Risk Factors Dashboard

example only and are not intended to be a complete listing or a representation as to whether or not the factors,events or contingencies discussed below have occurred in the past or their likelihood of occurring in the future.

Risks Related to Our Business and Industry

Our business, financial condition, and results of operations may be adversely affected by general economic and financial market conditions and current and future social and geopolitical instability.

Changes in domestic and global economic 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 may adversely impact the demand for our products and services, which could negatively impact our business, financial conditions, and results of operations. The world’s financial markets remain susceptible to significant stresses, including reduced liquidity and access to credit, increased borrowing costs, foreign currency fluctuations, and volatility in the valuations of securities generally. The world’s financial markets remain susceptible to significant stresses, resulting in reductions in available credit and government spending, economic downturn or stagnation, foreign currency fluctuations and volatility in the valuations of securities generally. As a result, our ability to access capital markets or other funding sources in the future may be limited or may not be available on commercially reasonable terms, if at all. As a result, our ability to access capital markets and other funding sources in the future may not be available on commercially reasonable terms, if at all.

Inflationary pressures and elevated interest rates could increase our costs for research and development, supply chain, labor, and other administrative expenses, which could in turn raise the cost of producing and distributing our products and services. Impacts from inflationary pressures, could increase our costs for research and development of our products, and administrative and other costs of doing business, which could in turn increase the costs for producing and distributing our products and services. In such environments, we may be unable to increase prices sufficiently to offset these higher costs. These impacts could be more pronounced in areas of our business where pricing is governed by long-term contractual arrangements, as we may not be able to quickly or easily adjust pricing, reduce costs, or implement countermeasures.

In addition, our hospital, pharmaceutical, and biotechnology customers may experience heightened financial and operational pressures as a result of macroeconomic conditions. Such pressures may include increased cost of funding, reduced access to capital markets, cash flow challenges, or difficulties complying with debt covenants. These conditions could, in turn, impede our 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 our products. Our pharmaceutical and biotechnology customers who are engaged in gene and cell therapy development, may face reduced availability of research and development funding, which could slow the pace of innovation, delay clinical trials, or constrain commercialization efforts. Any such customer constraints may adversely affect their willingness or ability to purchase our products and services, or may impair their ability to make timely payments, either of which could negatively impact our business, financial condition, and results of operations. Moreover, broader economic uncertainty, elevated unemployment levels, and rising health insurance premiums, co-payments, and deductibles may lead to cost-conscious consumers pursuing fewer elective or advanced medical treatments, which could reduce procedure volumes and demand for our products and services.

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 our business. Geopolitical changes and trends such as populism, protectionism, economic nationalism, as well as trade barriers, sanctions, and regulations may become disruptive and costly to our business. The global economy has been, and may continue to be, negatively affected by ongoing conflicts, including Russia’s invasion of Ukraine, instability in the Middle East, and heightened tensions in the Asia-Pacific region, particularly with respect to China and Taiwan. The global economy has been, and may continue to be, negatively impacted by the ongoing conflict resulting from Russia’s invasion of Ukraine in 2022, uncertainty in the Middle East region, or the increasing tensions between China and Taiwan. These developments may interfere with our supply chain, manufacturing costs, access to raw materials, and customer relationships. In addition, market uncertainty and volatility in various geographies may be magnified as a result of shifts in U.S. and foreign trade, economic, and regulatory policies following recent elections. Geopolitical uncertainty has also prompted many pharmaceutical and biotechnology companies to prefer sourcing from suppliers located closer to their manufacturing and research operations, or within their home markets, as a strategy to reduce exposure to security risks and cross-border disruptions. If we are unable to align with these preferences or establish sufficient local presence in key markets, our competitiveness with respect to certain international customers may be diminished. Although the majority of our operations are based in the United States, further escalation of geopolitical tensions could make it more costly or difficult to maintain our current international business or expand into additional markets, which could adversely affect our business, financial condition, and results of operations. Although the majority of our operations take place in the US, further escalation of geopolitical tensions could make it more costly to continue our current international business or expand to serve other markets, which may adversely affect our business, financial condition and results of operations.

We may fail to realize the anticipated benefits of our acquisition of IRRAS, and the combined company may not perform as we or the market expect, which could adversely affect our business, results of operations, and the price of our common stock.

On November 6, 2025, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with IRRAS Holdings, Inc. (“IRRAS”), a medical technology company focused on products used in neurocritical care, including treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management. The transaction closed in the fourth quarter of 2025.

We pursued the acquisition based on expectations that the transaction would enhance our commercial scale, expand our presence into neurocritical care, drive operational efficiencies, and support our long term strategy of central nervous system drug delivery innovation. These anticipated benefits are inherently subject to uncertainties and are based on assumptions regarding the performance of the combined businesses. There can be no assurance that the expected synergies, growth opportunities, or operating efficiencies will

be realized on the timeline anticipated, or at all. If we do not achieve these anticipated benefits, our financial condition, results of operations, and the market price of our common stock could be adversely affected.

The combined company may not perform as we or the market expect. Risks associated with integrating IRRAS into our business include:

The occurrence of any of these factors, individually or in the aggregate, could materially and adversely affect our business, results of operations, financial condition, and the market price of our common stock.

If we cannot maintain our current relationships or programs, or enter into new relationships or programs, with drug delivery customers, our revenue prospects could be meaningfully reduced. If we cannot maintain our current relationships or programs, or enter into new relationships or programs, with drug delivery customers, our revenue prospects could be meaningfully reduced.

We collaborate with pharma/biotech, academic, and contract research organization customers (collectively “drug delivery customers”) to provide products and services in connection with preclinical and clinical studies. We collaborate with pharma/biotech, academic, and contract research organization customers (collectively “drug delivery customers”) to provide products and services in connection with preclinical and clinical studies. The revenue attributable to our drug delivery customers may fluctuate in the future, which could have a material adverse effect on our financial condition and results of operations. In addition, the termination of these relationships or certain programs of our drug delivery customers could result in a temporary or permanent loss of revenue.

Our future success depends in part on our ability to maintain these relationships and establish new relationships, and our drug delivery customer's continued use of our products and services in their therapeutic programs through their research, development, and commercialization process. Our future success depends in part on our ability to maintain these relationships and establish new relationships, and our drug delivery customer's continued use of our products and services in their therapeutic programs through their research, development, and commercialization process. Many factors have the potential to impact such collaborations, including our customer’s satisfaction with our performance of services and our products, force majeure, regulatory approval, perceptions in connection with the safety of therapies or delivery mechanisms, our customers’ ability to access adequate and sustainable financing, our customers’ ability to achieve commercial success for their therapies, including overcoming barriers in reimbursement, physician adoption, and patient access to their therapies, and other factors that may be beyond our control. Our drug delivery customers may decide to decrease or discontinue their use of our products and services due to changes in research and product development plans, failures in their clinical trials, financial constraints, utilization of internal resources or services performed by other parties. Furthermore, our drug delivery customers may decide to decrease or discontinue their use of our products and services due to changes in research and product development plans, failures in their clinical trials, financial constraints, utilization of internal resources or services performed by other parties. Cancellation or renegotiation of a large agreement could adversely affect our business and, therefore, may adversely affect our operating results. In addition, we may also enter into agreements with customers for which we are paid a lump sum conditioned upon the achievement of development milestones. We may also enter into agreements with customers for which we are paid a lump sum conditioned upon the achievement of development milestones. Accordingly, in these cases, we bear the risk if we underprice our contracts, overrun our cost estimates, or if there is a failure by us or our customer to achieve the development milestones. Any such events could have an adverse effect on our business, results of operations, financial condition and cash flows. Such events could have an adverse effect on our business, results of operations, financial condition and cash flows.

The development of gene and cell therapies by our drug delivery customers is inherently risky, complex, costly, and uncertain. The development of gene and cell therapies by our drug delivery customers is inherently risky, complex, costly, and uncertain. These novel therapies involve the modification of genetic material or the use of engineered cells to treat diseases. Their development presents unique scientific, technical and regulatory challenges and face substantial risks. Even if early stage clinical trials are promising, later stage trials may fail to confirm these results, leading to delays or failures in product approval and potential termination of our relationship or certain programs with our drug delivery customers. Regulatory agencies, including the FDA, may impose more stringent

requirements on these novel therapies, and the evolving regulatory landscape may create additional hurdles, including longer review times, requests for additional data, or the need for post-approval monitoring, which would significantly impact development timelines. In addition, scalability of these therapies remains a challenge, and any disruption in raw material supply, safety controls, or quality consistency could delay or halt therapy development. Due to the nature of these novel therapies, there are risks of serious adverse events, including immune reactions or off-target effects. The long term effects of these therapies may not be fully understood at the time of approval, and thus even if a therapy is successfully approved for commercialization, it may continue to be subject to restrictive labeling or product recall and withdrawals. Market adoption of gene and cell therapies may be limited by reimbursement challenges, high treatment costs, physician hesitancy and competition from alternative therapies.

As a supplier to companies developing gene and cell therapies, we are subject to the risks faced by our drug delivery customers which could lead to the termination of their relationship or certain programs with us, reducing our revenue and revenue prospects, and reducing our exposure to research and clinical trials that further our business objectives. As a supplier to companies developing gene and cell therapies, we are subject to the risks faced by our drug delivery customers which could lead to the termination of their relationship or certain programs with us, reducing our revenue and revenue prospects, and reducing our exposure to research and clinical trials that further our business objectives.

We engage in conversations with drug delivery customers regarding potential opportunities on an ongoing basis. We engage in conversations with drug delivery customers regarding potential opportunities on an ongoing basis. There is no assurance that any of these conversations will result in an agreement, or if an agreement is reached, that the resulting relationship will be successful or that preclinical, clinical, or research studies conducted as part of the engagement will be continued or will produce successful commercial outcomes.

The sizes of the markets for our products and services and any future products and services may be smaller than we estimate and may decline.

Our estimates of the total addressable market for our products and services are based on a number of internal and third-party estimates and assumptions, including, without limitation, the assumed prices at which we can sell our products and services in the market. Our estimates of the total addressable market for our products and services are based on a number of internal and third-party estimates and assumptions, including, without limitation, the assumed prices at which we can sell our products and services in the market. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.

As a result, our estimates of the annual total addressable market for our products and services in different market segments may prove to be incorrect. As a result, our estimates of the annual total addressable market for our products and services in different market segments may prove to be incorrect. If the actual number of patients with indications who would benefit from our products, the price at which we can sell our products or the annual total addressable market for our products is smaller than we have estimated, it may impair our prospective market and revenue opportunity.

Our ClearPoint system and our IRRAflow system may not achieve broad market adoption.

To date, a substantial majority of the sales of our ClearPoint system have been derived from a limited number of hospitals, and the IRRAflow system has also historically been used by a relatively small group of neurocritical care centers. Our future growth depends on our ability to increase physician and hospital awareness of both products and on the willingness of hospitals to adopt our technologies for their neurosurgical and neurocritical care procedures. Our future growth depends on our ability to increase physician and patient awareness of our products, and on the willingness of hospitals to adopt our products for their neurosurgical procedures. Neither the ClearPoint system nor the IRRAflow system may gain broad market adoption unless we continue to convince physicians and hospitals of their respective benefits.

Moreover, even if physicians and hospitals understand the potential benefits of our systems, they may still elect not to use them for a variety of reasons, such as:

Our ability to execute our growth strategy and become profitable depends on increased adoption of both the ClearPoint system and the IRRAflow system. Historically, a substantial portion of our revenue has been generated from sales of disposable products used with the ClearPoint system, and the IRRAflow system similarly relies on utilization driven sales of its disposable catheters and consumables. We are therefore highly dependent on growing the installed base and procedure volumes for both systems. We cannot provide assurance that either system will achieve broad market acceptance among hospitals and physicians. We cannot provide assurance that our ClearPoint system will achieve broad market acceptance among hospitals, physicians, or patients. Any failure of the ClearPoint system or the

IRRAflow system to achieve meaningful market acceptance and penetration would harm our future prospects and have a material adverse effect on our business, financial condition, and results of operations.

Our future business growth is dependent on our ability to market and sell both the ClearPoint system and the IRRAflow system, and on our ability to integrate and effectively manage a combined commercial team that must support two distinct product platforms; our limited experience selling the ClearPoint system in the operating room may further increase these challenges.

