TRiCares Raises $50m in Series D Financing to Support Upcoming Clinical Milestones
25 July 2024 - 7:00AM
UK Regulatory
TRiCares Raises $50m in Series D Financing to Support Upcoming
Clinical Milestones
TRiCares Raises $50m in Series D
Financing to Support Upcoming Clinical Milestones
Paris, France and Munich, Germany, July
25, 2024 – TRiCares SAS (“TRiCares”), a privately held
pioneer in the field of minimally invasive treatment of tricuspid
regurgitation, today announces it has raised $50 million (€46
million) in a Series D financing round.
The round was raised from a single, strategic
investor. The proceeds from this financing will primarily be used
to support the company through upcoming US and EU clinical
milestones for its transfemoral tricuspid heart valve replacement
system, Topaz. 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 recently secured Investigational Device
Exemption (IDE) for an EFS from the United States Food and Drug
Administration (FDA). The study will commence in the coming months,
with patients to be enrolled at up to 8 potential sites in the
United States and Canada, overseen by leading principal
investigators Susheel Kodali, MD (NewYork-Presbyterian/Columbia
University Irving Medical Center) and Gorav Ailawadi, MD
(University of Michigan Health System).
Preparations at potential sites are underway,
with the completion of the study set to lay the foundations for an
IDE Pivotal trial in the US. Alongside 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.
Ahmed Elmouelhi, President & CEO of
TRiCares, commented: “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.”
Tricuspid regurgitation (TR) is a serious
cardiac condition affecting more than 1.8 million patients in the
US, for which the current standard treatment options are open heart
surgery or supportive care. However, open heart surgery is not
suitable for most patients with TR, due to its high mortality risk.
Topaz is an innovative, 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 $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.
About TRiCares
TRiCares is a dedicated medical device company
located in Paris, France and Munich, Germany having the vision of
bringing to the market a transfemoral tricuspid valve replacement
system (TTVR). This TTVR system aims at helping patients suffering
from severe tricuspid regurgitation (TR) without the need for
open-heart surgery. With a unique dual stent design, the company
was able to produce two valve sizes that both fit into a
low-profile catheter system. This catheter system is inserted via
the femoral vein and transports the prosthesis into the right half
of the heart, where it is finally released to replace the diseased
tricuspid valve. This user-friendly implantation technique also
allows the treatment of severely ill patients. The company is
currently conducting a clinical trial in the US, Canada, and
several European countries.
The experienced team of TRiCares is supported by
the leading European life science venture capital firms: 415
Capital, Andera Partners, Bayern Kapital, BioMed Partners, Credit
Mutuel Innovation, GoCapital, Karista, and Wellington Partners.
For further information please contact:
TRiCares SAS
Ahmed Elmouelhi,
President & CEO
info@tricares.de
ICR Consilium
Lucy Featherstone
T: +44 (0)20 3709 5700
tricares@icrhealthcare.com