Xeltis Completes Enrolment in World’s First Study of Spontaneous Tissue Growth

Xeltis, a privately held medical device company, 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. The study, which is led by cardiac surgeon Prof. Leo Bockeria at the Bakoulev Center 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 singleventricle heart physiology. Early study follow-up indicates that the investigational treatment has the potential to be a one-time, definitive treatment for these pediatric 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 Center 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 ETG for the first time,” said Prof. 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.”

About Endogenous Tissue Growth and Xeltis Technology
Endogenous Tissue Growth is the process of natural tissue growth from within the body, without the use of external stem cells or animal-derived products. Because the tissue produced through ETG is the patient’s own, the treatment has the potential to overcome the limitations of current standard of care. No foreign material is permanently implanted in the body, so long-term medication may no longer needed. In addition, the risk of repeated surgeries may be reduced.

Xeltis’ products are synthetic matrices designed to work by stimulating and guiding the body’s natural healing response from the inside. The matrices are intended to biodegrade over time as the new valves and vessels grow, leaving no foreign material behind.

Xeltis’ first product will be a replacement valve for children born with a congenital heart malformation requiring replacement of their pulmonary valve. Nearly 100,000 children are born every year with such a medical condition. Under current standard of care, surgeons may implant plastic grafts or parts of animal bodies to repair the damaged or malformed hearts and vessels. However, these techniques have limited efficacy and are plagued with complications, including the potential for rejection, stenosis, calcification and chronic infection. Additionally, the grafts are incapable of growing with the patient, requiring multiple surgeries and medication for life.

“The completion of study enrollment and the very positive early clinical follow-up marks a significant milestone for Xeltis and the new and emerging field of ETG,” said Laurent Grandidier, chief executive officer, Xeltis. “If the results prove our technology feasible, we will be one important step closer to realizing our vision of making it possible for these children to be treated with only one surgery in their lifetimes.”