Novostia is a medical device company incorporated in 2017 in the Canton of Neuchâtel (Switzerland) which aims at providing adults as well as young patients suffering from heart disease with a lifelong answer to their aortic and mitral valvulopathy: the TRIFLO valve. Valvular heart disease affects more than 100 million people worldwide. Every year more than 500.000 patients undergo a heart valve replacement. For patients younger than 65 years, valves currently available present serious constraints: either blood clot formation requiring lifelong problematic anticoagulation therapy with mechanical valves, or deterioration leading to replacement on average every 10 years with tissue valves. Therefore, cardiovascular surgeons are seeking a durable and non thrombogenic valve prosthesis. Thanks to a unique patented tri-leaflet design, which allows for optimal blood flow hemodynamics, and the use of a novel high-performance biocompatible material (PEEK), TRIFLO valve limits blood clot formation, while offering a lifelong durability. TRIFLO valve could thereby substantially improve the quality of life of millions of patients worldwide, whilst reducing overall healthcare costs. The current team at Novostia comprises all in all, employees, and strategic partners, about 150 experienced professionals in medical devices, quality and regulatory affairs, cardiovascular surgery, research, engineering, precision manufacturing, market access, fundraising, and business development. The EIC Accelerator grant, combined with €6.5M raised in 2018 and €2.5M raised in 2021 from private investors, has enabled the company to perform preclinical activities to launch the first phase of clinical studies, a fundamental step towards CE Marking, FDA Approval and China NMPA Approval, prerequisites for entering the market. To enter the market and expand its business, Novostia has considered three alternatives: signing distribution or even production license agreements with companies active in the medical devices sector; selling all or part of its activities to an already established multinational company that manufactures and sells heart valves; pursuing an autonomous development strategy as a new independent player and selling directly, through its own commercial distribution network or, indirectly, through regional distributors, the valves it would manufacture or subcontract to its current partners.
