Biggest changeResults of operations for the years ended December 31, 2024 and 2023 The following table sets forth the results of the Company's operations for the periods presented (in thousands): For the Year Ended December 31, 2024 2023 Change Revenue $ 420 $ 442 $ (22 ) Cost of revenues 42 30 12 Selling, general and administrative expenses 11,349 17,122 (5,773 ) Research and development expenses 272 475 (203 ) Loss on impairment of goodwill — 60,934 (60,934 ) Change in fair value of royalties payable (2,239 ) 7,208 (9,447 ) Other income (expense), net (1) (20 ) 339 (359 ) Income tax provision 3,141 — 3,141 (1) Constitutes the operating activities within other income (expense), net in the consolidated statements of operations, except for the change in fair value of royalties payable that is presented separately in the table above. 56 Table of Contents Revenues The decrease in revenues of approximately $22 thousand for the year ended December 31, 2024 as compared to the prior year was due to lower product sales of the VIVO System that was partially offset by our first sales of LockeT in 2024.
Biggest changeResults of operations for the years ended December 31, 2025 and 2024 The following table sets forth the results of our operations for the periods presented (in thousands): For the Year Ended December 31, 2025 2024 Change Revenue $ 819 $ 420 $ 399 Cost of revenues 63 42 21 Selling, general and administrative expenses 12,075 11,349 726 Research and development expenses 862 272 590 Acquired in-process research and development expenses 1,967 — 1,967 Loss on impairment of intangible assets 6,995 — 6,995 Change in fair value of royalties payable due to related parties 5,709 (2,239 ) 7,948 Loss on debt extinguishment (3,260 ) — (3,260 ) Net loss on trading debt securities (564 ) — (564 ) Other (expense) income, net (1) (247 ) (20 ) (227 ) Income tax provision (benefit) (1,810 ) 3,141 (4,951 ) (1) Constitutes the operating activities within other income (expense), net in the audited consolidated statements of operations, except for the change in fair value of royalties payable, loss on debt extinguishment, and net loss on trading debt securities that are presented separately in the table above. 56 Table of Contents Revenues The increase in revenues of approximately $399 thousand for the year ended December 31, 2025 as compared to the prior year was due to an increase of $408 thousand in LockeT sales and $3 thousand in licensing fees for VIVO software upgrade services, partially offset by a $12 thousand decrease in VIVO System sales.
Net cash provided by financing activities During the year ended December 31, 2024, net cash provided by financing activities of $8.6 million primarily consisted of net cash proceeds from the issuance of common stock and warrants of $7.3 million, the issuance of notes payable to related parties of $1.5 million, and the exercise of warrants of $1.2 million, partially offset by the payment of offering costs of $1.4 million.
During the year ended December 31, 2024 , net cash provided by financing activities of $8.6 million primarily consisted of net cash proceeds from the issuance of common stock and warrants of $7.3 million, the issuance of notes payable to related parties of $1.5 million, and the exercise of warrants of $1.2 million, partially offset by the payment of offering costs of $1.4 million.
New Accounting Pronouncements See Note 2 in the consolidated financial statements included elsewhere in this Annual Report for a description of new accounting pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial position, and cash flows as applicable. 62 Table of Contents
New Accounting Pronouncements See Note 2 in the audited consolidated financial statements included elsewhere in this Annual Report for a description of new accounting pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial position, and cash flows as applicable. 62 Table of Contents
If we are unable to do so, we will be required to reduce our spending rate to align with expected revenue levels and cash reserves, although there can be no guarantee that we will be successful in doing so.
If we are unable to do so, we will be required to reduce our spending to align with expected revenue levels and cash reserves, although there can be no guarantee that we will be successful in doing so.
Off-balance sheet arrangements Subsequent to the Merger, we have not engaged in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, as a part of our ongoing business. Accordingly, we did not have any off-balance sheet arrangements during any of the periods presented.
Off-balance sheet arrangements We have not engaged in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, as a part of our ongoing business. Accordingly, we did not have any off-balance sheet arrangements during any of the periods presented.
ITEM 7. 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 in conjunction with our audited consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K for the period ended December 31, 2024 (this "Annual Report").
ITEM 7. 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 in conjunction with our audited consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K for the period ended December 31, 2025 (this "Annual Report").
