Completion of TARGET Study Enrollment Signals Cardiovalve's Path to CE Mark Approval

Cardiovalve Achieves Milestone in TARGET Study for CE Mark Approval

Venus Medtech (Hangzhou) Inc., trading under the ticker 2500.HK, recently announced the significant milestone of completing patient enrollment in its TARGET study, designed for the transcatheter replacement of the tricuspid valve (TTVR). A total of 150 patients were successfully recruited in this study, which is pivotal in advancing the company's application for CE marking in Europe.

The successful completion of enrollment underscores a promising progression for Cardiovalve's revolutionary TTVR system, aimed at treating tricuspid regurgitation, a condition that can lead to serious heart complications. Cardiovalve is now preparing to submit its CE marking application to European regulators, expected to take place within this year. Looking ahead, the company plans a commercial launch of its TTVR system in Europe by 2027, showing commitment to bringing innovation to the cardiology field.

Future Directions: Study AHEAD

In addition to the TARGET study, Cardiovalve is gearing up for the launch of its next clinical trial named AHEAD. This study is set to evaluate the safety and efficacy of its mitral valve replacement system in patients experiencing significant mitral regurgitation. The AHEAD study will serve as a basis for a subsequent CE marking application for the mitral system, showcasing Cardiovalve's commitment to comprehensive solutions in cardiac therapy.

Presentation at TCT 2025

Cardiovalve will also participate in the upcoming TCT 2025 conference, where it plans to present preliminary data on its mitral regurgitation system. The planned session, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," is scheduled for October 28, 2025, at the Moscone Center in San Francisco. With Dr. Christian Frerker leading the presentation, this session is expected to attract attention from the healthcare community, underlining advancements in transcatheter technologies.

About Cardiovalve

Cardiovalve, a subsidiary of Venus Medtech, stands at the forefront of innovation in transcatheter valve replacement technology. The company has successfully established itself in the cardiac therapy landscape, with over 150 approved patents and a dedicated, experienced team. With operations centered in its state-of-the-art manufacturing facility, Cardiovalve is on a mission to develop next-generation solutions that enhance patient outcomes while mitigating the need for open-heart surgery.

With a portfolio that covers all four heart valves—including transcatheter solutions for aortic, pulmonary, mitral, and tricuspid valves—Venus Medtech continues to lead the charge towards effective treatments for structural heart diseases. The company boasts global R&D centers in China, the United States, and Israel, enhancing its innovative capabilities and ensuring its products meet the highest standards of quality and efficacy.

As Cardiovalve prepares for its next steps, the culmination of the TARGET study reinforces its position as a key player in the field of cardiac intervention, promising hope for patients suffering from heart valve disorders globally.