03/17/2026 | Press release | Distributed by Public on 03/17/2026 15:21
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes thereto included elsewhere in this Annual Report. This discussion and analysis contains forward-looking statements that are based upon current expectations and involve risks, assumptions and uncertainties. You should review the "Risk Factors" section of this Annual Report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis.
Overview
We are a commercial-stage medical device company that develops and commercializes integrated systems used in minimally invasive neurosurgical procedures in the brain. We have deployed significant resources to fund our efforts to develop the foundational capabilities for enabling MRI-guided interventions, building an intellectual property portfolio, and identifying and building out commercial applications for the technologies developed by our company. Over the past several years, we have expanded our capabilities beyond the MRI suite to include operating room based neurosurgical device products and a growing portfolio of services that support pharmaceutical and biotechnology partners developing gene and cell therapies. In 2025, with the acquisition of IRRAS, we expanded our portfolio into neurocritical care, focusing on treatments for intracerebral hemorrhage, intraventricular hemorrhage, and other conditions requiring intracranial fluid management.
Our business today consists of two integrated components: (i) a business providing medical devices for neurosurgical applications, and (ii) a business focused on partnerships in the biologics and drug delivery space.
Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software. The primary applications for the ClearPoint system are to target and guide: (a) the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters; and (b) the infusion of pharmaceuticals into the brain. The ClearPoint system was originally designed for use in an MRI setting. In 2021, we launched the SmartFrame Array Neuro Navigation System and Software, which allows for operating room placement of the ClearPoint system and completion of the procedure in the MRI suite. In 2024, we introduced the SmartFrame OR Stereotactic System to the market, which allows for complete procedures to be performed in the operating room. In 2025, we released the ClearPoint Navigation Software Version 3.0, which allows for the ClearPoint system navigation software to support end-to-end procedures in the operating room.
In 2022, we commenced commercialization of the ClearPoint Prism Neuro Laser Therapy System, a laser ablation system. The ClearPoint Prism Neuro Laser Therapy System was developed and is manufactured for us by CLS. We have exclusive global rights to commercialize the system for neuro applications.
In 2025, through the acquisition of IRRAS, we added the IRRAflowsystem to our portfolio of medical devices. The IRRAflow system integrates continuous irrigation, drainage, and real-time intracranial pressure monitoring to provide controlled, automated intracranial fluid management within neurocritical care and operating room settings.
The second component of our business is focused on partnerships in the biologics drug and delivery space, supporting our customers from the earliest stages of their research through their clinical study and commercialization process. Since 2021, a growing and significant part of the revenue from our business has been derived from preclinical development services, which include protocol consultation and solutions for preclinical study design and execution. Our consulting services include a core competency of in vivo biology services in large and small research models to assist our customers with establishing drug safety prior to and in support of their human clinical trials.
Currently, we have more than 60 biologics and drug delivery customers who are evaluating using our products and services in trials to inject gene and cell therapies directly into the brain. These partnerships involve drug development programs that are at various stages of development ranging from preclinical research to late-stage regulatory trials for multiple distinct disease states. This part of our business potentially represents the largest opportunity for growth; however, our ability to grow in this market is dependent on our ability to maintain and establish new relationships with pharmaceutical company customers, such customers' continuation of research and product development plans, such customers achieving success in completion of clinical trials and subsequent regulatory approvals of their drugs and biologics, and such customers' realization of commercial success for their therapies, including overcoming barriers in reimbursement, physician adoption, and patient access to their therapies. In 2024, the U.S. Food and Drug Administration (the "FDA") granted marketing authorization for our SmartFlow cannula to be used to deliver a gene therapy for the treatment of aromatic L-amino acid decarboxylase deficiency to regions of interest within the brain.
2025 Milestones and Developments
Factors Which May Influence Future Results of Operations
The following is a description of factors which may influence our future results of operations, and that we believe are important to an understanding of our business and results of operations.
Macroeconomic Trends
We continue to monitor the impacts of various macroeconomic trends, 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. Such changes in domestic and global macroeconomic conditions may lead to increased costs for our business. Additionally, these macroeconomic trends could adversely affect our customers, which could impact their willingness to spend on our products and services, or their ability to make payments, which could harm our collection of accounts receivable and financial results. 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. The rapid development and fluidity of these situations precludes any prediction as to the ultimate impact they will have on our business, financial condition, results of operation and cash flows, which will depend largely on future developments.
