Xeltis Completes Enrollment in Study of Spontaneous Tissue Growth Technology

Xeltis AG has completed enrollment in a five-patient feasibility study of implantable products designed to spur the spontaneous growth of natural, healthy heart valves and vessels. With its proprietary technology, the company has pioneered a new therapeutic category called Endogenous Tissue Growth, or ETG, in which surgeons use unique implants designed to allow the body to repair itself by growing natural, healthy tissue.

Xeltis’ first-in-human feasibility study, led by esteemed 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 single-ventricle heart physiology. Early study follow-up indicates the investigational treatment  potentially can be a one-time, definitive treatment for these kids, who under the current standard of care must undergo multiple 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 Bockeria. “If proven valid, this therapy will finally end the 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.”

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 the current standard of care, Xeltis claims. No foreign material is permanently implanted in the body, so long-term medication may no longer be needed.

Xeltis’ technology uses Nobel prize-winning science known as “supramolecular chemistry,” or the chemistry of assembled molecules. Xeltis’ products are synthetic matrices designed to work by stimulating and guiding the body’s natural healing response from the inside. The matrices are designed to biodegrade over time as the new valves and vessels grow, leaving no foreign material behind.

The children in Xeltis’ feasibility study were born with only one heart ventricle as compared to two healthy, functioning ventricles that pump blood throughout the body. The first enrolled patient was 6-year-old Dominika Zhurkina; before her surgery last fall, Zhurkina was easily winded, had ashen skin and was not very active. At her one-month follow-up visit, her skin was a healthy pink, and she was able to run and enjoy one of her favorite hobbies, dancing. At her three-month follow-up visit, she continued to enjoy her more active lifestyle.

“Everything started to change from the very first day, from the moment Dominika was discharged from the hospital,” Zhurkina’s father Sergey said at her three-month follow-up visit. “We noticed immediately that she could easily walk one kilometer without stopping, breathing calmly. Before, we would walk for 100 meters, and she would have to stop and rest. On that very first day, we just came out of hospital and walked to the parking without any problem.”

Xeltis is developing 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, according to the company. Under the 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,” Xeltis CEO Laurent Grandidier said. “If the results prove our technology feasible, we will be one step closer to realizing our vision of making it possible for these children to be treated with only one surgery in their lifetimes.”

Xeltis is a Swiss medical device company that develops heart valve replacement and vascular surgery technology. Its products are synthetic matrices designed to work by stimulating and guiding the body’s natural healing response from the inside. The company was founded in 2006.