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Note 1 - Organization and Nature of Operations
3 Months Ended
Mar. 31, 2025
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]

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"). 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”). 

 

On February 17, 2025, Catheter formed a new subsidiary, Cardionomix, Inc. ("Cardionomix"), in order to pursue the potential strategic acquisition of certain assets previously held by Cardionomic, Inc. ("Cardionomic"), a third party entity that has ceased operations. Catheter owns 82% of the subsidiary’s issued and outstanding common stock. The Company’s Chief Executive Officer and Chairman of the Board and certain of his affiliates own 12%. The remaining 6% is held by certain business associates of the Company’s Chief Executive Officer. As of March 31, 2025, operations had yet to be started in Cardionomix. The asset acquisition closed on May 5, 2025, and discussions to obtain funding have begun.

 

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.

 

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 unaudited condensed 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 unaudited condensed 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 uncertainty related to its ability to continue as a going concern.

 

The Company has incurred recurring net losses from operations and negative cash flows from operating activities since inception. For the three months ended March 31, 2025, the Company incurred $4.0 million in net loss and used $2.3 million in cash for operating activities. As of March 31, 2025, the Company had an accumulated deficit of $296.4 million and cash and cash equivalents of $0.5 million.

 

Management expects operating losses and negative cash flows to continue for the foreseeable future as the Company invests in its commercial capabilities and expands its product portfolio through strategic asset acquisitions. On January 14, 2025, the Company acquired 100% of the membership interests of Perikard, LLC, which was accounted for as an asset acquisition primarily consisting of a single patent for pericardial access technology. The Company issued 275,000 shares of its common stock valued at $113 thousand as consideration and may be obligated to make future royalty payments equal to 10% of net sales of the pericardial access kit for five years following the closing date (see Note 14, Asset Acquisition). In addition, on April 22, 2025, the Company entered into an asset purchase agreement with the assignor of Cardionomic, Inc. (“Cardionomic”), wherein it purchased Cardionomic’s late-stage treatment in development for acute decompensated heart failure, consisting of patents and trademarks related to Cardiac Pulmonary Nerve Simulation (CNPS) System (see Note 18, Subsequent Events). The Company issued 1,000,000 restricted shares of its common stock valued at $310 thousand and a promissory note for $1.5 million. The promissory note has an interest rate of 4% per annum with no principal nor interest payable until the maturity date, which is three years after the date of issuance. The purchased assets have not been cleared for commercial use and require further research and regulatory approval before commercialization. In addition, on May 12, 2025, the Company entered into a Securities Purchase Agreement for a private placement with three institutional investors.  Pursuant to the Securities Purchase Agreement, the Company sold an aggregate of (i) 1,500 PIPE Units and (ii) 1,500 additional shares of a new series of the Company's preferred stock, designated Series B Convertible Preferred Stock, par value $0.0001 per share.  Each PIPE Unit consists of: (i) one share of Series B Convertible Preferred Stock and (ii) Series L Warrants to purchase approximately 2,858 shares of Common Stock at an exercise price of $0.50 per share.  The aggregate stated value of the 3,000 shares of Series B Convertible Preferred Stock issued was $3.0 million.  As consideration for the PIPE Units and Series B Convertible Preferred Stock, the Company collected $1.5 million in cash and secured Convertible Promissory Notes of QHSLab, Inc. previously held by one of the investors, before deducting placement agent fees and offering expenses of $0.2 million.  (See Note 18, Subsequent Events)  The Company expects to continue to incur additional expenses as it undertakes the required research, development, and commercialization activities for the purchased assets. These negative cash flows have substantially depleted the Company’s cash. 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. 

 

Management estimates that 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 unaudited condensed consolidated financial statements. The accompanying unaudited condensed 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 financing to fulfill its operating and capital requirements for at least 12 months from the date of the issuance of the unaudited condensed 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.