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VTAK US Equity

Catheter Precision, Inc.Health Care · Surgical & Medical Instruments & Apparatus · CIK 1716621 · FY ends Dec 31
$0.21
-0.01 (-4.31%)
USD · as of 2026-08-19 · marketstack

VTAK · 10-K · period ended 2024-12-31

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filed 2025-03-31 · EDGAR original ↗

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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"). The following discussion and analysis of our financial condition and results of operations contain forward-looking statements that involve a number of risks, uncertainties and assumptions. Actual events or results may differ materially from our expectations. Important factors that could cause actual results to differ materially from those stated or implied by our forward-looking statements include, but are not limited to, those set forth in Item 1A. Risk Factorsof this Annual Report, many of which are outside of our control. 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. (“Old Catheter”), a privately held Delaware corporation (the “Merger”), which became a wholly owned subsidiary of the Company. Following the Merger, we discontinued the Company’s legacy lines of business and the use of any of its DABRA-related assets. We shifted the focus of our operations to Old Catheter’s product lines. 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).

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.

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. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently.

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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. We aim to establish VIVO as an integral tool used by cardiac electrophysiologists during ablation treatment of ventricular arrhythmias by reducing procedure time and patient complications and increasing procedural success.

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. VIVO allows for the acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician. 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. 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. 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. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. LockeT is a sterile Class I product that was registered with the FDA in February 2023, at which time we began initial shipments to distributors. In May 2024, we recognized our first sale of LockeT. In May 2023, Catheter submitted LockeT for CE Mark approval. CE Mark approval is expected in first half of 2026, at which time initial international shipments to distributors will begin. 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.

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Clinical studies for LockeT began during the year ended December 31, 2023. The current studies are planned to show the product’s effectiveness and benefits, including faster wound closure, earlier ambulation, potentially leading to early hospital discharge, and lower costs for the healthcare provider and/or insurance payor. These clinical studies are intended to provide crucial data for marketing and to expand our indications for use with the FDA. For more information about our clinical studies, refer to Item 1, Business.

Recent Developments

October 2024 Warrant Inducement Offer

On October 25, 2024, the Company executed the Warrant Inducement Offer Letters with certain holders of the Company’s existing warrants. Pursuant to the terms and conditions of the Warrant Inducement Offer Letters, the holders immediately exercised an aggregate of (i) 33,160.8 Series E Warrants, (ii) 499,909.34 Series F Warrants, (iii) 499,909.34 Series G Warrants, (iv) 1,990,000 Series H Warrants, and (v) 2,325,000 Series I Warrants (collectively, the “2024 Existing Warrants”) to purchase 5,347,981 shares of the Company’s common stock at a reduced exercise price of $0.70 per share of common stock. In consideration for the immediate exercise of the 2024 Existing Warrants for cash, the Company agreed to issue unregistered new Series K Common Stock Purchase Warrants (“Series K Warrants”) to purchase up to 10,695,962 shares of common stock. The Series K Warrants have an exercise price of $0.70 per share of common stock, are not exercisable until stockholders' approval is obtained (“Stockholder Approval”), and have a term of 5.5 years following Stockholder Approval.

In addition to the Series K Warrants, the Company also issued 320,879 Placement Agent Warrants to the Placement Agent as part of their compensation. The Placement Agent Warrants have the same terms as the Series K Warrants, except that the exercise price is $1.085 per share and the warrants are exercisable six months after the date of issuance.

Pursuant to the terms of the Warrant Inducement Offer Letters, in the event that the exercise of the 2024 Existing Warrants would cause a holder to exceed the beneficial ownership limitations included therein, the Company issued the number of shares of common stock that would not cause a holder to exceed such beneficial ownership limitations and held the remaining balance of shares of common stock in abeyance. Accordingly, the Company held an aggregate of 3,096,000 shares of common stock in abeyance (the “Abeyance Shares”) as of December 31, 2024. The Abeyance Shares are evidenced through the holder’s existing warrants and will be held by the Company until the holder sends notice that the remaining balance of shares of common stock may be issued without surpassing the beneficial ownership limitations. Until such time, the Abeyance Shares are evidenced through the holder’s existing warrants and deemed to be prepaid.

The Company received aggregate gross proceeds of $3.7 million in cash, prior to deducting placement agent fees and offering expenses of $0.4 million, resulting in net proceeds of $3.3 million. The Company further recorded a deemed dividend of $5.2 million in connection with the modification of the 2024 Existing Warrants as well as the issuance of the Series K Warrants.

September 2024 Public Offering

On August 30, 2024, the Company entered into an underwriting agreement to issue and sell in a public offering (i) 347,277 Common Stock Units, priced at a public offering price of $1.00 per unit, with each unit consisting of (a) one share of Common Stock, (b) one warrant to purchase one share of Common Stock at an exercise price of $1.00 per share that expires on the six month anniversary of the date of issuance (a “Series H Warrant”), (c) one warrant to purchase one share of Common Stock at an exercise price of $1.00 per share that expires on the eighteenth month anniversary of the date of issuance (a “Series I Warrant”), and (d) one warrant to purchase one share of Common Stock at an exercise price of $1.00 per share that expires on the five year anniversary of the date of issuance (a “Series J Warrant”), and (ii) 2,773,000 Pre-Funded Warrant Units, priced at a public offering price of $0.9999 per unit, with each unit consisting of (a) one pre-funded warrant to purchase one share of Common Stock at an exercise price of $0.0001 per share that has no expiration date (a “Pre-Funded Warrant”), (b) one Series H Warrant, (c) one Series I Warrant, and (d) one Series J Warrant.

In addition to the securities described above, the Company granted the underwriter a 45-day Overallotment Option to purchase up to (i) 468,041 additional shares of Common Stock, (ii) 468,041 additional Series H Warrants, (iii) 468,041 additional Series I Warrants, and/or (iv) 468,041 additional Series J Warrants, solely to cover over-allotments. On August 30, 2024, the underwriter partially exercised the Overallotment Option to purchase an additional 458,623 shares of Common Stock, 458,623 Series H Warrants, 458,623 Series I Warrants, and 458,623 Series J Warrants.

In the aggregate, the Company issued and sold (i) 805,900 Common Stock Units, (ii) 2,773,000 Pre-Funded Warrant Units, and (iii) 214,734 Representative Warrants that were issued as part of the underwriter’s compensation. The Representative Warrants have an exercise price of $1.55, are not exercisable until March 1, 2025, and expire on August 29, 2029. The public offering closed on September 3, 2024. The net proceeds to the Company, after deducting the underwriting discount, commissions, management fee and offering expenses payable by the Company, were approximately $2.6 million.

The net proceeds from the financing transactions summarized above have been used to advance the development and commercialization of our novel electrophysiology technologies and solutions and to support general corporate purposes.

Components of our results of operations for the years ended December 31, 2024 and 2023

Revenues

Prior to the Merger, product revenues consisted of sales of catheters for use with the DABRA laser in our atherectomy clinical trials. After the Merger, we shifted the focus of our operations to Old Catheter’s product lines, such that our legacy DABRA laser is no longer in use. 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.

We had two primary products in 2024: the VIVO System and the LockeT device. We did not recognize any revenues from LockeT during 2023.

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We invoice the customer for the VIVO System and related software upgrade services after physical possession and control of the 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. 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. 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. 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.

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.

Research and development expenses

Research and development ("R&D") expenses are expensed as incurred and include the following: research grants paid to other parties; product development; cost of clinical studies to support new products and product enhancements, including expanded indications; supplies used for internal R&D and clinical activities; and cost of outside consultants who assist with technology development and clinical affairs.

Results 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,

Research and development expenses 272 475 (203 )

Change in fair value of royalties payable (2,239 ) 7,208 (9,447 )

Other income (expense), net (1) (20 ) 339 (359 )

(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.

