TRiCares SAS has announced it has raised US$50 million (€46 million) in a Series D financing round, with proceeds to support the upcoming US and EU clinical studies for the Topaz transfemoral tricuspid valve replacement system. The round was raised from a single, strategic investor.
Upcoming milestones include the completion of an early feasibility study (EFS) in the USA, the initiation of a pivotal trial in Europe, and advancing additional valve sizes for Topaz, as well as a next-generation delivery system, the company said in a press release.
TRiCares recently secured investigational device exemption (IDE) for an EFS from the US Food and Drug Administration (FDA). The study will commence in the coming months, with patients to be enrolled at up to eight potential sites in the USA and Canada, overseen by leading principal investigators Susheel Kodali (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, USA) and Gorav Ailawadi, MD (University of Michigan Health System, Ann Arbor, USA).
Preparations at potential sites are underway, with the completion of the study set to lay the foundations for an IDE pivotal trial in the USA. Alongside these US clinical programmes, work continues with EU clinical investigations—with the ongoing first-in-human trial nearing completion, and an EU Pivotal (CE mark) trial commencing soon.
Ahmed Elmouelhi, president & CEO of TRiCares, 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 (TR) patients worldwide with our Topaz valve and look forward to providing updates on patient enrolment in the USA, alongside our efforts in Europe.”
Topaz is a minimally invasive valve designed specifically to aid patients suffering from severe TR, without the need for open heart surgery. To date, more than 25 Topaz implantations have successfully been performed across Europe and Canada.
TRiCares previously closed a US$55 million (€51 million) Series C financing round, with investors including 415 Capital, Andera Partners, Bayern Kapital, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners.
