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LUMA Vision Leads the Way in Cardiac Imaging Technology

LUMA Vision, renowned for its pioneering technology in cardiac 4D imaging and navigation, is setting a new standard in the medical field with the recent expansion of its clinical program. This expansion includes the enrollment of the first patients in two significant European studies that utilize the cutting-edge VERAFEYE™ platform for guiding catheter ablation procedures. These studies are taking place at Na Homolce Hospital in Prague and KBC University Hospital in Split, with contributions from prominent doctors, Dr. Vivek Reddy, Dr. Petr Neuzil, Dr. Ante Anic, and Dr. Anish Amin.

The introduction of VERAFEYE™ into these clinical environments marks a notable development for LUMA Vision as it continues to enhance the capabilities of catheter ablation technologies. With the ability to leverage both 2D and 4D imaging, this platform provides real-time guidance for ablation workflows, ensuring that medical professionals can achieve precise anatomical models while navigating complex procedures.

During these trials, patients undergoing treatment utilized various Pulsed Field Ablation (PFA) systems, showcasing VERAFEYE™'s versatility and compatibility within existing ablation technologies. The advanced imaging system delivers an impressive 360-degree view, giving operators the clarity needed to perform effective treatments in single-operator settings—a feature that significantly increases both efficiency and accuracy during procedures.

The latest version of the VERAFEYE™ system, which LUMA Vision is leveraging in these studies, is currently entering the regulatory landscape with the submission of a 510(k) application. This crucial step signifies the company's intention to launch commercially by 2026, reinforcing the system's potential as an invaluable resource for cardiac electrophysiology.

This significant milestone was underscored during a visit by two health ministers—Judith Gerlach, Bavaria’s Minister of Health, and Jennifer Carroll MacNeill, Health Minister of Ireland—who toured LUMA Vision's facility in Munich. Their visit emphasized the importance of European collaborations in advancing cardiac healthcare innovations. Minister MacNeill praised the VERAFEYE™ platform, stating, "What you are building here with the VERAFEYE™ platform is genuinely a world-first technology. An open platform, AI-driven 4D imaging system designed to help cardiologists see the heart in a way that has never been possible."

Furthermore, Minister Gerlach remarked on LUMA Vision's contributions to enticing innovation within Europe, highlighting the successful partnership between Irish and Bavarian teams to create groundbreaking medical technologies. Jenny Melia, CEO of Enterprise Ireland, echoed these sentiments, emphasizing the organization's commitment to fostering Irish companies to achieve growth and impact on a global scale.

As LUMA Vision prepares for the anticipated regulatory approval and the subsequent commercial roll-out later this year, it sets its sights on scaling operations in key international markets. The open imaging and navigation platform not only enhances ablation procedures but is also expected to extend its application to structural heart interventions, including left atrial appendage closure and valve placements.

About LUMA Vision

Founded by Fionn Lahart and Christoph Hennersperger, LUMA Vision is a privately funded medical technology firm with its base in Dublin, Ireland, and Munich, Germany. The company is dedicated to developing next-gen cardiac visualization and navigation systems, striving to empower healthcare professionals with precision tools that transform patient outcomes. The flagship product, VERAFEYE™, stands out for its groundbreaking real-time intraprocedural imaging capabilities that redefine the standards in both electrophysiology and structural heart interventions.

To learn more about LUMA Vision and their innovations, visit www.lumavision.com.