PRESS RELEASE, May 22nd 2025

TRiCares presents promising First-In-Human Topaz data at EuroPCR 2025

Paris, France and Munich, Germany, 22 May, 2025 – TRiCares SAS (“TRiCares”), a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, is presenting data in a late-breaking session at EuroPCR today from its first-in-human trial of Topaz, its Transcatheter Tricuspid Valve Replacement (TTVR) system.

Today, Dr Julien Dreyfus, MD, PhD will present 30-day post-procedural data from 20 tricuspid regurgitation (TR) patients treated with Topaz across eight specialist cardiac centers in Europe. The TRICURE First-In-Human study demonstrated significant elimination of TR in treated patients, with grade ‘none’ (0+) or ‘mild’ (1+) TR reported in all patients implanted with Topaz. In addition, zero permanent pacemakers were required due to the investigational device. The implantation procedure lasted, on average, 35 minutes.

These early clinical results from Topaz compare favorably with existing TTVR treatment approaches, with a procedure that is fast, easy-to-use, and less demanding of imaging specialists.

Further details on the data will be shared in today’s oral presentation at EuroPCR 2025 and on Clinicaltrials.gov.

“We are highly encouraged by the results of this first-in-human trial. These initial findings serve as important validation for our ongoing clinical trials for Topaz in Europe and the US,” said Ahmed Elmouelhi, President & CEO of TRiCares. “I want to extend our sincere gratitude to the participating hospitals, the dedicated interventional teams and clinical investigators who contributed to these patient outcomes. To date, the TRiCares team has overseen 60 Topaz implantations, and we continue to work closely with clinicians to refine the procedure and technique.”

The initial findings will be used to inform the company's ongoing European pivotal trial (NCT06581471) and U.S. Early Feasibility Study (NCT06506942).

EuroPCR presentation details

Session: Tricuspid hotline: new devices

Title: TRiCares Topaz transfemoral TRICUspid heart valve REplacement system first-in-human trial

Presenter: Julien Dreyfus, MD, PhD, FESC, Cardiologist at Centre Cardiologique du Nord, Saint-Denis, France

Location: Theatre Bordeaux

Date/time: Thursday, 22 May 2025, 08:30 – 09:30 CEST