ClearPoint Neuro

What ClearPoint Neuro does

ClearPoint Neuro (NASDAQ: CLPT) is a publicly traded medical device company headquartered in Solana Beach, California, founded in 1998 (originally as MRI Interventions, Inc.). The company develops and commercializes MRI-guided stereotactic navigation platforms used in minimally invasive neurosurgical procedures, including deep brain stimulation (DBS), laser interstitial thermal therapy (LITT), biopsy, and direct drug and gene therapy delivery to the brain. Its product portfolio includes the FDA-cleared, CE-marked ClearPoint Neuro Navigation System, the SmartFlow Neuro Cannula (the first commercially approved device in the US and Europe for gene therapy delivery to the brain), the ClearPoint Prism Neuro Laser Therapy System for MRI-guided LITT, and complementary hardware platforms including the SmartFrame Array, SmartFrame OR, Maestro Brain Model, and Velocity Alpha MR Drill. In November 2025 the company acquired the IRRAflow System, extending its reach into adjacent neurosurgical fluid management technology.

The company generates revenue primarily through capital hardware sales to neurosurgical hospitals and academic medical centers, supplemented by consumable and accessory revenue per procedure. Its go-to-market is anchored in a finite universe of high-volume neurosurgical centers, with a growing commercialization vector through gene and cell therapy sponsors that use the SmartFlow cannula as a delivery device in clinical trials. The business model is hardware-led with an expanding recurring-revenue layer tied to per-case disposables and procedural volume.

Name

ClearPoint Neuro

Legal name

ClearPoint Neuro, Inc.

Website

https://clearpointneuro.com

Company type

Public

Founded year

1998

Operating status

Operating

Headcount range

101–250 employees

Short description

ClearPoint Neuro is a publicly traded medical device company (NASDAQ: CLPT) that develops MRI-guided stereotactic navigation systems, laser therapy, and cannulas for neurosurgical procedures, serving hospitals, academic centers, and gene therapy developers.

Ownership category

akta.pro rank

Product category

Neurosurgical Navigation & Drug Delivery Devices

NAICS

Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Neurogenetics & Rare Neurologic Diseases (HLAKAIAO)

akta.pro secondary industries

Neurology/CNS Gene Therapies (HLAAACAH), Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

Keywords

• Neurosurgical navigation platforms
• Stereotactic neurosurgery systems
• Convection-enhanced delivery
• Neuro laser therapy
• Intracranial pressure monitoring

Headquarters

HQ city

Solana Beach

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Marketing or Sales, Personnel, Operations, Infrastructure

Revenue model

1. Navigation System Hardware and Software: Sale of ClearPoint Neuro Navigation Systems including SmartFrame hardware, software licenses (v3.0, Array 1.2), and related capital equipment to hospitals and surgery centers
2. SmartFlow Cannula Sales: Sale of disposable SmartFlow cannulas for intraparenchymal drug delivery. Over 8,000 cannulas sold to date supporting 60+ investigational products. First device commercially approved in US and Europe for gene therapy delivery
3. IRRAflow System Products: Sale of IRRAflow Active Fluid Exchange Systems including control units, dual-lumen catheters, intelligent cassettes, and disposables for neurocritical care following November 2025 acquisition of IRRAS
4. ClearPoint Prism Laser System: Sale of ClearPoint Prism Neuro Laser Therapy Systems including mobile laser units, laser applicators, and disposables for neurosurgical ablation procedures
5. Pre-Clinical Services: Comprehensive preclinical translational services including neurosurgical consultation, study design, on-site support, case reporting, safety/toxicology studies, GLP/non-GLP studies, and regulatory support for biopharma partners
6. Software Licensing and Updates: Revenue from software licenses including ClearPoint Navigation Software, Array Software, and Maestro Brain Model software with version updates and upgrades

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels7 records

Core offering

ClearPoint Neuro develops and sells MRI-guided stereotactic neurosurgical navigation systems, disposables, and software that enable precise brain and spine procedures including electrode placement, laser ablation, biopsy, and intraparenchymal drug delivery. Its flagship products include the ClearPoint Neuro Navigation System, SmartFlow Neuro Cannula (the first commercially approved device for gene therapy delivery to the brain in the US and Europe), ClearPoint Prism Neuro Laser Therapy System, and the IRRAflow System for neurocritical care. The company also provides preclinical translational services to biopharma partners developing gene and cell therapies for CNS disorders.

