Core Insights - Catheter Precision, Inc. is positioned to expand the commercialization of its LockeT device following the recent addition of key electrophysiology (EP) ablation procedures to the ambulatory surgery centers (ASC) by the Centers for Medicare and Medicaid Services (CMS) [1][2] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias and advancing electrophysiology procedures through collaboration with physicians [5] Product Information - The LockeT device is a suture retention device designed for wound closure after percutaneous venous punctures, classified as a Class 1 device registered with the FDA and has received CE Mark approval [4] Industry Impact - The addition of EP ablation codes to the ASC-Covered Procedures List (ASC-CPL) by CMS, effective January 1, 2026, significantly enhances Medicare beneficiary access to EP services, marking a major advancement in the delivery of EP care in over two decades [2] Market Opportunity - The new CMS codes will facilitate additional patient scheduling and allow for the use of LockeT in more facilities, supporting physicians and patients in post-ablation recovery while ensuring cost-effectiveness and safety [3]

Core Insights - Catheter Precision, Inc. has secured its first multi-year agreement in France for the VIVO™ system, marking a significant commitment to the French electrophysiology market [1][4] - The VIVO system will be installed at the Centre Hospitalier Régional Universitaire (CHRU) Nancy, enhancing the hospital's capabilities in complex arrhythmia ablation [1][2] - This follows a successful deployment at CHU Rennes, which was Catheter Precision's largest purchase order in Europe, indicating strong demand and positive early results [3][4] Company Overview - Catheter Precision is a US-based medical device company focused on developing advanced technologies for cardiac electrophysiology [6] - The company aims to improve treatment for cardiac arrhythmias through innovative solutions and collaboration with healthcare professionals [6] Product Details - The VIVO system is a non-invasive 3D imaging technology that helps physicians identify the origins of ventricular arrhythmias before procedures, thereby streamlining workflows and reducing procedure times [5] - VIVO has received marketing clearance from both the U.S. FDA and has the CE Mark, indicating its compliance with regulatory standards [5] Market Position - The installation of VIVO at prestigious hospitals like CHRU Nancy and CHU Rennes reflects the growing momentum and clinical value of the product in the French market [4] - The involvement of leading academic centers is crucial for the early adoption of VIVO among physicians, which is expected to drive long-term usage [4]

Core Insights - Catheter Precision, Inc. has received notification from the United States Patent and Trademark Office regarding the allowance for two new patents, enhancing its intellectual property portfolio in the cardiac electrophysiology market [1][4]. Patent Details - The first patent is titled "Methods of Ventricular Arrhythmia Localization Using a 3D Model," which will be assigned to Kardionav, a joint venture aimed at developing new applications for cardiac ventricular therapies [2]. - The second patent, "Neurostimulation Devices and Methods," focuses on improving cardiac ventricular function, particularly for heart failure patients, and will be assigned to Cardionomix, a subsidiary of Catheter Precision [3]. Company Overview - Catheter Precision is a U.S.-based medical device company dedicated to innovating solutions for cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [6]. - The company's VIVO technology is a non-invasive 3D imaging system that helps identify the origins of ventricular arrhythmias before procedures, thereby improving workflow and reducing procedure time [5].

Core Insights - Catheter Precision, Inc. has received its first European purchase order for its product LockeT, marking a significant milestone in its market expansion efforts [1][3] - The successful evaluation of LockeT in Italy follows its acceptance in France and Germany, indicating strong clinical value and versatility [2][4] - The product is designed to assist in wound closure after percutaneous venous punctures and has received both FDA registration and CE Mark approval [4] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias, particularly in the electrophysiology market [5] - The company collaborates with physicians to continuously advance its product offerings [5] Product Details - LockeT is a suture retention device aimed at streamlining closure after catheter ablation procedures while being cost-effective [4] - The device is classified as Class 1 and is registered with the FDA, having also received CE Mark approval [4]

Core Viewpoint - Catheter Precision, Inc. has received a new patent for its VIVO technology, enhancing its intellectual property portfolio and supporting its mission to improve non-invasive identification of ventricular arrhythmias [1][2]. Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [4]. Product Information - VIVO (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps physicians identify the origin of ventricular arrhythmias before procedures, thereby improving workflow and reducing procedure time. It has received marketing clearance from the U.S. FDA and holds the CE Mark [3]. Patent Significance - The newly granted patent titled "Methods of Ventricular Arrhythmia Localization Using a 3D Heart Model" allows the company to further advance its identification methods, providing essential information to physicians for successful patient treatment [1][2].