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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. VIVO System product sales decreased by $214 thousand from $442 thousand for the year ended December 31, 2023 to $228 thousand for the year ended December 31, 2024. LockeT sales increased by $191 thousand from $0 for the year ended December 31, 2023 to $191 thousand for the year ended December 31, 2024.The decrease in VIVO System product sales primarily relates to two customer accounts that accounted for 53% of VIVO System sales in 2023 and placed large, one-time orders for disposable VIVO patches in 2023. In October 2024, one of the two customer accounts placed an order for disposable VIVO patches totaling $30 thousand. The order for disposable VIVO patches was fulfilled and recognized as revenues during the year ended December 31, 2024.

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. During 2023, the VIVO manufacturing process was changed from 3D printing components of the VIVO Positioning Patches to the use of a more cost-effective specialized mold. This new process also allows for larger build quantities, which in turn further reduced production costs and led to a reduction in the manufacturing cost of VIVO Positioning Patches of approximately 40%. Accordingly, the VIVO Positioning Patches manufactured under the new process and sold in 2024 had lower costs per unit than those manufactured under the old process and sold in 2023.

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 fees 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. Furthermore, the decrease in selling, general and administrative expenses was impacted by a decrease in stock-based compensation expense of $1.2 million, which primarily related to the one-time, stock compensation expense incurred for Old Catheter stock options that were assumed in connection with the Merger in 2023. In addition, there was a decrease in salaries and benefits of $0.5 million, resulting from a $2.1 million decrease in costs related to the Company's former Chief Executive Officer’s and Chief Financial Officer's compensation, partially offset by a $1.6 million increase in salaries and benefits due to an increased departmental headcount. The remaining balance of the decrease in selling, general and administrative expenses of $0.7 million relates to other consulting services as a result of internalizing certain services, investor relations and SEC fees due to fewer stockholder meetings in 2024 relative to 2023, and insurance expense due to lower insurance premiums in 2024 relative to 2023.

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. The net decreases were primarily the result of the discontinuation of the historical products of the Company that were previously under development.

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Loss on impairment of goodwill

We test for goodwill impairment at the reporting level annually in the fourth quarter or more frequently if a change in circumstances or the occurrence of events indicates that potential impairment exists. As a result of the Merger with Old Catheter, the Company recognized $60.9 million of goodwill. Due to a sustained decrease in our share price during 2023, we concluded that a triggering event occurred indicating that potential impairment existed that required us to assess if goodwill was impaired during 2023. In accordance with ASC 350, Intangibles - Goodwill and Other, we performed a quantitative goodwill impairment test, which resulted in the carrying amount of the reporting unit exceeding its fair value, indicating that the goodwill of the reporting unit was impaired. We utilized a combination of an income and market-based approach to assess the fair value of the reporting unit during 2023. The income approach considered the discounted cash flow model, considering projected future cash flows (including timing and profitability), discount rate reflecting the risk inherent in future cash flows, perpetual growth rate, and projected future economic and market conditions while the guideline public company market-based approach considered marketplace earnings multiples from within a peer public company group.

We recorded the impairment charge of $60.9 million for the year ended December 31, 2023 within loss on impairment of goodwill in the consolidated statement of operations. There was no remaining goodwill balance as of December 31, 2023.

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. The discount rate was 22.5% and 28.0% as of December 31, 2024 and 2023, respectively. 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.

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. This increase in our income tax provision was primarily attributable to a nonrecurring adjustment resulting from an ownership change as defined under Section 382 of the Internal Revenue Code.

Liquidity and capital resources

As of December 31, 2024, we had cash and cash equivalents of approximately $2.9 million and an accumulated deficit of approximately $292 million. 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. We issued a total of $1.5 million of related party notes payable in Q2 and Q3 2024 that will become due and payable on January 31, 2026.

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These negative cash flows and additional costs associated with the Merger paid during the year ended December 31, 2023 have substantially depleted our cash. Following the Merger with Old Catheter, we further reduced staff and other costs while assuming the operating costs of Old Catheter. Since the first quarter of 2024, we’ve begun to rejuvenate our sales force and hired a Chief Commercial Officer. We will continue to monitor our operating costs and seek to reduce our current liabilities. Such actions may impair our ability to proceed with certain strategic activities.

We expect operating losses and negative cash flows to continue for the foreseeable future as we invest in our commercial capabilities. We expect that our operating expenses may increase significantly as we maintain and protect our intellectual property portfolio, hire additional personnel, expand our markets, implement new commercial and marketing strategies, and enhance our existing products. We believe that our current cash on hand of $787 thousand as of March 14, 2025 will not be sufficient to fund our current operations, including without limitation, to repay our outstanding short-term notes that will become due and payable on January 31, 2026. 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. 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. Accordingly, we will likely be required to raise additional cash through debt or equity transactions and bridge loans to continue our operations and pay our debts as they come due, and 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.

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. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Cash flows for the years ended December 31, 2024 and 2023 (in thousands)

For the Year Ended December 31,

Net cash provided by (used in):

Investing activities (67 ) (61 )

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.

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.

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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, 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.

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, 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.

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.

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. 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. 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. Our estimates are based on current facts, historical experience and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material.

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We believe the following discussion addresses our most critical accounting policies, which are those that are most important to our financial condition and results of operations and require our most difficult, subjective and complex judgments.

Accounting for long-lived assets - estimated useful lives

Intangible assets acquired from business combinations are initially measured at their estimated fair values and are then amortized on a straight-line basis over their estimated useful lives. 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.

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. 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.

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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. The expected term of the options is the estimated period of time until exercise and was determined using the SEC’s safe harbor rules, using an average of vesting and contractual terms, as we did not have sufficient historical experience of similar awards. Expected stock price volatility is based on historical volatilities of certain “guideline” companies, as the Company does not have sufficient historical stock price data. The risk-free interest rate is based on the implied yield available on U.S. Treasury zero-coupon issues with an equivalent term. The estimated fair value of stock-based compensation awards is amortized on a straight-line basis over the relevant vesting period, adjusted for actual forfeitures at the time they occur.

Royalties payable

We are obligated to pay royalties under various royalty agreements Old Cather had entered into. On January 9, 2023, prior to the consummation of the Merger, Old Catheter entered in an agreement with its convertible promissory noteholders, which substantially consisted of amounts due to David A. Jenkins, previously Old Catheter's Chairman of the Board of Directors prior to the Merger, and, currently, the Company’s Executive Chairman of the Board of Directors and Chief Executive Officer, and certain of his affiliates, to forgive all accrued interest and future interest expense in exchange for a future royalty right. We will pay to the noteholders a total royalty equal to approximately 12% of net sales of LockeT, which commenced upon the first commercial sale in 2024, through December 31, 2035.

In addition, the Company finalized an Invention Assignment and Royalty Agreement (the "Royalty Agreement") that had previously been entered into by Old Catheter with the inventor of LockeT in exchange for the assignment and all rights to LockeT. Pursuant to the agreement, we will pay a 5% royalty on net sales up to $1 million in royalties. After $1 million has been paid, and if, and only if, a U.S. patent is granted by the United States Patent and Trademark Office, then we will continue to pay a royalty at a rate of 2% of LockeT net sales, until total cumulative royalties of $10 million have been paid. No royalty payments will be due under this Royalty Agreement after December 31, 2033.

During 2006 and 2007, Old Catheter entered into two investment grant agreements with a non-profit foundation for the purpose of funding the initial development of Old Catheter's AMIGO System. The agreement calls for the payment of sales-based royalties to the foundation, upon successful commercialization of the AMIGO System. We are not currently selling the AMIGO System.

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.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Our financial statements and supplementary data required by this item are set forth at the pages indicated in Item 15.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

There were no such disagreements or events during the specified periods.

