ClearPoint Neuro, Inc.

ClearPoint Neuro, Inc. operates as a commercial-stage medical device company that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain. The company's business consists of two integrated components: a business providing medical devices for neurosurgical applications, and a business focused on partnerships in the biologics and drug delivery space. The primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software, with primary applications to target and guide the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters, as well as the infusion of pharmaceuticals into the brain. In 2025, through the acquisition of IRRAS Holdings, Inc., the company expanded its portfolio into neurocritical care, focusing on treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management. The biologics and drug delivery component supports customers from earliest stages of research through clinical study and commercialization, with a core competency of in vivo biology services in large and small research models.

The company faces competition from larger, well-established companies such as Monteris Medical, Inc. and Medtronic, which offer devices for laser ablation under direct MRI guidance, as well as Brainlab, Medtronic, Elekta, FHC Inc., Integra LifeSciences Holdings Corporation, and Neurologica Corporation for conventional stereotactic neurosurgical procedures. Zimmer Biomet Holdings, Inc.'s ROSA robot is an operating room alternative to the ClearPoint system. In the neurocritical care market following the IRRAS acquisition, key competitors include Medtronic plc, Spiegelberg GmbH & Co. KG, Sophysa, B. Braun, and Integra LifeSciences. For biologics and drug delivery, companies such as Brainlab and Renishaw plc offer navigational platforms and cannulas useful for drug delivery under MRI. The company's competitive advantages include its integrated ClearPoint system, the SmartFlow Neuro cannula which received De Novo marketing authorization for intraputaminal administration of eladocagene exuparvovec-tneq for AADC deficiency, and its growing portfolio of over 60 pharma/biotech, academic, and contract research organization partners.

The company generates revenue through two integrated components: medical devices for neurosurgical applications and biologics and drug delivery partnerships. Revenue from medical devices includes sales of disposable components, reusable hardware, and software, with a business model focused on producing high margin revenue from sales of disposable components while selling reusable components at lower margins to secure hospital installations. The company may install ClearPoint reusable components at a hospital but retain title for an agreed-upon period while the hospital evaluates the purchase opportunity, for a rental fee, or for a placement fee bundled into the price of a disposable products stocking order. For the IRRA flow system, recurring revenue is generated primarily through disposable catheters and procedure-specific consumables, while the control unit serves as durable capital equipment placed within hospitals. The biologics and drug delivery business generates revenue through preclinical studies, clinical trial support, regulatory consultation, device development services, surgical workflow guidance, and diversified partnership arrangements, including event-based payments subject to customer achievement of specified development and regulatory milestones.

The company's product portfolio includes the ClearPoint system, which consists of hardware components including a head fixation frame, computer workstation and in-room monitor, disposable components including the SmartFrame trajectory device, hand controller, SmartFlow Neuro cannula, SmartGrid patch, and customized surgical draping, and menu-driven software that guides surgical planning, device alignment, navigation to target, and procedure monitoring. The ClearPoint Prism Neuro Laser Therapy System, developed and manufactured by CLS with exclusive global rights for neuro applications, is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy for neuro applications under 1.5T and 3.0T MRI guidance. The IRRA flow system, added through the IRRAS acquisition, integrates continuous irrigation, drainage, and real-time intracranial pressure monitoring to provide controlled, automated intracranial fluid management within neurocritical care and operating room settings, consisting of a control unit, proprietary dual-lumen catheters, and procedure-specific disposables. The company also provides consulting services for improving outcome predictability and optimizing preclinical and clinical workflows, with expertise concentrated in benchtop testing, preclinical studies, clinical trial support, regulatory consultation, and translation from preclinical to clinical settings.

In 2025, the company completed the acquisition of IRRAS Holdings, Inc., which brought the IRRA flow active fluid-exchange system into the product portfolio. The company entered into a debt financing arrangement with an affiliate of Oberland Capital Management under which it may borrow up to $105.0 million ¹ from time to time in tranches, raising approximately $48.1 million ² in net proceeds under this arrangement during 2025. The company raised approximately $3.3 million ³ in net proceeds from the sale of shares of its common stock to an affiliate of Oberland Capital Management. The company entered into a lease for a new preclinical research facility named ClearPoint Advanced Laboratories located in San Diego, California, allowing for additional capacity to perform larger studies and offer additional services to biopharma partners. Several of the company's partners advanced through preclinical and clinical review, with over ten pharmaceutical partners receiving expedited US FDA review designations. The company received FDA Clearance for the ClearPoint 3.0 Software which includes both operating room navigation capability and features enhanced for laser therapy applications, FDA 510(k) clearance expanding compatibility of the ClearPoint PRISM Neuro Laser Therapy System with 1.5T scanners in addition to the previously cleared 3T compatible system, European Medical Device Regulation certification for the SmartFlow Neuro Cannula, and several expanded regulatory approvals for product use in Canada, Hong Kong, and Taiwan, bringing the total number of international clearances for key therapy delivery products to 34 countries worldwide.

