Cardiovalve Reaches Key Milestone After Completing TARGET Study Enrollment for Tricuspid Valve Replacement

Cardiovalve Marks Milestone in TTVR Study Enrollment

Venus Medtech (Hangzhou) Inc., known in the stock exchange as 2500.HK, has achieved a significant milestone in its ongoing efforts to enhance heart valve replacement technology. The company has officially completed patient enrollment for its TARGET study, which is pivotal for the CE registration of their Transcatheter Tricuspid Valve Replacement (TTVR) system. With a total of 150 patients enrolled, this development is crucial as it prepares the company for an anticipated European regulatory submission later this year.

Advancements Towards CE Approval

The TARGET study’s completion signifies a major step forward for Cardiovalve. This system is designed to effectively treat patients experiencing tricuspid regurgitation, a condition that can lead to various complications, including heart failure. As the company gears up to submit its CE Mark application, they are optimistic about the prospects, pending which, the commercial launch is projected for 2027.

In tandem with the advancements in the TTVR study, Cardiovalve is looking to the future. They plan to initiate another study known as the AHEAD study. This new research will focus on assessing the safety and effectiveness of a mitral valve replacement system specifically aimed at individuals suffering from significant mitral regurgitation. The objective of this endeavor is also to support a future CE Mark application for the mitral valve system, demonstrating Cardiovalve's commitment to expanding its innovative solutions in the heart valve sector.

Presenting at TCT 2025

The company is set to showcase initial data on its mitral valve system at the upcoming TCT 2025 conference, scheduled for October 28, 2025. Dr. Christian Frerker will present on the exciting advancements in a session specifically tailored to new generation mitral technologies. This presentation, titled "Transcatheter Mitral Valve Replacement Using the New Generation Cardiovalve System," will be held at the Moscone Center in San Francisco, setting the stage for potential collaboration and interest from the medical community.

About Cardiovalve and Venus Medtech

Cardiovalve, a subsidiary of Venus Medtech, is pioneering the transcatheter valve replacement technology landscape. With an impressive portfolio of over 150 approved patents and a robust manufacturing facility, the company is well-positioned to lead the charge in structural heart therapies. The ultimate aim is to provide healthcare practitioners with advanced solutions that drastically improve patient outcomes while eliminating the need for traditional open-heart surgery.

Venus Medtech stands at the forefront of innovation for transcatheter heart valve solutions addressing structural heart diseases. Featuring a comprehensive pipeline that spans all four heart valves (TAVR, TPVR, TMVR, and TTVR), they are committed to developing effective treatments for life-threatening cardiovascular conditions, supported by global research and development centers in China, the US, and Israel.

As Cardiovalve progresses towards its CE registration goals, the healthcare industry eagerly anticipates the impact of its innovative solutions on patient care and the growing field of minimally invasive cardiac procedures.