Significant unmet clinical need

Novel and protected technology

Estimated $3+ billion market by 2030

The challenge of Tricuspid Regurgitation

Tricuspid regurgitation (TR) is a life-threatening and often overlooked condition, affecting millions worldwide. It occurs when the Tricuspid Valve fails to close properly, causing blood to flow backward into the heart. For patients, this condition presents significant physical, emotional, and financial challenges.

>4.6M

people in Europe and the United States suffer from clinically relevant TR [4][6].

>500k

new cases of clinically relevant TR are diagnosed annually in Europe and the United States [5].

>30%

estimated mortality in patients with severe TR within one year of diagnosis [7].

>70%

estimated mortality in patients with severe TR within four years of diagnosis [7].

>4.6M

people in Europe and the United States suffer from clinically relevant TR [4][6].

>500k

new cases of clinically relevant TR are diagnosed annually in Europe and the United States [5].

>30%

estimated mortality in patients with severe TR within one year of diagnosis [7].

>70%

estimated mortality in patients with severe TR within four years of diagnosis [7].

Pharmacological
treatments

Pharmacological treatments including diuretics, provide symptomatic relief but fail to address the underlying valve dysfunction, resulting in disease progression [8].

Traditional
surgical

Traditional surgical options, such as valve repair or replacement, are associated with a high in-hospital mortality rate of 8-10%. Procedural risks are often unsuitable for elderly or comorbid patients [5][7].

Quality
of life

TR severely impacts quality of life, causing fatigue, swelling, and reduced independence. Patients experience isolation, anxiety, depression, and frequent hospitalizations, with limited treatments adding emotional and financial strain.

The t-heart solution

A New Era in TR Treatment

Disclaimer: Access featured in the video is Transjugular, T-Heart delivery system enables Transfemoral access as well.

We are developing a next-generation device for a one-step transcatheter (transfemoral and transjugular) tricuspid valve replacement (TTVR) system. The system is designed to eliminate tricuspid regurgitation in diseased and enlarged tricuspid valves.

Using a proprietary anchoring structure, our innovative device conforms to the dilated annulus anatomy. By restoring the heart valve to its physiological size, our technology aims to enhance cardiac function, improve health outcomes, and elevate the quality of life for patients.

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For news and updates

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We are a team of world-class experts

T-Heart was co-founded in late 2018 with iBionext, a company builder and investor that supports and finances the development of companies with a strong technological breakthrough in Health Tech in Paris, France.

Ella Faktorovich

CEO

Alain Dibie, MD

Inventor, CSO and Director

Alexia Perouse

Chairwoman of the Board

Bernard Gilly

Director

Sarah Sorrel

Independent Director

Ella Faktorovich

CEO

Alain Dibie, MD

Inventor, CSO and Director

Alexia Perouse

Chairwoman of the Board

Bernard Gilly

Director

Sarah Sorrel

Independent Director

Contact

References

1. Lurz P. TRISCEND II: A randomized trial of transcatheter tricuspid valve replacement vs medical therapy. PCR London Valves, November 2023. 2. Fender EA, Zack CJ, Nishimura RA. Isolated tricuspid regurgitation: Outcomes and therapeutic interventions. Heart. 2018;104:798–806. 3. Chorin E, Rozenbaum Z, Topilsky Y, et al. Tricuspid regurgitation and long-term clinical outcomes. Eur Heart J Cardiovasc Imaging. 2019;21:157–65. 4. Heitzinger G, Pavo N, Koschatko S, et al. Contemporary insights into the epidemiology, impact, and treatment of secondary tricuspid regurgitation across the heart failure spectrum. Eur J Heart Fail. 2023;25:857–67. 5. Adamo M, Chioncel O, Benson L, et al. Prevalence, clinical characteristics, and outcomes of heart failure patients with isolated or combined mitral and tricuspid regurgitation: An analysis from the ESC-HFA Heart Failure Long-Term Registry. Eur J Heart Fail. 2023;25:1061-71. 6. McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42:3599–726. 7. Dreyfus J, Audureau E, Bohbot Y, et al. TRI-SCORE: A new risk score for in-hospital mortality prediction after isolated tricuspid valve surgery. Eur Heart J. 2022;43:654–62. 8. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021;43:561–632.