Core Insights - Catheter Precision, Inc. has received CE Mark approval for its advanced vascular closure device, LockeT, allowing it to enter European markets [2][3] - The European Vascular Closure Devices Market is projected to grow from $3.1 billion in 2024 to $4.3 billion by 2028, with a CAGR of 7% from 2023 to 2028 [3] - The company has already received its first order for 100 units of LockeT, indicating strong initial demand [1][4] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias and electrophysiology procedures [6] - LockeT is a Class 1 device designed for wound closure after percutaneous venous punctures and has received both FDA registration and CE Mark approval [5] Market Strategy - The company is actively engaging with distribution partners to market LockeT in newly accessible countries following CE Mark approval [4] - The CEO emphasized the economic advantages of LockeT compared to competitors, highlighting its ease of deployment and patient comfort [4]

Transaction Details - The Buyer, Cardionomix, Inc., will acquire Purchased Assets from Seller, Cardionomic, LLC, for a total consideration of $1,500,000 in the form of a promissory note and 1,000,000 shares of common stock from Catheter Precision, Inc. (VTAK) [13][14] - The Closing Date for the transaction is set to occur ten days from the Effective Date, which is April 22, 2025 [15] - The Purchased Assets do not include cash, accounts receivable, or any other excluded assets as defined in the agreement [8] - Seller will retain all liabilities and obligations not assumed by Buyer, referred to as Excluded Liabilities [17] - Buyer has confirmed that it is duly organized and has the necessary authority to enter into this Agreement [19][20] - The execution of this Agreement does not violate any provisions of Buyer or Seller's governing documents or applicable laws [28] - No broker or finder is entitled to any fees in connection with this transaction based on arrangements made by Buyer [29] - Seller has good and marketable title to all Purchased Assets, which are sold on an "AS IS" basis [33] - Buyer acknowledges that the aggregate consideration reflects the "AS IS" condition of the Purchased Assets [35] - There are no claims or proceedings pending against Seller that might affect the Purchased Assets [38] - No governmental approvals are required for the consummation of the transactions contemplated by this Agreement [39] - Seller is not required to be registered as an investment company under the Investment Company Act of 1940 [41] - The VTAK Shares will be validly issued and fully paid upon issuance, free of restrictions other than those imposed by applicable laws [24] - The Absolute Holding Period for the VTAK Shares extends through six months from the date of Closing [44] - Buyer agrees to pay all sales, transfer, use or other taxes related to the sale of the Purchased Assets under this Agreement [56] - Buyer and VTAK shall use commercially reasonable efforts to maintain the listing of VTAK's shares of common stock on NYSE American or another nationally recognized securities exchange [58] - Seller shall deliver complete and correct digital copies of all documents and materials made available to Buyer within ten business days after the Closing [65] - The NYSE American shall have approved the listing of the VTAK Shares upon notice of issuance [71] - Seller acknowledges that it has had an opportunity to ask questions and receive answers concerning the terms and conditions of this transaction [52] - The agreement specifies that each party shall bear its own expenses related to the negotiation and consummation of the transaction [83] - The governing law for the agreement is the internal laws of the State of California [92] - The agreement includes a limitation of liability clause, preventing Buyer from asserting claims against Seller's officers or employees [95] - The agreement allows for execution in counterparts, making electronic signatures valid and binding [90] Financial Terms - The principal amount of the loan is $1,500,000 with a fixed interest rate of 4% per annum [109][110] - Interest accrues daily, calculated by dividing the applicable rate by 360, and is due in full on the maturity date of April [■], 2028 [110] - Borrower can prepay the principal balance at any time without penalty, with prepayments applied first to costs, then to accrued interest, and finally to the principal [111] - All outstanding principal and accrued interest will become immediately due if the borrower files for bankruptcy or similar proceedings [112] - Borrower agrees to pay all costs incurred by the payee in collecting this note, including attorney fees [114] - The note is governed by the laws of the State of Nevada [115] - The borrower is Cardionomix, Inc., represented by David Jenkins as the authorized signatory [121] Intellectual Property - The assets acquired by the Buyer include all U.S. and foreign issued patents, patent applications, and statutory invention registrations [106] - The company has filed multiple patents related to cardiac modulation and neurostimulation systems across various countries, including the US, Europe, and Australia, with significant publications dating from 2017 to 2023 [131][132][133][135][138] - The patent for "Cardiac Contractility Neurostimulation Systems and Methods" was published in the US with application number 62/558,169 on September 13, 2017, indicating ongoing innovation in cardiac treatment technologies [132] - The company has received patent approvals for systems and methods affecting cardiac contractility, with a notable patent issued in Australia (2017229496 B2) on July 14, 2022, enhancing its intellectual property portfolio [132] - A recent patent related to "Methods for Detecting Catheter Movement" was published in the US, with application number 16/816,681, reflecting advancements in medical device technology [132] - The company is actively pursuing international patent protection, with filings in countries such as Canada, China, and India, demonstrating a strategic approach to global market expansion [135][138] - The patent for "Systems and Methods for Denoising Physiological Signals During Electrical Neuromodulation" was published in the US, indicating a focus on improving the accuracy of physiological monitoring technologies [138] - The company has a diverse range of patents related to neurostimulation, with multiple applications filed in the US and PCT, showcasing its commitment to research and development in this field [135][138] - The patent portfolio includes innovations aimed at reducing duty cycles during neurostimulation, which could enhance the efficiency of cardiac treatments [131] - The company has made significant strides in developing electrode assemblies for neuromodulation, with a patent issued on May 16, 2023, indicating progress in device technology [135] - The ongoing patent filings and approvals reflect the company's strategic focus on expanding its technological capabilities and market presence in the cardiac and neuromodulation sectors [132][138] - The company has filed multiple patents related to "Chronically Implantable Systems and Methods for Affecting Cardiac Contractility and/or Relaxation" across various countries, including the US, Japan, and China, with the latest filing on August 17, 2023 [139] - The "CARDIONOMIC" trademark is registered in multiple jurisdictions, including the US, Canada, and Europe, indicating a strong brand presence in the medical device market [141] - The company has also registered the "NVAD" trademark in several countries, showcasing its commitment to expanding its product offerings in neuromodulation technology [142] - The "CPNS" trademark is registered in various regions, including the US and Australia, further emphasizing the company's focus on cardiac and pulmonary nerve stimulation technologies [144] - The company has a significant number of patents pending and granted, which may enhance its competitive advantage in the medical technology sector [139] - The latest patent related to "Methods and Systems for Neuromodulation" was published on August 10, 2023, indicating ongoing innovation efforts [140] - The company is actively pursuing international patent protection, with filings in regions such as Europe, Asia, and North America, reflecting its global strategy [139] - The company has established a robust intellectual property portfolio, which is crucial for maintaining market leadership and driving future growth [141] - The filing dates for various patents span from 2020 to 2023, demonstrating a consistent pipeline of new technologies and solutions [139] - The company is positioned to leverage its patented technologies for market expansion and potential partnerships in the healthcare sector [139]

