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Novostia: Announcement Agreement for FIH

Novostia announced that they have received the green light from the Lithuanian State Health Care Accreditation Agency under the Ministry of Health to launch the First-in-Human implantations (FIH) of its aortic heart valve prosthesis: the TRIFLO. These implants are scheduled to begin in December 2023, at Vilnius University Hospital Santaros Klinikos, under the supervision of Professor Kęstutis Ručinskas.

This agreement to launch FIH represents a major milestone in the TRIFLO valve project developed by Novostia. Since its inception in 2017, Novostia has made tremendous progress in terms of industrial processes, verification & validation testing, with scientific confirmation in silico, in vitro and in vivo of the TRIFLO valve’s superior performance compared to the competition.

The TRIFLO Heart Valve prosthesis is a breakthrough in design and materials, as well as a manufacturing prowess which is based on the most advanced machining techniques.

Today, Novostia can leverage an experienced team in-house and a network of world-class, reliable, and highly committed partners and investors, who are equipped to deliver the highest quality and expected growth potential upon market entry.

Successes have been achieved at a fast and steady pace since 2017, and more intensively since 2020. They have moved from a prototype to a highly innovative implantable medical device, a truly game changer. Nothing would have been possible without the support of all our scientific, industrial, medical, legal, and financial partners to whom we extend our warmest thanks. This project is supported and co-financed by the European Union through the EIC Accelerator program, by the Swiss Confederation through Innosuisse, and by the Canton of Vaud through the SPEI and the Biopôle.

Let’s celebrate this milestone looking forward to the next achievement.


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