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 Viewpoint - Catheter Precision, Inc. has acquired heart failure-related assets from Cardionomic, Inc., marking a significant milestone in expanding its product offerings in the cardiac electrophysiology market [1][2][3] Group 1: Acquisition Details - The acquisition involves certain assets related to a new therapy for acute decompensated heart failure (ADHF), a condition affecting over 1 million Americans annually [2] - The CPNS System, developed by Cardionomic, utilizes electrical stimulation via a temporary catheter in the pulmonary artery to target the root cause of heart failure [2] - Initial studies of the CPNS System have shown positive results, indicating potential for effective treatment options [2] Group 2: Company Overview - Catheter Precision is focused on developing innovative medical devices aimed at improving the treatment of cardiac arrhythmias [3] - The company collaborates with physicians to advance its products and bring new solutions to market [3]

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 Viewpoint - Catheter Precision, Inc. has signed a definitive agreement to acquire assets related to the Cardiac Pulmonary Nerve Stimulation (CPNS) System from Cardionomic, Inc. through its subsidiary Cardionomix, Inc. This acquisition aims to address acute decompensated heart failure (ADHF), a condition affecting over 1 million Americans annually, with promising initial clinical results indicating significant efficacy [1][2][4]. Group 1: Acquisition Details - The acquisition involves 1,000,000 shares of unregistered common stock and a three-year promissory note of $1.5 million at 4% interest, with no principal or interest due until maturity [5]. - The transaction is subject to normal closing conditions, including NYSE American listing approval [6]. Group 2: Clinical Efficacy - Initial clinical studies have shown significant positive results, including less worsening of acute heart failure, increased fluid loss without renal function deterioration, improved quality of life at thirty days, reduced mortality or hospitalization at six-month follow-up, and a 2.8x improvement over standard care in the WIN ratio [5]. Group 3: Market Potential - The U.S. market for the CPNS System is estimated to exceed $1 billion in annual revenues, given the high number of hospital admissions for heart failure [4]. - The therapy targets hospitalized ADHF patients with an ejection fraction of 50% or less, who exhibit fluid overload despite diuretic treatment [2]. Group 4: Strategic Partnerships - The acquisition is supported by previous investors, including the Cleveland Clinic Foundation, Abbott Laboratories, and New Enterprise Associates (NEA), who will receive economic interests in Catheter Precision's common stock and the Cardionomix note [4][9]. - Discussions are ongoing with various investors to secure additional funding for the new subsidiary, which will support the development of the acquired assets [4].

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]