Project description
A durable biocompatible artificial heart valve
Every year, more than half a million people undergo heart valve replacement surgery. However, available valves pose certain limitations and require lifelong anticoagulation therapy or replacement after 10 years. The EU-funded TRIFLO project has developed a unique valve made of high-performance biocompatible material that allows optimal blood flow, prevents the formation of clots and has great durability. The project will test the innovative valve in clinical trials and undertake the necessary activities towards its marketing. The clinical implementation of the valve will improve the quality of life of patients with valvular heart disease and reduce overall healthcare costs.
Objective
Novostia is a medical device company with the mission to provide young patients suffering from heart disease with a solution for life: the TRIFLO valve.
Valvular heart disease affects more than 100 million people worldwide. Every year >500.000 patients undergo a heart valve replacement. For patients younger than 65 years, currently available valves have serious constraints: either blood clot formation requiring lifelong dangerous anticoagulation therapy (with mechanical valves), or deterioration leading to replacement on average every 10 years (with animal tissue-based valves). Therefore, cardiovascular surgeons are urgently seeking a durable and non-thrombogenic valve prosthesis.
Thanks to a unique patented tri-leaflet design, which allows for optimal blood flow patterns, and the use of a novel high-performance biocompatible material, the TRIFLO valve does not induce blood clot formation, while at the same time is durable for life. The TRIFLO valve could thereby substantially improve the quality of life of millions of patients worldwide, whilst reducing overall healthcare costs. Novostia’s technology results from a unique collaboration between a cardiovascular surgeon and an aerospace engineer. The team includes seasoned experts in medical devices, quality and regulatory affairs, cardiovascular surgery and engineering.
The EIC Accelerator grant, combined with €6.5M raised in 2018 from private investors, will enable the company to finalize activities necessary to complete first clinical trials, a major step towards CE Marking and commercialization. Novostia will then target a licensing agreement with a global medical device company to ensure an effective marketing and clinical implementation of the device. Alternatively, sales via regional distributors will be considered.
Fields of science
Not validated
Not validated
Keywords
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
1066 Epalinges
Switzerland
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.