Core Viewpoint - Catheter Precision, Inc. reported significant operational updates and financial results for Q1 2025, highlighting growth in sales and strategic acquisitions aimed at enhancing its product pipeline in the electrophysiology market [1][6]. Commercial Endeavors - Approximately 50 hospitals are evaluating Catheter Precision's devices, VIVO and LockeT, indicating a strong sales pipeline [3]. - The company acquired Cardionomics, Inc.'s assets, including a new therapy for acute decompensated heart failure, which affects over 1 million Americans annually [3]. - The acquisition of PeriKard, LLC aims to develop a kit for easier access to the pericardial space, improving existing methods [3]. - New and repeat customers placed orders during the March quarter, reflecting growing market acceptance [3]. Clinical Studies and Presentations - Four abstracts were accepted for presentation at the Heart Rhythm Society Symposia, showcasing the efficacy of VIVO and LockeT in various clinical scenarios [3]. - A study involving 125 centers in Europe showed VIVO's accuracy over 94% and long-term procedural success exceeding 83% [3]. - LockeT demonstrated safety and effectiveness in a study of 139 patients, improving hemostasis in large-bore access procedures [3]. - VIVO's accuracy in scar-dependent VT was validated, predicting exit site locations with 89% accuracy [3]. Financial Highlights - Total assets as of March 31, 2025, were $24.8 million, with total shareholders' equity at $7.9 million [12]. - Sales revenues for Q1 2025 increased by 74% to approximately $143 thousand compared to $82 thousand in Q1 2024 [12]. - The net loss for the quarter was approximately $4.0 million, with $1.2 million attributed to non-cash charges [12]. - The cash position at the end of the quarter was $450 thousand, and a $1.5 million investment was announced shortly after [12]. Future Outlook - The company is optimistic about the growth of its product pipeline and expects clinical acceptance of new products to take 9-12 months [7]. - Ongoing and planned clinical studies for both VIVO and LockeT are set to further demonstrate their efficacy and improve workflows [5].

