ClearPoint Neuro, Inc.

Previous wording

Any investment in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below and all information contained in this Annual Report before you decide whether to purchase our common stock. If any of the following risks or uncertainties actually occurs, our business, financial condition, results of operations and prospects would likely suffer, possibly materially. In addition, the trading price of our common stock could decline due to any of these risks or uncertainties, and you may lose part or all of your investment.

Current wording

Any investment in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below and all information contained in this Annual Report before you decide whether to purchase our common stock. If any of the following risks or uncertainties actually occurs, our business, financial condition, results of operations and prospects would likely suffer, possibly materially. In addition, the trading price of our common stock could decline due to any of these risks or uncertainties, and you may lose part or all of your investment. The matters described below reflect our beliefs and views as to factors, events or contingencies that could materially and adversely affect our business, financial condition, results of operations, and growth prospects, and/or the price of our common shares in the future. References in this section to past events or conditions are provided by way of 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.

Previous wording

Changes in domestic and global economic conditions, such as inflationary pressure, changes in monetary policy, decreasing consumer confidence and spending, the introduction of or changes in tariffs or trade barriers, and 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, 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 and other funding sources in the future may not be available on commercially reasonable terms, if at all. 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 a higher inflationary environment, we may be unable to raise the prices of our products and services to sufficiently keep up with the rate of inflation. Impacts from inflationary pressures could be more pronounced and adversely impact aspects of our business where revenue streams and price commitments are linked to contractual agreements that extend further into the future, as we may not be able to quickly or easily adjust pricing, reduce costs, or implement countermeasures.

Current wording

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. 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.

Previous wording

Additionally, our hospital and pharmaceutical customers could experience financial and operational pressures as a result of macroeconomic conditions which could impact their ability to access capital markets and other funding sources, increase cost of funding, cause cash flow problems, or impede their ability to comply with debt covenants, which in turn could impede their ability to provide patient care, conduct further research and development, marketing and commercialization efforts, or impact their profitability. To the extent that our customers continue to face such financial pressures, it could impact their willingness to spend on our products and services or their ability to make payment, either of which could adversely affect our business, financial condition and results of operations. Further, with economic uncertainty, an increase in unemployment rates, and increasing health insurance premiums, co-payments and deductibles may result in cost-conscious consumers pursuing fewer medical treatments and procedures, which, in turn, could adversely affect procedure volumes and the demand for our products and services.

Current wording

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.

Previous wording

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 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 geopolitical developments may interfere with our supply chain, production costs, and customer relationships. In addition, market uncertainty and volatility in various geographies may be magnified as a result of potential shifts in U.S. and foreign trade, economic and other policies following the recent U.S elections. Although the majority of our operations take place in the U.S., 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.

Current wording

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. 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. 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.

Previous wording

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 the ability to deliver therapies to our drug delivery customers’ satisfaction, regulatory approval, perceptions in connection with the safety of therapies or delivery mechanisms, our customers’ ability to access adequate and sustainable financing, and other factors that may be beyond our control. 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.

Current wording

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. 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. 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.

Previous wording

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 outcomes.

Current wording

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.

Previous wording

Our ClearPoint system may not achieve broad market adoption.

Current wording

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

Previous wording

To date, a substantial majority of the sales of our ClearPoint System have been derived from a limited number of hospitals. 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. Our ClearPoint system may not gain broad market adoption unless we continue to convince physicians, hospitals and patients of its benefits. Moreover, even if physicians and hospitals understand the benefits of our ClearPoint system, they still may elect not to use our ClearPoint system for a variety of reasons, such as:

Current wording

To date, a substantial majority of the sales of our ClearPoint system have been derived from a limited number of hospitals, and the IRRA flow 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. Neither the ClearPoint system nor the IRRA flow system may gain broad market adoption unless we continue to convince physicians and hospitals of their respective benefits.

