ClearPoint Neuro Inc
For the period ended Mar 31, 2025. Filed May 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001285550-24-000121
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0000950170-25-070545
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 77 previous paragraphs and 66 current paragraphs.
32 unchanged; 29 reworded; 5 added; 14 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
Research and Development Costs. Research and development costs were $3.4 million for the three months ended March 31, 2025, compared to $2.6 million for the same period in 2024, an increase of $0.8 million, or 29%. The increase was due primarily to higher product development costs of $0.4 million, higher personnel costs, including share-based compensation of $0.2 million, and higher regulatory fees of $0.1 million.
Current report
Interest Income, net. Net interest income was $0.2 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase in net interest income is a result of having no interest expense in the three months ended March 31, 2025 due to the full repayment of the First Closing note in August 2024, partially offset by lower interest income as a result of decreased investment in U.S. Government securities. See Note 6 to the Condensed Consolidated Financial Statements included in Part 1, Item 1 in this Quarterly Report for additional information with respect to the First Closing Note.
Current report
Additional information with respect to the public offerings and 2020 secured convertible notes is in Notes 8 and 6, respectively, to the condensed consolidated financial statements included in Part 1, Item 1 in this Quarterly Report.
Current report
Net Cash Flows from Operating Activities. Net cash flows used in operating activities for the three months ended March 31, 2025, were $6.2 million, an increase of $2.3 million from the three months ended March 31, 2024. This increase was primarily due to a higher net loss of $1.9 million and higher payments made against accrued liabilities, mainly as a result of bonus payouts, partially offset by higher share-based compensation expense and deferred revenue.
Current report
The Company did not have any net cash flows from investing activities for the three months ended March 31, 2024.
Removed paragraphs (14)
Previous report
Research and Development Costs. Research and development costs were $3.3 million for the three months ended September 30, 2024, compared to $2.4 million for the same period in 2023, an increase of $0.9 million, or 36%. The increase was due primarily to higher personnel costs and product and software development costs, each in the amount of $0.5 million, partially offset by lower trial costs of $0.1 million.
Previous report
Interest Income (Expense). Net interest income was $0.2 million for the three months ended September 30, 2024, compared to $0.1 million for the same period in 2023, as a result of increased investment in U.S. Government debt securities stemming from the capital raise in March 2024 as well as lower interest expense due to the early repayment of the First Closing Note.
Previous report
Nine months ended September 30, 2024, Compared to the Nine months ended September 30, 2023
Previous report
Revenue. Total revenue was $23.6 million for the nine months ended September 30, 2024, and $17.1 million for the nine months ended September 30, 2023, which represents an increase of $6.5 million, or 38%.
Previous report
Biologics and drug delivery revenue, which includes sales of services and disposable products related to customer-sponsored preclinical and clinical trials utilizing our products, increased 37% to $13.1 million for the nine months ended September 30, 2024, from $9.5 million for the same period in 2023. Our overall revenue growth is attributable to a $2.9 million increase in product revenue resulting from higher demand for disposables as multiple partners progress in their trials, and a $0.6 million increase in service and other revenue related to new preclinical trials and service agreements entered into with our Partners during the nine months ended September 30, 2024, as compared to the same period in 2023.
Previous report
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 14% to $7.4 million for the nine months ended September 30, 2024, from $6.5 million for the same period in 2023. Product revenue increased 33%, or $1.8 million, resulting from newly activated accounts, increased case count, and new product offerings, including the SmartFrame OR and Prism Laser Therapy, during the nine months ended September 30, 2024, compared to the same period in 2023. This was partially offset by a decrease in service and other revenue of $0.9 million primarily as a result of pausing a co-development program with one of our Brain Computer Interface partners.
Previous report
Cost of Revenue and Gross Profit. Cost of revenue was $9.3 million, resulting in gross profit of $14.4 million and gross margin of 61%, for the nine months ended September 30, 2024, and was $7.5 million, resulting in gross profit of $9.6 million and gross margin of 56% for the nine months ended September 30, 2023. The increase in gross margin was primarily due to lower costs for the nine months ended September 30, 2024 due to the transition to the new manufacturing facility, occurring in 2023, and higher volumes for the nine months ended September 30, 2024.
