March 28, 2023 — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision-making in the EP lab, is proud to announce the achievement of significant milestones demonstrating both the clinical and commercial success of the ECGenius System.1 The ECGenius System is an innovative EP recording technology that includes a proprietary hardware amplifier allowing electrophysiologists to acquire high-fidelity, low-noise cardiac electrograms to improve the diagnosis and treatment of complex atrial arrhythmias such as atrial fibrillation (AF).
In recent months, CathVision has achieved several key milestones:
- Physician Validation & Confirmed Market Opportunity: Since receiving FDA clearance in May of 2022, several world-renowned hospitals, including Cleveland Clinic, Johns Hopkins Hospital, Houston Methodist Hospital, IU Health Methodist Hospital, NYU Langone Health, and Valley Health, have repeatedly utilized the ECGenius System during the current limited market release. Leading electrophysiologists at these hospitals have recognized ECGenius' ability to provide clear signal data that helps clinicians identify, diagnose, and treat complex cardiac arrhythmias. As a result, in many EP labs, the ECGenius System has replaced existing EP recording systems, including LabSystem Pro and CardioLab, as the primary EP system for measuring, analyzing, recording, and routing pacing.
- Clinical Progress: In the past 18 months, three clinical studies have completed the evaluation of the ECGenius System and CARDIALYTICS suite of artificial intelligence-powered analytics using RF, cryo, and pulsed-field ablation technologies at AZ Sint-Jan Brugge-Oostende, UZ Gent, UZ Brussels, Clinique Pasteur Toulouse, University of Vermont Medical Center, and Rigshospitalet (National Hospital of Denmark).2 Additionally, two clinical studies, with patients enrolled at the prestigious institution of NYU Langone Health in New York and OLV Hospital Aalst in Belgium, aim to validate the clinical utility of automated electrogram analyses using high-quality signal data to analyze ablation therapy progress using the Signal Complexity module when treating patients with persistent atrial fibrillation.
- Strengthened Intellectual Property (IP) Portfolio: CathVision's core IP is centered on both low-noise inventions (ECGenius System) and algorithm innovation (CARDIALYTICS). The Company's technologies are covered by 13 patent families, of which six are granted and seven are pending.
- Scientific Recognition: CathVision's ECGenius System and CARDIALYTICS' AI-based analytics have received industry recognition with seven scientific abstracts featuring the technology accepted for presentation at the upcoming Heart Rhythm Society (HRS) conference in New Orleans. This attention further solidifies ECGenius System's place as an exciting technology that will advance the field of electrophysiology.
"It's rewarding and validating to see our ECGenius System and CARDIALYTICS suite making such a positive impact in the electrophysiology field," said Mads Matthiesen, CEO of CathVision. "Our team has invested many years of research and development to create a solution to a challenge that many EPs didn't previously recognize because innovation in EP recording technology has been lacking for so long. By introducing high-quality, low-noise signal data, Electrophysiologists can more clearly see the complexity of every heartbeat, which gives them the potential to vastly improve patient treatment. The recognition and adoption of the ECGenius System demonstrates the importance of our advanced technology and the critical need to evolve EP recording."
The ECGenius System is commercially available in the United States in limited market release. For more information: https://cathvision.com/
1 ECGenius System is cleared for sale in the US. Not approved for sale in the rest of the world.
2 CARDIALYTICS is not cleared for sales.