PRESS RELEASE, November 6th 2025

TRiCares completes first TC-L 55mm Topaz implant in ongoing TRICURE EU Pivotal study

TRiCares is pleased to share that its TRICURE EU pivotal study has been amended to include a larger, TC-L, 55mm valve, alongside the current TC-M, 45mm valve.

The first use of the TC-L, 55mm valve in the European study recently took place at the AZORG Heart Centre, Aalst, Belgium. The procedure was conducted by Dr Liesbeth Rosseel, Interventional Cardiologist, and Dr Marc Vanderheyden, Interventional Cardiologist, proctored by Professor Pascal Lim.

This larger valve size has been designed to expand to a broader TR patient population. Alongside the existing TC-M 45mm valve, Topaz is now a viable treatment option for 85-90% of all patients presenting with a TR diagnosis.

The ongoing TRICURE EU study (NCT06581471) is taking place at sites in Belgium, Denmark, France, Germany, and Spain. The TRICURE Early Feasibility Study (NCT06506942) is enrolling in the US.

Ahmed Elmouelhi, President & CEO of TRiCares, commented: “Advancing this additional valve size is an important achievement, made possible by the Series D financing secured in 2024, and the hard work of the team at TRiCares. As we continue with studies in Europe and the US, we are pleased to be able to offer this flexibility in valve sizes, for the benefit of clinicians and patients.”