Paris, France, 8 November 2021 – T-Heart, a privately-owned MedTech company developing a truly novel and differentiated transcatheter tricuspid prosthetic heart valve that is specifically designed for tricuspid regurgitation, today announced it has successfully completed several pre-clinical transcatheter implantations with up to 150 days follow-up.
The company was created in December 2018 based on the innovative design of a unique tricuspid valve by Dr. Alain Dibie, CSO and interventional cardiologist, specializing in the structural heart, currently practicing at the renowned Institut Mutualiste Montsouris (IMM) in Paris, France.
Based on Dr. Dibie’s initial design, T-Heart successfully developed a transcatheter tricuspid prosthetic heart valve, thereby overcoming specific anatomical and physiological challenges. The tricuspid valve has been overlooked over the past couple of decades thereby becoming known as “the forgotten valve”. Tricuspid regurgitation is a progressive condition in which blood leaks backward through the tricuspid valve, potentially leading to heart failure and death.
In June 2021, T-Heart initially released a positive pre-clinical report with over 3 months follow-up. The R&D plan continued its momentum with chronic animal implantations with 150 days follow-up with its proprietary delivery system.
The feasibility of the animal study is underway at IMMR, a world-class market leader in the design and conduct of preclinical studies in large models, best renowned for complex cardiovascular procedures.
T-Heart’s unique design enables the interventional cardiologist to replace the diseased tricuspid valve with a simple one-step technique and allows for broad applicability to a larger patient population with minimal device sizes, addressing a $3.0+ billion potential market opportunity.
Alain Dibie, CSO of T-Heart and inventor of the design said, “I am thrilled to witness that transcatheter tricuspid heart valve implantations have become a reality. I am proud of the T-Heart team for developing a functional prototype and being able to achieve transcatheter animal implantations with 150 days follow-up. I am hopeful and excited at the idea of soon making this device widely available for patients suffering from severe tricuspid regurgitation and significantly improving their quality of life.”
Soad El-Ghazouani, CEO at T-Heart said, “In view of recent advances in percutaneous techniques for aortic and mitral valves, we did not want to miss the tremendous market opportunity of the tricuspid valve. Tricuspid regurgitation is a common problem and serious illness that has long been neglected, leading to a large number of untreated patients. Cardiac surgeons and interventional cardiologists have been awaiting a transcatheter-based solution to help patients with severe tricuspid insufficiency. We are proud of T-Heart achievements to date and believe the company to be well positioned to continue creating value by soon moving into the clinic”
CONTACTS
T-HEART
Soad El-Ghazouani +33 (0)1 85 73 27 05
IBIONEXT
Alexia Perouse
ABOUT T-HEART
T-Heart is a French medical device company focused on the treatment of Tricuspid Regurgitation, a true medical unmet need. Tricuspid regurgitation is a progressive condition in which blood leaks backward through the tricuspid valve, potentially leading to heart failure and death. The transcatheter tricuspid market represents a $3.0+ billion potential opportunity, although currently, limited treatment options exist to address this market.
T-Heart has developed a truly novel and differentiated transcatheter tricuspid prosthetic heart valve that is specifically designed for tricuspid heart valve regurgitation, thereby addressing the specific anatomical challenges. In addition, T-Heart’s unique design enables the interventional cardiologist to replace the diseased tricuspid valve with a simple one-step technique and allows for broad applicability to a larger patient population with minimal device sizes.
Since its inception, T-Heart has assembled an impressive team, comprised of management and external experts, has successfully proved the concept through pre-clinical testing and initiated its Q-Sub for EFS with the FDA.
For more information: www.theartvalve.com
ABOUT IBIONEXT
iBionext is a venture capital firm that supports and finances the development of companies with a strong technological breakthrough in HealthTech. Launched as a network of start-ups in 2012, iBionext is the first French company builder and investment fund to operationally cover the entire value chain of its investments, from creation to growth. All iBionext companies are grouped on a single site, in the “Passage de l’Innovation”, Paris, France. Since its creation, the iBionext network has enabled the creation of 9 companies – Pixium Vision (Euronext: ALPIX), GenSight Biologics (Euronext: SIGHT), Tissium, Prophesee, ChronoLife, BrainEver, Tilak Healthcare, BrainEver, GrAI Matter Labs and T-Heart, which have raised over €600M. More than 18 clinical trials were completed, are underway or completed worldwide and 400+ employees specializing in cutting-edge sectors have joined these companies.
For more information: www.ibionext.com