The Company ’ s Critical Accounting Estimates The information set forth below relates to the Company’s critical accounting policies and estimates. The discussion and analysis of our financial position and results of operations is based on our consolidated financial statements included elsewhere in this Annual Report, which have been prepared in accordance with U.S. GAAP.
Critical Accounting Estimates The information set forth below relates to our critical accounting policies and estimates. The discussion and analysis of our financial position and results of operations is based on our audited consolidated financial statements included elsewhere in this Annual Report, which have been prepared in accordance with U.S. GAAP.
As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date the consolidated financial statements for the year ended December 31, 2024 are issued.
As a result of these factors, management has concluded that there is substantial doubt about our ability to continue as a going concern for a period of one year after the date of the audited consolidated financial statements for the year ended December 31, 2025 are issued.
The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Our audited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Accounting for impairment of long-lived assets The Company periodically reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that such assets might be impaired and the carrying value of the long-lived assets may not be recoverable.
Accounting for impairment of long-lived assets We periodically review our long-lived assets for impairment whenever events or changes in circumstances indicate that such assets might be impaired and the carrying value of the long-lived assets may not be recoverable.
Selling, general and administrative expenses Selling, general and administrative ("SG&A") expenses consist of employee-related costs, including salaries, benefits and stock-based compensation expenses. Other SG&A expenses include amortization of intangible assets, professional services fees, including legal, audit and tax fees, insurance costs, general corporate expenses and facility-related expenses.
Other SG&A expenses include amortization of intangible assets, professional services fees, including legal, audit and tax fees, insurance costs, general corporate expenses and facility-related expenses.
All forward-looking statements included in this Annual Report are based on information available to us as of the time we file and, except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements. Overview On January 9, 2023, the Company merged with the former Catheter Precision, Inc.
All forward-looking statements included in this Annual Report are based on information available to us as of the time we file and, except as required by law, we undertake no obligation to update publicly or revise any forward-looking statements. Overview Catheter Precision, Inc. was incorporated in California on September 4, 2002, and reincorporated in Delaware in July 2018.
We regularly evaluate estimates and assumptions related to business combinations, including the determination of the purchase price and related allocations to the fair value of assets acquired and liabilities assumed, provisions for legal contingencies, income taxes, deferred income tax asset valuation allowances, valuation of warranties liabilities, royalties payable due to related parties, share based compensation, evaluation of impairment of long-lived assets and goodwill, valuation of long-lived assets and their associated estimated useful lives, and revenues.
We regularly evaluate estimates and assumptions related to asset acquisitions, including the provisions for legal contingencies, income taxes, deferred income tax asset valuation allowances, royalties payable due to related parties, share based compensation, evaluation of impairment of long-lived assets, valuation of long-lived assets and their associated estimated useful lives, trading debt securities, and convertible notes payable.
The CE Mark designation, which affirms the product’s conformity with European health, safety, and environmental protection standards, allows us to market that product in countries that are members of the EU and the European Free Trade Association. Catheter has commenced limited sales of the VIVO System in Europe and the UK through independent distributors.
We have been cleared to label the VIVO System with the CE Mark in the EU and certain other countries. The CE Mark designation, which affirms the product’s conformity with European health, safety, and environmental protection standards, allows us to market that product in countries that are members of the EU and the European Free Trade Association.
Our newest product, LockeT® (“LockeT”), is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure.
Our second and newest primary product, LockeT® ("LockeT”), is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently.
We believe certain of our accounting policies are critical to understanding our financial position and results of operations. The preparation of these consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures.
The preparation of these audited consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenue, expenses and related disclosures.
Cash flows for the years ended December 31, 2024 and 2023 (in thousands) For the Year Ended December 31, 2024 2023 Net cash provided by (used in): Operating activities $ (9,271 ) $ (20,619 ) Investing activities (67 ) (61 ) Financing activities 8,646 8,386 Net change in cash and cash equivalents $ (692 ) $ (12,294 ) Net cash used in operating activities During the year ended December 31, 2024, net cash used in operating activities of $9.3 million primarily consisted of a net loss of $16.6 million, partially offset by non-cash adjustments related to depreciation and amortization of $2.1 million, an increase in deferred income tax provision of $3.1 million, and change in fair value of royalties payable of $2.2 million.