Previous report
Research and Development Costs. Research and development costs were relatively flat at $9.1 million for the nine months ended September 30, 2024 and 2023. Personnel costs, including share-based compensation, were higher for the nine months ended September 30, 2024 by $0.7 million as compared to the same period in 2023. This was offset by lower product and software development costs of $0.7 million as a result of reprioritization of certain research and development initiatives.
Previous report
Sales and Marketing Expenses. Sales and marketing expenses were $10.7 million for the nine months ended September 30, 2024, compared to $9.2 million for the same period in 2023, an increase of $1.4 million, or 15%. This increase was due primarily to higher personnel costs, including share-based compensation, of $1.1 million resulting from increases in headcount, and increased travel costs of $0.3 million.
Previous report
General and Administrative Expenses. General and administrative expenses were $8.8 million for the nine months ended September 30, 2024, compared to $9.0 million for the same period in 2023, a decrease of $0.3 million, or 3%. This decrease was due primarily to lower bad debt expense of $1.4 million mainly as a result of subsequent recoveries, partially offset by higher personnel costs and share-based compensation of $0.8 million and higher occupancy costs of $0.3 million.
Previous report
Interest Income (Expense). Net interest income was $0.6 million for the nine months ended September 30, 2024, compared to $0.3 million for the same period in 2023, as a result of increased investment in U.S. Government debt securities stemming from the capital raise in March 2024 as well as lower interest expense due to the early repayment of the First Closing Note.
Previous report
Net Cash Flows from Operating Activities. Net cash flows used in operating activities for the nine months ended September 30, 2024, were $7.7 million, a decrease of $4.8 million from the nine months ended September 30, 2023. This decrease was due to a lower net loss of $3.9 million, and a net decrease in operating assets and liabilities of $1.1 million, partially offset by a net decrease in non-cash items of $0.2 million. The change in operating assets and liabilities is primarily due to higher accounts payable and accrued liabilities, partially offset by lower deferred revenue. The change in the non-cash items results primarily from recoveries in the allowance for credit losses, partially offset by higher share-based compensation expense.
Previous report
Net cash flows provided by investing activities for the nine months ended September 30, 2023, were $9.1 million and consisted of proceeds from the maturities of short-term investments, partially offset primarily by equipment acquisitions related to our new manufacturing site in Carlsbad, California.
Previous report
•the ability to maintain our existing relationships with our Partners and to enter into new relationships;
Reworded paragraphs (29)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited Condensed Consolidated Financial Statements and the related notes thereto appearing in Part I, Item 1 of this Quarterly 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 section titled "Risk Factors" appearing in the 2023 Form 10-K and in Part II, Item 1.A of this Quarterly Report for a discussion of important risk 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. In addition, historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.
Current wording
The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited Condensed Consolidated Financial Statements and the related notes thereto appearing in Part I, Item 1 of this Quarterly 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 section titled “Risk Factors” appearing in our 2024 Form 10-K and in Part II, Item 1.A of this Quarterly Report for a discussion of important risk 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. In addition, historical results and trends that might appear in this Quarterly Report should not be interpreted as being indicative of future operations.
Previous wording
The foundational part of our business is providing medical devices for neurosurgery applications. Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software, which is in commercial use globally. The primary applications for the ClearPoint system are to target and guide the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters, as well as the delivery 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 allow for operating room placement of the ClearPoint system, and in 2024, we released the SmartFrame OR Stereotactic System, which allows for complete procedures to be performed in the operating room. In 2022, we commercialized the ClearPoint Prism Neuro Laser Therapy System as our first therapy product offering. We have exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through our Swedish partner, CLS.
