First Xeltis study with encouraging results

Xeltis, a privately-held medical device company dedicated to transforming standards of care in cardiovascular treatments, today announces that it has successfully completed the first-ever feasibility clinical trial on Endogenous Tissue Growth (ETG). ETG is a novel therapeutic category pioneered by Xeltis in which surgeons use synthetic bioabsorbable implants designed to allow the body to repair itself by growing natural, healthy tissue from the inside, leaving nothing behind as the implant is absorbed.

In this study, five children born with only one heart ventricle, instead of two healthy, functioning ventricles that pump blood throughout the body, were implanted with Xeltis’ vascular graft and were followed up for 12 months. The study was led by renowned cardiac surgeon Prof. Leo Bockeria at the Bakoulev Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences in Moscow.

Remarkable results
“The results of this study are remarkable. At 12 months follow-up all clinical parameters are positive and all indicators show that patients have successfully grown their own blood vessels”, Prof. Leo Bockeria states. “This first feasibility study provides hope that we will soon be able to offer one-time, definitive treatments for pediatric patients born with congenital malformations, who currently must undergo multiple critical surgeries as they age and often need medication throughout their lifetimes, as well as for several other types of applications in the cardiovascular field.”

Laurent Grandidier, CEO at Xeltis, adds “The successful completion of our first clinical trial marks the advent of a paradigm shift in cardiovascular treatments. We believe it will be possible one day to replace most commonly used implantable cardiovascular devices by Xeltis’ technology. This will enable significantly improved patient outcomes and lower costs of healthcare. This successful clinical trial is a first, remarkable, step in that direction.“

The picture shows first Xeltis feasibility study patient Dominika Zhurkina with her parents at her three-month follow-up visit at the Bakoulev Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences. Copyright Xeltis.

ETG and Xeltis’ proprietary technology
Under current standards of care, surgeons or cardiologists implant permanent prostheses made of plastics or parts of animal bodies to repair damaged or malformed hearts and vessels. Because of the limitations of these materials and their long-term presence in the body, the current techniques have limited efficacy, are plagued with complications and often require long-term medication.

On the other hand, Xeltis’ matrices have the properties to be bioabsorbed over time as new valves and vessels grow, hence leaving no foreign material behind. Because the tissue produced through ETG is the patient’s own, the treatment has the potential to stretch the boundaries of current standards of care.