Revenues
In 2010, we received 510(k) clearance from the FDA to market our ClearPoint system in the U.S. for general neurosurgical procedures; in February 2011 and May 2018, we also obtained CE marking for our ClearPoint system and SmartFlow Neuro cannula, respectively; and in June 2020 we obtained CE marking for version 2.0 of our ClearPoint software and our Inflexion head fixation frame. In January 2021, we received 510(k) clearance for the SmartFrame Array Neuro Navigation System. In September 2022, the ClearPoint Prism Neuro Laser Therapy System, for which we have exclusive global rights to commercialize, received 510(k) clearance through our Swedish partner, CLS. The Prism laser is the first therapy product we have commercialized. In January 2024, we received 510(k) clearance from the FDA for the SmartFrame OR Stereotactic System.
In 2021, we started providing consulting services to our pharmaceutical and other medical technology customers for improving outcome predictability and optimizing preclinical and clinical workflows. Our expertise is concentrated in benchtop testing, preclinical studies, clinical trial support, regulatory consultation, and over-arching translation from the preclinical to the clinical setting to enhance accuracy and precision of drug delivery.
Future revenue from sales of our ClearPoint platform products and services is difficult to predict and may not be sufficient to offset our continuing research and development expenses and our increasing selling, general and administrative expenses. As a result of the IRRAS acquisition, revenue is expected to grow over the coming years due to a larger combined organization, expanded product offerings, and increased customer reach, both in the U.S. and internationally.
Generating recurring revenue from the sale of products remains an important part of our business model for our ClearPoint system. Our product revenue was approximately $23.9 million and $18.6 million for the years ended December 31, 2025 and 2024, respectively, and was almost entirely related to our ClearPoint system. Our service revenue was approximately $13.1 million and $12.8 million for the years ended December 31, 2025 and 2024, respectively, of which 89% and 92%, respectively, related to the biologics and drug delivery service line.
Our revenue recognition policies are more fully described in Note 2 to the consolidated financial statements elsewhere in this Annual Report.
Underlying the revenue from sales of products and services to our biologics and drug delivery customers is the number of direct customers and end users of our products and/or services ("Partners"). Our Partners consist of pharmaceutical and biotech companies, academic institutions, or customer-sponsored contract research organizations that are developing methods to deliver a wide variety of molecules, genes or proteins to targeted brain tissue or structures that would need to bypass the blood-brain barrier for the treatment of a variety of disorders. This is a novel area in which commercialization must be preceded by FDA-mandated clinical trials, which are expensive and time consuming to conduct, and for which commercial success is uncertain, pending, in part, on the outcome of those trials. While our revenue from sales of products and services to our biologics and drug delivery customers is indicative of growth, the number of Partner relationships is also of importance as we recognize the possibility that some Partners' research will reach commercial success, and others may not. To the extent our Partners achieve commercial success, our expectation is that we will share in such success through our Partners' use of our products and services in their delivery of therapies. At December 31, 2025, we had more than 60 Partners, similar to the number of Partners as of the same date in 2024.
Cost of Revenue
Cost of revenue includes the direct costs associated with the assembly and purchase of components for neurosurgery navigation products, biologics and drug delivery products, non-neurosurgery therapy products, and capital equipment that we have sold, and for which we have recognized revenue in accordance with our revenue recognition policy, as well as labor hours for the cost of providing preclinical, consulting, and service revenue. Cost of revenue also includes the allocation of manufacturing overhead costs and depreciation of loaned systems installed under our ClearPoint placement program, as well as provisions for obsolete, impaired, or excess inventory. The IRRAS acquisition is expected to impact cost of revenue and reduce overall gross margins in the near term as IRRAflow currently operates at sub-scale production levels, resulting in higher per-unit manufacturing costs compared to the existing product portfolio.
Research and Development Costs
Our research and development costs consist primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint system products, cannulas, and enhancements. Such costs include salaries, travel, and benefits for research and development personnel; materials and laboratory supplies in research and development activities; outside consultant costs; and licensing costs related to technology not yet commercialized. We anticipate that, over time, our research and development costs may increase as we: (i) develop devices and services for delivery of therapeutics into the central nervous system, (ii) expand products into the OR and therapeutics space, (iii) expand the application of our technological platforms internationally, and (iv) invest in the IRRAflowproduct portfolio and clinical evidence.
Product development timelines, likelihood of success, and total costs can vary widely by product candidate. There are also risks inherent in the regulatory clearance and approval process. At this time, we are unable to estimate with any certainty the costs that we will incur in our efforts to expand the application of our technological platforms.
