A larger preclinical study of Foldax’s transcatheter Tria Valve is right around the corner. The news comes after the Salt Lake City, UT-based company presented favorable results from the first animal study of the valve at the Cardiovascular Research Technologies Annual Conference.

Investigators for the pilot study of four ovine subjects reported the Tria TAVR (valve) demonstrated satisfactory deployment, function and good hemodynamic results. There was no pannus, calcification or thrombosis on leaflet surfaces (out to as long as 90 days post-implantation).

“Expanding TAVR into young patients requires enhanced hemodynamics and durability with greater life expectancy. In this small animal study, we found that the TRIA transcatheter biopolymer valve showed promising hemodynamic results with encouraging durability,” said Dr. Yakubov. “Having a TAVR that can last the lifetime of a younger patient is something we need in cardiovascular medicine and it will be exciting to see outcomes from this valve as it moves into humans.”

The company said on the basis of this pilot study, Foldax plans to conduct a larger pre-clinical study of its transcatheter valve in 2022 intended to support a first-in-human study.

Foldax hasn’t let the pandemic slow down its pace. After all the company is in the middle of developing three products. The firm raised $20 million in a Series D round in June of 2020 and shortly after it won FDA approval to expand a clinical study of its surgical aortic valve.  

Foldax would cap off 2020 by receiving an IDE from FDA for a mitral valve clinical study.