TRiCares SAS, a privately held pioneer in the minimally invasive treatment of tricuspid regurgitation, announced it has raised $50 million (€46 million) in a Series D funding round. The funding round was raised from a single strategic investor.
The proceeds from this funding will primarily be used to support the company through upcoming US and EU clinical milestones for its transfemoral tricuspid heart valve replacement system Topaz. And this would include the completion of an Early Feasibility Study (EFS) in the US, the initiation of a pivotal trial in Europe, and advancing additional valve sizes for Topaz, as well as a next-generation delivery system.
TRiCares also recently secured Investigational Device Exemption (IDE) for an EFS from the US Food and Drug Administration (FDA). And the study will commence in the coming months, with patients to be enrolled at up to 8 potential sites in the US and Canada, overseen by leading principal investigators Susheel Kodali, MD (New York-Presbyterian/Columbia University Irving Medical Center) and Gorav Ailawadi, MD (University of Michigan Health System).
The preparations at the potential sites are underway, with the completion of the study set to lay the foundations for an IDE Pivotal trial in the US. And along with these US clinical programs, work continues apace with EU clinical investigations – with the ongoing first-in-human trial nearing completion, and an EU Pivotal (CE mark) trial commencing soon.
Tricuspid regurgitation (TR) is a serious cardiac condition affecting over 1.8 million patients in the US, for which the current standard treatment options are open heart surgery or supportive care. But open heart surgery is not suitable for most patients with TR, due to its high mortality risk.
Topaz is a minimally invasive valve designed specifically to aid patients suffering from severe TR, without the need for open heart surgery. So far, over 25 Topaz implantations have successfully been performed across Europe and Canada.
TRiCares previously closed a $55 million (€51 million) Series C funding, with investors including 415 Capital, Andera Partners, Bayern Kapital, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners.
KEY QUOTE:
“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.”
– Ahmed Elmouelhi, President & CEO of TRiCares