Total revenue for the year ended December 31, 2025 was approximately $37.0 million ⁴, compared to $31.4 million ⁵ for the year ended December 31, 2024, representing an increase of 18% ⁶. Product revenue was approximately $23.9 million ⁷ for 2025 compared to $18.6 million ⁸ for 2024, and service and other revenue was approximately $13.1 million ⁹ for 2025 compared to $12.8 million ¹⁰ for 2024. Gross profit was $22.7 million ¹¹ for 2025 compared to $19.1 million ¹² for 2024, with gross margin of 61% ¹³ for both years. Net loss was $25.5 million ¹⁴ for 2025 compared to $18.9 million ¹⁵ for 2024, an increase of 35% ¹⁶. Basic and diluted net loss per share was $0.90 ¹⁷ for 2025 compared to $0.70 ¹⁸ for 2024.

The biologics and drug delivery business potentially represents the largest opportunity for growth, dependent on the company's ability to maintain and establish new relationships with pharmaceutical company customers, such customers' continuation of research and product development plans, achievement of success in completion of clinical trials and subsequent regulatory approvals of their drugs and biologics, and realization of commercial success for their therapies including overcoming barriers in reimbursement, physician adoption, and patient access. The company currently has more than 60 pharma/biotech, academic, and contract research organization partners who are evaluating or using its products and services in trials to inject gene and cell therapies directly into the brain, involving drug development programs at various stages from preclinical research to late-stage regulatory trials for multiple distinct disease states. In 2024, the FDA granted marketing authorization for the SmartFlow Neuro cannula to be used to deliver a gene therapy for the treatment of aromatic L-amino acid decarboxylase deficiency directly to regions of interest within the brain. The company may in the future seek new or expanded indications for use of the IRRA flow system, including indications related to subdural hematomas, extended-duration infusions, oncology, or intracranial drug delivery.

The company's growth also depends on expanding the installed base and procedure volumes for both the ClearPoint system and the IRRA flow system. Following the acquisition of IRRAS, the combined commercial organization is responsible for promoting both systems across two distinct clinical settings with different decision-makers, clinical priorities, and procurement pathways. The company has relatively limited experience marketing and selling the ClearPoint system in the operating room environment, having launched the SmartFrame Array Neuro Navigation System and Software in 2021, the SmartFrame OR Stereotactic System in 2024, and the ClearPoint Navigation Software Version 3.0 in 2025. The company's future business prospects also depend on its ability to develop and commercialize new products and services, such as the company's proprietary robotic neuro-navigation system, and to complete research and development initiatives related to the IRRA flow system including enhancements to its workflow, expansion of its labelling, and potential design modifications or product improvements necessary to expand clinical use or improve adoption in neurocritical care settings.

The IRRAS acquisition is expected to impact cost of revenue and reduce overall gross margins in the near term as IRRA flow currently operates at sub-scale production levels, resulting in higher per-unit manufacturing costs compared to the existing product portfolio. The company expects increases in sales and marketing expenses as a result of the larger combined sales organization, primarily reflecting higher salary and personnel-related costs associated with the larger commercial team following the IRRAS acquisition. The company anticipates increases in operating expenses over the next twelve months to support commercialization activities, with corresponding decreases in operating losses and cash used in operations, though there can be no assurance that these results will be achieved.

The company's internal manufacturing operations are generally conducted at single locations, with final assembly of many ClearPoint system components occurring at its Carlsbad, California facility, and manufacturing of the reusable control unit and hardware for the IRRA flow system performed at a San Diego, California facility acquired through the IRRAS acquisition. The company's biologics and drug delivery research and development service capabilities are performed at a single facility in San Diego, California, and the company does not maintain a backup site for performance of these services. In 2025, the company entered into a lease of approximately 30,000 square feet ¹⁹ of space within a life science building in San Diego, California to perform research and development services for pharmaceutical and biotech customers. The company relies on single-source suppliers for many components, component assemblies, and finished products, including the catheter and other procedure-specific disposables used with the IRRA flow system, which are sourced from third-party manufacturers under master service agreements.