Sales and Marketing, and General and Administrative Expenses
Our sales and marketing, and general and administrative expenses consist primarily of salaries, incentive-based compensation, travel and benefits, including related share-based compensation; marketing costs; professional fees, including fees for outside attorneys and accountants; occupancy costs; insurance; and other general and administrative expenses, which include, but are not limited to, corporate licenses, director fees, hiring costs, taxes, postage, office supplies, information technology and meeting costs. We expect increases in our sales and marketing expenses as a result of the larger combined sales organization, primarily reflecting higher salary and personnel-related costs associated with the larger commercial team following the IRRAS acquisition.
Critical Accounting Estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. ("GAAP"). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements as well as the reported revenues and expenses during the reporting periods. The accounting estimates that require our most significant,
difficult and subjective judgments are discussed below. We evaluate our estimates and judgments on an ongoing basis. Actual results may differ materially from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 2 to our consolidated financial statements included elsewhere in this Annual Report, we believe that the following accounting policies and estimates are most critical to a full understanding and evaluation of our reported financial results.
Business Combinations.The IRRAS acquisition has been accounted for under the acquisition method of accounting in accordance with ASC 805. Under the acquisition method of accounting, we record the assets acquired and liabilities assumed at their estimated fair values as of the acquisition date. The excess of the cost of the acquired business and the fair value of the assets acquired and liabilities assumed is recognized as goodwill. During the measurement period, which is up to one year from the acquisition date, we may adjust provisional amounts that were recognized at the acquisition date to reflect new information obtained about facts and circumstances that existed as of the acquisition date. See Note 3 to our consolidated financial statements included elsewhere in this Annual Report for additional information regarding the IRRAS acquisition.
Determining the fair value of assets acquired and liabilities assumed requires management to make significant estimates and assumptions used in estimating the fair value of acquired technology and other identifiable intangible assets. Although we believe that the assumptions and estimates we have made are reasonable and appropriate, they are inherently subjective. The assistance of an independent third-party valuation firm was used to determine the estimated fair values and useful lives of finite-lived intangible assets including developed technology, customer relationships, and trademarks. Valuation methods were based on the income-based approaches including the multi-period excess earnings method, distributor method, and relief-from-royalty method for developed technology, customer relationships, and trademarks, respectively. Critical estimates and assumptions used in valuing acquired intangible assets include the timing and amount of forecasted revenue, expenses, and cash flows, the life cycle of each asset, the potential regulatory and commercial success risk, competitive trends impacting the assets, and the discount rate reflecting the risk inherent in future cash flows. If the subsequent actual results and updated projections change compared with the assumptions and projections used to develop these values, we could record impairment charges. In addition, we have estimated the economic lives of certain acquired assets and these lives are used to calculate amortization expense. If our estimates of the economic lives change, amortization expenses could be accelerated or slowed.
Revenue Recognition. Revenue is recognized when control of our products and services are transferred to our customers in an amount that reflects the consideration we expect to receive from our customers in exchange for those products and services, in a process that involves identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the distinct performance obligations in the contract, and recognizing revenue when or as the performance obligations have been satisfied.
Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require significant judgment. We evaluate each product or service promised in a contract to determine whether it represents a distinct performance obligation. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. When a contract calls for the satisfaction of multiple performance obligations for a single contract price, we typically allocate the contract price among the performance obligations based on the relative stand-alone selling prices for each such performance obligation customarily charged by us.
We consider a performance obligation satisfied once we have transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. Product revenue is generally recognized at a point in time, generally upon shipment, however, it may be recognized upon delivery based on the contractual terms with certain customers. Service revenue is generally recognized over time as the services are delivered to the customer based on the extent of progress towards completion of the performance obligation. The selection of the method used to measure progress towards completion requires judgment and is based on the nature of the products or services to be provided. Depending on which better depicts the transfer of control to the customer, we may use output methods, such as time elapsed, or input methods, such as labor hours expended or costs incurred, to measure our progress toward complete satisfaction of the performance obligation. We recognize revenue for satisfied performance obligations only when we determine there are no uncertainties regarding payment terms or transfer of control.
