Feb. 27, 2014 12:00 UTC

Xeltis Completes Enrollment in World's First Study of Spontaneous Tissue Growth Technology; Early Follow-up Shows Promise in Children with Congenital Heart Defect

ZURICH--(BUSINESS WIRE)-- Xeltis, a privately held medical device company dedicated to transforming standards of care in heart valve replacement and vascular surgery, has announced that it has finished enrollment 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, 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, which is 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 that the investigational treatment has the potential to be a one-time, definitive treatment for these pediatric patients, who under the 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 the current standard of care. No foreign material is permanently implanted in the body, so long-term medication may no longer be needed. In addition, the risk of repeated surgeries may be reduced.

At the foundation of Xeltis’ technology is 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 as compared to two healthy, functioning ventricles that pump blood throughout the body. The first enrolled patient was 6-year-old Dominika Zhurkina. Prior to her Oct. 22, 2013 surgery, Dominika was easily winded, had ashen skin and was very limited in her activity. 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,” said Dominika’s father, Sergey, 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.”

Healthcare Impact

Millions of people around the world suffer from congenital heart defects, degenerative heart damage and vascular diseases. If Xeltis’ technology is proven feasible, safe and effective, Xeltis has the potential to revolutionize the practice of cardiac and vascular surgeries.

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 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,” 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.”

Ultimately, the company’s technology has potential for broad application across a number of cardiovascular conditions and patient populations, serving as the platform for a multi-billion dollar business.

About Xeltis

Xeltis is a European medical device company dedicated to transforming standards of care in heart valve replacement and vascular surgery. The company develops implantable products intended to enable for the first time the spontaneous growth of natural, healthy heart valves and vessels. 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’ proprietary technology is based on Nobel Prize-winning science.

For more information, visit www.xeltis.com.

Photos of Dominika at her three-month follow-up visit are available for download at www.xeltis.com/media-kit/.

CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL UNITED STATES LAW TO INVESTIGATIONAL USE.

Contacts

Media Contacts/US:
Nobles Global Communications
Barbara Van Dyke, + 1 512-431-2552
Barbara@noblesgc.com
or
Diana Soltesz, + 1 818-618-5634
Diana@noblesgc.com
or
Media Contact/Europe:
medeuronet
Marija Gjorgjioska, +44 779689 4628
marijagj@medeuronet.com


Source: Xeltis