FORT MILL, S.C., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (VTAK - NYSE/American), a US based medical device company and a leading developer of innovative solutions for cardiac procedures, is pleased to announce a strategic distribution agreement with FuMedica AG, a premier Swiss medical device distributor. This partnership will introduce Catheter Precision’s LockeT suture retention device to hospitals and clinics across Switzerland. LockeT is a novel suture retention tool designed to simp ...

First European Purchase Order for LockeT ReceivedFort Mill, SC, Sept. 02, 2025 (GLOBE NEWSWIRE) -- – Catheter Precision, Inc. (VTAK - NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced the introduction of LockeT in Italy. Following the first successful procedures and clinical acceptance in France and Germany a successful product evaluation was completed in Italy. The first procedures in Italy were perfo ...

Core Insights - Catheter Precision, Inc. has successfully completed the first LockeT procedures in France, marking a significant step in the adoption of its cardiac electrophysiology technologies in Europe [1][2] - The procedures were conducted at CHU Rennes, which is also a commercial partner for the company's VIVO product line [2] - The LockeT device is designed to improve procedural efficiency and patient outcomes following cardiac ablation procedures, indicating a strong market need in Europe [3] Product Information - LockeT is a suture retention device aimed at assisting in wound closure after percutaneous venous punctures, classified as a Class 1 device with FDA registration and CE Mark approval [4] - VIVO (View Into Ventricular Onset) is a non-invasive 3D imaging system that helps identify the origin of ventricular arrhythmias before procedures, thus streamlining workflow and reducing procedure time; it has also received FDA marketing clearance and CE Mark [5] Company Overview - Catheter Precision is a U.S.-based medical device company focused on developing innovative solutions for the treatment of cardiac arrhythmias, emphasizing collaboration with physicians and continuous product advancement [6]

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 - Catheter Precision, Inc. has received registration and approval for its LockeT product in the United Kingdom, which is a significant step for the company to launch sales in the UK market [1] - The LockeT product, a suture retention device, previously received CE Mark approval for European distribution in May 2025 [1][4] - The partnership with HC21, a UK-based distributor, aims to enhance market access for LockeT, leveraging HC21's annual revenue of €180 million and extensive network in the medical device sector [2] Product Details - LockeT is designed to assist in wound closure after percutaneous venous punctures and is classified as a Class 1 device registered with the FDA [4] - The product's intuitive design is expected to improve patient comfort and recovery, facilitating earlier discharge after cardiac procedures [3] Market Impact - The introduction of LockeT is aligned with the NHS's efforts to reduce waiting lists, which recently saw its first reduction in 17 years, potentially allowing clinicians to deliver more treatments efficiently [3] - Catheter Precision aims to collaborate closely with UK healthcare providers to maximize the benefits of LockeT for patients across the nation [3]

Core Insights - Catheter Precision, Inc. has successfully completed the first LockeT cases in Germany, specifically at Zentralklinik Bad Berka, one of the largest hospitals in Thuringia [1] - The physician team has performed 10 successful cases using the LockeT device, showcasing its versatility across various sheath sizes from 6F to 17Fr [2] - The CEO of Catheter Precision highlighted Germany as a significant market in Europe, emphasizing the potential for expanding the use of LockeT in other centers within the country [3] Product Information - LockeT 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] - The company focuses on developing innovative solutions for cardiac arrhythmias and collaborates with physicians to advance its product offerings [5]

Financial Performance - Revenue from product sales increased 128% year over year in Q2 2025, reaching approximately $212 thousand compared to $93 thousand in Q2 2024 [2] - First half 2025 revenue increased 103% over the first half of 2024, totaling approximately $355 thousand compared to $175 thousand [2] - Sequential quarter-over-quarter sales increased by 48% [2] - Net loss for Q2 2025 was approximately $5.4 million, with about $3.2 million attributed to non-cash charges [2] - Total assets as of June 30, 2025, were $25.6 million, and total shareholders' equity was $6.5 million [2] Product Developments - The CE Mark for the LockeT product was received during the quarter, with sales expected to commence in Europe in Q3 2025 [2] - Significant clinical data was presented at the annual Heart Rhythm Society symposium, showcasing the accuracy and long-term outcomes of the VIVO system, which demonstrated over 94% accuracy in a multi-center study involving 125 patients [2] - VIVO's long-term procedural success rate was over 83% [2] - The efficacy and safety of LockeT in large-bore access electrophysiological procedures were validated in a study involving 139 patients [2] - VIVO predicted exit site locations with 89% accuracy in a novel study related to scar-dependent VT [2] Strategic Initiatives - The acquisition of Cardionomic's heart failure assets was completed, forming an 82%-owned subsidiary, Cardionomix [2] - The formation of Kardionav, Inc., a majority-owned joint venture, was completed to develop an implant-based software product for precise ablation site localization [2] - CEO David Jenkins expressed excitement about increasing sales, strong clinical data, and strategic transactions aimed at enhancing the future value of the company [3]

Core Insights - Catheter Precision, Inc. is experiencing significant growth in sales of its LockeT device, with Q2 2025 sales projected to be the highest to date, showing a 200% increase compared to Q2 2024 [1] - Several US hospitals are expected to place purchase orders exceeding $100,000 each for LockeT by the end of 2025, including notable institutions like Montefiore, Eisenhower Health, and Overland Park Regional Medical Center [2] - The company has received CE Mark approval for LockeT, allowing sales in Europe, and is actively expanding its distribution network in Italy, Spain, Portugal, and the UK [3] Company Activities - The CEO of Catheter Precision expressed enthusiasm about the sales pipeline and upcoming activities, including a live demonstration of LockeT at an Italian symposium scheduled for June 16 [4] - The company is focused on increasing product awareness and usage while expanding its market presence in Europe [4] Product Information - LockeT is a Class 1 medical device designed for wound closure after percutaneous venous punctures, registered with the FDA and having received CE Mark approval [5] - Catheter Precision is dedicated to developing innovative solutions for cardiac arrhythmias and advancing electrophysiology procedures through collaboration with physicians [6]

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]

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].