TRiCares, a Germany-based medical technology company focused on minimally invasive treatment of tricuspid regurgitation, has raised $50m in a Series D financing round.
The company intends to use proceeds from the financing, raised from a single, strategic investor, to advance its transfemoral tricuspid heart valve replacement system, Topaz.
It includes completing an Early Feasibility Study (EFS) in the US, launching a clinical trial in Europe, and advancing additional valve sizes for Topaz, along with a next-gen delivery system.
TRiCares previously secured $55m in a Series C financing round with investors, including 415 Capital, Andera Partners, Bayern Kapital, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners.
TRiCares president and CEO Ahmed Elmouelhi said: “I’m thrilled that we have secured this significant financing at such an important stage for the business.
“This financing builds on previous investments from leading European life science venture capital firms, to whom we are grateful for their ongoing support and counsel.
“We remain focused on improving treatment options for tricuspid regurgitation patients worldwide with our Topaz valve and look forward to providing updates on patient enrollment in the US, alongside our efforts in Europe.”
TRiCares recently secured the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for an EFS of its Topaz system.
The company will begin the study in the coming months, by enrolling patients at up to 8 potential sites in the US and Canada.
The study will be overseen by Susheel Kodali from Columbia University Irving Medical Center and Gorav Ailawadi from the University of Michigan Health System, as principal investigators.
Currently, preparations are underway at potential sites, and the completion of the study is anticipated to lay the foundations for an IDE Pivotal trial in the US.
In addition, works at EU clinical investigation sites are also underway, with the ongoing first-in-human trial reaching completion, and a CE mark trial planned soon, said the German company.