Under certain agreements, we are entitled to receive event-based payments subject to our customer's achievement of specified development and regulatory milestones. Variable consideration is included in the transaction price if, in our judgment, it is probable that these milestones will be achieved and a significant future reversal of cumulative revenue under the contract will not occur. At the end of each reporting period, we re-evaluate the probability of achievement of such milestones, and if necessary adjust our estimate of the overall transaction price. The probability assessment is largely based on communications with our customers and historical, current, and forecasted information that is reasonably available. A revenue reversal is possible if it is determined that achievement of a milestone which was previously deemed probable, will not occur.
Inventory. Inventory is carried at the lower of cost (first-in, first-out method) or net realizable value. Items in inventory relate predominantly to our neurosurgical products, drug delivery and biologic products, therapy products and capital equipment. We periodically review our inventory for excess and obsolete items and provide a reserve upon giving consideration to factors such as its physical condition, sales patterns, and expected future demand in order to estimate the amount necessary to write down any slow moving, obsolete, or damaged inventory. These estimates could vary from actual amounts based upon future economic conditions, customer inventory levels, or competitive factors that were not foreseen or did not exist when the estimated write-downs were made.
Results of Operations
Comparison of the Year Ended December 31, 2025 to the Year Ended December 31, 2024
|
Year Ended December 31, |
Percentage |
|||||||||||
|
(Dollars in thousands) |
2025 |
2024 |
Change |
|||||||||
|
Product revenue |
$ |
23,859 |
$ |
18,626 |
28 |
% |
||||||
|
Service and other revenue |
13,112 |
$ |
12,764 |
3 |
% |
|||||||
|
Total revenue |
36,971 |
31,390 |
18 |
% |
||||||||
|
Cost of revenue |
14,279 |
12,268 |
16 |
% |
||||||||
|
Gross profit |
22,692 |
19,122 |
19 |
% |
||||||||
|
Research and development costs |
13,897 |
12,392 |
12 |
% |
||||||||
|
Sales and marketing expenses |
16,461 |
14,478 |
14 |
% |
||||||||
|
General and administrative expenses |
16,498 |
11,986 |
38 |
% |
||||||||
|
Other income (expense): |
||||||||||||
|
Other expense, net |
(146 |
) |
(40 |
) |
NM |
|||||||
|
Interest income |
1,213 |
1,390 |
(13 |
)% |
||||||||
|
Interest expense |
(2,388 |
) |
(518 |
) |
361 |
% |
||||||
|
Net loss before income taxes |
(25,485 |
) |
(18,902 |
) |
35 |
% |
||||||
|
Income tax expense |
55 |
12 |
NM |
|||||||||
|
Net loss |
$ |
(25,540 |
) |
$ |
(18,914 |
) |
35 |
% |
||||
NM - The percentage change is not meaningful.
Revenue.Total revenue was approximately $37.0 million and $31.4 million for the years ended December 31, 2025 and 2024, respectively.
|
Year Ended December 31, |
Percentage |
|||||||||||
|
(Dollars in thousands) |
2025 |
2024 |
Change |
|||||||||
|
Biologics and drug delivery |
||||||||||||
|
Disposable products |
$ |
7,338 |
$ |
5,606 |
31 |
% |
||||||
|
Services and license fees |
11,702 |
11,704 |
(0 |
)% |
||||||||
|
Subtotal - Biologics and drug delivery revenue |
19,040 |
17,310 |
10 |
% |
||||||||
|
Neurosurgery navigation and therapy |
||||||||||||
|
Disposable products |
14,831 |
10,285 |
44 |
% |
||||||||
|
Subtotal - Neurosurgery navigation and therapy revenue |
14,831 |
10,285 |
44 |
% |
||||||||
|
Capital equipment and software |
||||||||||||
|
Systems and software products |
1,690 |
2,735 |
(38 |
)% |
||||||||
|
Services |
1,410 |
1,060 |
33 |
% |
||||||||
|
Subtotal - Capital equipment and software revenue |
3,100 |
3,795 |
(18 |
)% |
||||||||
|
Total revenue |
$ |
36,971 |
$ |
31,390 |
18 |
% |
||||||
Biologics and drug delivery revenue, which include sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products, increased 10% to $19.0 million for the year ended December 31, 2025, from $17.3 million for the year ended December 31, 2024. This increase is attributable to $1.7 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials.
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 44% to $14.8 million during the year ended December 31, 2025, from $10.3 million for the year ended December 31, 2024. The increase is driven by an increased customer base, additional revenues due to sales of the IRRAflowproduct, and higher sales for new offerings of SmartFrame OR, Prism Laser Therapy, and introduction of our 3.0 operating room software, during the year ended December 31, 2025, compared to the year ended December 31, 2024.