Historically, our commercial efforts have been focused on selling and supporting the ClearPoint system for neurosurgical procedures performed in the MRI suite. Although we recently expanded our ClearPoint navigation technology for use in the operating room through the launches of the SmartFrame Array Neuro Navigation System and Software, the SmartFrame OR Stereotactic System, and ClearPoint Navigation Software Version 3.0, we have relatively limited experience marketing and selling the ClearPoint system in the operating room environment, and our limited experience in this setting may make adoption more difficult, slower, or more costly than we anticipate.

Following our acquisition of IRRAS, our combined commercial organization is also responsible for promoting the IRRAflow system within neurocritical care units. Successfully commercializing both the ClearPoint system and the IRRAflow system requires coordinated and effective sales, marketing, and clinical support across two distinct clinical settings with different decision-makers, clinical priorities, and procurement pathways. The need to grow adoption of two systems in two different hospital environments amplifies the commercial complexity that we must now manage.

Integrating and managing the combined commercial organization presents additional risks, including:

Our ability to achieve our business objectives depends on expanding the installed base and procedure volumes for both the ClearPoint system and the IRRAflow system. If we are unable to overcome the challenges associated with our limited operating room experience, or if we cannot integrate the combined commercial teams effectively to support both platforms, we may fail to achieve anticipated growth. Any such failure could have a material adverse effect on our business, financial condition, and results of operations. Any of these events could materially and adversely affect our business, financial condition and results of operations.

Our long-term growth depends on our ability to compete effectively in the neurosurgery and neurocritical care markets by developing and commercializing new products and services through our research and development efforts, independently and through third-party collaborations, including key development work required to support broader adoption of the IRRAflow system.

Our future business prospects depend in part on our ability to develop and commercialize new products and services, such as the Company’s proprietary robotic neuro-navigation system. Following our acquisition of IRRAS, our growth also depends on our ability to complete certain research and development initiatives related to the IRRAflow system, including enhancements to its workflow, expansion of its labelling, as well as potential design modifications or product improvements that may be necessary to expand clinical use or improve adoption in neurocritical care settings. If we are unable to complete these development efforts successfully, or if they take longer or cost more than anticipated, adoption of the IRRAflow system may be limited.

New technologies, techniques or products could emerge from competitors that might offer better combinations of price and performance than our products and services. New technologies, techniques or products could emerge from competitors that might offer better combinations of price and performance than our products and services. It is important that we anticipate changes in technology and market demand, as well as customer preferences and practices, to successfully commercialize new technologies to meet our prospective customers’ needs on a timely and cost-effective basis.

We might be unable to successfully commercialize our marketed products or services or obtain authorization to market new products. We might be unable to successfully commercialize our marketed products or services or obtain authorization to market new products. The success of any new product offering, including enhancements or next generation versions of the IRRAflow system, will depend on numerous factors, including our ability to:

If we do not develop and obtain regulatory authorization to market new products in time to meet market demand, or if demand for these products, including future versions or enhancements of the IRRAflow system, does not materialize as expected, our results of operations will suffer. Our internal research and development efforts and our outsourced design and development initiatives may require substantial investment of time and resources before we can determine the commercial viability of a new product, technology, or modification. Our internal research and development efforts and our outsourced third-party design and development initiatives may require a substantial investment of time and resources before we are adequately able to determine the commercial viability of a new product, technology, material or other innovation. Even if we are able to develop enhancements or new generations of our products successfully, they may not produce sales that exceed the costs of development, and they may be rendered obsolete by changing customer preferences or the introduction of competing technologies.

Limitations in the existing clinical evidence for the IRRAflow system may affect clinical and commercial adoption.

The existing clinical literature regarding the IRRAflow system has significant limitations, and further clinical studies may be required to demonstrate safety and effectiveness of the device. If additional supportive data is not generated, clinical acceptance and broader commercial adoption of the IRRAflow system could be adversely affected.

The clinical evidence currently available regarding the IRRAflow system consists primarily of retrospective studies, small case series, single-center experiences, feasibility studies, and other observational analyses, many of which involve limited patient populations, lack randomization or control groups, and may not be powered to demonstrate statistically significant differences in clinical outcomes. As a result, their findings may be subject to bias and other methodological limitations inherent in non-randomized and small-scale research.

Because the majority of available clinical data is derived from retrospective or observational analyses, it may not provide the same level of evidentiary support as large scale prospective, randomized controlled trials. In addition, the differences in study design, patient selection, treatment protocols, and endpoints may limit the comparability and generalizability of the outcomes reported in the clinical data. These factors may make it more difficult to draw definitive conclusions regarding the safety, efficacy, or clinical benefit of the IRRAflow system based on the current available data.

Regulatory authorities, healthcare providers, payors, and other stakeholders may require more robust clinical evidence, including larger, well controlled prospective studies, before supporting broader adoption, reimbursement or expanded indications for the IRRAflow system. Future clinical studies may not produce favorable results, or they may not confirm the findings of the earlier reported data. If future data fails to demonstrate the safety and efficacy of the IRRAflow system, or if additional studies are required and we cannot complete them in a timely or cost-effective manner, our ability to commercialize the IRRAflow system could be adversely impacted.

If coverage and reimbursement from third-party payors for procedures utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability will suffer. If coverage and reimbursement from third-party payors for procedures utilizing our products are inadequate, adoption of our products will be adversely affected and our revenues and prospects for profitability will suffer.

Our products are purchased by hospitals, which bill various third-party payors, including governmental healthcare programs, such as Medicare, and private insurance plans, for procedures in which our products are used. Our products are purchased by hospitals, which bill various third-party payors, including governmental healthcare programs, such as Medicare, and private insurance plans, for procedures in which our products are used. Reimbursement is a significant factor considered by hospitals in determining whether to acquire and utilize medical devices. Therefore, our ability to successfully commercialize our products depends significantly on the adequacy of coverage and reimbursement from these third-party payors.

Third-party payors, whether foreign or domestic, governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. Third-party payors, whether foreign or domestic, governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the U.S., no uniform policy of coverage and reimbursement for medical device products and services exists among third-party payors. Therefore, coverage and reimbursement for medical device products and services can differ significantly from payor to payor. In addition, payors continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming

and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained if obtained.

Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed systems.

Because in most cases, hospitals are reimbursed for the procedures in which our products are used and our products are not separately reimbursed, the additional cost associated with the use of our products could impact hospital profit margins. Because in most cases, hospitals are reimbursed for the procedures in which our products are used and our products are not separately reimbursed, the additional cost associated with the use of our products could impact hospital profit margins. Some hospitals could believe third-party reimbursement levels are not adequate to cover the cost of our products. Furthermore, some physicians could believe third-party reimbursement levels are not adequate to compensate them for performing the procedures in which our products are used. Failure by hospitals and physicians, whether in the U.S. or abroad, to receive an amount that they consider to be adequate reimbursement for procedures in which our products are used will deter them from purchasing or using our products and will limit our revenues and prospects for profitability.

We currently have significant customer concentration, so economic difficulties or changes in the purchasing policies or patterns of our key customers could have a significant impact on our business and operating results. We currently have significant customer concentration, so economic difficulties or changes in the purchasing policies or patterns of our key customers could have a significant impact on our business and operating results.

A small number of our customers account for a substantial portion of our revenues. A small number of our customers account for a substantial portion of our revenues. In 2025, one pharmaceutical customer, a related party as described in Note 2 to the consolidated financial statements included elsewhere in this Annual Report, for whom we provide clinical services in support of the customer’s clinical trials and earn a quarterly fee, accounted for 8% of our total revenues, and 15% of our biologics and drug delivery revenue. Our five largest hospital customers account for approximately 21% of our revenues from selling medical devices for neurosurgical applications. Our five largest hospital customers account for approximately 31% of our neurosurgery navigation revenues. Revenues from almost all our customers are not based on long-term, committed volume purchase contracts, and we may not continue to generate a similar level of revenues from our largest customers, or any other customer. Revenues from almost all our customers are not based on long-term, committed volume purchase contracts, and 21 Table of Contents we may not continue to generate a similar level of revenues from our largest customers, or any other customer. Because of our current customer concentration, our revenues could fluctuate, possibly significantly, due to a reduction or delay in our biotechnology and pharmaceutical customers’ preclinical studies or clinical trials, or in orders from any of our significant hospital customers, which could harm our business and results of operations.

We rely on single facilities for manufacturing and performance of services, which exposes us to significant risk of disruption.

Our internal manufacturing operations are generally conducted at single locations, which may limit our ability to provide an adequate supply of our products, and any disruption at these facilities could render us unable to produce our products, increase our expenses and decrease our revenue. Our internal manufacturing operations are generally conducted at a single location, which may limit our ability to provide an adequate supply of our products, and any disruption at our manufacturing facility could render us unable to produce our products, increase our expenses and decrease our revenue. Currently, final assembly of many of our products’ components for our ClearPoint System occurs at our Carlsbad, California facility, in an area that is at risk of experiencing serious fires and power outages and is considered to lie in an earthquake risk zone. Currently, final assembly of many of our products’ components occurs at our Carlsbad, California facility, in an area that is at risk of experiencing serious fires and power outages and is considered to lie in an earthquake risk zone. Following our acquisition of IRRAS, we also relied on IRRAS’s manufacturing facility in San Diego, California, where the manufacturing of the reusable control unit and hardware for the IRRAflow system is performed. This San Diego facility is similarly exposed to regional risks, including wildfires, seismic activity, and potential utility interruptions. In addition, we may face additional risks associated with integrating and maintaining manufacturing operations acquired from IRRAS.

If either our Carlsbad or San Diego facility experiences a disruption, we would have no other means of assembling our products until we are able to restore the manufacturing capability at our current facility or develop the same capability at an alternative facility. If our facility experiences a disruption, we would have no other means of assembling those components until we are able to restore the manufacturing capability at our current facility or develop the same capability at an alternative facility. We do not maintain backup manufacturing facilities for these operations, making us highly dependent on the continued availability and performance of our Carlsbad and San Diego sites.

In addition, our biologics and drug delivery research and development service capabilities are performed at a single facility in San Diego, California. We do not maintain a backup site for performance of these services, which makes us vulnerable to disruption. If our San Diego facility were to become unavailable due to natural disasters, power outages, fires, earthquakes, or other unforeseen events, we would be unable to continue providing research and development services to our customers until operations could be restored or replicated at another facility, which could delay our service activities and negatively impact our business and our future relationships with customers.

A disaster or disruption could damage, destroy, or delay our manufacturing or service operations, which could lead to additional expenses and decreased revenue due to our inability to supply products and services. The insurance we maintain may not cover, in whole or in part, our losses in any particular case. With or without insurance, damage to our facilities due to a natural disaster or casualty event could have a material adverse effect on our business, financial condition and results of operations. With or without insurance, damage to our facility or our other property due to a natural disaster or casualty event could have a material adverse effect on our business, financial condition and results of operations.

Our reliance on single-source suppliers for components, finished products and services could harm our ability to meet demand for our products or services in a timely manner or within budget. Our reliance on single-source suppliers for components, finished products and services could harm our ability to meet demand for our products or services in a timely manner or within budget.

Many of our components, component assemblies, and finished products are provided to us by single-source suppliers. This includes the catheter and other procedure-specific disposables used with the IRRAflow system, which we currently source from third-party manufacturers with specialized expertise and established quality systems. These manufacturers supply IRRAflow disposables under master service agreements that govern the terms of our supply relationships. While we have identified alternative sources for certain IRRAflow disposables, we do not currently maintain multiple qualified suppliers for all of these products.

The ClearPoint Prism Neuro Laser Therapy System is supplied to us by CLS, and we rely on CLS as a single-source supplier for this product. CLS may itself rely on single source suppliers for certain components, subassemblies, or materials used in the manufacture of the ClearPoint Prism Neuro Laser Therapy System. Any disruption or delays in CLS’s supply chain, including disruptions affecting their own single-source suppliers, could adversely impact the availability, cost, or performance of the product and, in turn, our ability to support customer demand.