Current wording
The foundational part of our business is providing medical devices for neurosurgery applications. Our primary medical device product, the ClearPoint system, is an integrated system comprised of hardware components, disposable components, and intuitive, menu-driven software, which is in commercial use globally. The primary applications for the ClearPoint system are to target and guide the insertion of deep brain stimulation electrodes, biopsy needles, and laser catheters, as well as the infusion of pharmaceuticals into the brain. 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 allow for operating room placement of the ClearPoint system, and in 2024, we commenced limited market release of the SmartFrame OR Stereotactic System, which allows for complete procedures to be performed in the operating room. In 2022, we commercialized the ClearPoint Prism Neuro Laser Therapy System as our first therapy product offering. We have exclusive global commercialization rights to the ClearPoint Prism Neuro Laser Therapy System through our Swedish partner, CLS.
Previous wording
The second part of our business is focused on partnerships in the biologics and drug delivery space. Our services include protocol consultation and solutions for preclinical study design and execution for the delivery of pharmaceutical agents to the brain. We also partner with customers to develop devices used for administration of therapies into the central nervous system. Currently, we have more than 50 biologics and drug delivery customers who are evaluating or 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 customers, such customers' continuation of research and development plans, and such customers' achievement of success in completion of clinical trials and subsequent regulatory approvals of their biologics and drugs.
Current wording
The second part of our business is focused on partnerships in the biologics drug and delivery space. Our services include protocol consultation and solutions for preclinical study design and execution for the delivery of pharmaceutical agents to the brain. 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 customers, such customers' continuation of research and development plans, and such customers' achievement of success in completion of clinical trials and subsequent regulatory approvals of their biologics and drugs.
Previous wording
Substantially all our revenue for the three and nine months ended September 30, 2024 and 2023 relates to (i) sales of our ClearPoint system products and related services and (ii) providing services to our customers in the biologics and drug delivery space. We have financed our operations and internal growth primarily through the sale of equity securities and the issuance of notes payable. We have incurred significant losses since our inception in 1998 as we have devoted substantial efforts to research and development. As of September 30, 2024, we had accumulated losses of $186.0 million. We may continue to incur operating losses as we expand our ClearPoint system platform, services to our pharmaceutical and other medical technology customers, and our business generally.
Current wording
Substantially all our revenue for the three months ended March 31, 2025 and 2024 relates to (i) sales of our ClearPoint system products and related services and (ii) consulting services from our customers in the biologics and drug delivery space. We have financed our operations and internal growth primarily through the sale of equity securities and the issuance of notes payable. We have incurred significant losses since our inception in 1998 as we have devoted substantial efforts to research and development. As of March 31, 2025, we had accumulated losses of $197.4 million. We may continue to incur operating losses as we expand our ClearPoint system platform, consulting services to our pharmaceutical and other medical technology customers, and our business generally.
Previous wording
We continue to monitor the impact of various macroeconomic trends, such as global economic and supply chain disruptions, geopolitical instability (including instability resulting from military conflicts), labor shortages, inflationary conditions, and legislative and political developments. Impacts from inflationary pressures, such as increasing costs for research and development of our products, administrative and other costs of doing business, and our access to capital markets and other sources of funding in the future could adversely affect our business, financial condition and results of operations. Additionally, these trends could adversely affect our customers, which could impact their willingness to spend on our products and services, or their ability to make payment, which could harm the Company's collection of accounts receivable and financial results. The continued 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.
Current wording
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.
Previous wording
In 2010, we received 510(k) clearance from the U.S. Food and Drug Administration (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 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 represents the first therapy product we have commercialized. In January 2024, we received 510(k) clearance from the FDA for the SmartFrame OR Stereotactic System.
Current wording
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 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 represents the first therapy product we have commercialized. In January 2024, we received 510(k) clearance from the FDA for the SmartFrame OR Stereotactic System.
Previous wording
In 2021, we started providing 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. In 2024, we expanded our services to our pharmaceutical and other medical technology customers to include development of devices used for administration of therapies into the central nervous system.
Current wording
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.
Previous wording
Future revenue from sales of products and services is difficult to predict and may not be sufficient to offset our continuing research and development expenses and selling, general and administrative expenses.
Current wording
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.