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 18% to $3.1 million for the year ended December 31, 2025, from $3.8 million for the year ended December 31, 2024, due to a decrease in the placements of ClearPoint navigation capital and software and Prism laser units.
Cost of Revenue and Gross Profit.Cost of revenue was $14.3 million, resulting in gross profit of $22.7 million for the year ended December 31, 2025, compared to $12.3 million, resulting in gross profit of $19.1 million for the year ended December 31, 2024. Gross margin was 61% for both the years ended December 31, 2025 and December 31, 2024.
Research and Development Costs.Research and development costs were $13.9 million for the year ended December 31, 2025, compared to $12.4 million for the year ended December 31, 2024, an increase of $1.5 million, or 12%. The increase was due to higher product and software development costs of $1.2 million, an increase in personnel costs, including share-based compensation expense, of $0.2 million, and additional costs due to the acquisition of IRRAS.
Sales and Marketing Expenses.Sales and marketing expenses were $16.5 million for the year ended December 31, 2025, compared to $14.5 million for the year ended December 31, 2024, an increase of $2.0 million, or 14%. This increase was due to higher personnel costs, including share-based compensation expense, of $1.4 million resulting from increases in headcount in our clinical team, as well as increased costs of $0.9 million due to the acquisition of IRRAS, partially offset by decreased marketing costs of $0.2 million and decreased travel costs of $0.2 million.
General and Administrative Expenses. General and administrative expenses were $16.5 million for the year ended December 31, 2025, compared to $12.0 million for the year ended December 31, 2024, an increase of $4.5 million, or 38%. This increase was due primarily to severance expense of $1.4 million in connection with the IRRAS acquisition, increased professional service fees of $1.0 million, higher personnel costs, including share-based compensation, of $0.9 million, higher information technology and software costs of $0.5 million, increased bad debt expense of $0.2 million, and additional costs of $0.2 million related to the IRRAS acquisition.
Interest Income.Interest income for the year ended December 31, 2025 was $1.2 million, compared with $1.4 million for the year ended December 31, 2024. The decrease in interest income is primarily due to decreased investment in U.S. Government securities due to lower cash balances in the first half of 2025.
Interest Expense.Interest expense for the year ended December 31, 2025 was $2.4 million compared with $0.5 million for the year ended December 31, 2024. The increase was due to the issuance of notes payable in May and November 2025. See Note 9 to the consolidated financial statements included elsewhere in this Annual Report for more information regarding the notes payable issued in May and November 2025.
Liquidity and Capital Resources
We have incurred net losses since our inception, which has resulted in a cumulative deficit at December 31, 2025 of $216.9 million. In addition, our use of cash from operations amounted to $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.
In May 2025, we entered into a Stock Purchase Agreement (the "2025 SPA") with TPC Investments III LP, an affiliate of Oberland Capital Management LLC (the "2025 Investor") relating to the purchase and sale in a registered direct offering of an aggregate of 275,808 shares of our common stock at a price of $12.69 per share, based on the trailing 30-trading day volume-weighted average price of our common stock. The aggregate net proceeds to us from the offering totaled approximately $3.3 million, after deducting offering expenses payable by us. See Note 11 to our consolidated financial statements included elsewhere in this Annual Report for more information regarding the 2025 SPA.
Contemporaneously with entering into the 2025 SPA, we entered into a note purchase agreement (the "2025 NPA") with the 2025 Investor and CALW SA, LLC, as purchaser agent, under which we may sell to the 2025 Investor tranches of notes ("Notes") in an aggregate principal amount of up to $105.0 million. Under the terms of the 2025 NPA, (a) we sold a Note in the principal amount of
$30.0 million (the "First Purchase Note") to the 2025 Investor upon signing of the 2025 NPA, (b) at our option, we may sell an additional $25.0 million in principal amount of Notes, in up to two increments of $12.5 million each, at any time prior to December 31, 2026, and (c) at our and 2025 Investor's option, we may sell up to $50.0 million in principal amount of Notes, at any time prior to December 31, 2026 (the "Third Tranche of Notes").
In connection with the signing of the merger agreement pursuant which we acquired IRRAS, we and the 2025 Investor entered into an amendment to the 2025 NPA pursuant to which the 2025 Investor agreed to purchase $20.0 million in principal amount of the Third Tranche of Notes under the 2025 NPA following the closing of the IRRAS acquisition (the "Third Tranche Note"). The Third Tranche Note was sold to the 2025 Investor in November 2025.
