LUMA Vision Submits IPO Prospectus Highlighting VERAfeye Platform’s Breakthrough in 4D Intracardiac Imaging and Large-Focal PFA for Precise, Efficient, and Safe Atrial Fibrillation Ablation

LUMA Vision Announces Successful Completion of 15 VERAFEYE-Guided Persistent Atrial Fibrillation (AFib) Ablation Procedures in Clinical Study with CardioFocus Collaboration

This study aims to partially evaluate whether VERAFEYE's 4D navigation and imaging platform can fully guide catheter ablation procedures, including pulmonary vein isolation, posterior wall isolation, and tricuspid isthmus ablation using CardioFocus's large-area focal PFA ablation catheter QuickShot Nav.

The first 15 surgical cases demonstrated that VERAFEYE integrates high-resolution intracardiac imaging (2D and 4D) with navigation capabilities, automatically generating dual-atrial digital anatomical models via acquisition solely from the right atrium. This technology provides clinicians with real-time four-dimensional visualization of the beating heart, enabling a simplified dual-catheter ablation workflow and enhancing the precision and efficiency of complex procedures. By combining AI-driven anatomical modeling with automated catheter tracking guidance, VERAFEYE is redefining the planning, execution, and validation of paroxysmal and persistent atrial fibrillation ablation procedures—setting a new standard for efficiency and accuracy in the era of pulsed field ablation.

The study results highlight VERAFEYE inShorten operation time, improve anatomical accuracy, and reduce complicationsin terms of potential, it achieves this goal by providing doctors with real-time, accurate, and dynamic views of cardiac interactions throughout the entire ablation process.

PI Evaluation

"In the initial ablation of persistent atrial fibrillation, adopting an empirical ablation strategy is the preferred approach. The innovative 3D modeling technology of the VERAFEYE system allows me to complete imaging (2D intracardiac echocardiography), navigation, and rapid digital anatomy construction using only a single catheter, which is unique in this field. When the rapid digital anatomy model generated by VERAFEYE is combined with a large focal pulsed field ablation platform like CardioFocus QuickShot, the operator has an ideal dual-catheter toolkit that can complete an empirical ablation plan, including linear ablation beyond pulmonary vein isolation, in less than an hour. This redefines procedural efficiency."

---Ante Anic KBC Split

Executive Evaluation

"Treating the first group of patients marks a key milestone in the development of LUMA Vision. We sincerely thankKBC SplitPartnering with CardioFocus. Our goal is to improve patient outcomes by enhancing the accuracy, efficiency, and precision of cardiac procedures. VERAFEYE, a breakthrough cardiac guidance platform powered by advanced machine learning and artificial intelligence, aims to set a new standard of care by integrating with third-party devices and catheters. We have already validated that VERAFEYE can guide atrial fibrillation treatments with unparalleled clarity and precision, and in the future, it will also support interventional procedures such as left atrial appendage closure and structural heart disease surgeries. This technology will have a profound clinical impact, and we look forward to bringing it to a broader global market by 2026.

---Fionn Lahart  CEO of LUMA Vision

VerafeyeIs a novelIntegrated 4D Imaging and GuidanceHang Platform, providing an unparalleled range of anatomical capture and versatility for solutions tailored to interventional cardiology applications.VerafeyeUsing proprietary catheter sensors, combined with advanced digital imaging and deep learning, provides unprecedented high-resolution, 360-degree images of the beating heart and surrounding anatomy.VerafeyeCan be used during cardiac surgery with other catheters or systems, and has multiple applications on one platform, providing all the imaging guidance required during cardiac surgery in real time without the need for external systems such as X-ray or DSA.

Its ultrasound catheter is a new type of ultrasound catheter with a track view, capable of imaging all structures around the catheter with an unprecedented field of view.

VerafeyeAdopting an end-to-end closed-loop platform and leveraging computational power and a unique software system to provide real-time 4D imaging with response speeds akin to the speed of sound, thereby achievingSeamless Real-Time Image SetRebuild accurate and actionable cardiac data forProvide precise guidance for electrophysiology and structural heart disease surgeries, and achieve shorter operation times.

LUMA VisionLUMA Vision, Ltd. (formerly OneProjects Ltd) is an innovative medical device company headquartered in Dublin, Ireland, and Munich, Germany. LUMA Vision originated as a spin-off from the Irish BioInnovate program and Trinity College Dublin. The company has designed and developed an innovative 4D imaging and navigation end-to-end platform for cardiac applications, providing data during treatment.