Core Insights - Catheter Precision, Inc. has initiated the LockeT Compare Study, enrolling its first three patients, aimed at evaluating the safety profile of the LockeT suture retention device [1][2] - The study will enroll up to 100 patients and compare the LockeT device with internal closure devices, focusing on reducing groin complications post-cardiac catheter procedures [2] - The LockeT device has shown clinical data indicating safety, effectiveness, and cost reduction without altering hospital practices [2][3] Company Overview - Catheter Precision is a U.S.-based medical device company dedicated to improving cardiac arrhythmia treatment through innovative technology and collaboration with physicians [4] - The LockeT device is a Class 1 device registered with the FDA and has received CE Mark approval, designed for wound closure after percutaneous venous punctures [3][4]

Core Insights - Heart Hospital of New Mexico has successfully completed 200 ventricular ablation procedures using Catheter Precision's VIVO system, marking a significant milestone for both the hospital and the technology [1][3]. Company Overview - Catheter Precision, Inc. is a U.S.-based medical device company focused on developing advanced products for the cardiac electrophysiology market [5]. - The company aims to improve the treatment of cardiac arrhythmias through innovative technology and collaboration with healthcare professionals [5]. Product Details - The VIVO system (View Into Ventricular Onset) is a non-invasive 3D imaging tool that helps physicians identify the origin of ventricular arrhythmias before procedures, thereby enhancing workflow and reducing procedure time [4]. - VIVO has received marketing clearance from the U.S. FDA and holds the CE Mark, indicating its compliance with European health standards [4]. Hospital Context - Heart Hospital of New Mexico is part of the Lovelace Health system, which includes five hospitals and over 300 healthcare providers, and is dedicated exclusively to cardiovascular care [2].

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]

Financial Highlights - Total assets on December 31, 2024, were $27.7 million [3] - Total shareholders' equity on December 31, 2024, was $11.8 million [3] - Total outstanding shares of common stock on December 31, 2024, were 8,004,633 [3] - Fourth quarter revenue was $149 thousand, a sequential increase of 55% over Q3 2024 [3] - Full year 2024 revenue was $420 thousand [3] - Net loss for the fourth quarter was $5.6 million, with $3.1 million being non-cash charges [3] - Total net loss for 2024 was $16.6 million, with $7.5 million being non-cash charges [3] Operational Updates - A new Chief Commercial Officer (CCO) joined in Q2 2024, leading to a majority replacement of the prior sales team [2][3] - The first sales of LockeT occurred in Q2 2024 and grew sequentially each quarter [3] - By year-end, 26 institutions had evaluated LockeT through surgical procedures [3] - The CE Mark for LockeT is anticipated to be received in Q2 2025, allowing sales in 32 European countries [3] - Anticipated EU LockeT sales are expected to begin in Q3 2025 [3] - VIVO marketing and sales progress continues in the US and multiple international markets [3] Clinical Studies and Publications - Two clinical studies were published in 2024 related to VIVO and LockeT [3] - Multiple IRB approvals were received in Q4 2024 and Q1 2025 for new LockeT studies [3] - A Randomized Controlled Trial (RCT) for VIVO is planned to begin in Q3 2025 [3] Product Information - VIVO is a non-invasive 3D imaging system that streamlines workflow and reduces procedure time [5] - LockeT is a suture retention device intended to assist in hemostasis after percutaneous venous punctures [6]

S-1/A 1 rmed_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on August 26, 2024 Registration No. 333-279930 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Catheter Precision, Inc. (Exact name of registrant as specified in its charter) David Jenkins Executive Chairman of the Board and Chief Executive Officer Catheter Precision, Inc. 1670 Highway 160 West, Suite 205 Fort Mill, S ...