ClearPoint Neuro, Inc. - Global Leader in MRI-Guided Neurosurgery and CNS Drug Delivery

📢 Key Milestones (2025–2026):
   In November 2025, ClearPoint completed the acquisition of IRRAS Holdings, Inc., expanding into neurocritical care with the IRRAflow product line and adding approximately 40 U.S. commercial hires. In January 2026, the company received EU MDR Certification for ClearPoint Navigation Software Version 3.0.2, introducing intraoperative CT workflow capabilities. In April 2026, Health Canada approved the ClearPoint Neuro Navigation System for sale in Canada. FY2025 revenue reACHed a record $37.0 million (up 18% year-on-year), marking the eleventh consecutive year of growth.

Company Profile (Updated April 2026)

ClearPoint Neuro, Inc. (NASDAQ: CLPT) is a global medical device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The company was incorporated in 1998 as MRI Interventions, Inc. and changed its name to ClearPoint Neuro, Inc. in February 2020. Headquartered in Solana Beach, California, the company develops and commercializes platforms for performing minimally invasive surgical procedures in the brain under direct, intra-procedural magnetic resonance imaging (MRI) guidance.

ClearPoint Neuro uniquely provides both established clinical products and pre-clinical development services for controlled drug and device delivery. The company's flagship ClearPoint Neuro Navigation System has FDA clearance and CE marking and is used in healthcare and research centers across North America, Europe, Asia, and South America. The company has attracted more than 60 active biopharma partners, is currently supporting more than 25 global clinical trials, and more than 10 partner programs have been accepted to some form of FDA expedited regulatory review.

Development History:

- 1998: Incorporated as MRI Interventions, Inc.

- 2010: ClearPoint system received FDA 510(k) clearance for neuro-navigation procedures

- 2014: Expanded commercial operations and began building biopharma partnerships for CNS drug delivery

- 2020.02: Renamed ClearPoint Neuro, Inc. to reflect expanded focus on neurosurgery and biologics delivery

- 2021: Completed secondary public offering; expanded installed base to over 100 global centers

- 2023: Surpassed 5,000 procedures performed with ClearPoint system support

- 2024: Revenue grew 31% year-on-year to $31.4 million

- 2025.05: Annual meeting approved election of 8 directors, appointment of Cherry Bekaert LLP as independent auditor, Employee Stock Purchase Plan, and Sixth Amended Incentive Compensation Plan

- 2025.08: Opened ClearPoint-controlled CRO facility in Torrey Pines, San Diego, enabling larger, higher-value GLP and partner studies

- 2025.09: FDA cleared ClearPoint Prism® Neuro Laser Therapy System for expanded compatibility with 1.5T MRI scanners (in addition to previously cleared 3T); 1.5T systems account for approximately 60% of U.S. clinical use and over 70% of global installed MRI base

- 2025.09: Unveiled prototype of proprietary robotic neuro-navigation system at the 75th Annual Congress of Neurological Surgeons in Los Angeles

- 2025.09: Announced appointment of Dr. Paul Larson as Chief Medical Officer, effective January 2026

- 2025.11: Completed acquisition of IRRAS Holdings, Inc. for $5 million cash and 1,325,000 shares; entered into agreement to access an additional $20.0 million in funding under existing note financing arrangement with Oberland Capital

- 2026.01: Received EU MDR Certification for ClearPoint Navigation Software Version 3.0.2, unifying the global navigation platform with intraoperative CT and Cone-beam CT compatibility

- 2026.01: Dr. Paul Larson officially joined as Chief Medical Officer

- 2026.04: Received Health Canada approval for the ClearPoint Neuro Navigation System, expanding commercial footprint to Canada

Core Mission: To enAble precise navigation to the brain and spine, supporting minimally invasive neurosurgery, cell and gene therapy delivery, and advancing treatments for neurological diseases.