Previous wording

the familiarity of the established physician with other devices and surgical approaches;

Current wording

the familiarity of physicians with other devices, drainage systems, or established surgical approaches;

Previous wording

lack of exposure to the ClearPoint system in the fellowship training period where preferences for surgical methods are formed;

Current wording

lack of exposure to the ClearPoint system or the IRRA flow system during residency or fellowship training, when preferences for surgical and critical care methods are formed;

Previous wording

budgetary constraints with respect to the purchase of our ClearPoint system hardware and software;

Current wording

budgetary constraints with respect to the purchase or placement of our ClearPoint system hardware or the IRRA flow control unit;

Previous wording

the price of our ClearPoint system disposable products, which may be higher than devices used with other surgical approaches; and

Current wording

the pricing of our disposable products, which may be higher than devices used with alternative approaches; and

Previous wording

Our ability to execute our growth strategy and become profitable depends upon the adoption by physicians and hospitals of the ClearPoint system for use in neurosurgical procedures. Historically, a substantial portion of our revenue is generated from sales of the disposable products utilized with our ClearPoint system, and we are therefore highly dependent on growing the installed base of the ClearPoint system for our success. We cannot provide assurance that our ClearPoint system will achieve broad market acceptance among hospitals, physicians, or patients. Any failure of the ClearPoint system to achieve meaningful market acceptance and penetration will harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.

Current wording

Our ability to execute our growth strategy and become profitable depends on increased adoption of both the ClearPoint system and the IRRA flow system. Historically, a substantial portion of our revenue has been generated from sales of disposable products used with the ClearPoint system, and the IRRA flow 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. Any failure of the ClearPoint system or the

Previous wording

We started selling our ClearPoint system in 2010, and to date, sales of the ClearPoint system have been primarily focused on its use for neurosurgical procedures in the MRI suite. In 2021, we launched the SmartFrame Array Neuro Navigation System and Software, and in 2024, we commercialized the SmartFrame OR Stereotactic System. Both SmartFrame Array and SmartFrame OR allow for operating room placement of our technology. We have relatively limited experience marketing and selling our ClearPoint system and products for use with neurosurgical procedures in the operating room. If our team fails to adequately promote, market and sell the ClearPoint system, and other new products that we may develop in the future, in this new environment, our sales could suffer.

Current wording

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.

Previous wording

Our long-term growth depends on our ability to compete effectively in the neurosurgery market by developing and commercializing new products and services through our research and development efforts, independently and through third-party collaborations.

Current wording

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.

Previous wording

Our future business prospects depend in part on our ability to develop and commercialize new products and services, such as the Maestro Brain Model, the ClearPoint Prism Neuro Laser Therapy System, SmartFrame OR, and preclinical development and device development services for pharmaceutical partners. 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.

Current wording

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.

Previous wording

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 will depend on numerous factors, including our ability to:

Current wording

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:

Previous wording

properly identify and anticipate customer needs;

Current wording

properly identify and anticipate customer needs across neurosurgery and neurocritical care;

Previous wording

develop and introduce new products or services in a timely manner;

Current wording

develop and introduce new products, enhancements, or modifications in a timely manner;

Previous wording

obtain the necessary regulatory authorizations to market new products or product enhancements;

Current wording

obtain the necessary regulatory authorizations to market new products, including any enhancements or expanded indications for the IRRA flow system;

Previous wording

If we do not develop and obtain regulatory authorization to market new products in time to meet market demand, or if there is insufficient demand for these products, our results of operations will suffer. 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. In addition, even if we are able to develop enhancements or new generations of our products successfully, these enhancements or new generations of products may not produce sales in excess of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.

Current wording

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 IRRA flow 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. 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.

Previous wording

A small number of our customers account for a substantial portion of our revenues. In 2024, 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 9% of our total revenues, and 17% of our biologics and drug delivery revenue. 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. 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.

Current wording

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. 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. 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.

Previous wording

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.

Current wording

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. 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. 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 IRRA flow 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.