The net proceeds from the sale of the First Purchase Note, after deducting the debt discount and debt issuance costs of $0.6 million and $0.7 million, respectively, was approximately $28.7 million. The net proceeds from the sale of the Third Tranche Note, after deducting the debt discount and debt issuance costs, was approximately $19.4 million. See Note 9 to our consolidated financial statements included elsewhere in this Annual Report for more information regarding the 2025 NPA.
In March 2024, we completed a public offering of 2,653,848 shares of our common stock for net proceeds of approximately $16.2 million after deducting our payment of underwriting discounts and commissions and other offering expenses. See Note 11 to our consolidated financial statements included elsewhere in this Annual Report for more information.
In November 2024, we established an at-the-market equity offering program under which we may offer and sell, from time to time, shares of our common stock having aggregate sales proceeds of up to $50 million. As of December 31, 2025, we did not sell any shares of common stock under our at-the-market equity offering program. See Note 11 to our consolidated financial statements included elsewhere in this Annual Report for more information regarding our at-the-market equity offering program.
As a result of these transactions and our business operations, our cash and cash equivalents totaled $45.9 million at December 31, 2025. In management's opinion, based on our current forecasts, our existing cash and cash equivalent balances at December 31, 2025 are sufficient to support our operations and meet our obligations for at least the next twelve months from the date of issuance of the financial statements included elsewhere in this Annual Report.
We may offer and sell additional equity or issue additional notes payable to raise funds for working capital, capital expenditures, or other general corporate purposes. Our primary uses of cash and operating expenses relate to paying employees and consultants, marketing our products, and supporting our research and development of future product offerings.
Cash Flows
Cash activity for the years ended December 31, 2025 and 2024 is summarized as follows:
|
Year Ended December 31, |
||||||||
|
(in thousands) |
2025 |
2024 |
||||||
|
Net cash flows used in operating activities |
$ |
(23,925 |
) |
$ |
(8,950 |
) |
||
|
Net cash provided by (used in) investing activities |
615 |
(275 |
) |
|||||
|
Net cash provided by financing activities |
50,179 |
6,189 |
||||||
|
Net change in cash and cash equivalents |
$ |
26,869 |
$ |
(3,036 |
) |
|||
Net Cash Flows Used in Operating Activities.Net cash flows used in operating activities for the year ended December 31, 2025 was $23.9 million, an increase of $15.0 million from the year ended December 31, 2024. This increase was primarily due to a higher net loss of $6.6 million, and the paydown of accounts payable and accrued expenses of $10.6 million, the majority of which were liabilities assumed from the IRRAS acquisition. We do not expect to incur cash outflows for the payment of assumed liabilities of a similar magnitude in future periods, as the paydown of the liabilities assumed in connection with the IRRAS acquisition represents a non-recurring event.
Net Cash Flows Provided by (Used in) Investing Activities.Net cash flows provided by investing activities in 2025 were $0.6 million and related to cash acquired from the IRRAS acquisition, partially offset by equipment acquisitions.
Net cash flows used in investing activities in 2024 were $0.3 million and related to equipment acquisitions.
Net Cash Flows Provided by Financing Activities. Net cash provided by financing activities in 2025 consisted primarily of proceeds, net of financing costs and discount, of $48.1 million from the issuance of the notes payable; proceeds, net of offering costs, of $3.3 million from our common stock offering; partially offset by $1.9 million in payments for taxes related to shares withheld in connection with the vesting of restricted stock awards.
Net cash provided by financing activities in 2024 consisted of proceeds, net of offering costs, of $16.2 million from the public offering of our common stock and $0.4 million from the issuance of common stock under our employee stock purchase plan. These proceeds were partially offset by the repayment of the remaining $10 million outstanding under secured convertible notes issued in 2020 and payments of $0.4 million for taxes related to shares withheld in connection with vesting of restricted stock awards.
Operating Capital and Capital Expenditure Requirements
To date, we have not achieved profitability. We expect to continue to incur net losses as we continue our efforts to expand the commercialization of our products and services and pursue additional applications for our technology platforms. Our cash balances are primarily held in a variety of demand accounts with a view to liquidity and capital preservation.
Our short- and long-term liquidity requirements include the following obligations:
Because of the numerous risks and uncertainties associated with the development and commercialization of medical devices, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to successfully commercialize our products and pursue additional applications for our technology platforms. Our future capital requirements will depend on many factors, including, but not limited to, the following: