Tricares SAS. (9/15/22). "Press Release: Tricares Raises €47m in a First Closing of Its Series C Financing to Fund Further Development of Minimally Invasive Treatment for Tricuspid Regurgitation". Paris & Munich.

	Organisation	Tricares SAS
	Group	Tricares (Group)
	Organisation 2	415 Capital Management GmbH
	Product	Topaz transfemoral tricuspid heart valve replacement system
	Product 2	venture capital
	Index term	Tricares–SEVERAL: investment, 202209 financing round Series C 1st closing €47m incl majority of new cash + also conversion of convertible loans
	Person	Straubinger, Helmut J. (Tricares 201603–2024032 CEO formerly JenaValve 200709 CEO RETIRED 3/24)
	Person 2	Groenewegen, Frederik (415 Capital 202209 General Partner)

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.”

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About TRiCares

TRiCares is a young medical device startup company located in Paris and Munich having the vision to bring to the market a transfemoral tricuspid valve replacement system. This system aims at helping patients suffering from severe tricuspid regurgitation (TR) without the need for open heart surgery. The experienced team of TRiCares is supported by the leading European life science venture capital firms: Andera Partners, BioMed Partners, Credit Mutuel Innovation, GoCapital, Karista, Wellington Partners and 415 Capital.

About Tricuspid Regurgitation (TR)

The tricuspid valve is the heart valve that regulates the blood between the right atrial and ventricular chamber. Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, causing blood to flow backwards into the right atrium. Tricuspid regurgitation is a frequent problem and a severe disease that was neglected for many years, leading to a large number of untreated patients without an effective treatment option. Cardiac surgeons and interventional cardiologists have long waited for a transcatheter based solution. The progress in developing minimally invasive treatment options for heart valves as well as the experience gained in numerous research projects has strongly increased the awareness of the importance of this disease.

About the Medical Need

Heart valve diseases are among the most serious cardiac complications affecting at least 12.7 million patients in Europe and many more worldwide. In the last decade, innovative minimally invasive catheter-based solutions have been developed for the treatment of aortic and mitral heart valve disease, creating a fast-growing transcatheter heart valve replacement market. However, for patients with tricuspid heart valve disease (tricuspid regurgitation), no solution exists to replace the diseased heart valve due to anatomic, functional and technological challenges. Only repair options by so-called clipping devices have been developed. But this technique is not suitable for all patients and the treatment success is limited. Consequently, open-heart surgeries to repair the insufficient valve and medical treatments still represent the standard treatment options. Due to excessive risk of the procedures (10–35 % surgical mortality), more than 99 % of TR patients are considered ineligible for the curative surgeries and are only maintained on symptomatic pharmacologic treatment with poor prognosis (2.2 years median survival). Therefore, physicians are urgently seeking minimally invasive, low-risk solutions to improve clinical outcomes in TR patients.

Record changed: 2024-03-30