We generally purchase components and component assemblies for the ClearPoint System through purchase orders rather than long-term supply agreements. We generally do not maintain large volumes of inventory for components, component assemblies, or finished products for the ClearPoint System. While alternative suppliers exist and have been identified for substantially all components of the ClearPoint System, the disruption or termination of the supply of components and component assemblies could cause a significant increase in the cost of these components, which could affect our operating results. While alternative suppliers exist and have been identified for substantially all components, the disruption or termination of the supply of components and component assemblies could cause a significant increase in the cost of these components, which could affect our operating results. We also depend on single-source service providers for many of the services that we need to produce our products. We also depend on single-source service providers for many of the services that we perform for our customers.

Our dependence on a limited number of third-party suppliers and service providers and the challenges we may face in obtaining adequate supplies and services involve several risks, including limited control over pricing, availability, quality and delivery schedules. A disruption or termination in the supply of components or finished products could also result in our inability to meet demand for our products, which could harm our ability to generate revenues, lead to customer dissatisfaction and damage our reputation. Disruptions in the global supply chain could negatively affect our single-source suppliers and could further exacerbate the risk that we are unable to meet the demand for our products. Furthermore, if we are required to change the supplier of a key component or component assembly of our products, we may be required to verify that the new supplier maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. Disruptions to our service providers could impact our ability to provide products to our customers, damage our customer relationships, and cause material adverse impacts to our financial results. Disruptions to our service providers could impact our ability to provide critical services to our customers, damage our customer relationships, and cause material adverse impacts to our financial results. The delays associated with the verification of a new supplier or service provider could also adversely affect our ability to meet demand for our products and services.

Our use of hazardous materials in manufacturing and in the conduct of services may exposes us to significant health, safety, environmental, and regulatory risks.

We may use, store, generate, handle, and dispose of hazardous materials, including but not limited to chemicals, solvents, reagents, and radioactive isotopes used for biomarkers in testing, in our operations and services. These types of activities are subject to an extensive, evolving framework of environmental, health, safety, nuclear-materials, and transportation laws and regulations in the jurisdictions where we operate, which may include licensing and permit requirements, employee exposure limits, monitoring and reporting obligations, and strict rules governing storage, transport, and waste disposal. Despite our policies and training, hazardous materials incidents may occur, including spills, releases, contamination, accidental exposures, or improper handling or disposal.

Any such incident or any failure to obtain, maintain, or comply with applicable permits and licenses could result in enforcement actions; civil, criminal, or administrative penalties; remediation and decontamination obligations; shutdowns or restrictions on use of our facilities; product or service delays; and claims for personal injury, property damage, or environmental harm. Certain environmental laws can impose strict, joint and several liability for contamination, which could make us responsible for costs regardless of fault. Radioactive materials carry additional requirements for specialized facilities, training, monitoring, recordkeeping, waste management, and decommissioning. We also may depend on third parties to handle hazardous and radioactive materials safely, and their non-compliance or incidents could disrupt our operations, expose us to liability, or damage our reputation.

Compliance costs can be significant and may increase over time due to more stringent standards, expanded enforcement priorities (including with respect to emerging contaminants), or changes in how hazardous and radioactive materials are classified, transported, or disposed. We may incur capital or operating expenditures to achieve or maintain compliance, to obtain or renew licenses, or to complete decommissioning and site-closure activities.

Although we maintain insurance that we believe to be customary for our industry, such insurance may not be available on commercially acceptable terms, may contain significant exclusions (including for radiation-related losses), retentions, or limits, and may not cover all potential liabilities, costs, or damages arising from hazardous or radioactive materials. We may be unable to obtain or maintain adequate insurance coverage in the future, premiums could increase materially, and losses could exceed our policy limits. Any uninsured or under-insured liability, as well as any significant increase in insurance costs, could materially and adversely affect our business, financial condition, results of operations, and reputation.

To the extent we seek a new indication for use of, or new claims for, our products, the FDA may not grant 510(k) clearance or PMA approval of such new use or claims, which may affect our ability to grow our business.

We received 510(k) clearance to market our ClearPoint system for use in general neurosurgery interventional procedures, including DBS. We received 510(k) clearance to market our ClearPoint system for use in general neurosurgery interventional procedures, including DBS. We could seek to obtain additional, more specific indications for use of our ClearPoint system beyond the general neurosurgical intervention claim. To the extent we seek expanded claims for our ClearPoint system, such claims could, depending on their nature, require 510(k) clearance or FDA approval of a PMA. Moreover, some specific ClearPoint system claims could require clinical trials to support regulatory clearance or approval. In the event we seek a new indication for use of, or new claims for, the ClearPoint system that we believe are necessary or desirable for successful commercialization, the FDA may refuse our requests for 510(k) clearance or PMA approval. Likewise, to the extent clinical trials are necessary, we may not successfully complete or have the funds to initiate such clinical trials.

In the United States, our SmartFlow Neuro cannula has received 510(k) clearance from the FDA for the aspiration of CSF, or injection of Cytarabine into the ventricles and a De Novo marketing authorization for the intraputaminal administration of eladocagene exuparvovec-tneq for the treatment of adult and pediatric patients with AADC deficiency. In the United States, our SmartFlow cannula has received 510(k) clearance from the FDA for the aspiration of CSF, or injection of Cytarabine into the ventricles and a De Novo marketing authorization for the intraputaminal administration of eladocagene exuparvovec-tneq for the treatment of adult and pediatric patients with AADC deficiency. The SmartFlow Neuro cannula has also been CE marked for use in the EU for the delivery of approved fluids into the brain or aspiration of CSF. The SmartFlow cannula has also been CE marked for use in the EU for the delivery of approved fluids into the brain or aspiration of CSF. The SmartFlow Neuro cannula is being utilized in approved combination product clinical and preclinical studies by pharmaceutical companies and academic research customers for various research and clinical trials in connection with delivery of therapeutic agents. The SmartFlow cannula is being utilized in approved combination product clinical and preclinical studies by pharmaceutical companies and academic research customers for various research and clinical trials in connection with delivery of therapeutic agents. The growth of our drug delivery and biologics business is dependent upon our pharmaceutical company customers’ ability to obtain regulatory approval for the use of the SmartFlow Neuro cannula for delivery of their therapeutic agent, and/or our ability to expand the cleared indications for our SmartFlow Neuro cannula to include delivery of our pharmaceutical company customers’ therapeutic agents. The growth of our drug delivery and biologics business is dependent upon our pharmaceutical company customers’ ability to obtain regulatory approval for the use of the SmartFlow cannula for delivery of their therapeutic agent, and/or our ability to expand the cleared indications for our SmartFlow cannula to include delivery of our pharmaceutical company customers’ therapeutic agents. To the extent that our pharmaceutical partners are not successful in obtaining regulatory approval, or if we are unable to expand the cleared indications for use of our SmartFlow Neuro cannula, we may not be able to grow our business. To the extent that our pharmaceutical partners are not successful in obtaining 22 Table of Contents regulatory approval, or if we are unable to expand the cleared indications for use of our SmartFlow cannula, we may not be able to grow our business.

Following our acquisition of IRRAS, we may also seek new or expanded indications for use of the IRRAflow system, including indications related to subdural hematomas, extended-duration infusions, oncology, intracranial drug delivery, or other therapeutic areas beyond the system’s current cleared uses. Any such expanded indications or new claims for IRRAflow system may require additional 510(k) submissions or FDA approval of a PMA, depending on the nature and scope of the proposed indication. Certain expanded claims, particularly those involving new therapeutic modalities, extended treatment durations, or the delivery of pharmaceutical agents, may also require clinical trials to support FDA clearance or approval. If we pursue new indications or claims that we believe are important for broader clinical adoption or commercial success of IRRAflow system, the FDA may decline to grant the requested clearance or approval. Likewise, to the extent clinical studies are required, we may not successfully complete these studies, or may lack the financial or operational resources necessary to initiate or support them. If we are unable to obtain expanded indications or new claims for the IRRAflow system, our ability to grow this part of our business may be limited.

Clinical trials necessary to support 510(k) clearance or PMA approval for any new indications for use of our products would be expensive and could require the enrollment of large numbers of suitable patients, who could be difficult to identify and recruit. Clinical trials necessary to support 510(k) clearance or PMA approval for any new indications for use of our products would be expensive and could require the enrollment of large numbers of suitable patients, who could be difficult to identify and recruit. Delays or failures in any necessary clinical trials would prevent us from commercializing any modified product or new product candidate and could adversely affect our business, operating results and prospects.

Initiating and completing clinical trials necessary to support 510(k) clearance or PMA approval for our existing products or any other product candidates that we may develop, or additional safety and efficacy data that the FDA may require for 510(k) clearance or PMA approval for any new specific indications of our products that we may seek, would be time consuming and expensive with an uncertain outcome. Initiating and completing clinical trials necessary to support 510(k) clearance or PMA approval for our existing products or any other product candidates that we may develop, or additional safety and efficacy data that the FDA may require for 510(k) clearance or PMA approval for any new specific indications of our products that we may seek, would be time consuming and expensive with an uncertain outcome. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product candidate we advance into clinical trials may not have favorable results in later clinical trials.

Conducting successful clinical trials could require the enrollment of large numbers of patients, and suitable patients could be difficult to identify and recruit. Conducting successful clinical trials could require the enrollment of large numbers of patients, and suitable patients could be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects, the availability of appropriate clinical trial investigators and support staff, the proximity to clinical sites of patients that are able to comply with the eligibility and exclusion criteria for participation in the clinical trial, and patient compliance. For example, patients could be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to our product candidates.

Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy will be required and we may not adequately develop such protocols to support clearance or approval. Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy will be required and we may not adequately develop such protocols to support clearance or approval. Further, the FDA could require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial

could cause an increase in costs and delays in the approval and attempted commercialization of our product candidates or result in the failure of the clinical trial. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.

If we fail to obtain the necessary clearances, certifications or approvals for our new products, our ability to grow our business globally could be harmed. If we fail to obtain the necessary clearances, certifications or approvals for our new products, our ability to grow our business globally could be harmed.

Our business growth is dependent upon our ability to market and sell new products, including new therapy delivery devices, therapy devices and devices to allow us to expand our business into the operating room. Our business growth is dependent upon our ability to market and sell new products, including new therapy delivery devices, therapy devices and devices to allow us to expand our business into the operating room. Unless and until we obtain FDA clearance, authorization or approval for the new products in our pipeline, we will not be able to sell or promote them in the U.S. Under FDA regulations, unless exempt, a new medical device may only be commercially distributed after it has received 510(k) clearance, is authorized through the de novo classification process, or is the subject of an approved PMA. The FDA will clear marketing of a medical device through the 510(k) process if it is demonstrated that the new product is substantially equivalent to another legally marketed product not subject to a PMA. Sometimes, premarket submissions must be supported by clinical data. Clinical trials are expensive, time consuming, and their outcomes are uncertain. The PMA process typically is more costly, lengthy and stringent than the 510(k) process and usually requires more substantial clinical studies.

The FDA may not authorize marketing via de novo classification or clear our 510(k) applications on a timely basis or at all. Such delays or refusals, regardless of the cause, could have a material adverse effect on our business, financial condition, and results of operations. The FDA may also change its clearance and authorization policies, adopt additional regulations or revise existing regulations, or take or become subject to other actions, such as staffing changes, which may prevent or delay authorization or clearance of our products. Similar restrictions exist outside of the U.S.

To sell our products in member countries of the EU, our products must comply with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC) for products CE marked under the MDD (Medical Device Directive) and the general safety and performance requirements of the EU Medical Device Regulation (Regulation EU 2017/745) for products CE marked under the EU MDR (Medical Device Regulation). Compliance with these requirements is a prerequisite to be able to affix the CE mark to our products, without which they cannot be sold or marketed in the EU. To demonstrate compliance with these requirements we must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-declare the conformity of its products with the requirements of the EU Medical Devices Directive or the EU Medical Device Regulation, a conformity assessment procedure requires the intervention of an organization accredited or licensed by a member state of the EU to conduct conformity assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. Depending on the relevant conformity assessment procedure, the Notified Body would typically audit 23 Table of Contents and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. The Notified Body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device and its manufacturer and their conformity with the requirements. This certificate entitles the manufacturer to affix the CE mark to its medical devices after having prepared and signed a related EC Declaration of Conformity.