Core Product Portfolio

ClearPoint Neuro Navigation System

- ClearPoint System: Integrated MRI-guided neuro-navigation platform for the insertion of deep brain stimulation (DBS) electrodes, biopsy needles, laser catheters, and infusion of pharmaceuticals into the brain

- SmartFrame XG Stereotactic Frame: Provides precise stereotactic guidance for instrument placement during neurosurgical procedures including biopsies, catheter and electrode insertion (asleep or awake DBS lead placement)

- ClearPoint Navigation Software Version 3.0.2: Latest software platform unifying global navigation; introduces intraoperative CT and Cone-beam CT workflow capabilities alongside traditional MRI guidance; EU MDR certified January 2026

Biologics & Drug Delivery Services

- Pre-Commercial Drug Delivery: Development services for controlled drug and device delivery to the central nervous system (CNS) for biopharma partners

- Cell and Gene Therapy Enabling: Supports more than 25 global clinical trials for direct CNS delivery of therapeutics in preclinical studies and clinical trials

- CRO Facility (Torrey Pines): ClearPoint-controlled facility operational since August 2025, enabling larger, higher-value GLP and partner studies

Neurocritical Care (IRRAS Product Line)

- IRRAflow: Integrated irrigation and aspiration system for the treatment of intracranial bleeding; acquired through IRRAS Holdings, Inc. in November 2025

- Neurocritical Fluid Management: Expands ClearPoint's portfolio into cranial irrigation and aspiration for traumatic brain injury and hemorrhagic stroke

Laser Therapy & Access

- ClearPoint Prism® Neuro Laser Therapy System: MRI-guided laser interstitial thermal therapy (LITT) for brain tumors and epilepsy; FDA cleared for both 1.5T and 3T MRI guidance (September 2025)

- Procedural Support: Field-based clinical specialist team offering support and services to customers and partners worldwide

Financial Performance

FY2025 Results (Year Ended December 31, 2025)

Total Revenue: $37.0 million (up 18% year-on-year; up 14% organic growth); eleventh consecutive year of growth

- Product Revenue: $23.9 million

- Service and Other Revenue: $13.1 million (including $1.2 million from IRRAS in Q4)

Q4 2025 Revenue: $10.4 million (up 34% overall, up 19% organic year-on-year)

Gross Profit: $22.7 million; Gross Margin: ~61.4%

Operating Loss: $(24.2) million

Net Loss: $(26.0) million

Basic and Diluted Loss Per Share: $(0.91)

Cash and Cash Equivalents: $45.9 million (as of December 31, 2025)

FY2024 Results (Year Ended December 31, 2024)

Total Revenue: $31.4 million (up 31% year-on-year)

Net Loss: $(18.9) million

Basic and Diluted Loss Per Share: $(0.70)

2026 Outlook

- Revenue Guidance: $54 million – $60 million (including IRRAS integration and organic growth across all four product segments)

- Key Growth Drivers: Pre-commercial drug delivery products and services; neurosurgery navigation and robotics; laser therapy and access; neurocritical fluid management

Company Overview

Corporate Information

Legal Name: ClearPoint Neuro, Inc.

Former Name: MRI Interventions, Inc. (until February 2020)

Founded: 1998

Headquarters: Solana Beach, California, USA

Stock Exchange: NASDAQ

Stock Code: CLPT

Company Type: Public listed company

Industry: Medical Devices / Neurosurgery / CNS Drug Delivery

Employees: 172 (as of December 31, 2025; up 49.6% from 115 in 2024)

Market Cap: ~$444 million (as of early 2026)

52-Week Range: $9.76 – $30.10

Website: www.clearpointneuro.com

Leadership Team

President, CEO & Director: Joseph Michael Burnett (age 47; appointed November 2017; total compensation ~$2.53 million; directly owns 1.05% of company shares)

- Leads the company's "Fast. Forward." growth strategy; previously Vice President and General Manager of Neuro Diagnostics and Therapy at Philips, and Executive Vice President at Volcano Corporation

Chief Financial Officer: Danilo D'Alessandro (age 39; appointed September 2020; compensation ~$1.17 million; owns 0.35% of shares)

- Previously global Head of Finance for Philips Image Guided Therapy Devices Division

Chief Business Officer: Jeremy L. Stigall (age 40; compensation ~$1.13 million; owns 0.25% of shares)

Chief Operating Officer: Mazin Sabra (age 44; owns 0.23% of shares)

Chief Medical Officer: Dr. Paul Larson, M.D. (appointed September 2025; effective January 2026)

- Longstanding ClearPoint advisor; personally performed or overseen more than 100 cell and gene therapy clinical procedures; maintains appointments at UCSF and Banner Hospital, University of Arizona

General Counsel & Secretary: Ellisa Cholapranee, J.D.