Product overview

ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering a unified platform for precise navigation and delivery to the brain and spine. The core portfolio consists of the ClearPoint Neuro Navigation System (FDA-cleared and CE-marked MRI-guided stereotactic platform), the SmartFlow Neuro Cannula (first device approved in US and Europe for gene therapy delivery to brain parenchyma), and the ClearPoint Prism Neuro Laser Therapy System (MRI-guided LITT for brain tumors and epilepsy). Following the November 2025 acquisition of IRRAS Holdings, the portfolio expanded to include the IRRAflow System (active fluid exchange for neurocritical care). Add-on modules include the SmartFrame Array (multi-trajectory stereotactic frame), SmartFrame OR (operating room optical navigation platform), ClearPoint Maestro Brain Model (AI-powered segmentation software), and Pre-Clinical Orchestra Frame (pre-clinical research platform). The company serves 60+ biopharma partners across 90+ global neurosurgery centers, enabling drug delivery, neuromodulation, laser therapy, and biopsy procedures.

Differentiator

Problem solved

Functional benefit

Brands

• IRRAflow: Active fluid exchange system for intracranial pressure monitoring and CSF drainage in neurocritical care
• ClearPoint Prism
• SmartFlow
• SmartFrame OR
• SmartFrame Array
• Maestro Brain Model
• Pre-Clinical Orchestra Frame

Products and services

• ClearPoint Neuro Navigation System FDA-cleared and CE-marked MRI-guided stereotactic navigation platform for brain and spine procedures, providing real-time imaging guidance for electrode insertion, laser catheter placement, biopsy, and delivery of therapeutics to neurosurgeons and hospitals.
• SmartFlow Neuro Cannula MRI- and CT-compatible cannula for convection-enhanced delivery of biologics, gene therapy, and drugs directly to regions of interest in the brain, bypassing the blood-brain barrier. The first device commercially approved in the US and Europe for gene therapy delivery to brain parenchyma, used by biopharma partners and neurosurgeons.
• ClearPoint Prism Neuro Laser Therapy System

Quantifiable outcome

• Eleven consecutive years of revenue growth demonstrating sustained market traction
• +5 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature10 records

Partnerships

Eight partnerships are on record, tiered minor and core.

• Sungkyunkwan University (SONOCARELAB)minorStrategic or Co-development Partner · 27 May 202610-year focused ultrasound development partnership to develop blood-brain barrier drug delivery technology. Successfully demonstrated preclinical testing of intravenous delivery of large molecule tracers across blood-brain barrier using ClearPoint prototype system.
• IRRAS HoldingscoreStrategic or Co-development Partner · 20 November 2025ClearPoint Neuro completed acquisition of IRRAS Holdings in November 2025 for $5 million cash plus 1,325,000 shares. The acquisition expands ClearPoint into neurocritical care with IRRAflow technology for intracranial bleeding treatment and adds access to $0.5 billion global market. Revenue-sharing arrangement on specific IRRAS product sales.
• UCBminorStrategic or Co-development Partner · 1 May 2023Partnership with Belgium-based biopharmaceutical company UCB to enhance gene therapy delivery using ClearPoint's navigation technology for precise intracranial administration.
• Higgs Boson HealthminorGTM or Marketing Partner · 1 May 2022Collaboration to bring patient-facing digital application to market based on ManageMySurgery platform, specializing in drug delivery to brain/spine and BCI technology.
• Blackrock NeurotechminorStrategic or Co-development Partner · 1 July 2021Agreement to develop automated surgical solution for implanting brain-computer interfaces (BCIs) leveraging ClearPoint platform and software with Blackrock's Utah Array technology.
• UniQurecoreStrategic or Co-development PartnerUniQure uses ClearPoint's navigation system and SmartFlow cannula to administer AMT-130 gene therapy for Huntington's disease. AMT-130 could generate over $100 million in annual revenue for ClearPoint at peak if approved. BLA submission targeted for Q3 2026.
• PTC TherapeuticsminorStrategic or Co-development PartnerPTC Therapeutics uses ClearPoint SmartFlow cannula to deliver eladocagene exuparvovec gene therapy for AADC deficiency. First patient in Italy treated successfully at Policlinico Umberto I.
• Adeor Medical AGminorOEM/ Whitelabel/ Licensing PartnerGermany-based manufacturer of Velocity Alpha MR High Speed Surgical Drill System, distributed through ClearPoint. Drill operates at up to 80,000 rpm and integrates with SmartFrame navigation platform.