As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements or general safety and performance requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. As a general rule, demonstration of conformity of medical devices and their manufacturers with the essential requirements or general safety and performance requirements must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence. If we fail to remain in compliance with applicable European regulations, directives, and national member states laws, we would be unable to continue to affix the CE mark to our products, which would prevent us from selling them within the EU.

There is no assurance that future clearance or approval of our new products will be granted, or that we will be able to continue selling our products in any geography. There is no assurance that future clearance or approval of our new products will be granted, or that we will be able to continue selling our products in any geography. Such failures could hurt our ability to maintain and grow our business.

Our role as a collaborator, funder, and sponsor of current and future clinical studies in connection with the IRRAflow system requires significant resources, and in some cases, may limit our ability to control the conduct and outcomes of these studies. Negative or unfavorable results from these clinical studies could adversely impact adoption of our IRRAflow products.

We participate in a range of clinical research activities in connection with the IRRAflow system, including serving as a collaborator with third-party institutions, providing funding for investigator-initiated trials, and acting as the sponsor of company-initiated clinical studies. These activities require substantial financial, operational, and personnel resources. Our ability to initiate, manage, or continue these studies depends on the availability of internal resources, including qualified clinical, regulatory, and administrative personnel, as well as adequate funding. If we are unable to allocate sufficient resources, we may experience delays, interruptions, modifications, or terminations of ongoing or planned studies.

Where we support or collaborate on certain studies, we may have limited control over the design, timing, conduct, data collection, analyses, or publication of results. Investigators and institutions generally retain independent rights to publish study outcomes, and we may not be able to influence the nature, timing, or interpretation of such publications. Results from these studies, whether conducted by us or independently by third parties, may be negative, inconclusive, inconsistent with our expectations, or otherwise unfavorable.

Any current or future negative, inconclusive, or unexpected results, or the publication of data that is perceived as unfavorable, could reduce physician or patient confidence in the IRRAflow system, impair market acceptance, limit commercial adoption, or harm our reputation. In addition, delays or failures in our clinical research efforts could adversely affect our ability to obtain regulatory clearances or approvals for new indications for IRRAflow, expand market opportunities, or support reimbursement initiatives. Collectively, these risks could have a material adverse effect on our business, financial condition, and results of operations. Any of these events could materially and adversely affect our business, financial condition and results of operations.

The markets for medical devices are highly competitive, and we may not be able to compete effectively against the larger, well-established companies in our markets or emerging and small innovative companies that may seek to obtain or increase their share of the market. The markets for medical devices are highly competitive, and we may not be able to compete effectively against the larger, well-established companies in our markets or emerging and small innovative companies that may seek to obtain or increase their share of the market.

We will continue to face competition from products and techniques already in existence in the marketplace. We will continue to face competition from products and techniques already in existence in the marketplace. The markets for medical devices used in neurosurgical procedures is intensely competitive, and many of our competitors are much larger and have substantially more financial and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of companies dominate these markets.

These companies enjoy significant competitive advantages over us, including:

We may not succeed in overcoming the competitive advantages of these large and established companies. We may not succeed in overcoming the competitive advantages of these large and established companies. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies may introduce products that compete effectively against our products in terms of performance, price or both.

We sell our products outside of the U.S., and we are subject to various economic, political, regulatory, and other risks relating to international operations, which could harm our revenue and profitability.

We sell our products in several countries outside of the U.S. Our business strategy includes plans for expansion in countries where we currently operate as well as the introduction of our products to other international markets. Doing business outside of the U.S. exposes us to risks distinct from those we face in our domestic operations. For example, our operations outside of the U.S. are subject to different regulatory requirements in each jurisdiction where we operate or have sales. Our failure, or the failure of our distributors, to comply with current or future foreign regulatory requirements, or the assertion by foreign authorities that we or our distributors have failed to comply, could result in adverse consequences, including enforcement actions, fines and penalties, recalls, cessation of sales, civil and criminal prosecution, and the consequences could be disproportionate to the relative contribution of our international operations to our results of operations.

Engaging in business outside of the U.S. inherently involves a number of other difficulties and risks, including, but not limited to:

In addition, our business practices in foreign countries must comply with U.S. laws, including the Foreign Corrupt Practices Act (“FCPA”). We have a compliance program in place designed to reduce the likelihood of potential violations of the FCPA and other U.S. and foreign anti-bribery and anti-corruption laws. If violations were to occur, they could subject us to fines and other penalties as well as increased compliance costs.

Our exposure to each of these risks may increase our costs and require significant management attention. Our exposure to each of these risks may increase our costs and require significant management attention.

Disruptions of critical information systems or material breaches in the security of our systems could harm our business, customer relations and financial condition.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our customers, suppliers and business partners, and personally identifiable information of our customers and employees on our networks, and on third party-controlled applications. In the ordinary course of our business, we collect and store sensitive data, including intellectual property, our proprietary business information and that of our customers, suppliers and business partners, and personally identifiable information of our customers and employees on our networks, and on third party-controlled applications. The secure processing, maintenance and transmission of this information is critical to our operations and business strategy. The information technology and infrastructure which we rely upon may be vulnerable to attacks by hackers or breached due to human error, malfeasance or other disruptions. Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disruption of our operations and the services we provide to customers, and damage to our reputation and loss of confidence in our products and services, which could adversely affect our business, operating margins, revenues and competitive position. In addition, the regulatory environment regarding data security and privacy evolves frequently and has become increasingly restrictive.

We also rely in part on third-party information technology systems to store information, interface with customers, maintain financial accuracy, secure our data and accurately produce our financial statements. If our information technology systems do not effectively and securely collect, store, process and report relevant data for the operation of our business, whether due to equipment malfunction or constraints, software deficiencies, human error or cyber incident, our ability to effectively plan, forecast and execute our business plan and comply with applicable laws and regulations would be materially impaired. Any such impairment could have a material adverse effect on our results of operations, financial condition and the timeliness in which we report our operating results.

Our insurance coverage related to information risks, breaches, and business interruption is subject to deductibles and coverage limitations. Our insurance coverage related to information risks, breaches, and business interruption is subject to deductibles and coverage limitations. We may not be able to maintain our current insurance coverage on acceptable terms, if at all, and, if available, coverage may not be adequate to protect us against future claims. If we are unable to obtain insurance at an acceptable cost or on acceptable terms or otherwise protect against such information risks and breach claims, we could be exposed to significant liabilities.

Our acquisition activities, including our recent acquisition of IRRAS, may expose us to heightened cybersecurity risks that could adversely affect our business, financial condition, and results of operations.

We may engage in acquisition activity as part of our growth strategy, including our recent acquisition of IRRAS. Newly acquired companies may rely on information and operational technology systems that differ materially from our own and may not have cybersecurity protections comparable to those we have implemented. The integration of core systems and processes for such transactions often occurs after closing, which may create an elevated risk of cyber incidents during the intervening period. We may be subject to the data risks and cybersecurity vulnerabilities of an acquired company until we have had sufficient time to fully integrate the acquired company's customers, operations, and systems into our own infrastructure. Although we conduct due diligence with respect to the cybersecurity policies, procedures, and controls of our acquisition counterparties, there can be no assurance that such diligence will identify all material vulnerabilities, or that our policies, procedures, controls, and information security protocols will be sufficient to withstand a cyber-attack or other security breach with respect to the companies we acquire, particularly during the period between closing and final integration. Integrating newly acquired companies and implementing appropriate cybersecurity controls may be more resource-intensive and time-consuming than anticipated, and failure to appropriately integrate new acquisitions into our cybersecurity and information technology systems could lead to vulnerabilities and make our systems more complex to secure. In addition, if an acquired business's cybersecurity controls are materially weaker than ours, we may be exposed to existing cyber risks not identified prior to the acquisition that could impact our core operations until mitigated. Any such cybersecurity incident arising from or relating to an acquisition could result in significant business disruption, remediation costs, regulatory proceedings, private litigation, reputational damage, and loss of customer confidence, any of which could have a material adverse effect on our business, financial condition, and results of operations.

We may acquire other businesses, form joint ventures, or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt, or cause us to incur significant expense.

As part of our business strategy, we may pursue acquisitions or investments in other companies or technologies. We also may pursue strategic alliances and joint ventures that leverage our core technology and industry experience to expand our offerings or distribution. We have limited experience with acquiring or investing in other companies and forming strategic alliances and joint ventures. We have no experience with acquiring or investing in other companies and limited experience in forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition or investment candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance, or joint venture.

To finance any investments, acquisitions or joint ventures, it may be necessary for us to raise additional funds through public or private financings. To finance any investments, acquisitions or joint ventures, it may be necessary for us to raise additional funds through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

We face additional risks related to acquisitions, now and in the future, that may divert our management's attention, result in dilution to our stockholders, and consume resources that are necessary to sustain and grow our existing business. In particular:

We need to hire and retain additional qualified personnel to grow and manage our business. We need to hire and retain additional qualified personnel to grow and manage our business. If we are unable to attract and retain qualified personnel, including our senior management team, our sales, clinical support and marketing team and our engineering team, our business and growth could be seriously harmed.

Our performance depends on the talents and efforts of our employees. Our performance depends on the talents and efforts of our employees. Our future success will depend on our ability to attract, retain and motivate highly skilled personnel in all areas of our organization, but particularly as part of our sales, clinical support, product development and marketing teams. We plan to continue to grow our business and will need to hire additional personnel to support this growth. It is often difficult to hire and retain these persons, and we may be unable to replace key persons if they leave or fill new positions requiring key persons with appropriate experience. It is often difficult to hire and retain these persons, and we may be unable to replace key persons if they leave or fill new positions requiring key persons with appropriate experience, particularly in light of current labor market conditions. If we experience difficulties locating and hiring suitable personnel in the future, our growth may be hindered. Qualified individuals are in high demand, particularly in the medical device industry, and we may incur significant costs to attract and retain them. If we are unable to attract and retain the personnel we need to succeed, our business and growth could be harmed.

All our employees, including the members of our senior management team, are at-will employees, and therefore they may terminate employment with us at any time. All our employees, including the members of our senior management team, are at-will employees, and therefore they may terminate employment with us at any time. Accordingly, there are no assurances that the services of any of our employees will be available to us for any specified period of time. The loss of members of our senior management team, our sales, clinical support and marketing team or our engineering team, or our inability to attract or retain other qualified personnel, could have a material adverse effect on our business, financial condition, and results of operations. If the need to replace any of our key employees arises, the search and recruiting process likely would involve significant time and costs, and may significantly delay or prevent the achievement of our business objectives.

Risks Related to Our Financial Position

We have incurred losses since our inception, and we may continue to incur losses. If we fail to generate significant revenue from sales of our products and services, we may never achieve or sustain profitability.

We have incurred losses in each year since our inception in 1998 that have resulted principally from costs incurred in connection with our sales and marketing activities, research and development efforts, manufacturing activities and other general and administrative expenses associated with our operations, and we may continue to incur losses as we continue to invest capital in the sales and marketing of our products and services, and growth of our business generally. We have incurred losses in each year since our inception in 1998 that have resulted principally from costs incurred in connection with our sales and marketing activities, research and development efforts, manufacturing activities and other general and administrative expenses associated with our operations, and we may continue to incur losses as we continue to invest capital in the sales and marketing of our ClearPoint platform products and services, and growth of our business generally.

As a result of the numerous risks and uncertainties associated with developing medical devices and with our biologic and drug delivery customers’ development of safe and effective drugs, we are unable to predict the extent of any future losses or when we will become profitable, if at all. As a result of the numerous risks and uncertainties associated with developing medical devices and with our biologic and drug delivery customers’ development of safe and effective drugs, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Our profitability will depend on revenues from the sale of our products and services. Additionally, increases in our various costs that may be the result of inflationary pressures could further reduce our sales and profitability. We cannot provide any assurance that we will ever achieve profitability and, even if we achieve profitability, that we will be able to sustain or increase profitability on a quarterly or annual basis. Because of our relatively limited commercialization history in our biologics and drug delivery business, we have limited insight into the trends that may emerge and affect our business. Further, because of our relatively limited commercialization history in our biologics and drug delivery business, we have limited insight into the trends that may emerge and affect our business. In addition, following our acquisition of IRRAS, we also have limited insight into the trends, operational challenges, and market dynamics associated with operating a business in the neurocritical care space. We may make errors in predicting and reacting to relevant business trends, which could harm our business and financial condition. We may make errors in predicting and reacting to relevant business trends, which could harm our business and financial condition. Any failure to achieve and maintain profitability would continue to have an adverse effect on our stockholders’ equity and working capital and could result in a decline in our stock price or cause us to cease operations.