Previous wording
Generating recurring revenue from the sale of products is an important part of our business model for our ClearPoint system. Our product revenue was approximately $5.5 million and $14.1 million for the three and nine months ended September 30, 2024, respectively. Our service and other revenue was approximately $2.6 million and $9.6 million for the three and nine months ended September 30, 2024, respectively, of which 89% and 92%, respectively, is related to the biologics and drug delivery service line.
Current wording
Generating recurring revenue from the sale of products is an important part of our business model for our ClearPoint system. Our product revenue was $5.3 million for the three months ended March 31, 2025, and was almost entirely related to our ClearPoint system. Our service revenue was $3.2 million for the three months ended March 31, 2025, of which 91% is related to the biologics and drug delivery service line.
Previous wording
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, and 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 the commercial success is uncertain, pending, in part, 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 September 30, 2024, we had more than 50 Partners, which is similar to the number of Partners as of the same date in 2023.
Current wording
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 the 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 March 31, 2025, we had more than 60 Partners, as compared to more than 50 Partners as of the same date in 2024.
Previous wording
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 ClearPoint capital equipment and software that we have sold, and for which we have recognized the revenue in accordance with our revenue recognition policy, as well as labor hours and materials 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.
Current wording
Cost of revenue includes the direct costs associated with the assembly and purchase of components for functional neurosurgery navigation products, biologics and drug delivery products, non-neurosurgery therapy products, and ClearPoint capital equipment and software that we have sold, and for which we have recognized the revenue in accordance with our revenue recognition policy, as well as labor hours and materials for the cost of providing pre-clinical, 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.
Previous wording
Our research and development costs consist primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint system products 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 operating room and therapeutics space; and (iii) expand the application of our technological platforms internationally.
Current wording
Our research and development costs consist primarily of costs associated with the conceptualization, design, testing, and prototyping of our ClearPoint system products 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 intended for delivery of therapeutics into the central nervous system, (ii) expand products into the operating room and therapeutics space, and (iii) expand the application of our technological platforms internationally.
Previous wording
There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2024, as compared to the critical accounting policies and estimates described in our 2023 Form 10-K.
Current wording
There have been no significant changes in our critical accounting policies and estimates during the three months ended March 31, 2025, as compared to the critical accounting policies and estimates described in our 2024 Form 10-K.
Previous wording
Revenue. Total revenue was $8.1 million for the three months ended September 30, 2024, and $5.8 million for the three months ended September 30, 2023, which represents an increase of $2.4 million, or 41%.
Current wording
Revenue. Total revenue was $8.5 million for the three months ended March 31, 2025, and $7.6 million for the three months ended March 31, 2024, which represents an increase of $0.8 million, or 11%.
Previous wording
Biologics and drug delivery revenue, which includes sales of services and disposable products related to customer-sponsored preclinical and clinical trials utilizing our products, increased 27% to $4.4 million for the three months ended September 30, 2024, from $3.5 million for the same period in 2023. Our overall revenue growth is attributable to a $1.6 million increase in product revenue resulting from higher demand for disposables as multiple partners progress in their trials, partially offset by a decrease of $0.7 million in service and other revenue due to a reduction in the number of preclinical studies performed, during the three months ended September 30, 2024, compared to the same period in 2023.
Current wording
Biologics and drug delivery revenue, which includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, increased 9% to $4.7 million for the three months ended March 31, 2025, from $4.3 million for the same period in 2024. This increase is attributable to $1.2 million of higher product revenue resulting from greater demand for disposables as multiple partners progress in their trials, partially offset by a $0.8 million decrease in service revenue and other revenue due to less work performed in preclinical trials and consulting during the three months ended March 31, 2025, compared to the same period in 2024.
Previous wording
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 49% to $2.9 million for the three months ended September 30, 2024, from $1.9 million for the same period in 2023. The increase is driven by higher product revenue of $1.0 million resulting from newly activated accounts, increased case count, and new product offerings, including the SmartFrame OR and Prism Laser Therapy, during the three months ended September 30, 2024, compared to the same period in 2023.