Senior Vice President of Sales & Business Development: Robert Korn (appointed 2025)

Senior Vice President of Regulatory Affairs: Mary McNamara-Cullinane (appointed 2025)

Senior Vice President of Quality: Megan Faulkenberry (appointed 2025)

Global Market Presence & Partnerships

Installed Base

- Global Centers: More than 150 healthcare and research centers worldwide

- Geographic Reach: North America, Europe, Asia, South America, and Canada (approved April 2026)

- Procedures: Thousands of procedures performed and supported by the company's field-based clinical specialist team

Key Biopharma Partners

- Active Partners: More than 60 biopharma companies

- Clinical Trials: Supporting more than 25 global clinical trials

- FDA Expedited Programs: More than 10 partner programs accepted to some form of FDA expedited regulatory review (Fast Track, Breakthrough Therapy, etc.)

- uniQure / AMT-130: Strategic partner for Huntington's disease gene therapy delivery; estimated $20,000 worth of ClearPoint disposables per infusion; potential peak market of 30,000 U.S. patients

Strategic Collaborations

- Clinical Laserthermia Systems AB: License and collaboration agreement

- Koninklijke Philips N.V.: License and research agreement

- UCB Biopharma SRL: Partnership

- NE Scientific, LLC: Collaboration

- University of California, San Francisco (UCSF): Research agreement

- Johns Hopkins University: Research agreement

- Oberland Capital: Note financing arrangement providing up to $20 million additional funding

Key Competitors

- Medtronic: Global leader in DBS and neurosurgery navigation

- Boston Scientific: DBS and neuro-interventional devices

- Abbott (formerly St. Jude Medical): DBS systems and neurosurgery platforms

- Brainlab: Neurosurgery navigation and robotics

- Renishaw: NeuroMate robotic system for stereotactic neurosurgery

Competitive Advantages

- MRI-Guided Precision: Only commercially available platform enabling real-time intra-procedural MRI guidance for deep brain procedures

- Biopharma Ecosystem: Unique position as the leADINg enabler of CNS drug delivery for cell and gene therapy partners

- Integrated Platform: Combines navigation hardware, software, and disposable instruments with drug delivery services

- Expanding Indications: From DBS and biopsy to laser ablation, drug infusion, and now neurocritical care (via IRRAS)

- Clinical Validation: Thousands of procedures performed with strong safety and efficacy data

2026 Strategic Outlook

- "Fast. Forward." Strategy: Penetrate existing $1 billion aggregate market across four product segments — pre-commercial drug delivery, neurosurgery navigation and robotics, laser therapy and access, and neurocritical fluid management

- IRRAS Integration: Fully integrate IRRAflow product line and commercial team to drive neurocritical care revenue

- Robotics Development: Advance proprietary robotic neuro-navigation system from prototype to commercial launch

- Global Expansion: Leverage EU MDR certification and Health Canada approval to expand European and Canadian market presence

- CRO Services Growth: Scale Torrey Pines CRO facility to capture larger, higher-value GLP and partner studies

- AMT-130 Catalyst: Support uniQure's AMT-130 Huntington's gene therapy program targeting potential FDA approval around end of 2026

- Long-Term Vision ("Essential Everywhere"): Create a $10B+ addressable neuro drug delivery market alongside biopharma partners as cell and gene therapies commercialize

Contact Information

Global Headquarters

Address: Solana Beach, California, USA

Phone: +1 (888) 287-9109

Website: www.clearpointneuro.com

Investor Relations

Contact: Danilo D'Alessandro, Chief Financial Officer

Phone: +1 (888) 287-9109 ext. 3

Email: ir@clearpointneuro.com

Investor Website: ir.clearpointneuro.com

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