We currently have significant debt and may incur additional debt. Failure by us to fulfill our obligations under the applicable debt agreements may cause repayment obligations to accelerate. These agreements also contain certain covenants that restrict our operational and financial flexibility.

Under the 2025 NPA, the aggregate amount of our indebtedness, as of December 31, 2025 was $50.9 million.

Our indebtedness may:

In addition, the 2025 NPA includes certain affirmative and negative covenants, that, among other things, may limit our ability to: create liens on assets; incur additional indebtedness; make investments; make acquisitions and other fundamental changes to our business; and sell and dispose of property or assets.

Further, in the event of default by us under the 2025 NPA, the lenders would be entitled to exercise their remedies thereunder, including the right to accelerate the debt, upon which we may be required to repay all amounts then outstanding under the 2025 NPA which would harm our financial condition.

Our ability to make payments on our existing or any future debt will depend on our future operating performance and ability to generate cash and may also depend on our ability to obtain additional debt or equity financing. It will also depend on financial, business or other factors affecting our operations, many of which are beyond our control. We will need to use cash to pay principal and interest on our debt, thereby reducing the funds available to fund operations, strategic initiatives and working capital requirements. If we are unable to generate sufficient cash to service our debt obligations, an event of default may occur under the 2025 NPA which could result in an acceleration of such debt upon which we may be required to repay all the amounts outstanding under our debt instruments. Such an acceleration of our debt obligations could harm our financial condition.

We expect to need additional funding for our combined business following the acquisition of IRRAS, and we may not be able to raise capital when needed or on terms that are acceptable to us. If we fail to obtain necessary financing, we may be forced to delay, reduce, or eliminate commercialization efforts, product development activities, integration initiatives, or other aspects of our operations.

The cumulative net loss of the combined company from our inception through December 31, 2025 was approximately $216.9 million, and net cash used in operations was $23.9 million for the year ended December 31, 2025. Since inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable. At December 31, 2025, we had cash and cash equivalents totaling $45.9 million, driven primarily by 2025 note issuances, a 2025 stock sale, and a 2024 public offering, as discussed in Notes 9 and 11 to the consolidated financial statements included elsewhere in this Annual Report. On November 7, 2024, we entered into an At-The-Market Equity Offering Sales Agreement with Stifel, Nicolaus & Company, Incorporated, as sales agent, to sell shares of our common stock having aggregate sales proceeds of up to $50 million. As of December 31, 2025, we have not sold any shares of common stock under this agreement.

The acquisition of IRRAS has expanded our product portfolio and commercial footprint but has also increased our operating expenses and capital requirements. In addition to funding the ongoing commercialization of our ClearPoint platform, we must now support the IRRAflow system, integration-related activities, expanded sales and clinical support functions, and the continued development and adoption of both product lines. As a result, our future cash needs may be greater than previously anticipated.

In connection with the IRRAS acquisition, we also assumed certain known and unknown liabilities and obligations, including potential obligations relating to IRRAS’s historical operations, existing contractual commitments, product warranties, product performance issues, regulatory compliance matters, clinical data or study obligations, intellectual property matters, and any pending or future claims or litigation. If these liabilities or obligations are greater than expected, or if additional obligations arise that were not identified at the time of the acquisition, we may be required to dedicate additional financial or managerial resources, which could increase our cash requirements and adversely affect our business, results of operations, or financial condition.

Our plans for the next twelve months reflect our expectation of increased revenues from sales of our hardware products and related disposable products, driven by greater utilization of the ClearPoint system and IRRAflow system at existing installed sites, and the installation of the ClearPoint system and IRRAflow system at new sites. We also expect continued payments from strategic partnerships, consulting services, and the sale of systems and disposables to our pharmaceutical partners for gene and stem cell therapy trials. We anticipate increases in operating expenses over the next twelve months to support these activities, with corresponding decreases in operating losses and cash used in operations. We also anticipate increases over the next twelve months in operating expenses to support the expected increase in revenues, with resulting decreases in loss from operations and in cash flow used in operations. However, there can be no assurance that we will achieve these results.

As a result of the foregoing, it is uncertain whether we will need to seek additional funds through the sale of equity or debt securities, which would likely result in dilution to existing stockholders, the establishment of one or more credit facilities, or strategic partnerships or other collaborative arrangements. There is no assurance that we will be able to obtain additional financing on commercially reasonable terms, if at all, or that any financing we obtain will be sufficient to meet the needs of the combined company. There is no assurance, however, that we will be able to obtain such additional financing on commercially reasonable terms, if at all, and there is no assurance that any additional financing we do obtain will be sufficient to meet our needs. If we are not able to obtain additional funding on a timely basis, we may be unable to achieve anticipated operational or financial results, satisfy our obligations as they become due, or fully execute our integration or growth strategies. If our facility experiences a disruption, we would have no other means of assembling those components until we are able to restore the manufacturing capability at our current facility or develop the same capability at an alternative facility. An inability to raise a sufficient amount of additional capital would create substantial doubt about our ability to continue as a going concern. An inability to obtain a sufficient amount of additional funding would create substantial doubt as to our ability to continue as a going concern.

The funding requirements for our business will depend on many factors, including:

Raising additional funds may cause dilution to existing stockholders, restrict our operations, or require us to relinquish proprietary rights. Raising additional funds may cause dilution to existing stockholders, restrict our operations, or require us to relinquish proprietary rights.

Raising additional funds may cause dilution to existing stockholders, further restrict our operations, or require us to relinquish proprietary rights. Raising additional funds may cause dilution to existing stockholders, restrict our operations, or require us to relinquish proprietary rights. To the extent we raise additional capital through the sale of equity or convertible debt securities, existing ownership interests will be diluted, and the terms may include liquidation or other preferences that adversely affect such existing stockholders’ rights. We have already entered into debt financing arrangements that restrict our ability to take certain actions, such as incurring

additional debt, making certain capital expenditures or declaring dividends, and any future debt financing may impose similar or additional restrictions. If we secure additional funds through arrangements with a strategic or other collaboration partner, we may have to relinquish valuable rights to our technologies, products or product candidates or grant licenses on terms that are not favorable to us. Any of these events could adversely affect our ability to achieve our commercialization and/or product development goals and have a material adverse effect on our business, financial condition, results of operations and prospects.

Our cash, cash equivalents and short-term marketable securities are subject to economic risk. Our cash, cash equivalents and short-term marketable securities are subject to economic risk.

The Company may invest its cash, cash equivalents and short-term marketable securities in domestic bank deposits, money market funds, U.S. Government debt securities, corporate debt, and certificates of deposit. Certain types of these investments are subject to general credit, liquidity, market and interest rate risks. In the event these risks caused a decline in value of any of the Company’s investments, it could adversely affect the Company’s financial condition.

We currently, and may in the future, have assets held at financial institutions that may exceed the insurance coverage offered by the Federal Deposit Insurance Corporation (“FDIC”), and the loss of such assets could have a negative effect on our operations and liquidity.

We currently have our cash and cash equivalents held in deposit in accounts at certain FDIC-insured financial institutions, some of which include amounts in excess of the insurance coverage offered by the FDIC. We currently have our cash and cash equivalents held in deposit in accounts at certain FDIC-insured financial institutions, some of which include amounts in excess of the insurance coverage offered by the FDIC. In the future, we may maintain our cash assets at financial institutions in the United States in amounts that may be in excess of the FDIC insurance limit of $250,000. Though to date, we have experienced no loss or lack of access to cash in our operating accounts, in the event of a failure of any of these financial institutions where we maintain our deposits or other assets, we may incur a loss to the extent such deposits or assets exceeds the FDIC insurance limitation, which could have a material adverse effect upon our liquidity, financial condition and our results of operations.

Risks Related to Our Intellectual Property

If we, or the third parties from whom we license intellectual property, are unable to secure and maintain patent or other intellectual property protection for the intellectual property covering our marketed products or our product candidates, our ability to compete will be harmed.

Our commercial success depends, in part, on obtaining patent and other intellectual property protection for the technologies contained in our products and product candidates. Our commercial success depends, in part, on obtaining patent and other intellectual property protection for the technologies contained in our products and product candidates. The patent positions of medical device companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions. Our patent position is uncertain and complex, in part, because of our dependence on intellectual property that we license from others. If we, or the third parties from whom we license intellectual property, fail to obtain adequate patent or other intellectual property protection for intellectual property covering our products or product candidates, or if any protection is reduced or eliminated, others could use the intellectual property covering our products or product candidates, resulting in harm to our competitive business position. In addition, patent and other intellectual property protection may not provide us with a competitive advantage against competitors that devise ways of making competitive products without infringing any patents that we own or to which we have rights.

U.S. patents and patent applications may be subject to interference proceedings and U.S. patents may be subject to inter partes proceedings (“IPRs”), reissue and reexamination proceedings in the United States Patent and Trademark Office. Foreign patents may be subject to opposition or comparable proceedings in the corresponding foreign patent offices. Any of these proceedings could result in either loss of the patent or denial of the patent application, or loss or reduction in the scope of one or more of the claims of the patent or patent application. Changes in either patent laws or in interpretations of patent laws may also diminish the value of our intellectual property or narrow the scope of our protection. Interference, IPRs, reexamination and opposition proceedings may be costly and time consuming, and we, or the third parties from whom we license intellectual property, may be unsuccessful in such proceedings. Thus, any patents that we own or license may provide limited or no protection against competitors. In addition, our pending patent applications and those we may file in the future may not result in patents being issued or may have claims that do not cover our products or product candidates. Even if any of our pending or future patent applications are issued, they may not provide us with adequate protection or any competitive advantages. Our ability to develop additional patentable technology is also uncertain.

Non-payment or delay in payment of patent fees or annuities, whether intentional or unintentional, may also result in the loss of patents or patent rights important to our business. Non-payment or delay in payment of patent fees or annuities, whether intentional or unintentional, may also result in the loss of patents or patent rights important to our business. Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as do the laws of the U.S., particularly in the field of medical devices and procedures.

Others may assert that our products infringe their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our marketed products. Others may assert that our products infringe their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our marketed products.

There may be U.S. and foreign patents issued to third parties that relate to our business. Some of these patents may be broad enough to cover one or more aspects of our present technologies and/or may cover aspects of our future technologies. We do not know whether any of these patents, if asserted, would be held valid, enforceable and infringed. We cannot provide any assurance that a court or administrative body would agree with any arguments or defenses we may have concerning invalidity, unenforceability or non-infringement of any third-party patent. The medical device industry has been characterized by extensive litigation and administrative proceedings regarding patents and other intellectual property rights, and companies have employed such actions to gain a competitive advantage. If third parties assert infringement or other intellectual property claims against us, our management personnel will experience a significant diversion of time and effort and we will incur large expenses defending our company. If third parties in any patent action are successful, our patent portfolio may be damaged, we may have to pay substantial damages and we may be required to stop selling certain products, refrain from entering certain lines of business or obtain a license which, if available at all, may require us to pay substantial royalties. We cannot be certain that we will have the financial resources or the substantive arguments to defend our products from infringement or our patents from claims of invalidity or unenforceability, or to defend our products against allegations of infringement of third-party patents. In addition, any public announcements related to litigation or administrative proceedings initiated by us, or initiated or threatened against us, could negatively impact our business.

If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to successfully commercialize our marketed products and product candidates will be harmed, and we may not be able to operate our business profitably. 28 Table of Contents If the combination of patents, trade secrets and contractual provisions that we rely on to protect our intellectual property is inadequate, our ability to successfully commercialize our marketed products and product candidates will be harmed, and we may not be able to operate our business profitably.