Current wording
Neurosurgery navigation and therapy revenue, which primarily consists of disposable product commercial sales related to cases utilizing the ClearPoint system, increased 70% to $3.3 million for the three months ended March 31, 2025, from $1.9 million for the same period in 2024. The increase is driven by higher sales for new product offerings of SmartFrame OR and Prism Laser Therapy as well as an increased customer base, during the three months ended March 31, 2025, compared to the same period in 2024.
Previous wording
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, increased 133% to $0.8 million for the three months ended September 30, 2024, from $0.4 million for the same period in 2023 due to an increase in the placements of ClearPoint navigation capital equipment and software and Prism laser units.
Current wording
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, decreased 63% to $0.5 million for the three months ended March 31, 2025, from $1.4 million for the same period in 2024 due to a decrease in the placements of ClearPoint navigation capital and software and Prism laser units.
Previous wording
Cost of Revenue and Gross Profit. Cost of revenue was $3.3 million, resulting in gross profit of $4.8 million and gross margin of 60%, for the three months ended September 30, 2024, and was $2.5 million, resulting in gross profit of $3.3 million and gross margin of 57% for the three months ended September 30, 2023. The increase in gross margin was primarily due to lower costs for the three months ended September 30, 2024 due to the transition to the new manufacturing facility, occurring in 2023, and higher volumes for the three months ended September 30, 2024.
Current wording
Cost of Revenue and Gross Profit. Cost of revenue was $3.4 million, resulting in gross profit of $5.1 million for the three months ended March 31, 2025, and was $3.1 million, resulting in gross profit of $4.5 million for the three months ended March 31, 2024. Gross margin was 60% for the three months ended March 31, 2025, as compared to 59% in the same period in 2024. The increase in gross margin is due to lower excess and obsolete inventory for the three months ended March 31, 2025, as compared to the same period in 2024.
Previous wording
Sales and Marketing Expenses. Sales and marketing expenses were $3.5 million for the three months ended September 30, 2024, compared to $2.8 million for the same period in 2023, an increase of $0.7 million, or 25%. This increase was due primarily to higher personnel costs, including share-based compensation, of $0.6 million resulting from increases in headcount, and increased travel costs of $0.1 million.
Current wording
Sales and Marketing Expenses. Sales and marketing expenses were $3.8 million for the three months ended March 31, 2025, compared to $3.3 million for the same period in 2024, an increase of $0.5 million, or 17%. This increase was due primarily to additional personnel costs, including share-based compensation, resulting from increases in headcount.
Previous wording
General and Administrative Expenses. General and administrative expenses were $3.2 million for the three months ended September 30, 2024, compared to $2.9 million for the same period in 2023, an increase of $0.3 million, or 9%. This increase was due primarily to higher personnel costs and share-based compensation of $0.4 million, higher occupancy costs of $0.2 million, and higher professional fees of $0.1 million, partially offset by lower bad debt expense of $0.5 million mainly as a result of subsequent recoveries.
Current wording
General and Administrative Expenses. General and administrative expenses were $4.1 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024, an increase of $1.3 million, or 44%. This increase was due primarily to higher bad debt expense, higher personnel costs, including share-based compensation, and higher professional service fees, each in the amount of $0.4 million.
Previous wording
We have incurred net losses since our inception, which has resulted in a cumulative deficit at September 30, 2024 of $186.0 million. In addition, our use of cash from operations amounted to $7.7 million for the nine months ended September 30, 2024, and $13.7 million for the year ended December 31, 2023.
Current wording
We have incurred net losses since our inception, which has resulted in a cumulative deficit at March 31, 2025 of $197.4 million. In addition, our use of cash from operations amounted to $6.2 million for the three months ended March 31, 2025, and $9.0 million for the year ended December 31, 2024. Since inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable.
Previous wording
Since inception, we have financed our operations principally from the sale of equity securities and the issuance of notes payable. As discussed in Note 8, in March 2024, we completed a public offering of 2,653,848 shares of our common stock from which the net proceeds totaled approximately $16.2 million after deducting our payment of underwriting discounts and commissions and other offering expenses.
