Xeltis Completes Trial Enrollment for Biodegradable Scaffold

Xeltis AG has wrapped up enrollment in a five-patient feasibility study of implantable products designed to grow natural heart valves and vessels using its proprietary technology, Endogenous Tissue Growth (ETG).

The company’s first in-human feasibility study, led by cardiac surgeon Prof. Leo Bockeria, M.D., 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 muscles. Early study follow-up suggests the investigational technology potentially can be a one-time definitive treatment for these pediatric patients, who under the current standard of care must undergo multiple surgeries as the age and often must rely on medication throughout their lives. Xeltis said it chose the Bakoulev Center for its study because it is one of the largest and most experienced hospitals in the world for treating complex congenital heart diseases in children.

“The Xeltis technology is very exciting because it holds the promise to enable ETG for the first time,” Bockeria said. “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.”

ETG 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 potentially can overcome the limitations of current standard of care, Xeltis executives contend. No foreign material is permanently implanted in the body, so long-term medication no longer may be needed. In addition, the risk of repeated surgeries is possibly reduced.

The company’s ETG technology is based on 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 intended to biodegrade over time as the new valves and vessels grow, leaving no foreign material behind.

First Patient
The children in Xeltis’ feasibility study were born with only one heart ventricle (normal heart muscles have two functioning ventricles that pump blood throughout the body). The first enrolled patient was 6-year-old Dominika Zhurkina. Before her Oct. 22, 2013 surgery, Zhurkina was easily winded, had ashen skin and was very limited in her activity. At her one-month follow-up, her skin was a healthy pink, and she was able to run and enjoy one of her favorite hobbies — dancing, Xeltis researchers reported. At her three-month follow-up visit, the girl 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,” the girl’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 the hospital and walked to the parking lot without any problem.”

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 annually with such a medical condition, Xeltis bigwigs noted. Under the current standard of care, surgeons implant either plastic grafts or parts of animal bodies to repair the damaged or malformed hearts and vessels. However, these techniques have limited efficacy and can result in complications, including the potential for rejection, stenosis, calcification, and chronic infection, researchers claim. Also, the grafts are incapable of growing with the patient, requiring their replacement through additional surgeries and a lifetime dependence on medication.

“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, CEO. “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.”

Xeltis is a Swiss company that develops implantable products to grow natural heart valves and vessels.