ITEM 9A. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Executive Chairman of the Board and Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as of December 31, 2024. Our objective in designing our disclosure controls and procedures is that they provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based upon this evaluation, due to the existence of the material weaknesses found in our internal controls over financial reporting described below, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and procedures were not effective at the reasonable assurance level. As disclosed in our Form 10-Qs for the quarters ended March 31, 2024, June 30, 2024 and September 30, 2024, for the reasons set forth therein, our Chief Executive Officer and then-Interim Chief Financial Officer concluded that, as of March 31, 2024, June 30, 2024, and September 30, 2024, our disclosure controls and procedures were not effective at the reasonable assurance level. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis. In preparation of our financial statements for the period covered by this report, we identified material weaknesses in internal control over financial reporting related to our control environment that existed as of December 31, 2024, as described below. Specifically, we identified material weaknesses with respect to (1) the lack of segregation of duties, (2) the lack of designed and operating review controls with respect to oversight of the financial reporting process, and (3) review of work performed by service providers with regards to (i) management's provision of inputs for valuations to a third-party provider and (ii) the Section 382 calculation in the tax provision in that the Company's provision did not reference the correct dates when determining ownership changes resulting in material changes in the amount of expiring net operating losses available to be utilized. Notwithstanding the identified material weaknesses, management believes that the Financial Statements and related financial information included in this Annual Report fairly present, in all material respects, our balance sheets, statements of operations, shareholders’ equity and cash flows as of and for the periods presented.

Remediation Plan

Management is in the process of developing a remediation plan. The material weaknesses will not be considered remediated until management designs and implements effective controls that operate for a sufficient period of time and management has concluded, through testing, that these controls are effective. The Company will monitor the effectiveness of its remediation plans and will make changes management determines to be appropriate. Anticipated remediation measures include continuing assessment of the need to expand the Company’s current accounting and financial reporting teams to include individuals with requisite experience to meet the requirements associated with the increasing operations of a publicly traded company, establishment of policies and procedures to ensure full review and sign offs with respect to the inputs sent to third-party service providers as well as the reports and documentation upon the completion of their work prior to any adjustments being made to the financial statements, and establishment of policies and procedures to review the inputs to fair value and tax provision calculations as well as the outputs impacting the balance at each reporting period. In January 2025, we hired a new Chief Financial Officer and are in the process of establishing additional controls intended to eliminate the disclosed material weaknesses.

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Changes in Internal Control over Financial Reporting

There have been no changes in the Company’s internal control over financial reporting during the quarter ended December 31, 2024, which were identified in connection with management's evaluation required by paragraph (d) of Rules 13a-15 and that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Management’s Annual Report on Internal Control Over Financial Reporting and Attestation Report of the Registered Public Accounting Firm

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act). Management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework). Based on the assessment, management has concluded that its internal control over financial reporting was not effective as of December 31, 2024 to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP, due to the material weaknesses discussed above at “Evaluation of Disclosure Controls and Procedures.” Our independent registered public accounting firm, WithumSmith+Brown, PC ("Withum"), is not required to and has not issued an attestation report as of December 31, 2024 because we are not an “accelerated filer” or a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act.

Inherent Limitations on Effectiveness of Controls

Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

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ITEM 9B. OTHER INFORMATION

No director or officer (as defined in Rule 16a–1(f) under the Exchange Act) of the Company adopted or terminated (i) any contract, instruction or written plan for the purchase or sale of securities of the registrant intended to satisfy the affirmative defense conditions of Rule 10b5–1(c) under the Exchange Act; and/or (ii) any “non-Rule 10b5–1 trading arrangement” as defined in paragraph (c) of Item 408 of Regulation S-K, during the quarter ended December 31, 2024.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not Applicable.

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Composition of the Board

Our business and affairs are managed under the direction of our board of directors, or the Board, which currently consists of four members, three of whom are “independent” under NYSE American listing standards. Our bylaws provide that the number of directors will be fixed from time to time by resolution of the Board. All directors hold office until their successors have been elected and qualified or until their earlier death, resignation, disqualification or removal. We have divided the terms of office of the directors into three classes with staggered three year terms: Class I, whose term expires at the 2025 Annual Meeting of Stockholders; Class II, whose term expires at the 2026 Annual Meeting of Stockholders; and Class III, whose term expires at the 2027 Annual Meeting of Stockholders.

Information about the Board of Directors

The following table sets forth the names, ages as of March 12, 2025, and certain other information regarding each member of the Board. The following information has been furnished to us by the directors.

Current

Director Term

Name Class Age Position Since Expires

David A. Jenkins became Executive Chairman of the Board in January 2023. He became Interim Chief Executive Officer in April 2023 and was named Chief Executive Officer in January 2024. He has spent most of his career as an entrepreneur in the medical device industry, and has established numerous companies including Old Catheter, where he served as the CEO and as Chairman of Old Catheter’s Board. He has been Chairman of the Board of Old Catheter since Catheter’s inception in 2006 and has served as CEO of Old Catheter since December 2020. His prior experience includes having served as Chairman and CEO of Arrhythmia Research and overseeing the introduction to the market of Cardiolab, the first dual monitor, 32 channel electrophysiology recording system. This technology was later acquired by General Electric and continues to be sold into the market place today. Another of Mr. Jenkins’ companies, EP MedSystems, Inc., was sold to St. Jude Medical, Inc., now part of Abbott, for approximately $93 million in 2008. Mr. Jenkins also founded and served as the CEO of Transneuronix, Inc., a maker of implantable stimulators for the treatment of weight loss, which was later sold to Medtronic for $267 million in 2005. Mr. Jenkins holds a degree in accounting from the University of Kansas, and a master’s degree in business from the University of Texas, Austin. He began his career in public accounting with Coopers and Lybrand. We believe that Mr. Jenkins is qualified to serve as a director because of his extensive experience in the medical device industry.

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Martin Colombatto has served as a director of the Company since January 2017. Mr. Colombatto has served as a Venture and Industry Partner of Seven Peaks Ventures LLP, a venture capital fund based in Bend, OR, since January 2016. From December 2013 to August 2014, Mr. Colombatto served as a director of PLX Technology, Inc., a technology company. Mr. Colombatto has also served as the Chief Executive Officer and President of Staccato Communications, Inc., an Ultra-Wideband semiconductor company, from January 2006 to March 2009 and as Executive Chairman of Staccato Communications, Inc., from January 2006 to September 2010. Prior to joining Staccato, Mr. Colombatto served as Vice President and General Manager of the Networking Business unit of Broadcom Corp., a broadband communication semiconductor company, from July 1996 to July 2002. Mr. Colombatto was also previously employed by LSI Logic, an application specific semiconductor company, from August 1987 to July 1996. Mr. Colombatto also previously held engineering positions at Reliance Electric, a production automation and control company, from August 1985 to June 1987 and Texas Instruments, an electronics company, from June 1982 to April 1985. Mr. Colombatto holds a Bachelor of Science degree in Electronic Engineering Technology from California State Polytechnic University, Pomona. We believe that Mr. Colombatto is qualified to serve as a member of our board of directors due to his extensive management experience and familiarity with our business and strategy.

James Caruso has held senior level financial positions in both public and private companies for more than 40 years, including serving as Chief Financial Officer at several publicly traded and privately held medical device companies. He has managed all financial aspects of businesses and is proficient in SEC reporting and compliance requirements. Mr. Caruso also has extensive operational experience and has led post-acquisition business integration activities on several occasions. Mr. Caruso served as Chief Financial Officer of Catheter Precision, the private company acquired by us in 2023, from 2010 through 2016. From 2016 to the present, Mr. Caruso was retired. Mr. Caruso also served as Chief Financial Officer of EP MedSystems, Inc. (NASDAQ:EPMD), a company focused on cardiac electrophysiology that was acquired by St Jude Medical in 2008; Hi-Tronics Designs, Inc., a privately held medical device design and manufacturing company that was acquired by Advanced Neuromodulation Systems, Inc. in 2001; and Micron Products, Inc., a publicly traded medical device manufacturing company that was acquired by Arrhythmia Research Technology in 1991. Mr. Caruso spent five years in the audit practice at Deloitte (formerly Deloitte & Touche). Mr. Caruso received his Bachelor of Science in Business Administration from Rutgers University and an MBA from Fordham University and is a Certified Public Accountant. We believe that Mr. Caruso is qualified to serve as a director because of his senior level financial experience with public and private companies.