The company's research and development costs were $13.9 million ²⁰ for the year ended December 31, 2025, compared to $12.4 million ²¹ for the year ended December 31, 2024. The company anticipates that over time, research and development costs may increase as it develops devices and services for delivery of therapeutics into the central nervous system, expands products into the OR and therapeutics space, expands the application of its technological platforms internationally, and invests in the IRRA flow product portfolio and clinical evidence. As of December 31, 2025, the company had $50.9 million ²² in notes payable to the 2025 Investor due in 2031, with future interest payments variable based on the greater of Term SOFR and 4.30% ²³ plus 3.95% ²⁴, with a minimum rate of 8.25% ²⁵ and a cap of 9.50% ²⁶. At current interest rates, the company expects interest payments for the next 12 months to be approximately $2.5 million ²⁷. The company has an at-the-market equity offering program under which it may offer and sell shares of common stock having aggregate sales proceeds of up to $50 million ²⁸, though as of December 31, 2025, no shares had been sold under this program.

The company faces structural headwinds including general economic and financial market conditions such as persistent inflationary pressure, higher interest rates, changes in monetary policy, declining consumer and business confidence and spending, supply chain disruptions, the introduction of or changes in tariffs or trade barriers, and the potential for global or local recession. Geopolitical changes and trends such as populism, protectionism, economic nationalism, as well as tariffs, sanctions, and other trade restrictions may become disruptive and costly to the business. The company's hospital, pharmaceutical, and biotechnology customers may experience heightened financial and operational pressures as a result of macroeconomic conditions, including increased cost of funding, reduced access to capital markets, cash flow challenges, or difficulties complying with debt covenants, which could impede hospital customers' ability to provide patient care or reduce budgets for new capital equipment and technologies. Government funding cuts have further constrained hospital and healthcare system budgets, which may limit their ability to invest in new technologies and slow adoption of the company's products.

The company may fail to realize the anticipated benefits of its acquisition of IRRAS, and the combined company may not perform as expected, with risks including integrating operations, systems, technologies, and personnel being complex, costly, and time-consuming, and key employees of either company may choose not to remain. The company has incurred losses since its inception in 1998, with a cumulative net loss of approximately $216.9 million ²⁹ through December 31, 2025, and net cash used in operations was $23.9 million ³⁰ for the year ended December 31, 2025, and the company may never achieve or sustain profitability. The company has significant debt with $50.9 million ³¹ in notes payable as of December 31, 2025 under the 2025 NPA, which includes affirmative and negative covenants that may limit the company's ability to create liens, incur additional indebtedness, make investments, make acquisitions, and sell property, and in the event of default, lenders would be entitled to accelerate the debt. The company relies on single facilities for manufacturing and performance of services, with final assembly of ClearPoint system components at its Carlsbad, California facility and manufacturing of the IRRA flow control unit at a San Diego, California facility, both located in areas at risk of serious fires, power outages, and earthquakes, and the company does not maintain backup manufacturing facilities. The company's reliance on single-source suppliers for components, including the catheter and other procedure-specific disposables used with the IRRA flow system and the ClearPoint Prism Neuro Laser Therapy System supplied by CLS, could harm the company's ability to meet demand for products in a timely manner or within budget.

Management's message emphasizes the company's transformation through the acquisition of IRRAS, which expanded the portfolio into neurocritical care and broadened the company's reach into acute care settings, enabling an expanded set of solutions spanning functional neurosurgery, neurocritical care, and intracranial drug delivery. Management highlights the 2025 milestones including the completion of the IRRAS acquisition, the debt financing arrangement with an affiliate of Oberland Capital Management under which the company may borrow up to $105.0 million ³², the new preclinical research facility lease, and several regulatory approvals including FDA Clearance for ClearPoint 3.0 Software and European MDR certification for the SmartFlow Neuro Cannula. Management's strategic priorities include driving adoption of both the ClearPoint system and IRRA flow system, expanding the installed base and procedure volumes, maintaining and establishing new relationships with pharmaceutical company customers for biologics and drug delivery, and completing research and development initiatives related to the IRRA flow system including enhancements to its workflow and expansion of its labelling. Management states that the company's plans for the next twelve months reflect expectations of increased revenues from sales of hardware products and related disposable products driven by greater utilization at existing installed sites and installation at new sites, continued payments from strategic partnerships, consulting services, and sale of systems and disposables to pharmaceutical partners for gene and stem cell therapy trials, with anticipated increases in operating expenses and corresponding decreases in operating losses and cash used in operations.