Cash flows for the years ended December 31, 2025 and 2024 (in thousands) For the Year Ended December 31, 2025 2024 Net cash provided by (used in): Operating activities $ (8,296 ) $ (9,271 ) Investing activities 167 (67 ) Financing activities 5,344 8,646 Net change in cash and cash equivalents $ (2,785 ) $ (692 ) Net cash used in operating activities During the year ended December 31, 2025 , net cash used in operating activities of $8.3 million primarily consisted of a net loss of $17.7 million, an increase in deferred income tax benefit of $1.8 million, and change in fair value of royalties payable of $5.7 million, partially offset by non-cash adjustments related to loss on impairment of intangible assets of $7.0 million, depreciation and amortization expense of $2.1 million, acquired in-process research and development of $2.0 million, net loss on trading debt securities of $0.6 million, loss on debt extinguishment of $3.3 million, and stock-based compensation expense of $0.3 million and change in operating assets and liabilities of $1.6 million.
Subsequent renewals for software upgrade services are invoiced at inception of the renewed term. The timing of payment for the corresponding invoices depends on the credit terms identified in each contract. We recognize revenues for VIVO System at the point in time that the product is delivered to the customer.
We invoice the customer for VIVO System and related software upgrade services after physical possession and control of VIVO System has been transferred. Subsequent renewals for software upgrade services are invoiced at inception of the renewed term. The timing of payment for the corresponding invoices depends on the credit terms identified in each contract.
Management evaluates whether events or circumstances have occurred that indicate the remaining useful life or carrying value of the amortizing intangible should be revised and adjusted, if necessary. Should the sum of the undiscounted expected future net cash flows be less than the carrying value, the Company would recognize an impairment loss at that date.
Management evaluates whether events or circumstances have occurred that indicate the remaining useful life or carrying value of the amortizing intangible assets should be revised and adjusted, if necessary.
LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. 53 Table of Contents Our business strategy is to become a leading medical device company in the field of cardiac electrophysiology, and we are dedicated to developing and delivering electrophysiology products to provide patients, hospitals, and physicians with novel technologies and solutions to improve the lives of patients with cardiac arrhythmias.
Our business strategy is to become a leading medical device company in the field of cardiac electrophysiology developing and selling electrophysiology products to provide patients, hospitals, and physicians with novel technologies and solutions to improve the lives of patients with cardiac arrhythmias and reduce cost per procedure.
During the year ended December 31, 2023, net cash used in investing activities of $61 thousand consisted of purchases of property and equipment of $76 thousand, offset by proceeds from cash acquired as part of the Merger of $15 thousand.
During the year ended December 31, 2024 , net cash used in investing activities of $67 thousand consisted of purchases of property and equipment.
We recognize revenues for software upgrade services evenly over time over the term of the contract. We did not recognize any revenues for software upgrade services during 2024 and 2023. We recognize sales of LockeT at the point in time that the product is delivered to the customer. We are a business that has operations within multiple countries.
We recognize revenues for VIVO System at the point in time that the product is delivered to the customer. We recognize revenues for software upgrade services evenly over time over the term of the contract.
One of our two primary products is the View into Ventricular Onset (“VIVO” or “VIVO System”), which is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures.
One of our two primary products is the VIVO System, which is a non-invasive imaging system that offers 3D cardiac mapping to help with localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to EP procedures. 53 Table of Contents We have received FDA clearance to market and promote the VIVO System in the U.S. as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment for idiopathic ventricular arrhythmias.
During the year ended December 31, 2023, net cash used in operating activities of $20.6 million consisted of a net loss of $70.6 million, a change in fair value of royalties payable of $7.2 million, and a decrease in operating assets and liabilities of $7.1 million, partially offset by non-cash adjustments related to loss on impairment of goodwill of $60.9 million, stock-based compensation of $1.2 million, and depreciation and amortization of $2.1 million. 59 Table of Contents Net cash used in investing activities During the year ended December 31, 2024, net cash used in investing activities of $67 thousand consisted of purchases of property and equipment.
