Xeltis has announced that it has finished enrolment in a five-patient feasibility study of implantable products intended to enable for the first time the spontaneous growth of natural, healthy heart valves and vessels. With its proprietary technology, the company has pioneered an entirely new therapeutic category called Endogenous Tissue Growth, in which surgeons use unique implants designed to allow the body to repair itself by growing natural, healthy tissue.
According to a company release, Xeltis’ first-in-human feasibility study, led by cardiac surgeon Leo Bockeria at the Bakoulev Centre for Cardiovascular Surgery of the Russian Academy of Medical Sciences in Moscow, is focused on the implantation of a connecting tube (or “conduit”) designed to treat children born with single-ventricle heart physiology. Early study follow-up indicates that the investigational treatment has the potential to be a one-time, definitive treatment for these paediatric patients, who under current standard of care must undergo multiple dangerous surgeries as they age and often need medication throughout their lifetimes. Xeltis chose the Bakoulev Centre for its study because it is one of the largest and most experienced hospitals in the world for the treatment of complex congenital heart diseases in children.
“The Xeltis technology is very exciting because it holds the promise to enable endogenous tissue growth for the first time,” says Bockeria. “If proven valid, this therapy will finally end the tragic cycle of repeat surgery and lifelong medication that these children and their families must currently endure. This will not only alleviate pain and suffering for families, it will save billions of healthcare dollars each year.”