Andrew Arno Mr. Arno has 30 years of experience handling a wide range of corporate and financial matters, including work as an investment banker and strategic advisor to emerging growth companies. Since October 2023, he has served as the Managing Member of Unterberg Legacy Capital, LLC. He was previously Vice Chairman of Special Equities Group, LLC, a privately held investment banking firm affiliated with Dawson James Securities Inc., and previously with Bradley Woods & Co. Ltd., and he held that role from June 2019 to March 2023. Prior to joining Special Equities Group, LLC, Mr. Arno served as Vice Chairman at Chardan Capital Markets, LLC, from July 2015 to June 2019. From June 2013 until July 2015, Mr. Arno served as Managing Director of Emerging Growth Equities, an investment bank, and Vice President of Sabr, Inc., a family investment group. He was previously President of LOMUSA Limited, an investment banking firm. From 2009 to 2012, Mr. Arno served as Vice Chairman and Chief Marketing Officer of Unterberg Capital, LLC, an investment advisory firm that he co-founded. He was also Vice Chairman and Head of Equity Capital Markets of Merriman Capital LLC, an investment banking firm, and served on the board of the parent company, Merriman Holdings, Inc. Mr. Arno currently serves on the boards of directors of Oncocyte Corporation, Smith Micro Software, Inc. and XXII Century Group, Inc., a tobacco products company, which are all public companies, and on the boards of Independa Inc., a software company, and Comhear Inc., an audio technology R&D company, both of which are private. Mr. Arno previously served as a director of Asterias Biotherapeutics, Inc. from August 2014 until it was acquired by Lineage Cell Therapeutics, Inc. (“Lineage”) in March 2019. Mr. Arno received a BS degree from George Washington University. We believe Mr. Arno is qualified to serve on our Board of Directors because of his financial expertise and his experience as a director on other public company boards.

Executive Officers

David A Jenkins became Executive Chairman of the Board in January 2023. He became Interim Chief Executive Officer in April 2023 and was named Chief Executive Officer in January 2024. His biographical information is set forth above at “Information About the Board of Directors.”

Philip Anderson, age 58, became Chief Financial Officer on January 6, 2025. Mr. Anderson was retired from November 2022 to December 2024. Previously, he served as the Chief Financial Officer of Heritage Distilling Corporation, an adult beverage distiller, from August 2021 to November 2022. From August 2020 to June 2021, he served as Chief Financial Officer of Crown Electrokinetics Corp., a pre-revenue technology/hardware company in the areas of smart windows, fiber optics and water quality solutions. He served as Chief Financial Officer of Kubient, Inc., a supplier of fraud detection and prevention solutions to the global digital advertising market, from June 2019 to January 2020. Prior to serving as a CFO Mr. Anderson was a hedge fund partner for 17 years focused on investing in small and microcap companies. He received a Bachelor of Arts in Business Management from Ithaca College and an MBA with concentration in Finance from Hofstra University.

Marie-Claude Jacques, age 40, became Chief Commercial Officer on May 1, 2024. From January 2023 to January 2024, she was the Director of Field Integration for Boston Scientific Corporation, a Fortune 500 manufacturer of medical devices used in rhythm management, endoscopy, neuromodulation, peripheral interventions and neurology/pelvic health. Ms. Jacques was employed with the AF Solutions Group of Boston Scientific’s cardiology division. From February 2022 to December 2022, she was the Vice President of Sales, Access Solutions for that group. From August 2022 to December 2022, Ms. Jacques was Vice President of US sales for Baylis Medical Company Inc., a company that offers advanced transseptal access solutions as well as guidewires, sheaths and dilators used to support catheter-based left-heart procedures. From June 2014 to August 2022, Ms. Jacques was Director of US Sales for Baylis Medical Company Inc. Ms. Jacques has been a part of the medical device field for over 15 years. She began her career with Baylis Medical and was an integral part in growing and scaling the sales' US business. Mrs. Jacques led the company to double digit sales growth for consecutive years and participated in market development which led to the acquisition by Boston Scientific in 2022. She has a bachelor’s degree in microbiology from Université Laval and a Master’s degree in Business Administration from University of Warwick.

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Delinquent Section 16(a) Reports

Section 16(a) of the Exchange Act requires our executive officers and directors, and persons who own more than 10% of a registered class of our equity securities, to file reports of ownership and changes of ownership on Forms 3, 4 and 5 with the SEC. Such directors, executive officers and 10% stockholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file.

Based solely on our review of the copies of such forms, and written representations that we have received from certain reporting persons that they filed all required reports, we believe that all of our officers, directors and greater than 10% stockholders complied with all Section 16(a) filing requirements applicable to them with respect to transactions during 2024, other than one late Form 3 filed by Andrew Arno, who began serving as a director in July 2024.

Audit Committee

The members of our Audit Committee are Andrew Arno and James Caruso. Mr. Caruso serves as the chairperson of our Audit Committee. The Board has determined that each member of the Audit Committee is an independent director under the NYSE American listing rules, satisfies the additional independence criteria for audit committee members and satisfies the requirements for financial literacy under the NYSE American listing rules and Rule 10A-3 of the Exchange Act, as applicable. The Board has also determined that Mr. Caruso qualifies as an audit committee financial expert within the meaning of the applicable rules and regulations of the SEC and satisfies the financial sophistication requirements of the NYSE American listing rules.

Corporate Governance Principles andCodeof Ethicsand Conduct

The Board has adopted corporate governance principles. These principles address items such as the qualifications and responsibilities of our directors and director candidates and corporate governance policies and standards applicable to us in general. In addition, the Board has adopted a written code of ethics and conduct that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. A copy of our corporate governance principles and code of ethics and conduct are available on our website, www.catheterprecision.com, under the Investor tab under “Corporate Governance”, then “Governance Documents.” If the Board makes any substantive amendments to, or grants any waivers from, the code of ethics and conduct for any officer or director, it will disclose the nature of such amendment or waiver on the Company’s website.

Insider Trading Policy

We have adopted an Insider Trading Policy and procedures governing the purchase, sale and/or other dispositions of our securities by directors, officers and employees that is reasonably designed to promote compliance with insider trading laws, rules and regulations, and the NYSE American listing standards applicable to us. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K for the year ended December 31, 2024. In addition, with regard to the Company’s trading in its own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements.

ITEM 11. EXECUTIVE COMPENSATION

Director Compensation

With respect to 2024, the compensation committee and the Board did not retain a compensation consultant in connection with determining compensation of non-employee directors. In January 2024, the compensation committee recommended, and the Board approved, 2024 compensation to all non-employee directors consisting of a cash retainer of $50,000 and an award of non-qualified stock options to purchase 2,500 shares of Company common stock to each non-employee director. Options were granted on January 8, 2024, have a purchase price of $4.00 per share, a 10-year term, and vest quarterly over three years. Then in January 2025, the compensation committee recommended, and the Board approved, that annual cash compensation be reduced from $50,000 to $30,000, effective July 1, 2024, with an adjustment made to the final payment to the non-employee directors for 2024. On January 28, 2025, the compensation committee recommended and granted, and the Board approved, an award of non-qualified stock options to purchase 100,000 shares of Company common stock to each non-employee director. Options were granted on January 29, 2025, have a purchase price of $0.42 per share, a 10-year term, and vested 33.33% on the grant date, with the remainder vesting 33.33% on the first anniversary of the grant date and 33.34% vesting on the second anniversary of the grant date. Retainer cash payments will be paid in cash on or about the last day of each fiscal quarter of the Company in arrears to each non-employee director.

We also reimburse our non-employee directors for reasonable, customary and documented travel expenses to attend meetings of our board of directors and committees of our board of directors.

Our non-employee directors remain eligible to receive equity awards and cash or other compensation outside of the compensation described above, as may be provided from time to time at the discretion of our Board of Directors.

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2024Director Compensation Table

The following table sets forth information regarding compensation earned or paid to our non-employee directors during the year ended December 31, 2024:

Fees Earned or Option

Paid in Cash Awards Total

($) ($)(5) ($)

(3) Mr. Francis served on the Board from January 2, 2024 to July 3, 2024.

(4) Mr. Arno joined the Board on July 3, 2024.

See Executive Compensation for information about the compensation of Mr. David Jenkins, a director who is also an executive officer.