Our success and ability to compete is dependent, in part, upon our ability to maintain the proprietary nature of our technologies. Our success and ability to compete is dependent, in part, upon our ability to maintain the proprietary nature of our technologies. We rely on a combination of patent, copyright, trademark and trade secret law and nondisclosure agreements to protect our intellectual property. However, such methods may not be adequate to protect us or permit us to gain or maintain a competitive advantage. Our patent applications may not issue as patents in a form that will be advantageous to us, or at all. Our issued patents, and those that may issue in the future, may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products.

To protect our proprietary rights, we may in the future need to assert claims of infringement against third parties to protect our intellectual property. To protect our proprietary rights, we may in the future need to assert claims of infringement against third parties to protect our intellectual property. There can be no assurance that we will be successful on the merits in any enforcement effort. In addition, we may not have sufficient resources to litigate, enforce or defend our intellectual property rights. Litigation to enforce our intellectual property rights in patents, copyrights or trademarks is highly unpredictable, expensive and time consuming and would divert human and monetary resources away from managing our business, all of which could have a material adverse effect on our financial condition and results of operations even if we were to prevail in such litigation. In the event of an adverse judgment, a court could hold that some or all of our asserted intellectual property rights are not infringed, or that they are invalid or unenforceable, and could award attorney fees.

Despite our efforts to safeguard our unpatented and unregistered intellectual property rights, we may not be successful in doing so or the steps taken by us in this regard may not be adequate to detect or deter misappropriation of our technologies or to prevent an unauthorized third party from copying or otherwise obtaining and using our products, technologies or other information that we regard as proprietary. Despite our efforts to safeguard our unpatented and unregistered intellectual property rights, we may not be successful in doing so or the steps taken by us in this regard may not be adequate to detect or deter misappropriation of our technologies or to prevent an unauthorized third party from copying or otherwise obtaining and using our products, technologies or other information that we regard as proprietary. Additionally, third parties may be able to design around our patents. Furthermore, the laws of foreign countries may not protect our proprietary rights to the same extent as the laws of the U.S. Our inability to adequately protect our intellectual property could allow our competitors and others to produce products based on our technologies, which could substantially impair our ability to compete.

We have entered into confidentiality and intellectual property assignment agreements with our employees and consultants as one of the ways we seek to protect our intellectual property and other proprietary technologies. We have entered into confidentiality and intellectual property assignment agreements with our employees and consultants as one of the ways we seek to protect our intellectual property and other proprietary technologies. However, these agreements may not be enforceable, or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.

Our employees and consultants may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Our employees and consultants may unintentionally or willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third party illegally obtained and is using our proprietary know-how is expensive and time-consuming, and the outcome is unpredictable. In addition, courts outside the U.S. are sometimes less willing to protect know-how than courts in the U.S. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. Failure to obtain or maintain intellectual property protection could adversely affect our competitive business position.

We rely on patent rights and licenses from third parties which are subject to termination or expiration. We rely on patent rights and licenses from third parties which are subject to termination or expiration.

Patents have a limited lifespan. Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited.

Even if patents covering our products are obtained, once the patent life has expired, we may be open to competition from competitive products, as our ability to prevent competitors from copying our technology may be limited. Given the amount of time required for the

development, testing and regulatory review of potential new medical technologies, patents protecting such candidates might expire before or shortly after such candidates are commercialized. Additionally, should any patent licenses be prematurely terminated for any reason, or if the patents and intellectual property assigned to us or owned by third parties that we have licensed are challenged or defeated, our research efforts could be materially and adversely affected. There is also the related risk that we may not be able to make the required payments under any patent license, in which case we may lose to ability to use one or more of the licensed patents. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

We may not be able to protect our intellectual property rights throughout the world. We may not be able to protect our intellectual property rights throughout the world.

Third parties may attempt to commercialize competitive products in foreign countries where we do not have any patents or patent applications and/or where legal recourse may be limited. Third parties may attempt to commercialize competitive products in foreign countries where we do not have any patents or patent applications and/or where legal recourse may be limited. This may have a significant commercial impact on our foreign business operations.

Filing, prosecuting and defending patents on our products in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. 29 Table of Contents Filing, prosecuting and defending patents on our products in all countries throughout the world would be prohibitively expensive, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries do not favor the enforcement of patents, trade secrets and other intellectual property protection. In particular, many countries limit the enforceability of patents against certain third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. Even in foreign jurisdictions that enforce intellectual property rights to the same or a similar extent as do the laws of the United States, uneven enforcement and procedural barriers may exist in such countries, and proceedings to enforce our intellectual property rights could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not being issued and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

If we lose access to third-party software that is integrated into our products, our costs could increase and new installations of our products could be delayed, potentially hurting our competitive position. If we lose access to third-party software that is integrated into our products, our costs could increase and new installations of our products could be delayed, potentially hurting our competitive position.

We have received licenses from third parties to certain software that is integrated into the software components of our products. We have received licenses from third parties to certain software that is integrated into the software components of our products. In return, we have agreed to pay license fees and royalties subject to commercial arrangements with such third-party licensors. A loss of any of the licenses could impede our ability to offer and sell our products to customers until equivalent software could be identified, licensed or developed, and integrated into our products. These delays, if they occur, would harm our business, operating results and financial condition.

Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others. Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others.

We rely, in part, upon licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development of our products and technology. We rely, in part, upon licenses to certain patent rights and proprietary technology from third parties that are important or necessary to the development of our products and technology. These and other licenses may not provide exclusive rights to use such intellectual property and technology, and we may not have intellectual property rights through such licenses in all territories in which we may wish to develop or commercialize our technology and products in the future. As a result, we may not be able to prevent competitors from developing and commercializing competitive products in territories included in all of our licenses.

In addition, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications covering the technology that we license from third parties. In addition, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications covering the technology that we license from third parties. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced and defended in a manner consistent with the best interests of our business. If our licensors fail to prosecute, maintain, enforce and defend such patents, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected.

Our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not in sole and exclusive control or may not be the sole owners of the patents we in-license. Our licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not in sole and exclusive control or may not be the sole owners of the patents we in-license. This could materially and adversely affect our business, financial condition and results of operations.

The agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement. In spite of our best efforts, our licensors might also conclude that we have materially breached our license agreements and terminate the license agreements, thereby removing our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours. In addition, we may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to larger financial commitments. Any of these events could materially and adversely affect our business, financial condition and results of operations.

Risks Related to Legal and Regulatory Compliance

We operate in a highly-regulated industry and any failure to comply with the extensive government regulations may subject us to fines, injunctions and other penalties that could harm our business.

We are subject to extensive regulation by the FDA and various other federal, state and foreign governmental authorities. We are subject to extensive regulation by the FDA and various other federal, state and foreign governmental authorities. Government regulations and foreign requirements specific to medical devices are wide ranging and govern, among other things:

We are subject to ongoing regulatory requirements, including: required submissions of safety and other post-market information; manufacturing facility registration and device listing requirements; compliance with medical device current Good Manufacturing Practice regulations, as codified in the QMSR; requirements regarding field corrections and removals of our marketed products; reporting of adverse events and certain product malfunctions to regulatory bodies; and numerous recordkeeping requirements. We are subject to ongoing regulatory requirements, including: required submissions of safety and other post-market information; manufacturing facility registration and device listing requirements; compliance with medical device current Good Manufacturing Practice regulations, as codified in the QMSR; requirements regarding field corrections and removals of our marketed products; reporting of adverse events and certain product malfunctions to regulatory bodies; and numerous recordkeeping requirements. If we or any of our collaborators or suppliers fail to comply with applicable regulatory requirements, a regulatory agency may take action against us, including any of the following sanctions:

We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation, administrative, or executive action, either in the U.S. or abroad. The implementation of new policies and priorities by future administrations are unknown and could materially impact the regulation of our products. If executive actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

In addition, our biologics and drug delivery business may be subject to regulations and guidance concerning the procurement and use of research animals for research purposes. In addition, our biologics and drug delivery business may be subject to regulations and guidance concerning the procurement and use of research animals for research purposes. Such regulations and guidance are evolving and continues to be developed for other areas that impact the biomedical research community on both a national and international basis. Our failure to comply with these regulations and guidance could have a material adverse effect on our business.

Federal legislation and other payment and policy changes may have a material adverse effect on our business. Federal legislation and other payment and policy changes may have a material adverse effect on our business.

Since enactment of the Affordable Care Act in 2010, there have been a number of legal challenges as well as other legislative and regulatory changes to the healthcare system that could limit the acceptance and availability of our products, which would have an adverse

effect on our financial results and business. The full effects of the Affordable Care Act may be unknown until all outstanding legal issues are resolved, the statutory provisions are fully implemented, and CMS, the FDA, and other federal and state agencies issue final applicable regulations or guidance. These developments could result in increased coordination between hospitals and physicians and alignment of financial incentives between hospitals and physicians to control hospital costs. Such payment reform efforts and increased coordination among hospitals and physicians may lead to voluntary reductions in the array of choices currently available to physicians with respect to diagnostic services, medical supplies and equipment, which could result in hospitals reducing the overall number of vendors from which they purchase supplies, equipment and products. The Affordable Care Act may continue to be periodically subject to legal challenges or a continuing political effort to limit its scope, and the Affordable Care Act may change in the future in ways that could have a material adverse effect on our business or results of operations.

The Medicare Access and CHIP Reauthorization Act, or the Medicare Access Act, removed the sustainable growth rate or SGR, methodology applicable to fees for physician services. The Medicare Access Act also replaced the previous fee-for-service payment system with a more value-based system. As a result, reimbursements from the Medicare program may be reduced. As noted above, failure by hospitals and physicians to receive an amount that they consider to be adequate reimbursement for procedures in which our products are used may deter them from purchasing or using our products and will limit our sales growth.

The Affordable Care Act also imposes, among other things, an annual excise tax on any entity that manufactures or imports medical devices offered for sale in the U.S. In December 2019, President Trump signed into law a permanent repeal of the medical device tax under the Affordable Care Act, but there is no guarantee that such repeal will not reverse course in the future. If such an excise tax on sales of our products in the U.S. is enacted, it could have a material adverse effect on our business, results of operations and financial condition.

The Inflation Reduction Act (“IRA”), aimed at curbing inflationary pressures, may have direct and indirect consequences for pharmaceutical and biotech companies in the context of their research and development expenditures. In particular, the IRA measures to control inflation have implications for future drug pricing. Our pharmaceutical and biotech customers rely on predictable pricing to fund research and development efforts. If pricing flexibility is constrained, these companies may limit spending on their pipeline, which may adversely affect the future revenue of our biologics and drug delivery business. The One Big Beautiful Bill Act includes significant reductions in Medicaid funding, which could impact demand and reimbursement for our products and the therapies of our pharmaceutical and biotech customers. It is unknown what form any future changes or any law would take and how or whether it may affect our business in the future. It is unknown what form any future changes or any law would take and how or whether it may affect our business in the future.

Various healthcare reform proposals have also emerged at the state level. Various healthcare reform proposals have also emerged at the state level. We cannot predict what healthcare initiatives will be implemented at the federal or state level, or the effect any recently promulgated or future legislation or regulation will have on us. However, an expansion in government’s role in the U.S. healthcare industry may lower reimbursements for our products, reduce medical procedure volumes and adversely affect our business, possibly materially. We expect that changes or additions to the Affordable Care Act, the Medicare and Medicaid programs and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry.

The success of our biologics and drug delivery business is dependent on timely regulatory approval and commercialization of cell and gene therapies. In addition, our biologics and drug delivery business may be subject to regulations and guidance concerning the procurement and use of research animals for research purposes.

A significant portion of our growth strategy depends on the continued clinical progress, regulatory approval, and commercial launch of cell and gene therapies (“CGTs”) that use our delivery-related medical devices and systems. The U.S. Food and Drug Administration (“FDA”) maintains an evolving regulatory framework for CGTs and related delivery devices. Any material change in FDA policy, guidance, or review practices; adjustments in the agency’s risk tolerance or evidentiary standards; reduced availability of expedited review pathways; or extended review timelines could delay or prevent approval of our customers’ products and adversely affect our business.

The FDA may modify eligibility or evidentiary criteria for expedited programs, limit their use, or require additional data before or after approval. Even when such programs are granted, limited agency resources may reduce their impact on review timelines. The FDA’s expectations for clinical trial design, long-term safety follow-up, manufacturing controls, labeling, and post-marketing obligations for CGTs continue to evolve and may result in additional studies, data requirements, or delays for our customers’ programs. Similar developments relating to device-drug or device-biologic combinations may require new data or supplemental submissions by our customers and, in some cases, by us.