Product Development and Regulatory Approvals - The VIVO System has been utilized in over 1,000 procedures in the U.S. and EU by more than 30 physicians, with no reported device-related complications[200]. - The company received FDA clearance for the VIVO System as a pre-procedure planning tool for patients with structurally normal hearts undergoing ablation treatment[200]. - LockeT, a new suture retention device, was registered with the FDA in February 2023, with initial shipments to distributors beginning shortly thereafter[202]. - The company recognized its first sale of LockeT in May 2024, following CE Mark approval received in April 2025[202]. - Cardionomix, a new subsidiary, was formed to acquire assets related to late-stage treatment for acute decompensated heart failure, with a transaction closing on May 5, 2025[208]. Financial Performance - Revenue for the three months ended March 31, 2025, was $143 thousand, an increase of approximately $61 thousand compared to $82 thousand for the same period in 2024[222]. - LockeT sales increased by $128 thousand from $0 for the three months ended March 31, 2024, to $128 thousand for the three months ended March 31, 2025[223]. - VIVO System product sales decreased by $67 thousand from $82 thousand for the three months ended March 31, 2024, to $15 thousand for the same period in 2025[223]. - Net cash used in operating activities was $2.3 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024[235]. - As of March 31, 2025, the company had cash and cash equivalents of $0.5 million and an accumulated deficit of $296.4 million[231]. Expenses and Financial Obligations - Selling, general and administrative expenses increased by approximately $829 thousand for the three months ended March 31, 2025, primarily due to an increase in salaries and benefits[225]. - Research and development expenses increased by approximately $66 thousand for the three months ended March 31, 2025, primarily due to hiring a full-time employee[226]. - Acquired in-process research and development expenses recognized were $119 thousand for the three months ended March 31, 2025, related to the acquisition of Perikard, LLC[227]. - The change in fair value of royalties payable due to related parties decreased by $1.1 million from March 31, 2024, to March 31, 2025, due to a decrease in the discount rate[228]. Future Expectations and Royalties - The company expects operating losses and negative cash flows to continue until sales and gross profit increase sufficiently to cover operating expenses[233]. - The company will pay a total royalty of approximately 12% of net sales of LockeT, starting from the first commercial sale in 2024 until December 31, 2035[248]. - A 5% royalty on net sales of LockeT will be paid up to $1 million, after which a 2% royalty will apply until cumulative royalties reach $10 million, contingent on a U.S. patent being granted[249]. - The company is not currently selling the AMIGO System, which has sales-based royalties due upon successful commercialization[250]. Strategic Acquisitions - On January 14, 2025, the company acquired PeriKard, LLC for 275,000 shares valued at $113,000, with potential royalty payments of 10% on net sales for five years[205]. - The company issued a promissory note for $1.5 million to Cardionomic, with a 4% annual interest rate, maturing three years after issuance[208]. Goals and Objectives - The company aims to establish VIVO as an integral tool for cardiac electrophysiologists, improving procedural success and reducing complications[204]. - As of March 31, 2025, the company held 2,157,000 shares of common stock in abeyance due to beneficial ownership limitations[210]. - During the three months ended March 31, 2025, the company released and issued 939,000 abeyance shares[211].

Core Viewpoint - Catheter Precision has announced a $1.5 million private placement equity financing and the acquisition of promissory notes from QHSLab, Inc., aimed at enhancing its financial resources and expanding its market reach in cardiac electrophysiology and general cardiology [1][2]. Financing Details - The company sold 1,500 shares of Series B Preferred Stock for $1.5 million, which are convertible into 4,287,000 shares of common stock, equating to 2,858 shares of common stock per preferred share [3]. - Additionally, 4,285,716 Warrants were issued at an exercise price of $0.50 per share, with a call option if the common stock trades at $1.50 or more for twenty consecutive days [3]. - The Preferred Stock and Warrants do not have variable priced conversion features or voting rights, and the majority are not convertible until shareholder approval is obtained [3]. Acquisition of QHSLab Notes - The company issued another 1,500 shares of Series B Preferred Stock to acquire senior secured notes from QHSLab, with an approximate principal amount of $1.6 million, currently in default and accruing default interest at 18% [4]. - The notes are convertible into QHSLab common stock at a rate of $0.20 per share, but their valuation is uncertain due to the default status [4]. - Catheter Precision and QHSLab are pursuing a strategic partnership in the cardiovascular space [4]. Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing advanced solutions for cardiac arrhythmias and electrophysiology procedures [6].