Processes and Procedures for Executive Compensation

The Compensation Committee assists the Board in discharging the Board’s responsibilities relating to oversight of the compensation of the chief executive officer and other executive officers, including reviewing and approving or making recommendations to the Board with respect to the compensation, plans, policies and programs for the chief executive officer and other executive officers and administering the equity compensation plans for executive officers and employees.

The Compensation Committee annually reviews the compensation, plans, policies and programs for the chief executive officer and other executive officers. In connection therewith, the Compensation Committee considers, among other things, each executive officer’s performance in light of established individual and corporate goals and objectives and the recommendations of our chief executive officer. In particular, the Compensation Committee considers the recommendations of the chief executive officer when reviewing base salary and incentive performance compensation levels of the executive officers and when setting specific individual and corporate performance targets under the annual incentive bonus plan for the executive officers. While the chief executive officer provides input on his compensation, he does not participate in compensation committee or Board deliberations regarding his own compensation. The Compensation Committee may delegate its authority to a subcommittee, but it may not delegate any power or authority required by agreement, law, regulation or listing standard to be exercised by the Compensation Committee as a whole.

Named Executive Officers

The named executive officers for 2024 (“NEOs”), which consist of our principal executive officer, our former Interim Chief Financial Officer, and our Chief Commercial Officer, who were our only executive officers as of December 31, 2024, were as follows:

● David A. Jenkins, Executive Chairman and Chief Executive Officer;

● Margrit Thomassen, former Interim Chief Financial Officer and Secretary; and

● Marie-Claude Jacques, Chief Commercial Officer.

Mr. Jenkins was appointed Executive Chairman upon effectiveness of the Merger on January 9, 2023 and interim Chief Executive Officer beginning April 28, 2023, and Chief Executive Officer beginning January 2, 2024. Margrit Thomassen served as Interim Chief Financial Officer from January 1, 2024, through January 6, 2025. Marie-Claude Jacques was appointed as Chief Commercial Officer beginning May 1, 2024.

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Summary Compensation Table

The following table provides information regarding the compensation of the NEOs for 2024 and 2023, as applicable:

Non-Equity

Stock Option Incentive Plan All Other

Salary Bonus Awards Awards Compensation Compensation Total

Name and Principal Position Year ($) ($) ($) ($)(1) ($) ($) ($)

Former Interim Chief Financial Officer and Secretary

Chief Commercial Officer

Executive Employment Agreements and Arrangements

David A. Jenkins

In January 2023, we entered into an oral employment agreement with David A. Jenkins, Chairman of the Board. In accordance with the terms of Mr. Jenkins’ employment agreement, he is entitled to annual compensation of $300,000.

Marie-Claude Jacques

In April 2024, we entered into an offer letter agreement with Marie-Claude Jacques, Chief Commercial Officer. In accordance with the terms of the offer letter, she is entitled to guaranteed annual salary compensation for the first two years of employment of $400,000. After two years her annual salary compensation is reduced to $240,000. She also received 25,000 non-plan stock options, at an exercise price of $5.321 per share, vesting annually over 5 years, exercisable over ten years per the terms of the offer letter.

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Outstanding Equity Awards at 2024 Fiscal Year-End

As of December 31, 2024, NEOs held the following equity awards:

David Jenkins — — — — —

Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Non-Public Information

Option grants to employees, executive officers and non-employee directors are made by the Compensation Committee (the "Committee") under the 2023 Incentive Plan from time to time, as determined by the Committee. The Committee does take material non-public information into account when determining the timing and terms of stock awards, in that if the Company determines that it is in possession of material non-public information on an anticipated grant date, the Committee expects to defer the grant until a date on which the Company is not in possession of material non-public information. The Company does not time the release of material non-public information based on equity award grant dates or for the purpose of affecting the value of executive compensation. For all stock option awards, the exercise price is the closing price of our common stock on the NYSE American on the last trading day preceding the grant date.

The following table presents information regarding stock options issued to our NEOs in fiscal year 2024 during any period beginning four business days before the filing or furnishing of a periodic report or current report disclosing material non-public information and ending one business day after the filings or furnishing of such report with the SEC:

Perquisites, Health, Welfare and Retirement Benefits

Our named executive officers are eligible to participate in our employee benefit plans, including our medical, dental, vision, group life, disability and accidental death and dismemberment insurance plans, in each case on the same basis as all of our other employees.

We generally do not provide perquisites or personal benefits to our named executive officers, except in limited circumstances. Our board of directors may elect to adopt qualified or non-qualified benefit plans in the future if it determines that doing so is in our best interests.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The following table sets forth certain information with respect to the beneficial ownership of our common stock as of March 17, 2025 by:

● each of our named executive officers;

● each of our directors; and

● all of our executive officers and directors as a group.

The percentage ownership information shown in the table is based on an aggregate of 9,268,632 shares of our common stock outstanding as of March 17, 2025.

We have determined beneficial ownership in accordance with the rules of the Securities and Exchange Commission. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities. In addition, the rules include shares of common stock issuable pursuant to: (i) the exercise of stock options that are either immediately exercisable or exercisable on or before May 16,2025, which is 60 days after March 17, 2025 and (ii) outstanding warrants to purchase common stock held by that person that are either immediately exercisable or exercisable on or before May 16, 2025. These shares are deemed to be outstanding and beneficially owned by the person holding those options and warrants for the purpose of computing the percentage ownership of that person, but they are not treated as outstanding for the purpose of computing the percentage ownership of any other person.

Unless otherwise noted below, the address of each of the individuals and entities named in the table below is c/o Catheter Precision, Inc., 1670 Highway 160 West, Suite 205, Fort Mill, South Carolina 29708. Beneficial ownership representing less than 1% is denoted with an asterisk (*).

Unless otherwise indicated, the persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community property laws.

Number of Shares Percentage of

of Common Stock Common Stock

Beneficially Beneficially

Owned Owned

5% Stockholders:

Jenkins Family Charitable Institute (2) 966,982 9.93 %

Directors and Named Executive Officers:

Marie-Claude Jacques (9) 30,000 *

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EQUITY COMPENSATION PLAN INFORMATION

Information as of December 31, 2024, regarding the Company’s equity compensation plans is summarized in the following table:

Number of Securities

Remaining Available for

Future Issuance Under

Number of Securities to be Equity Compensation

Issued Upon Exercise of Weighted-Average Plans (Excluding

Outstanding Options and Exercise Price of Securities Reflected

Restricted Stock Units Outstanding Options (1) in Column (a))

Plan Category (a) (b) (c)

Equity compensation plans not approved by security holders (3) 42,097 $ 5.78 0

(1) The weighted average exercise price is based solely on outstanding options.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE

The information required by the Item will be included in the 2025 Proxy Statement, and is incorporated herein by reference, or will be included in an amendment to this report if the 2025 Proxy Statement is not filed on or before April 30, 2025.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES

Our independent registered public accounting firm is Withum (auditor ID: 100) since June 21, 2023.

Fees Paid to the Independent Registered Public Accounting Firms

The following table represents aggregate fees for services provided to us in the fiscal year ended December 31, 2024 by Withum. It does not include fees billed to us for services rendered by our previous auditor, Haskell & White LLP, during 2024:

(Withum) (Withum)

Audit-Related Fees (2) — —

Tax Fees (3) — —

All Other Fees (4) — —

Auditor Independence

During the year ended December 31, 2024, there were no other professional services provided by Withum that would have required our audit committee to consider their compatibility with maintaining Withum’s independence.

Pre-Approval Policy

Our audit committee’s policy is to pre-approve all audit and permissible non-audit services provided by the independent accountants and the related estimated fees. These services may include audit services, audit-related services, tax services and other services. Our audit committee generally pre-approves particular services or categories of services on a case-by-case basis. The independent registered public accounting firm and management are required to periodically report to our audit committee regarding the extent of services provided by the independent registered public accounting firm in accordance with these pre-approvals, and the fees for the services performed to date. All of Withum’s services to the Company for fiscal year 2024 described above were pre-approved by our audit committee.

