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

Periodic Reporting for period 1 - TRIFLO (One Valve For Life: The First Durable Non-Thrombotic Heart Valve Prosthesis)

Reporting period: 2020-04-01 to 2021-03-31

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 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, 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 €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.
During this first one-year period, Novostia made significant progress toward first-in-human clinical trial, including:

- Implementation of the Quality Management System
- Improvement of the industrial manufacturing process and quality control.
- Performance of new in-vitro testing confirming the outstanding performances of the TRIFO valve, especially its high resistance to wear and fatigue.
- Performance of new long-term in-vivo studies, in both the aortic and highly thrombogenic pulmonary conditions, with outstanding results, confirming the low thrombogenicity potential of the valve and its very low acoustic signal. (results presented during the international congress of the Heart Valve Society Meeting on April 9, 2021)
- Preparation of the clinical trials strategy
- Strengthening of the support from Key Opinion Leaders.
- Drafting of the Technical Documentation for regulatory approvals.
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 65 years old, ~30 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.
• Thanks to the combination of a unique design and innovative material, TRIFLO is very silent, improving the quality of life of patients.
Figure 1: pictures of explanted valves after long term animal studies with no anti-coagulation