Core Insights - Catheter Precision, Inc. has announced new clinical data regarding its VIVO product, a non-invasive mapping system for identifying areas of ventricular arrhythmia, which shows over 95% accuracy and a reduction in procedure time by nearly 30% [2][4]. Company Overview - Catheter Precision is a US-based medical device company focused on developing advanced solutions for cardiac arrhythmias, collaborating with physicians to enhance electrophysiology procedures [6]. Product Details - VIVO (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps physicians identify the origin of ventricular arrhythmias before procedures, thereby streamlining workflow and reducing procedure time. It has received marketing clearance from the U.S. FDA and holds the CE Mark [5]. Clinical Data Highlights - New clinical data indicates that VIVO not only functions as intended but may also improve patient outcomes, with significant reductions in procedure time and less burden of ventricular tachycardia (VT) during procedures [4]. - The data is being prepared for submission to industry journals for further detailed publication [3]. Expert Contributions - The new data has been compiled and presented by leading industry physicians, including Professor Sabine Ernst, Professor Tarv Dhanjal, and Dr. Dhanunjaya Lakkireddy [2].

Core Insights - Catheter Precision, Inc. is participating in the 46th annual Heart Rhythm Society (HRS) meeting from April 24 to 27, 2025, in San Diego, California, showcasing its advancements in cardiac electrophysiology [1][2] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, particularly in electrophysiology procedures [8] Product Highlights - The company will feature four abstracts at HRS 2025, including three for its VIVO system and one for the LockeT device, indicating strong research validation and product resonance with the electrophysiology community [3][4] - VIVO is a non-invasive 3D imaging system that aids in identifying the origin of ventricular arrhythmias, streamlining workflow and reducing procedure time, and has received FDA marketing clearance and CE mark [6] - LockeT is a suture retention device designed for wound closure after percutaneous venous punctures, classified as a Class 1 device registered with the FDA [5] Research Findings - A multi-center study in Europe demonstrated that VIVO achieved over 94% accuracy in pre-procedure localization, with long-term procedural success exceeding 83% [7] - VIVO's efficacy in mapping and ablation for difficult-to-map premature ventricular contractions (PVCs) was highlighted in studies from two centers [7] - The safety and effectiveness of LockeT were confirmed in a study involving 139 patients, particularly for large-bore access electrophysiological procedures [7] - A novel study showed VIVO's accuracy in predicting exit site locations for scar-dependent ventricular tachycardia (VT), with an 89% prediction rate and an 86% correlation with successful ablation sites [7]

Core Points - Catheter Precision, Inc. announced that its audited financial statements for the year ended December 31, 2024, included an audit opinion with a Substantial Doubt Regarding Going Concern paragraph [1] - This announcement complies with NYSE American Company Guide Section 610(b), which mandates a separate public announcement for audit opinions containing a going concern paragraph [2] Financial Information - The audit opinion indicating substantial doubt about the company's ability to continue as a going concern was disclosed in the Annual Report on Form 10-K filed on March 31, 2025 [1] - The announcement does not alter the company's consolidated financial statements or its Annual Report on Form 10-K for the year ended December 31, 2024 [2]

Core Insights - Catheter Precision, Inc. has received a notice of allowance for its first US patent for the LockeT product, a surgical closure device for orthoscopic entry wounds, filed in December 2022 [1][2] - The company has also secured international patents for LockeT in China, Europe, and the United Kingdom, which is significant for its distribution discussions in these markets [2] - The company anticipates receiving the CE mark for LockeT within the current quarter, enabling revenue generation in Europe [2] Company Overview - Catheter Precision is a US-based medical device company focused on innovative solutions for cardiac arrhythmias, emphasizing the development of advanced technology for electrophysiology procedures [4] - The LockeT device is a Class 1 suture retention device designed to assist in wound closure after percutaneous venous punctures and is registered with the FDA [3] Market Position - The company has begun rolling out LockeT in the US market and has received positive feedback from hospitals, indicating a demand for products that improve outcomes while reducing costs per procedure [2]

Financial Performance - Total assets as of December 31, 2024, were $27.7 million[7] - Total shareholders' equity as of December 31, 2024, was $11.8 million[7] - Fourth quarter revenue was $149 thousand, representing a sequential increase of 55% over Q3 2024[7] - Full year 2024 revenue totaled $420 thousand[7] - Net loss for the fourth quarter was $5.6 million, with $3.1 million attributed to non-cash charges[7] - Total net loss for 2024 was $16.6 million, of which $7.5 million were non-cash charges[7] Product Development and Sales - The first sales of LockeT occurred in Q2 2024 and grew sequentially each quarter through the end of the year[1] - 26 institutions evaluated LockeT by year-end, either conducting or having completed their evaluations[1] - CE Mark for LockeT is anticipated in Q2 2025, allowing sales in 32 European countries[1] - Randomized Controlled Trial (RCT) for VIVO is planned to begin in Q3 2025[1]