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PART IV — FINANCIAL INFORMATION

ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES.

(a) We have filed the following documents as part of this Annual Report:

1. Financial Statements.

Page

Report of Independent Registered Public Accounting Firm F-1

Consolidated Balance Sheets F-5

Consolidated Statements of Operations F-6

Consolidated Statements of Stockholders’ Equity F-7

Consolidated Statements of Cash Flows F-8

Notes to Consolidated Financial Statements F-9

2. Financial Statement Schedules.

There are no financial statement schedules provided because the information called for is either not required or is shown either in the financial statements or the notes thereto.

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3. Exhibits.

Exhibit Number Description Incorporated by Reference

Form File No. Exhibit Filing Date

4.1 RESERVED

4.2* Description of Capital Stock

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Exhibit Number Description Incorporated by Reference

Form File No. Exhibit Filing Date

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Exhibit Number Description Incorporated by Reference

Form File No. Exhibit Filing Date

10.31.8*+ Non-plan Stock Option Award granted January 6, 2025 to Philip Anderson

10.31.9*+ Offer Letter to Philip Anderson dated January 3, 2025

10.31.10*+ Offer Letter to Marie-Claude Jacques dated April 24, 2024

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Exhibit Number Description Incorporated by Reference

Form File No. Exhibit Filing Date

19.1* Insider Trading Policy dated March 21, 2025

21.1 Subsidiaries of the Registrant

24.1* Power of Attorney (contained on signature page).

101.INS* Inline XBRL Instance Document.

101.SCH* Inline XBRL Taxonomy Extension Schema Document.

101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document.

* Filed herewith.

+ Indicates a management contract or compensatory plan.

ITEM 16.FORM 10–K SUMMARY.

None.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

CATHETER PRECISION, INC.

Date: March 28, 2025 By: /s/ David A. Jenkins

David A. Jenkins

Executive Chairman and Chief Executive Officer

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POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints David A. Jenkins and Philip Anderson, and each of them, his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, to sign any and all amendments (including post-effective amendments) to this Annual Report on Form 10-K and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each of said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that each of said attorneys-in-facts and agents, or his substitute or substitutes, or any of them, shall do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

Signature Title Date

David A. Jenkins (Principal Executive Officer)

/s/ Philip Anderson Chief Financial Officer March 28, 2025

Philip Anderson (Principal Financial and Accounting Officer)

/s/ James Caruso Director March 28, 2025

James Caruso

/s/ Martin Colombatto Director March 28, 2025

Martin Colombatto

/s/ Andrew Arno Director March 28, 2025

Andrew Arno

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of

Catheter Precision, Inc.:

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Catheter Precision, Inc., (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023 and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Substantial Doubt Regarding Going Concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring losses from operations and negative cash flows from operations and expects to continue to incur operating losses that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to Catheter Precision, Inc. in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. Catheter Precision, Inc. is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

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Fair Value of Royalties Payable

Description of the Matter

The Company had $9.2 million of royalties payable as of December 31, 2024, based on the fair value of the royalties payable related to the LockeT royalty agreements acquired in connection with the prior year merger. We identified the fair value of royalties payable as a critical audit matter. In determining the fair value, management must generate revenue projections through the expiration of the royalty agreements. They must also calculate a revenue-adjusted discount rate which is then applied to calculate the present value of the royalties payable. There is significant uncertainty associated with the projections due to limited sales history available as the related product only began sales in the current year. In addition, the calculation of the discount rate requires the involvement of management's valuation specialists.

How the Critical Matter was Addressed in the Audit

To determine the reasonableness of the fair value of the royalties payable, we:

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Assessment of ASC 360 Impairment Analysis

Description of the Matter

In accordance with ASC 360, Impairment and Disposal of Long-Lived Assets ("ASC 360"), the Company, at least annually or more frequently if certain events or changes in circumstances indicate the carrying value may not be recoverable, performs an impairment analysis. As a result of the sustained negative cash flows from operations and continued losses from operations, the Company assessed their intangible assets and long-lived assets for impairment.

To determine whether the carrying amount of the long-lived asset group is recoverable, the Company determined the estimated future cash flows of the group for a period consistent with that of the primary assets of the group. The sum of the undiscounted cash flows was then compared to the carrying amount of the long-lived assets as of December 31, 2024 to conclude whether the asset group carrying value is recoverable.

We identified the ASC 360 impairment analysis as a critical audit matter due to the estimation and subjectivity needed to identify impairment triggers and perform an impairment test. The inputs to the test are subjective as they are based on management's forecasts. Additionally, there is complexity that requires the Company to involve valuation specialists in performing the quantitative test.

How the Critical Matter was Addressed in the Audit

To determine the reasonableness of the conclusion the long-lived assets were not impaired we:

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Accounting For Warrants Associated with September 2024 Public Offering

Description of the Matter

The Company issued warrants in connection with the September 2024 Public Offering. The accounting for the issuance of these warrants involves evaluation of complex accounting guidance to be performed by management as it relates to determining the accounting classification of the warrants.

This matter was identified as a critical audit matter due to the complexity in accounting for the warrants and the significant impact of these conclusions on the Company's consolidated financial statements.

How the Critical Matter was Addressed in the Audit

Our principal audit procedures performed to address this critical audit matter included the following:

Accounting For Warrants and Modification of Warrants Associated with October 2024 Warrant Inducement

Description of the Matter

The Company modified the exercise price of existing warrants in connection with the October 2024 Warrant Inducement. In consideration for the exercise, warrant holders were issued new warrants. The accounting for the modification and issuance of these warrants involves complex and subjective judgment by management as it relates to determining the accounting classification of the warrants and determining the fair value of the warrants at issuance and modification dates.

This matter was identified as a critical audit matter due to the complexity in accounting for the warrants and the significant impact of these conclusions on the Company's consolidated financial statements.

How the Critical Matter was Addressed in the Audit

Our principal audit procedures performed to address this critical audit matter included the following:

● Reviewed the Warrant Inducement Offer to common stock purchase warrants.

/s/ WithumSmith+Brown, PC

We have served as Catheter Precision, Inc.’s auditor since 2023.

East Brunswick, New Jersey

March 28, 2025

PCAOB ID Number 100

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CATHETER PRECISION, INC.

Consolidated Balance Sheets

(in thousands, except par value data)

ASSETS

Current Assets

Cash and cash equivalents $ 2,873 $ 3,565

Accounts receivable, net 70 137

Prepaid expenses and other current assets 316 415

Property and equipment, net 91 70

Operating lease right-of-use assets, net 105 179

Other non-current assets 8 8

LIABILITIES AND STOCKHOLDERS' EQUITY

Current Liabilities

Current portion of royalties payable due to related parties 32 —

Current portion of operating lease liabilities 98 91

Royalties payable due to related parties 9,213 6,974

Deferred tax liability 3,141 —

Notes payable due to related parties 1,500 —

Interest payable due to related parties 61 —

Operating lease liabilities 13 97

Commitments and contingencies (see Note 17)

Stockholders' Equity

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 27,770 $ 30,736

See accompanying notes to consolidated financial statements.

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CATHETER PRECISION, INC.

Consolidated Statements of Operations

(in thousands, except per share data)

Year Ended December 31,

Cost of revenues 42 30

Operating expenses

Loss on impairment of goodwill — 60,934

Research and development 272 475

Other income (expense), net

Interest expense (91 ) —

Other expense, net (10 ) (8 )

Change in fair value of royalties payable due to related parties (2,239 ) 7,208

Total other income (expense), net (2,259 ) 7,547

Loss from operations before income taxes (13,502 ) (70,572 )

Income tax provision 3,141 —

Deemed dividend on warrant inducement offer (5,158 ) (800 )

Net loss attributable to common stockholders $ (21,801 ) $ (71,372 )

See accompanying notes to consolidated financial statements.

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CATHETER PRECISION, INC.