During the year ended December 31, 2024 , net cash used in operating activities of $9.3 million primarily consisted of a net loss of $16.6 million, partially offset by non-cash adjustments related to depreciation and amortization of $2.1 million, an increase in deferred income tax provision of $3.1 million, and change in fair value of royalties payable of $2.2 million. 59 Table of Contents Net cash provided by (used in) investing activities During the year ended December 31, 2025 , net cash provided by investing activities of $167 thousand consisted of proceeds from the sale of trading debt securities of $300 thousand, partially offset by purchases of property and equipment of $17 thousand and purchases of acquired in-process research and development of $116 thousand.
Accordingly, our current activities primarily relate to Old Catheter’s historical business, which comprises the design, manufacture and sale of new and innovative medical technologies focused in the field of cardiac electrophysiology (EP).
Our current activities primarily relate to Old Catheter’s historical business, which comprises the design, manufacture and sale of new and innovative medical technologies focused in the field of cardiac electrophysiology ("EP"). On February 17, 2025, we formed a new subsidiary, Cardionomix, Inc. ("Cardionomix"), to acquire certain assets previously held by Cardionomic, Inc. ("Cardionomic"), a third-party entity that had ceased operations.
We may not be able to secure financing in a timely manner or on favorable terms, if at all.
If we are unable to do so, we will be required to suspend a portion or all of our operations and/or potentially seek relief from our creditors. We may not be able to secure financing in a timely manner or on favorable terms, if at all.
We began a limited commercial launch of VIVO in 2021 and to date, VIVO has been utilized in more than 1,000 procedures in the U.S. and EU by over 30 physicians, with no reported device-related complications. We have been cleared to label the VIVO System with the CE Mark in the EU and certain other countries.
VIVO allows for the acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. To date, VIVO has been utilized in more than 1,000 procedures in the U.S. and EU by over 30 physicians, with no reported device-related complications.
Research and development expenses The decrease in research and development expenses of approximately $0.2 million for the year ended December 31, 2024 as compared to the prior year was primarily due to a decrease in product development costs of $0.1 million, and a decrease in regulatory affairs related expenditures of $0.1 million.
Research and development expenses The increase in research and development expenses of approximately $0.6 million for the year ended December 31, 2025 as compared to the prior year was primarily due to an increase in professional fees of $0.3 million and an increase in salaries and benefits of $0.3 million.
Cost of revenues The increase in cost of revenues of approximately $12 thousand for the year ended December 31, 2024 as compared to the prior year was due to order fulfillment charges that are now being incurred for LockeT, partially offset by lower cost of revenues for the VIVO Positioning Patches.
Cost of revenues The increase in cost of revenues of approximately $21 thousand for the year ended December 31, 2025 as compared to the prior year was primarily due to an increase in LockeT sales, partially offset by higher product margins for LockeT devices.
If events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and the expected undiscounted future cash flows attributable to the asset are less than the carrying amount of the asset, an impairment loss equal to the excess of the assets carrying value over its fair value is recorded in the Company’s consolidated statements of operations at that date. 61 Table of Contents Stock-based compensation We calculate the cost of awards of equity instruments based on the grant date fair value of the option awards issued to employees, members of our board of directors and nonemployee consultants using the Black-Scholes option pricing valuation model ("Black-Scholes model"), which incorporates various assumptions including volatility, expected term and risk-free interest rate.
If events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable and the expected undiscounted future cash flows attributable to the asset are less than the carrying amount of the asset, an impairment loss equal to the excess of the assets carrying value over its fair value is recorded in our audited consolidated statements of operations at that date. 61 Table of Contents Royalties payable We are obligated to pay royalties related to the sales of LockeT and AMIGO System under various royalty agreements executed by Old Catheter.
During the year ended December 31, 2023, net cash provided by financing activities of $8.4 million primarily consisted of net cash proceeds from the private placement of securities of $8.0 million and proceeds from the exercise of warrants of $1.3 million, partially offset by the payment of offering costs of $0.6 million and payment of convertible promissory notes and accrued interest of $0.3 million.
Net cash provided by financing activities During the year ended December 31, 2025 , net cash provided by financing activities of $5.3 million primarily consisted of net cash proceeds from the issuance of common stock and warrants of $4.9 million, proceeds from the issuance of notes payable due to related parties of $0.3 million, proceeds from the issuance of convertible notes payable of $0.3 million, partially offset by $0.2 million in payments on notes payable.