Current wording
In March 2024, we completed a public offering of 2,653,848 shares of our common stock from which the net proceeds totaled approximately $16.2 million after deducting our payment of underwriting discounts and commissions and other offering expenses. In November 2024, we entered into an ATM Agreement pursuant to which we may offer and sell, from time to time, shares of our common stock, having aggregate sales proceeds of up to $50 million, subject to the terms and conditions of the ATM Agreement. Through March 31, 2025, we did not issue any shares of common stock under the ATM Agreement.
Previous wording
In August 2024, we repaid in full the remaining $10 million outstanding under the SPA entered into in 2020, pursuant to which we issued secured convertible notes to two investors raising gross proceeds of $25 million, of which $15 million had been previously converted to common stock. See Note 6 to the Condensed Consolidated Financial Statements included above in Part I, Item 1 in this Quarterly Report for additional information with respect to the secured convertible notes.
Current wording
In August 2024, we repaid in full the remaining $10 million outstanding under the secured convertible notes issued in 2020 to two investors raising gross proceeds of $25 million, of which $15 million had been previously converted to common stock.
Previous wording
As a result of these transactions and our business operations, our cash and cash equivalents totaled $21.6 million at September 30, 2024. In management’s opinion, based on our current forecasts for revenue, expense and cash flows, our existing cash and cash equivalent balances at September 30, 2024, are sufficient to support our operations and meet our obligations for at least the next twelve months.
Current wording
As a result of these transactions and our business operations, our cash and cash equivalents totaled $12.4 million at March 31, 2025. In management’s opinion, based on our current forecasts for revenue, expense and cash flows, our existing cash and cash equivalent balances at March 31, 2025, are sufficient to support our operations and meet our obligations for at least the next twelve months.
Previous wording
Cash activity for the nine months ended September 30, 2024 and 2023 is summarized as follows:
Current wording
Cash activity for the three months ended March 31, 2025 and 2024 is summarized as follows:
Previous wording
Net Cash Flows from Investing Activities. Net cash flows used in investing activities for the nine months ended September 30, 2024, were nominal and related to equipment acquisitions.
Current wording
Net Cash Flows from Investing Activities. Net cash flows used in investing activities for the three months ended March 31, 2025 were $0.2 million and related to equipment acquisitions.
Previous wording
Net Cash Flows from Financing Activities. Net cash flows provided by financing activities for the nine months ended September 30, 2024, consisted of proceeds, net of offering costs, of $16.2 million received from the public offering of our common stock and $0.3 million in proceeds from the issuance of common stock under the employee stock purchase plan. This is partially offset by the repayment of the 2020 secured convertible note of $10.0 million and payments of $0.3 million for taxes related to shares withheld in connection with the vesting of restricted stock awards.
Current wording
Net Cash Flows from Financing Activities. Net cash flows used in financing activities for the three months ended March 31, 2025, consisted primarily of payments for taxes related to shares withheld in connection with the vesting of restricted stock awards of $1.3 million.
Previous wording
Net cash flows provided by financing activities for the nine months ended September 30, 2023, consisted of proceeds from the issuance of common stock under the employee stock purchase plan, partially offset by payments for taxes related to shares withheld in connection with the vesting of restricted stock awards.
Current wording
Net cash flows provided by financing activities for the three months ended March 31, 2024, consisted of proceeds, net offering costs, of $16.2 million received from the public offering of our common stock, partially offset by payments for taxes related to shares withheld in connection with the vesting of restricted stock awards of $0.2 million.
Previous wording
•the ultimate duration and impact of macroeconomic trends, including inflationary pressures, supply chain disruptions, geopolitical instability (including military conflicts), and legislative and political developments;
Current wording
the ultimate duration and impact of macroeconomic trends, including inflationary pressures, changes in monetary policy, decreasing consumer confidence and spending, the introduction of or changes in tariffs or trade barriers, global or local recession, and geopolitical instability;
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
NM – The percentage change is not meaningful.
Previous report — wording carried elsewhere
Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and related services, increased 180% to $3.2 million for the nine months ended September 30, 2024, from $1.1 million for the same period in 2023 due to an increase in the placements of ClearPoint navigation capital equipment and software and Prism laser units.