Previous wording

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. 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 a backup manufacturing facility, making us dependent on our current facility for the continued operation of our business. A natural or other disaster could damage or destroy our manufacturing equipment and cause substantial delays in our manufacturing operations, which could lead to additional expense and decreased revenue due to lack of supply. 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 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.

Current wording

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. 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.

Previous wording

Many of our components, component assemblies, and finished products are provided to us by single-source suppliers. We generally purchase components and component assemblies 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. We have not identified alternative suppliers for some of the finished products that we commercialize. 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 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 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.

Current wording

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. 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.

Previous wording

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 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 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 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 cannula, we may not be able to grow our business.

Current wording

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. 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 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 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. 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.

Previous wording

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. Examples of such large, well-known companies include Medtronic, Abbott, Elekta and Brainlab.

Current wording

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.

Previous wording

the need to hire additional personnel to promote our products outside of the U.S.;

Current wording

the need to hire additional personnel to promote and support our products outside of the U.S.;

Previous wording

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 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.

Current wording

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 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.

Previous wording

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, 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.

Current wording

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. 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.

Previous wording

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.

Current wording

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.

Previous wording

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. 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. 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.

Current wording

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. 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. 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.

Previous wording

We expect to need additional funding for our business, and we may not be able to raise capital when needed or on terms that are acceptable to us, which could force us to delay, reduce or eliminate our commercialization efforts or our product development programs.

Current wording

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.

Previous wording

The cumulative net loss from our inception through December 31, 2024 was approximately $191.4 million. Net cash used in operations was $9.0 million for the year ended December 31, 2024. Since our inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable. At December 31, 2024, we had cash and cash equivalent balances aggregating $20.1 million, resulting primarily from a 2024 public offering and note issuances pursuant to the 2020 Financing Transaction as discussed in Note 7 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 to sell shares of our common stock having aggregate sales proceeds of up to $50 million.

Current wording

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.

Previous wording

Our plans for the next twelve months reflect our anticipation of increases in revenues from sales of our hardware products and related disposable products as a result of greater utilization at existing installed sites and the installation of our products at new sites, as well as payments from strategic partnerships, consulting services and sales of systems and disposables to our pharmaceutical partners for gene and stem cell therapy trials. 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 is no assurance that we will be able to achieve anticipated results, and even in the event such results are achieved, we expect to continue to consume cash in operations over at least the next twelve months.

Current wording

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 IRRA flow system at existing installed sites, and the installation of the ClearPoint system and IRRA flow 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. However, there can be no assurance that we will achieve these results.

Previous wording

As a result of the foregoing, it is uncertain whether or not it will be necessary to seek additional sources of funds from the sale of equity or other debt securities, which likely would result in dilution to existing ownership interests, from the establishment of a credit facility, or from entry into an agreement with a strategic partner or some other form of collaborative relationship. 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 the additional financing on a timely basis, we may be unable to achieve anticipated results, and may not be able to meet other obligations as they become due. An inability to obtain a sufficient amount of additional funding would create substantial doubt as to our ability to continue as a going concern.

Current wording

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. 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. An inability to raise a sufficient amount of additional capital would create substantial doubt about our ability to continue as a going concern.

Previous wording

the timing of broader market acceptance and adoption of our ClearPoint platform products and services;

Current wording

the timing of broader market acceptance and adoption of our ClearPoint platform and IRRA flow system products and services;

Previous wording

the scope, rate of progress and cost of our ongoing product development activities relating to our ClearPoint system;

Current wording

the scope, rate of progress, and cost of our ongoing product development activities relating to the ClearPoint system and the IRRA flow system;

Previous wording

the cost and timing of expanding our sales, clinical support, marketing and distribution capabilities and other corporate infrastructure;

Current wording

the cost and timing of integrating and expanding our sales, clinical support, marketing, and distribution capabilities and other corporate infrastructure, including those required for the combined ClearPoint system and IRRA flow product lines;

Previous wording

the cost and timing of establishing inventories at levels sufficient to support our sales;

Current wording

the cost and timing of establishing inventories at levels sufficient to support our expanded product portfolio;