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One Valve For Life: The First Durable Non-Thrombotic Heart Valve Prosthesis

Periodic Reporting for period 2 - TRIFLO (One Valve For Life: The First Durable Non-Thrombotic Heart Valve Prosthesis)

Reporting period: 2021-04-01 to 2022-03-31

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 75 years, currently available valves have serious constraints: either blood clot formation requiring lifelong dangerous blood thinning medication (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, whist
being 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 and is supported by first class partners.

The EIC Accelerator grant, combined with €9 M raised 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.
During the second reporting period, we have improved our Swiss industrialized manufacturing process, finalized the implementation and maintenance of our ISO 13485 Quality Management System, performed new preclinical in-vitro and in-vivo testing as well as numerical simulations. We have obtained outstanding results which confirmed the low thrombogenicity and durability potential of the valve. New preclinical testing has been launched according to regulatory requirements to submit the application to the Ethic Committee and the Competent Authority to start our first-in-human clinical trial in a European center, scheduled by June 2023.
In the last 10 years there has been significant activity in the field of heart valve prostheses, which have led to the development of Transcatheter Valve Implantation (TVI) procedures. These technologies, however, primarily address the needs of elderly patients, have limited durability, might lead to vascular and neurological complications, and might lead to the need for permanent pacemaker implantation. Thus, younger patients (under 75 years old, ~50 million worldwide) still rely on mechanical valves associated with lifelong blood thinners medication or biological valves, which need to be replaced on average every 10 years, and even faster in children, leading to multiple reoperations.

TRIFLO should significantly improve the quality of life of young patients worldwide suffering from heart valve disease, whist reducing overall healthcare costs:

• TRIFLO has a three-leaflet design that mimic the natural aortic valve and effectively prevents blood clots formation due to optimal hemodynamic.
• TRIFLO is made of a new biocompatible material that is extremely durable and ensures the lifetime of the valves, avoiding reoperations.
• TRIFLO offers superior hemodynamic performance over current available technologies, being also silent, improving the quality of life of patients thanks to the combination of a unique design and innovative materials.
• TRIFLO offers excellent implantability, including through minimal invasive surgery, thanks to its unique design.
• TRIFLO offers a cost-effective solution for the healthcare systems and the patients, avoiding the severe complications associated with current technologies.
Figure 1: pictures of explanted valves after long term animal studies with no anti-coagulation