Selling, general and administrative expenses The decrease in selling, general and administrative expenses of approximately $5.8 million for the year ended December 31, 2024 as compared to the prior year was primarily due to a decrease in legal f ees of $2.0 million and a decrease in professional accounting fees of $1.4 million that were primarily incurred in connection with the Merger in 2023.
Selling, general and administrative expenses The increase in selling, general and administrative expenses of approximately $0.7 million for the year ended December 31, 2025 as compared to the prior year was primarily due to an increase in salaries and benefits of $0.3 million, an increase in stock-based compensation expense of $0.3 million, and an increase in professional fees of $0.1 million.
In September 2024, we received notification of the issuance of our first LockeT patent in the country of China and we also completed a Middle East distribution agreement for LockeT. 54 Table of Contents Clinical studies for LockeT began during the year ended December 31, 2023.
LockeT is a sterile Class I product that was registered with the FDA in the U.S. We recognized our first sale of LockeT in May 2024. In September 2024, we received notification of the issuance of our first LockeT patent in the country of China and we also completed a Middle East distribution agreement for LockeT.
We expect the need to complete an additional financing sometime in the next three to six months. Because expected revenues are not adequate to fund our planned expenditures and anticipated operating costs and liabilities beyond such point, we are currently evaluating potential means of raising cash through future capital transactions and additional bridge loans.
Because expected revenues are not adequate to fund our planned expenditures and anticipated operating costs and liabilities beyond such point, w e are currently evaluating potential means of raising cash, as described below, to fund our operations and to pay our debts as they come due.
Catheter’s international distributors are supported by two EU-based full-time consultants. In addition, our newest product is LockeT, a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure.
The software upgrade services revenues during the years ended December 31, 2025 and 2024 were not material. 55 Table of Contents LockeT is a suture retention device indicated for wound healing by distributing suture tension over a larger area in the patient in conjunction with a figure of eight suture closure.
The change in fair value of the royalties payable for the year ended December 31, 2024 as compared to the prior year was a decrease of $9.4 million, which is primarily driven by the change in forecasted royalty payments and discount rates used to estimate the fair value of royalties payable.
The change in fair value of royalties payable due to related parties decreased approximately $7.9 million for the year ended December 31, 2025 as compared to the corresponding period in the prior year.
For the year ended December 31, 2024, net cash used from operating activities was approximately $9.3 million. We have incurred recurring net losses from operations and negative cash flows from operating activities since inception.
Liquidity and capital resources As of December 31, 2025 , we had cash and cash equivalents of approximately $0.1 million and an accumulated deficit of approximately $309.5 million. For the year ended December 31, 2025 , net cash used from operating activities was approximately $8.3 million.
Other income, net The decrease in other income (expense), net of approximately $0.4 million for the year ended December 31, 2024, respectively, as compared to the prior year was primarily due to a decrease in investment income. Income Tax Provision. We recorded an income tax provision of $3.1 million in 2024, as compared to zero in 2023.
Income tax provision (benefit) We recorded an income tax benefit of $1.8 million for the year ended December 31, 2025 , as compared to an income tax provision of $3.1 million for the year ended December 31, 2024 This primarily relates to changes in the estimated amount of net operating losses that are not subject to limitations under Section 382 of the Internal Revenue Code.
Change in fair value of royalties payable As of the date of the Merger, the royalties payable was calculated using a discounted cash flow method utilizing a discount rate of 24.1%. At each reporting period, the fair value of the royalties payable is calculated using the discounted cash flow method.
We did not record a similar impairment charge in 2024. Change in fair value of royalties payable due to related parties The fair value of the royalties payable due to related parties is calculated using a discounted cash flow method.
During the years ended December 31, 2024 and 2023, approximately 34% and 25% of our sales were derived from customers outside the United States, respectively. Cost of revenues Cost of revenues for product sales consists primarily of costs of components, labor costs, and manufacturing overhead incurred to produce our products and support production.
Cost of revenues Cost of revenues for product sales consists primarily of costs of components, labor costs, and manufacturing overhead incurred to produce our products and support production. Selling, general and administrative expenses Selling, general and administrative ("SG&A") expenses consist of employee-related costs, including salaries, benefits and stock-based compensation expenses.