As sponsors pursue indications beyond rare or severe diseases, the FDA may apply more conservative benefit-risk standards, require larger or longer trials, or seek additional evidence of long-term efficacy and safety. In addition, periodic resource or staffing constraints at the FDA can extend review cycles, inspections, or regulatory correspondence. Any such changes or delays may postpone approvals or commercial launches of CGTs that rely on our products, which could result in lower utilization, deferred orders, and reduced revenues.

A government shutdown or prolonged lapse in federal appropriations could materially delay or disrupt FDA review and approval processes critical to our business, which could have a material adverse effect on our financial condition and results of operations.

Our business depends significantly on the timely review and clearance or approval of our products and our customers' products by the FDA. During a federal government shutdown or lapse in congressional appropriations, the FDA may furlough significant portions of its workforce, suspend or substantially delay the review of pending 510(k) submissions, de novo requests, PMA applications, and other regulatory submissions, and cease accepting new applications for the duration of the shutdown. Any such disruption could delay the clearance or approval of our products or our customers' products, including cell and gene therapies that rely on our delivery devices and systems, and could postpone the commercial launch of products that are critical to our growth strategy. In addition, FDA inspections necessary to support product approvals or manufacturing compliance may be suspended or significantly delayed during a shutdown period, further extending regulatory timelines. Our drug delivery customers, whose programs depend on timely FDA action, may experience delays in clinical trial authorizations, combination product reviews, or approval decisions, which could reduce their demand for our products and services and adversely affect our revenues. Similarly, any expanded indications we may seek for our products could be subject to extended review timelines as a result of a shutdown. The recent government shutdown, between October 1, and November 12, 2025, was the longest in history and paused new fee applications and slowed review timelines for 43 days. The duration and frequency of future government shutdowns are inherently unpredictable, and a prolonged shutdown could have compounding effects on our regulatory pipeline and those of our customers. Any such delays or disruptions could have a material adverse effect on our business, financial condition, and results of operations.

Our products may be subject to product recalls that could harm our reputation, business operating results and financial condition. Our products may be subject to product recalls that could harm our reputation, business operating results and financial condition. Likewise, products that are manufactured and sold by third parties and that are needed for procedures in which physicians use our products also may be subject to recalls, which could adversely impact our business, operating results and financial condition.

The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design, manufacture or labeling. The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design, manufacture or labeling. In the case of the FDA, the authority to require a recall must be based on an FDA finding that there is a reasonable probability that the device would cause serious injury or death. In addition, foreign governmental bodies have the authority to require the recall of our products in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if any material deficiency in a device is found. A government-mandated or voluntary recall by us could occur as a result of component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. We may initiate certain voluntary recalls involving our products in the future. Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA. If we determine that certain of those recalls do not require notification to the FDA, the FDA may disagree with our determinations and require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect our sales. In addition, the FDA could take enforcement actions against us, which could impair our ability to produce our products in a cost-effective and timely manner to meet our customers’ demands. Regulatory investigations or product recalls could also result in our incurring substantial costs, losing revenues and implementing a change in the design, manufacturing process or the indications for which our products may be used, each of which would harm our business.

In addition, products that are manufactured and sold by other companies and that are needed for procedures in which physicians use ClearPoint devices also could become subject to a recall. In addition, products that are manufactured and sold by other companies and that are needed for procedures in which physicians use ClearPoint devices also could become subject to a recall. ClearPoint devices are designed to enable a range of minimally invasive procedures in the brain. Those procedures involve insertion of a catheter, probe, electrode or other similar device into a target region of the brain, and most of those devices are manufactured and sold by other companies. Any of those devices may become the subject of a recall, whether required by the FDA or a foreign governmental body or initiated by the third-party manufacturer. The shortage or absence of any of those devices in the marketplace could adversely impact the number of procedures performed by physicians using our ClearPoint devices, which would adversely impact our financial condition and results of operations.

If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions. 32 Table of Contents If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

Under the FDA’s Medical Device Reporting regulations, we are required to report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our products malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. Under the FDA’s Medical Device Reporting regulations, we are required to report to the FDA any incident in which our products may have caused or contributed to a death or serious injury or in which our products malfunctioned and, if the malfunction were to recur, would likely cause or contribute to death or serious injury. In the future, we may experience events that may require reporting to the FDA pursuant to the medical device reporting regulations. In addition, all manufacturers placing medical devices in EU markets are legally bound to report any serious or potentially serious incidents involving devices they produce or sell to the relevant authority in whose jurisdiction the incident occurred. Any adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results. In addition, failure to report such adverse events to appropriate government authorities on a timely basis, or at all, could result in an enforcement action against us.

We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the U.S. or elsewhere.

We have obtained 510(k) clearance of the products that we commercialize for defined indications. Promotion or marketing of our products for any indications for use other than that cleared by the FDA would be considered off-label use.

Under the federal Food, Drug, and Cosmetic Act and other similar laws, we are prohibited from labeling or promoting our products, or training physicians, for such off-label uses. Under the federal Food, Drug, and Cosmetic Act and other similar laws, we are prohibited from labeling or promoting our products, or training physicians, for such off-label uses. The FDA defines labeling to include not only the physical label attached to the product, but also items accompanying the product. This definition also includes items as diverse as materials that appear on a company’s website. As a result, we are not permitted to promote off-label uses of our products, whether on our website, in product brochures or in customer communications. However, although manufacturers are not permitted to promote for off-label uses, in their practice of medicine, physicians may lawfully choose to use medical devices for off-label uses. Therefore, a physician could use our products for uses not covered by the cleared labeling.

The FDA and other regulatory agencies actively enforce regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance or approval has not been obtained. The FDA and other regulatory agencies actively enforce regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance or approval has not been obtained. If the FDA determines that our promotional materials or training constitutes promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled letter, warning letter, injunction, seizure, civil fine and criminal penalties. We could be enjoined from selling some or all of our products for any unapproved uses. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged and market adoption of our products would be impaired. In addition, the off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention and result in substantial damage awards against us.

If we or our third-party suppliers fail to comply with the FDA’s QMSR or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer. If we or our third-party suppliers fail to comply with the FDA’s QMSR or any applicable state equivalent, our manufacturing operations could be interrupted, and our potential product sales and operating results could suffer.

We and some of our third-party suppliers are required to comply with the FDA’s QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products and product candidates. We and some of our third-party suppliers are required to comply with the FDA’s QMSR, which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our products and product candidates. We and our suppliers will also be subject to the regulations of foreign jurisdictions regarding the manufacturing process to the extent we market our products in these jurisdictions. The FDA enforces the QMSR through periodic and unannounced inspections of manufacturing facilities. Our ClearPoint manufacturing facilities were last subject to an ISO 13485 surveillance audit and MDSAP surveillance audit in January 2025. We anticipate that we and certain of our third-party suppliers will be subject to future inspections. Our facilities were last subject to an ISO 13485 surveillance audit and MDSAP surveillance audit in October 2024. We anticipate that we and certain of our third-party suppliers will be subject to future inspections. The failure by us or one of our third-party suppliers to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations, could result in enforcement actions against us, which could impair our ability to produce our products in a cost-effective and timely manner to meet our customers’ demands. If we fail to comply with the FDA’s QMSR or any applicable state equivalent, we would be required to incur the costs and take the actions necessary to bring our operations into compliance, which may have a negative impact on our future sales and our ability to generate a profit.

We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws. 33 Table of Contents We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and regulations and could face substantial penalties if we are unable to fully comply with such laws.

Although we do not provide healthcare services or receive payments directly from Medicare, Medicaid or other third-party payors for our products or the procedures in which our products may be used, many state and federal healthcare laws and regulations governing financial relationships between medical device companies and healthcare providers apply to our business and we could be subject to enforcement by both the federal government, private whistleblowers and the states in which we conduct our business. Although we do not provide healthcare services or receive payments directly from Medicare, Medicaid or other third-party payors for our products or the procedures in which our products may be used, many state and federal healthcare laws and regulations governing financial relationships between medical device companies and healthcare providers apply to our business and we could be subject to enforcement by both the federal government, private whistleblowers and the states in which we conduct our business. The healthcare laws and regulations that may affect our ability to operate include:

The medical device industry has been under heightened scrutiny as the subject of government investigations and government enforcement or private whistleblower actions under the Anti-Kickback Statute and the False Claims Act involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure their business, including specifically arrangements with physician consultants. The medical device industry has been under heightened scrutiny as the subject of government investigations and government enforcement or private whistleblower actions under the Anti-Kickback Statute and the False Claims Act involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure their business, including specifically arrangements with physician consultants.

We may from time to time have agreements with physicians that could be scrutinized or could be subject to reporting requirements in the future, including consulting contracts in which we compensate physicians for various services, which could include:

The Affordable Care Act mandates increased transparency of arrangements between physicians and medical device companies. We believe that this increased transparency may also result in a heightened level of government scrutiny of the relationships between physicians and medical device companies. While we believe that all of our arrangements with physicians comply with applicable law, the increased level of scrutiny, coupled with the expanded enforcement tools available to the government under the Affordable Care Act, may increase the likelihood of a governmental investigation. If we become subject to such an investigation, our business and operations would be adversely affected even if we ultimately prevail because the cost of defending such investigation would be substantial. Moreover, companies subject to governmental investigations could lose both overall market value and market share during the course of the investigation.

In addition, we may provide customers with information on products that could be deemed to influence their coding or billing practices, and may have sales, marketing or other arrangements with hospitals and other providers that could also be the subject of scrutiny under these laws. In addition, we may provide customers with information on products that could be deemed to influence their coding or billing practices, and may have sales, marketing or other arrangements with hospitals and other providers that could also be the subject of scrutiny under these laws. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Any penalties, damages, fines, exclusions, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If the physicians or other providers or entities with which we do business are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business.

We are subject to various laws protecting the confidentiality and security of certain personal information, and our failure to comply could result in penalties and reputational damage. We are subject to various laws protecting the confidentiality and security of certain personal information, and our failure to comply could result in penalties and reputational damage.

We are subject to various laws and regulations protecting the confidentiality and security of certain patient health information, and our failure to comply with such laws and regulations could result in penalties and reputational damage. We are subject to various laws and regulations protecting the confidentiality and security of certain patient health information, and our failure to comply with such laws and regulations could result in penalties and reputational damage.

Within the U.S., numerous federal and state laws governing the collection, use, disclosure and storage of personal information may apply to us, including, without limitation, HIPAA, state data privacy laws (for example, the California Consumer Privacy Act and the California Privacy Rights Act), state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws. In addition, in certain cases, we may be a business associate of our HIPAA covered entity customers by virtue of receiving individually identifiable health information (referred to as “Protected Health Information” or “PHI”) from these customers. In these business associate relationships, we must comply with applicable HIPAA requirements, state data privacy and security requirements, and the contractual terms of our business associate agreements that govern its permitted uses and disclosures of PHI received from the covered entity counterparty. Our failure to comply with any of these laws may result in criminal and civil liability. Enforcement actions can be costly and interrupt regular operations which may adversely affect our business.

Outside the U.S., numerous countries in which we operate, manufacture, and sell our products have, or are developing, laws protecting data privacy and the confidentiality of certain personal data. For example, the EU General Data Protection Regulation (“GDPR”) introduced new data protection requirements in the European Economic Area and substantial fines for violations of the data protection rules. The GDPR applies extraterritorially, and we may be subject to the GDPR because of our EU subsidiaries and potential data processing activities that involve the personal data of individuals located in the EU, such as in connection with any EU customers, EU clinical trials or related to any employees in the EU. The GDPR imposes strict obligations and restrictions on controllers and processors of personal data, which could cause our costs of compliance to increase, potentially leading to harm to our business and financial condition.

Globally, the legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues that may affect our business. Globally, the legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues that may affect our business. There is a degree of uncertainty associated with the legal and regulatory environment around privacy and data protection laws, which continue to develop in ways we cannot predict. Privacy and data protection laws may be interpreted and applied inconsistently from country to country and impose inconsistent or conflicting requirements. Varying jurisdictional requirements could increase the costs and complexity of compliance or require us to change our business practices in a manner adverse to our business. A determination that we have violated privacy or data protection laws could result in significant damage awards, fines and other penalties that could, individually or in the aggregate, materially harm our business and reputation.

