TRiCares SAS, a privately held medtech company developing a minimally invasive treatment for tricuspid regurgitation, said it has signed a loan agreement for up to €20 million in non-dilutive financing with the European Investment Bank, the long-term lending institution of the European Union.
The company said the financing is intended to provide flexible support for research, development, and innovation activities, including advancing clinical studies for Topaz, its Transfemoral Tricuspid Heart Valve Replacement system, designed to replace the diseased tricuspid valve without open-heart surgery.
TRiCares said its ongoing European pivotal study is being conducted across multiple sites in Belgium, Denmark, France, Germany, and Spain, with Switzerland expected to follow. The study plans to enroll 80 patients. In the United States, the company said its TRICURE US Early Feasibility Study is progressing, with implantations already performed at major structural heart institutions. That study is expected to enroll 15 patients across eight sites.
The company said the Topaz system is built around a dual stent valve design and uses established transfemoral and transjugular delivery approaches. TRiCares said the valve is offered in two sizes, 45mm and 55mm, and is intended to cover the majority of patient anatomies.
TRiCares operates globally with offices in France, Germany, the United States, and Brazil, and is backed by a strategic partner and life science venture capital firms, including 415 Capital, Andera Partners, Bayern Kapital, BioMed Partners, Credit Mutuel Innovation, GoCapital, Karista, and Wellington Partners. The company said it is working toward regulatory milestones, including FDA approval and CE marking, and plans to move toward an IDE pivotal trial.
KEY QUOTE:
“We are pleased to have secured this loan agreement with the EIB, which is a clear validation of our approach and will be a valuable resource to support our clinical trials in the U.S. and Europe. We believe that Topaz has the potential to transform outcomes for tricuspid patients, and we look forward to providing further updates from our ongoing studies and plans to begin our IDE pivotal trial.”
Ahmed Elmouelhi, President & CEO, TRiCares