Consolidated Statements of Stockholders' Equity

(in thousands, except share data)

Series A Convertible Series X Convertible Additional Total

Preferred Stock Preferred Stock Common Stock Paid-In Accumulated Stockholders'

Shares Amount Shares Amount Shares Amount Capital Deficit Equity

Common stock issued upon exercise of options — — — — 40,233 — 238 — 238

Restricted stock awards cancelled or vested — — — — (42 ) — — — —

Stock-based compensation — — — — — — 1,217 — 1,217

Stock-based compensation — — — — — — 54 — 54

See accompanying notes to consolidated financial statements.

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CATHETER PRECISION, INC.

Consolidated Statements of Cash Flows

(in thousands)

For the Years Ended December 31,

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments to reconcile net loss to net cash used in operating activities:

Loss on impairment of goodwill — 60,934

Depreciation and amortization 2,109 2,075

Stock-based compensation 54 1,217

Change in fair value of royalties payable due to related parties 2,239 (7,208 )

Deferred income tax provision 3,141 —

Changes in operating assets and liabilities:

Accounts receivable 67 (66 )

Inventories (8 ) 8

Prepaid expenses and other current assets 99 876

Operating lease right-of-use assets and lease liabilities (3 ) 4

Current portion of royalties payable due to related parties 32 —

Interest payable due to related parties 61 (198 )

Net cash used in operating activities (9,271 ) (20,619 )

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchases of property and equipment (67 ) (76 )

Cash acquired as part of business combination — 15

Net cash used in investing activities (67 ) (61 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock and warrants — 238

Proceeds from notes payable due to related parties 1,500 —

Payment on notes payable (256 ) (107 )

Proceeds from notes payable 249 —

Proceeds from exercise of warrants 1,185 1,326

Payment of costs related to the warrant repricing — (181 )

Payment of convertible promissory notes and accrued interest — (250 )

Proceeds from the private placement of securities — 8,000

Net cash provided by financing activities 8,646 8,386

NET CHANGE IN CASH AND CASH EQUIVALENTS (692 ) (12,294 )

CASH AND CASH EQUIVALENTS, beginning of year 3,565 15,859

CASH AND CASH EQUIVALENTS, end of year $ 2,873 $ 3,565

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

Cash paid for interest $ 31 $ 204

SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING AND INVESTING ACTIVITIES

Property and equipment reclassified from inventories $ 19 $ —

Conversion of Series A Convertible Preferred Stock for common stock $ — $ 1

Non-cash consideration for Catheter acquisition $ — $ 72,544

Deemed dividend on warrant inducement offer $ (5,158 ) $ (800 )

See accompanying notes to consolidated financial statements.

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CATHETER PRECISION, INC.

Notes to Consolidated Financial Statements

(in thousands, except share data)

Note 1. Organization and Nature of Operations

The Company

Catheter Precision, Inc. ("Catheter" or the "Company”) was incorporated in California on September 4, 2002, and reincorporated in Delaware in July 2018. Catheter was initially formed to develop, commercialize and market its advanced excimer laser-based platform for use in the treatment of vascular and dermatological immune-mediated inflammatory diseases.

On January 9, 2023, Catheter entered into the Amended and Restated Agreement and Plan of Merger (the "Merger Agreement") with Catheter Precision, Inc. (“Old Catheter”), a privately held Delaware corporation. Under the terms of the Merger Agreement, Old Catheter became a wholly owned subsidiary of Catheter, together referred to as the Company, in a stock-for-stock merger transaction (the "Merger").

Prior to the Merger, Catheter developed the advanced excimer laser-based platform, which was developed as a tool in the treatment of Peripheral Artery Disease, which commonly occurs in the legs. After the Merger, and looking forward, this legacy Destruction of Arteriosclerotic Blockages by laser Radiation Ablation, laser and single-use catheter (together referred to as "DABRA") and related assets were no longer used. The Company ceased operations and marketing with respect to DABRA, and Catheter’s legacy lines of business were discontinued. The Company shifted the focus of its operations to Old Catheter’s product lines. Accordingly, the Company’s current activities primarily relate to Old Catheter’s historical business, which comprises the design, manufacture and sale of new and innovative medical technologies in the field of cardiac electrophysiology (“EP”).

One of the Company’s two primary products is the VIVO System, which is an acronym for View into Ventricular Onset (“VIVO” or “VIVO System”). VIVO 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. The VIVO System is commercially available in the European Union and has been placed at several hospitals in Europe. United States Food and Drug Administration ("FDA") 510(k) clearance was received, and the Company began a limited commercial release of VIVO in 2021 in the United States.

The Company’s 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 and is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. In addition, LockeT is a sterile, Class I product that was registered with the FDA in February 2023, at which time initial shipments began to distributors. Clinical studies for LockeT began during the year ended December 31, 2023. These studies are planned to show the product’s effectiveness and benefits, including faster wound closure and earlier ambulation, potentially leading to early hospital discharge and cost benefits. This information is intended to provide crucial data for marketing. The Company recorded its first commercial sale of LockeT to distributors in May 2024.

The Company’s product portfolio also includes the Amigo® Remote Catheter System (the "AMIGO" or "AMIGO System"), a robotic arm that serves as a catheter control device. Prior to 2018, Old Catheter marketed AMIGO. The Company owns the intellectual property related to AMIGO, and this product is under consideration for future research and development of a generation 2 product.

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Reverse stock split

On

July 3, 2024, at the annual meeting of stockholders of the Company, the stockholders approved an amendment to the Amended and Restated Certificate of Incorporation of the Company (the “Amendment”), which included a decrease in the authorized common stock and authorization for the Board, in its discretion, to effect a reverse stock split within specified parameters. The Amendment was effective

July 15, 2024, reducing the authorized common stock to

30 million shares and effecting a reverse stock split in which each

ten (

10) shares of the Company’s common stock, par value

$0.0001 per share, issued and outstanding immediately prior to the effective time, automatically combined into

one (

1) validly issued, fully paid and non-assessable share of the Company’s common stock, par value

$0.0001 per share.

No fractional shares were issued as a result of the reverse stock split. Stockholders who would otherwise have been entitled to receive a fractional share were entitled to receive their pro rata portion of the net proceeds obtained from the aggregation and sale by the exchange agent of the fractional shares resulting from the reverse stock split (reduced by any customary brokerage fees, commissions and other expenses). All references to share and per share amounts for all periods presented in the consolidated financial statements have been retrospectively restated to reflect this reverse stock split. All rights to receive shares of common stock under outstanding securities, including but not limited to, warrants and options, were adjusted to give effect to the reverse stock split. Furthermore, proportionate adjustments were made to the per share exercise price and the number of shares of Common Stock that may be purchased upon exercise of outstanding warrants and stock options granted by the Company, and the number of shares of Common Stock reserved for future issuance under the Company’s Equity Incentive Plan.

Going concern

The consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.

The Company has incurred recurring net losses from operations and negative cash flows from operating activities since inception. As of December 31, 2024, the Company had cash and cash equivalents of approximately $2.9 million. For the year ended December 31, 2024, the Company used $9.3 million in cash for operating activities. As of December 31, 2024, the Company had an accumulated deficit of approximately $292.4 million.

Management expects operating losses and negative cash flows to continue for the foreseeable future as the Company invests in its commercial capabilities. These negative cash flows have substantially depleted the Company’s cash. Following the Merger with Old Catheter, Management further reduced costs while assuming the operating costs of Old Catheter. Management will continue to monitor its operating costs and seek to reduce its current liabilities. Such actions may impair its ability to proceed with certain strategic activities.

Between May 30, 2024 and July 25, 2024, the Company issued five short-term promissory notes with related parties totaling $1.5 million with an 8% interest rate and a maturity date of August 30, 2024 (the “Related Party Notes”). On August 23, 2024, the Company amended the Related Party Notes to extend the maturity date to January 31, 2026. As part of the amendment, all interest accrued as of the amendment date was repaid to the noteholders and the contractual interest rate increased to 12% per annum as of the amendment date. See Note 9, Notes Payable for additional information.