Risks Related to Our Common Stock

The market price of our common stock may be volatile, and a stockholder may not be able to resell their shares at or above the price at which the shares were purchased.

Companies trading in the stock market in general have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Companies trading in the stock market in general have experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. The market price of our common stock may be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.

In general, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses, or NOLs, to offset future taxable income. In general, under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change net operating losses, or NOLs, to offset future taxable income. Our existing NOLs may be subject to substantial limitations arising from previous ownership changes. In addition, future changes in our stock ownership, many of which are outside of our control, could result in an ownership change under Section 382 of the Code. Our NOLs may also be impaired under state law. Accordingly, we may not be able to utilize a material portion of our NOLs. Furthermore, our ability to utilize our NOLs is conditioned upon our attaining profitability and generating U.S. federal taxable income. We have incurred net losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future; thus, we do not know whether or when we will generate the U.S. federal taxable income necessary to utilize our NOLs.

We have not paid dividends in the past and do not expect to pay dividends in the future. We have not paid dividends in the past and do not expect to pay dividends in the future.

We have never declared or paid cash dividends on our capital stock. We have never declared or paid cash dividends on our capital stock. We currently intend to retain all future earnings for the operation and expansion of our business and, therefore, do not anticipate declaring or paying cash dividends in the foreseeable future. The payment of dividends will be at the discretion of our Board of Directors and will depend on our results of operations, capital requirements, financial condition, prospects, contractual arrangements, any limitations on payments of dividends present in any of our future debt agreements and other factors our Board of Directors may deem relevant. If we do not pay dividends, a return on our stockholders’ investment will only occur if our stock price appreciates.

Anti-takeover provisions in our certificate of incorporation, bylaws and Delaware law could prevent or delay a change in control. Anti-takeover provisions in our certificate of incorporation, bylaws and Delaware law could prevent or delay a change in control.

We have 90,000,000 shares of common stock authorized, and 29,663,875 shares outstanding as of March 6, 2026. As a result, our Board of Directors will be able to issue a substantial number of additional shares of common stock, without seeking stockholder approval. We have 90,000,000 shares of common stock authorized, and 27,632,332 shares outstanding as of February 18, 2025. As a result, our Board will be able to issue a substantial number of additional shares of common stock, without seeking stockholder approval. In addition, provisions in our certificate of incorporation and bylaws, as well as provisions of Delaware law, may discourage, delay or prevent a merger, acquisition or change of control. These provisions could also discourage proxy contests and make it more difficult for stockholders to elect directors and take other corporate actions. These provisions:

In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any broad range of business combinations with any stockholder who owns, or at any time in the last three years owned, 15% or more of our outstanding voting stock, for a period of three years following the date on which the stockholder became an interested stockholder. In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any broad range of business combinations with any stockholder who owns, or at any time in the last three years owned, 15% or more of our outstanding voting stock, for a period of three years following the date on which the stockholder became an interested stockholder. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders.

Our Fourth Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the U.S. will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our Fourth Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another State court in Delaware or the federal district court for the District of Delaware) is the exclusive forum (to the fullest extent permitted by law, and subject to applicable jurisdictional requirements) for claims in the right of the corporation that are based upon a violation of a duty by a current or former director, officer, employee or stockholder in such capacity, or as to which the Delaware General Corporation Law confers jurisdiction upon the Court of Chancery of the State of Delaware.

Our Fourth Amended and Restated Bylaws further provide that the federal district courts of the U.S. will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933.

These exclusive-forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us and our directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any interest in any of our securities shall be deemed to have notice of and consented to these provisions. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ charter documents has been challenged in legal proceedings. It is possible that a court could find these types of provisions to be inapplicable or unenforceable, and if a court were to find either exclusive-forum provision in our Fourth Amended and Restated Bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm our business.

We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price. We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price.

We publicly provide financial guidance about our business and future operating results. We publicly provide financial guidance about our business and future operating results. In developing this guidance, our management makes certain assumptions and judgments about our future operating performance, including projected hiring of personnel, continued increase of our revenue, and continued stability of the macro-economic environment in our key markets. Furthermore, analysts and investors may develop and publish their own projections of our business, which may form a consensus about our future performance. Our business results may vary significantly from such guidance or that consensus due to a number of factors, many of which are outside of our control, and which could adversely affect our operations and operating results. Our business results may vary significantly from such guidance or that consensus due to a number of factors, many of which are outside 37 Table of Contents of our control, and which could adversely affect our operations and operating results. Furthermore, if we make downward revisions of our previously announced guidance, or if our publicly announced guidance of future operating results fails to meet expectations of securities analysts, investors, or other interested parties, the market price of our common stock could decline.

Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports. Securities analysts may not continue, or additional securities analysts may not initiate, coverage for our common stock or may issue negative reports. This may have a negative impact on the market price of our common stock.

Securities analysts provide research coverage of our common stock. Securities analysts provide research coverage of our common stock. Some analysts may publish statements that do not portray our technology, products or procedures using our product in a positive light. If we are unable to educate those who publicize such reports about the benefits we believe our business provides, or if one or more of the analysts who elects to cover us downgrades our stock, our stock price would likely decline rapidly. If one or more of these analysts ceases coverage of our company, we could lose visibility in the market, which in turn could cause our stock price to decline. The trading market for our common stock may be affected in part by the research and reports that industry or financial analysts publish about us or our business. If sufficient securities analysts do not cover our common stock, the lack of research coverage may adversely affect the market price of our common stock. It may be difficult for companies such as ours, with smaller market capitalizations, to attract and maintain sufficient independent financial analysts that will cover our common stock. This could have a negative effect on the market price of our stock. We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price. We may fail to meet our publicly announced guidance or other expectations about our business and future operating results, which could cause a decline in our stock price.

General Risk Factors

Damage to our reputation could harm our businesses, including our competitive position and business prospects.

Our ability to attract and retain customers, suppliers, investors and employees is impacted by our reputation. Our ability to attract and retain customers, suppliers, investors and employees is impacted by our reputation. Harm to our reputation can arise from various sources, including employee misconduct, security and privacy breaches, unethical behavior, litigation or regulatory outcomes, and scrutiny in connection with federal and state healthcare fraud and abuse laws and regulations. Such harm could also, among other consequences, increase the size and number of litigation claims and damages asserted or subject us to enforcement actions, fines and penalties and cause us to incur related costs and expenses.

The preclinical services that our biologics and drug delivery business provides to our customers are essential to drug discovery and development processes, and a significant number of these services are mandated by law. The preclinical services that our biologics and drug delivery business provides to our customers are essential to drug discovery and development processes, and a significant number of these services are mandated by law. Notwithstanding, certain special interest groups categorically object to the use of animals for valid research purposes. Historically, research activities with animals have been the subject

of adverse attention, including shareholder proposals and attempts to disrupt such services, impacting the industry. This may, in the future, include periodic demonstrations near facilities operated or utilized by us. Any negative attention, threats, acts of vandalism or legal action directed against our preclinical service activities, or our third-party service providers could harm our reputation and impair our ability to operate our business efficiently.

We have been, and could in the future become, subject to product liability or professional liability claims that could be expensive, divert management’s attention and harm our business. We have been, and could in the future become, subject to product liability or professional liability claims that could be expensive, divert management’s attention and harm our business.

Our business exposes us to potential product liability risks that are inherent in the manufacturing, marketing and sale of medical devices. Our business exposes us to potential product liability risks that are inherent in the manufacturing, marketing and sale of medical devices. We may be held liable if our products cause injury or death or are found otherwise unsuitable or defective during usage. Our ClearPoint system, ClearPoint Prism Neuro Laser Therapy System, IRRAflow system, and other products may incorporate mechanical and electrical parts, complex computer software and other sophisticated components, any of which can have defective or inferior parts or contain defects, errors or failures. Complex computer software is particularly vulnerable to errors and failures, especially when first introduced.

Because our products are designed to be used to perform complex surgical procedures, defects could result in a number of complications, some of which could be serious and could harm or kill patients. Because our products are designed to be used to perform complex surgical procedures, defects could result in a number of complications, some of which could be serious and could harm or kill patients. The adverse publicity resulting from any of these events could cause physicians or hospitals to review and potentially terminate their relationships with us.

We may also be subject to professional liability for errors in the clinical support that we provide to clinicians in connection with our products or for a misunderstanding of, or inappropriate reliance upon, the information we provide. We may also be subject to professional liability for errors in the clinical support that we provide to clinicians in connection with our products or for a misunderstanding of, or inappropriate reliance upon, the information we provide.

The medical device industry has historically been subject to extensive litigation over product liability and professional liability claims. 38 Table of Contents The medical device industry has historically been subject to extensive litigation over product liability and professional liability claims. A product liability or professional liability claim, regardless of its merit or eventual outcome, could result in significant legal defense costs, amounts paid in settlement or awards against us. Although we maintain liability insurance that we believe is appropriate, this insurance coverage is subject to deductibles and coverage limitations, and may not be adequate to protect us against any future liability claims. Additionally, we may be unable to maintain our existing liability insurance in the future at satisfactory rates or in adequate amounts. A liability claim, regardless of its merit or eventual outcome, could result in:

Our operations are vulnerable to interruption or loss due to natural disasters, power loss and other events beyond our control, which would adversely affect our business. Our operations are vulnerable to interruption or loss due to natural disasters, power loss and other events beyond our control, which would adversely affect our business.

To date, we do not have redundant facilities. To date, we do not have redundant facilities. We conduct many of our activities, including research and development, component processing, final assembly, packaging and distribution activities for most of our products, at our facilities located in Southern California, which is a seismically active area that has experienced major earthquakes in the past, as well as other natural disasters, including wildfires. We conduct many of our activities, including research and development, component processing, final assembly, packaging and distribution activities for most of our products, at our facility located in Southern California, which is a seismically active area that has experienced major earthquakes in the past, as well as other natural disasters, including wildfires. We have taken precautions to safeguard our facilities, including obtaining business interruption insurance. We have taken precautions to safeguard our facility, including obtaining business interruption insurance. However, any future natural disaster, such as an earthquake or a wildfire, pandemics, or other unanticipated catastrophes, such as telecommunications failures, cyberattacks, or terrorist attacks, at any of the locations in which we or our key partners, suppliers and customers do business, could significantly disrupt our operations, and delay or prevent product assembly, performance of services, and product shipment during the time required to repair, rebuild or replace our facility, which could be lengthy and result in significant expenses. Furthermore, the insurance coverage we maintain may not be adequate to cover our losses in any particular case or continue to be available at commercially reasonable rates and terms. In addition, our facilities may be subject to shortages of electrical power, natural gas, water and other energy supplies. In addition, our facility may be subject to shortages of electrical power, natural gas, water and other energy supplies. Any future shortage or conservation measure could disrupt our operations and cause expense, thus adversely affecting our business and financial results.

The requirements of being a public company may strain our resources and distract management. The requirements of being a public company may strain our resources and distract management.

As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”). As a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”). We are also subject to certain provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”). The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Dodd-Frank Act requires the SEC to adopt certain rules and

regulations relating to our public disclosures, corporate governance and executive compensation, among other things, and such rules and regulations require significant attention from management. Compliance with all of these laws, rules and regulations may from time to time divert management’s attention from other business concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.

The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting and management is required to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting and management is required to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year. To maintain the effectiveness of our disclosure controls and procedures and internal control over financial reporting, significant resources and management oversight is required. If we are not successful in maintaining effective internal control over financial reporting, there could be inaccuracies or omissions in the consolidated financial information we are required to file with the SEC. Additionally, even if there are no inaccuracies or omissions, we will be required to publicly disclose the conclusion of our management that our internal control over financial reporting or disclosure controls and procedures are not effective.

These events could cause investors to lose confidence in our reported financial information, adversely impact our stock price, result in increased costs to remediate any deficiencies, or attract regulatory scrutiny or lawsuits that could be costly to resolve and distract management’s attention.

ITEM 1B. UNRESOLVED STAFF COMMENTS.

Not applicable.