Scale indicators10 records

Recent moves4 records

Expansion highlights4 records

Emerging players

• AngioDynamics: AngioDynamics offers a portfolio including neurovascular and access devices. It is an adjacent emerging peer in neurointerventional and neurosurgical hardware, though less specialized in MRI-guided navigation.
• NovaBay Pharmaceuticals: NovaBay is a small-cap healthcare company developing products in ophthalmology and infectious disease. It is included as an emerging peer for capital markets and small-cap medtech comparability, though it operates in different therapeutic areas.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences provides a wide range of neurosurgical devices and instruments, including products used in neurosurgical procedures. It is a comparable specialty surgical and neurosurgery device player though not specialized in MRI-guided drug delivery.
• Stryker: Stryker's neurosurgery and spine portfolio (including navigation and surgical instruments) overlaps with ClearPoint's broader platform. As a large diversified medtech incumbent, Stryker competes on procurement, capital sales, and integrated OR solutions.
• Medtronic: Medtronic operates the StealthStation neurosurgery navigation platform and a broad DBS franchise, making it the most significant incumbent competitor. While not focused exclusively on MRI-guided delivery, Medtronic's installed base, capital, and hospital contracts represent a major competitive force.
• Varian (a Siemens Healthineers company): Varian, now part of Siemens Healthineers, provides radiotherapy, radiosurgery, and image-guided intervention platforms that overlap with neurosurgical precision navigation. As a large incumbent in image-guided therapy, it is a relevant adjacent peer for capital and platform comparisons.

Direct peers

• Renishaw: Renishaw's neuromate robotic stereotactic system competes directly in image-guided neurosurgery. While more focused on robotics than MRI-guided drug delivery, Renishaw is a relevant peer in the neurosurgical navigation category.
• Brainlab: Brainlab is a leading surgical navigation and planning software company with deep neurosurgery exposure. It directly competes with ClearPoint in image-guided neurosurgical navigation, with a broader product portfolio but less specialization in MRI-guided intraparenchymal drug delivery.
• Monteris Medical: Monteris Medical develops the NeuroBlate system for MRI-guided laser interstitial thermal therapy (LITT), directly competing with ClearPoint's ClearPoint Prism Neuro Laser Therapy System in neurosurgical ablation.

Regional players

• Penumbra: Penumbra is a neurovascular and stroke-focused device company that overlaps with ClearPoint's neurocritical care expansion via IRRAflow. While more focused on vascular thrombectomy, both companies address acute neurosurgical and neuro-ICU settings.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/ClearPointNeuro
• YouTubeyoutube.com/channel/UCm-c2HwZfw1kQtIeCDBziHw
• Facebookfacebook.com/ClearPointNeuro
• LinkedInlinkedin.com/company/mri-interventions-inc-
• Instagraminstagram.com/clearpointneuro

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Subsidiaries1 record

Funding overview

Funding rounds18 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ClearPoint Neuro