PRESS RELEASE, September 15th 2022

TRiCares Raises €47m in a First Closing of its Series C Financing

TRiCares Raises €47m in a First Closing of its Series C Financing to Fund Further Development of Minimally Invasive Treatment for Tricuspid Regurgitation.

Paris, France and Munich, Germany, September 15, 2022 – TRiCares SAS (“TRiCares”) a privately held pioneer in the field of minimally invasive treatment of tricuspid regurgitation, is pleased to announce today that it has successfully raised €47m from the first closing of its Series C financing round. The completion of the Series C financing round is expected later this year.

The proceeds of this financing will primarily be used to continue the development of the company’s transfemoral tricuspid heart valve replacement system (“Topaz”) up through to the application for a pivotal investigational device exemption (“IDE”) trial in the United States. To this end, TRiCares plans to initiate an early feasibility study across five centers in the US in 2023.

The proceeds of this financing will also support the on-going TRICURE first-in-human clinical study in Belgium as well as potential additional clinical trial applications elsewhere in Europe, along with further compassionate use implantations as appropriate.

The Series C financing was led by 415 Capital and strongly supported by existing investors Andera Partners, BioMed Partners, Credit Mutuel Innovation, GOCapital, Karista and Wellington Partners. Total gross proceeds of €47m include a significant majority of new cash as well as the conversion of certain convertible loans issued prior to 2022.

TRiCares is developing a transcatheter-based tricuspid valve replacement system aimed at addressing the need for a better treatment for this frequent and severe disease that avoids open heart surgery. Heart valve diseases are among the most serious cardiac conditions, affecting more than 12.7 million patients in Europe and many more worldwide. Owing to high mortality risk, access to open heart surgery is severely restricted and is not considered an option for more than 99% of patients with tricuspid regurgitation, leaving surgeons seeking minimally invasive, lower risk solutions to improve outcomes for patients with no other viable treatment options.

Topaz is an innovative device designed specifically to help patients suffering from severe tricuspid regurgitation without the need for open heart surgery. The Topaz device is implanted in a minimally invasive procedure through the patient’s femoral vein. It is designed specifically to fit the tricuspid valve anatomy and thus supports ease of positioning and functionality.

Helmut J. Straubinger, Chief Executive Officer of TRiCares, said: “This successful financing reflects the tremendous potential of the Topaz tricuspid valve replacement system, our continued progress in its development and strong support from investors for our strategy. As we seek to deliver a much-needed solution for patients with tricuspid regurgitation, we look forward to the further development of the Topaz system with a focus on the necessary preparations for a pivotal IDE trial in the US along with continuing to progress our clinical activities in Europe.”

Frederik Groenewegen, General Partner at 415 Capital, commented: “TRiCares is developing what we believe has the potential to become a best-in-class therapy option to restore quality of life for millions of patients suffering from tricuspid regurgitation. We have been encouraged by the early clinical experience with the TRiCares device and look forward to supporting the team as they work towards making their technology available to patients in the United States and Europe.”
Sofia Ioannidou, PhD, Partner at Andera Partners, commented: “The pioneering work that TRiCares is doing has the potential to save the lives of millions of patients around the world with tricuspid regurgitation who currently have no effective long-term treatment options. We are excited to continue accompanying TRiCares in its journey to develop a safe and effective transcatheter valve replacement system for these patients.”

Regina Hodits, PhD, Managing Partner at Wellington Partners, said: “We see that the Topaz tricuspid valve replacement system has the potential to become the global standard of care for patients suffering from tricuspid regurgitation. We are proud to continue supporting TRiCares as it progresses the development of its Topaz system towards the market.”