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Catheter Precision, Inc. Announces First Quarter 2025 Update and Financial Results
Globenewswire· 2025-05-14 20:30
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].
New Clinical Data Presented about VIVO at the 46th Annual Heart Rhythm Association Conference
Globenewswire· 2025-05-01 12:00
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].
Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure™ lead and announces investigational clinical study results
Prnewswire· 2025-04-25 21:45
Core Insights - Medtronic has received FDA approval for the OmniaSecure™ defibrillation lead, which is designed for precise placement in the right ventricle and is the world's smallest defibrillation lead at 4.7 French (1.6mm) [1][5] - The OmniaSecure lead is built on the SelectSecure™ Model 3830 pacing lead and aims to treat life-threatening ventricular tachyarrhythmias and bradyarrhythmias [1][3] - Investigational studies presented at Heart Rhythm 2025 show a 100% defibrillation success rate when the lead is implanted in the left bundle branch (LBB) area, indicating potential for physiologic pacing [2][6] Company Overview - Medtronic is a global leader in healthcare technology, headquartered in Galway, Ireland, with a mission to alleviate pain, restore health, and extend life [10] - The company employs over 95,000 people across more than 150 countries and offers a wide range of medical technologies and therapies [10] Product Details - The OmniaSecure lead connects to an implantable defibrillator and is indicated for use in adults and adolescent patients aged 12 and up, including those with smaller anatomies [1] - The lead's design minimizes complications associated with larger-diameter leads, such as venous occlusion and tricuspid valve regurgitation [4][5] - The LEADR LBBAP study, which is a global, prospective, non-randomized trial, has enrolled approximately 300 patients across 24 sites in 11 countries [9]