therapy (LITT) market in the United States.
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ClearPoint Neuro (CLPT) is expected to drive future revenue growth over the next 2-3 years through several key initiatives and market expansions:
- Acquisition of IRRAS Holdings: The planned acquisition of IRRAS Holdings, Inc. is anticipated to significantly boost ClearPoint Neuro's market presence in neurocritical care, a global market estimated at $0.5 billion. This acquisition is projected to contribute to a combined 2026 revenue forecast of $54.0 million to $60.0 million. The deal adds IRRAS's IRRAflow system and more than 50 active customers to ClearPoint's portfolio.
- Growth in Biologics & Drug Delivery Segment and ClearPoint Advanced Laboratories (CAL): The Biologics & Drug Delivery segment remains a crucial long-term growth driver, with expectations for double-digit growth in the fourth quarter of 2025 and continued expansion through 2026 and 2027. The recent operational launch of ClearPoint Advanced Laboratories (CAL), a new preclinical and GLP-compliant facility, is set to increase capacity fivefold and enable higher-margin work, such as pivotal toxicology studies and expanded service offerings for biopharma clients.
- Expanded Market and Adoption of Neurosurgery Navigation & Therapy Products: Growth is expected from the continued strong adoption of the ClearPoint 3.0 operating room navigation software. Furthermore, the recent FDA clearance for 1.5T MRI compatibility for the ClearPoint PRISM Laser Therapy System meaningfully expands its addressable market by more than 50% in the neuro-LITT market, setting the stage for new installations and continued sales growth.
- Global Market Expansion and New Customer Activations: ClearPoint Neuro has expanded its regulatory clearances to 34 countries, including new approvals in Canada, Taiwan, and Hong Kong, which broadens its ability to standardize therapy delivery across multiple geographies and facilitate international trials. The company activated five new global customers during the third quarter of 2025.
- Development of a Robotic Neuro-Navigation System: The development of a prototype Robotic Neuro-Navigation System is a strategic initiative that positions ClearPoint Neuro with a unified software platform capable of deploying navigation across MRI, iCT, and Robotics modalities, aiming to enhance minimally invasive cranial surgeries and open new avenues for growth.
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Share Issuance
- In February 2021, ClearPoint Neuro completed a public offering of 2,127,660 shares of common stock, resulting in approximately $46.8 million in net proceeds to fund product development, research and development activities, working capital, and general corporate purposes.
- In May 2025, Oberland Capital purchased 275,808 shares of ClearPoint Neuro's common stock for approximately $3.5 million in gross proceeds.
- ClearPoint Neuro expects to issue 1,325,000 shares of common stock as part of the consideration for the acquisition of IRRAS Holdings, Inc., anticipated to close in Q4 2025, which is projected to result in approximately 4.7% dilution.
Inbound Investments
- In May 2025, ClearPoint Neuro entered into a financing agreement with Oberland Capital Management LLC for up to $105 million in note financing, with an initial $30 million funded at closing.
- The agreement with Oberland Capital includes options for ClearPoint Neuro to access an additional $25 million and a further $50 million in note financing prior to December 31, 2026.
- An additional $20 million in potential funding from Oberland Capital was secured, contingent upon the closing of the IRRAS acquisition.
Outbound Investments
- In November 2025, ClearPoint Neuro announced an agreement to acquire IRRAS Holdings, Inc., a medical technology company focused on neurocritical care, with the transaction expected to close in Q4 2025.
- The acquisition consideration includes $5 million in cash and 1,325,000 shares of ClearPoint Neuro common stock, along with future revenue share payments on certain IRRAS products.
- This strategic acquisition aims to expand ClearPoint Neuro's drug delivery portfolio, add new indications, and enhance commercial scale by bringing over 50 active customers and 10 additional patent families.
Capital Expenditures
- Capital expenditures for the last 12 months, ending June 2025, totaled approximately $736,000.
- The proceeds from the May 2025 financing agreement with Oberland Capital are intended for general corporate purposes, which may include capital expenditures, working capital, and administrative expenses.
- Research and development costs increased by $0.1 million, or 4%, for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to higher product and software development costs.