On August 30, 2024, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Ladenburg Thalmann & Co. Inc. as representative (the “Representative”) of the underwriters named in the Underwriting Agreement (the “Underwriters”). Pursuant to the Underwriting Agreement, the Company completed a public offering of its securities on September 3, 2024 (the “September 2024 Public Offering”) and sold an aggregate of (i) 805,900 Common Stock Units and (ii) 2,773,000 Pre-Funded Units. The Company collected gross proceeds of approximately $3.6 million before deducting underwriting discounts, commissions, and offering expenses payable by the Company of $1.0 million. See Note 13, Equity Offerings for additional information.

On October 25, 2024, the Company executed the Warrant Inducement Offer Letters (the “2024 Warrant Inducement Offer”) with certain holders of the Company’s existing warrants. Following the close of the 2024 Warrant Inducement Offer, such warrant holders immediately exercised an aggregate of (i) 33,160.8 Series E Warrants, (ii) 499,909.34 Series F Warrants, (iii) 499,909.34 Series G Warrants, (iv) 1,990,000 Series H Warrants, and (v) 2,325,000 Series I Warrants (collectively the “2024 Existing Warrants”) to purchase 5,347,981 shares of the Company’s common stock at a reduced exercise price of $0.70 per share of common stock. In consideration for the immediate exercise of the 2024 Existing Warrants for cash, the Company agreed to issue unregistered new Series K Common Stock Purchase Warrants (“Series K Warrants”) to purchase up to 10,695,962 shares of common stock. The Company received aggregate gross proceeds of $3.7 million in cash, prior to deducting placement agent fees and offering expense of $0.4 million. See Note 13, Equity Offerings for additional information.

Based on the Company’s liquidity resources, there is substantial doubt about the Company’s ability to continue as a going concern within 12 months from the date of issuance of the consolidated financial statements. The accompanying consolidated financial statements have been prepared on the basis of the Company continuing to operate in the normal course of business and do not reflect any adjustments to the assets and liabilities related to the substantial doubt of its ability to continue as a going concern.

Management’s ability to continue as a going concern is dependent upon its ability to raise additional funding. Management plans to raise additional capital through public or private equity or debt financings to fulfill its operating and capital requirements for at least 12 months from the date of the issuance of the consolidated financial statements. However, the Company may not be able to secure such financing in a timely manner or on favorable terms, if at all. Furthermore, if the Company issues equity securities to raise additional funds, its existing stockholders may experience dilution, and the new equity securities may have rights, preferences and privileges senior to those of the Company’s existing stockholders.

Note 2. Summary of Significant Accounting Policies

Principles of consolidation

The consolidated financial statements of the Company include the accounts of the Company and Old Catheter. All intercompany transactions have been eliminated in consolidation.

Basis of presentation

The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The Financial Accounting Standards Board (“FASB”) establishes these principles to ensure financial condition, results of operations, and cash flows are consistently reported. Any reference in these notes to applicable accounting guidance is meant to refer to the authoritative nongovernmental GAAP as found in the FASB Accounting Standards Codification ("ASC").

Use of estimates

The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. The Company’s consolidated financial statements are based upon a number of estimates including, but not limited to, the accounting for the Old Catheter business combination (see Note 3, Business Combination), allowance for credit losses, evaluation of impairment of long-lived assets and goodwill, valuation of long-lived assets and their associated estimated useful lives, reserves for warranty costs, fair value of royalties payable due to related parties, evaluation of probable loss contingencies, fair value of preferred stock and warrants issued, including valuation of the deemed dividend, and fair value of equity awards granted.

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Concentrations of credit risk

The Company's financial instruments that are exposed to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company generally maintains cash and cash equivalent balances in various operating accounts at financial institutions with high quality credit in amounts in excess of federally insured limits of $250,000. As of December 31, 2024, the Company had deposits in financial institutions in excess of federally insured limits of $2.6million. The Company has not experienced any losses related to its cash and cash equivalents and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. The Company has no significant off-balance sheet risk, such as foreign exchange contracts, option contracts, or other hedging arrangements.

The Company extends credit to customers in the normal course of business. Concentrations of credit risk with respect to accounts receivable exist to the full extent of amounts presented in the consolidated balance sheets. The Company does not require collateral from its customers to secure accounts receivable.

The Company had 3 customers that represented 62% and 67% of the Company's consolidated revenues for the years ended December 31, 2024 and 2023, respectively.

Reclassifications

Certain prior year financial statement amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on our previously reported results of operations or accumulated deficit. In the current year, the Company separately discloses interest income and interest expense in the consolidated statement of operations. For comparative purposes, amounts in the prior years have been reclassified to conform to current year presentations.

Segment reporting

The Company operates in one reportable segment, which includes all activities related to the marketing, sales, and development of medical technologies in the cardiac electrophysiology field. While the commercial efforts that coordinate the marketing, sales, and distribution of these products are organized by geographic region and product, all of these activities are supported by a single corporate team and distribution channels. The determination of a single reportable segment is consistent with the consolidated financial information available and regularly reviewed by the Company’s chief operating decision maker (“CODM”).

The CODM is the Company’s chief executive officer, who reviews and evaluates consolidated net loss reported on the consolidated statements of operations for purposes of assessing performance, making operating decisions, allocating resources and planning and forecasting for future periods. As the Company’s operations are managed at the consolidated level, there are no differences between the measurement of the reportable segments’ profit or losses and the Company’s consolidated statements of operations. Segment asset measures are not used as a basis for the CODM to evaluate the performance of or to allocate resources to the segment.

The following table summarizes segment revenues and significant segment expenses included in the measure of segment profit or loss (consolidated net loss) reviewed by the CODM:

For the Year Ended

December 31,

Less:

Cost of revenues 42 30

Loss on impairment of goodwill — 60,934

Depreciation and amortization expense 2,109 2,075

Stock-based compensation expense 54 1,217

Salaries and benefits expense 4,192 4,661

Research and development expenses 272 475

Interest income (81 ) (347 )

Interest expense 91 —

Change in fair value of royalties payable due to related parties 2,239 (7,208 )

Income tax expense 3,141 —

Reconciliation of net loss

Adjustments and reconciling items — —

(1) Other segment items include other expenses, net of $10 thousand, consulting fees of $505 thousand, investor relations and SEC fees of $459 thousand, insurance fees of $533 thousand, and other selling, general, and administrative expenses of $1,462 thousand for the year ended December 31, 2024. Other segment items include other expenses, net of $8 thousand, consulting fees of $730 thousand, investor relations and SEC fees of $691 thousand, insurance fees of $704 thousand, and other selling, general, and administrative expenses of $1,422 thousand for the year ended December 31, 2023. Other selling, general, and administrative expenses primarily consist of travel expenses, computer and information technology expenses, and rent expenses.

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Cash and cash equivalents

The Company considers all highly liquid investments purchased with an original maturity date of ninety days or less at the date of purchase to be cash equivalents. Cash and cash equivalents primarily represent funds invested in readily available checking and money market accounts.

Fair value measurements

Fair value represents the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants and is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. A three-tier fair value hierarchy is used to identify inputs used in measuring fair value as follows:

Level 1 - Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;

Level 2 - Inputs other than the quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and

Level 3 - Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

Cash equivalents, prepaid expenses, accounts receivable, accounts payable, and accrued expenses are reported on the consolidated balance sheets at carrying value which approximates fair value due to the short-term maturities of these instruments. The carrying value of our notes payable and notes payable due to related parties approximates the instruments' fair value due to the short-term maturities of these debt instruments.

The following table details the fair value measurements within the fair value hierarchy of the Company’s financial instruments:

Total Level 1 Level 2 Level 3

Assets:

Cash Equivalents

Money market fund 12 12 — —

Liabilities

Royalties payable due to related parties $ 9,213 $ — $ — $ 9,213

Total liabilities $ 9,213 $ — $ — $ 9,213

Total Level 1 Level 2 Level 3

Assets:

Cash Equivalents

Money market fund 10 10 — —

Liabilities

Royalties payable due to related parties $ 6,974 $ — $ — $ 6,974

Total liabilities $ 6,974 $ — $ — $ 6,974

Source: SEC EDGAR (public domain) · 10-K for the period ended 2024-12-31, filed 2025-03-31 · accession 0001437749-25-009918

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