Xeltis receives PEI conditional approval to initiate tissue-engineered cardiovascular graft study

Xeltis, a biomedical technology company developing growing, living and self-healing cardiovascular implants using tissue-engineering technology, has announced conditional approval by the Paul Erlich Institute (PEI) in Germany to commence the first clinical study of its tissue-engineered cardiovascular grafts. The prospective, single-center study will evaluate the safety and efficacy of Xeltis' autologous tissue-engineered vascular grafts in pediatric patients requiring completion of a total cavo-pulmonary connection (TCPC). Sponsored by the University of Zurich, the trial will include up to 10 patients and will be performed at Heart Center Leipzig, Germany (HZL).

"I am delighted to lead the development of clinical data supporting Xeltis' autologous tissue-engineered implants, which are truly unique in the world," said Prof. Friedrich-Wilhelm Mohr, director of the heart surgery department at HZL.

The study's Principal Investigator Prof. Martin Kostelka, head of pediatric surgery at HZL, added, "Due to their expected longevity, ability to grow and very low risk of thrombosis and infection, these new grafts hold the promise to deliver life-saving therapy for children born with cardiovascular defects. We very much look forward to enrolling our first patient in this important trial."

Xeltis designed its tissue-engineered implants to address a significant unmet clinical need in cardiovascular therapies. Today's grafts are made of artificial material or of animal tissue, both having significant limitations such as potential rejection, limited durability and calcification over time. In contrast, Xeltis implants are "regrown" from the patients' own cells. The resulting implants are, therefore, designed to behave like native organs, with unlimited durability, no risk of rejection and no need for anticoagulants. In addition, children implanted with today's grafts face the critical problem of outgrowing their implants, requiring them to undergo one or more reoperations, each with an increasing rate of morbidity. Because Xeltis' implants have the ability to grow as the child grows, they may remove the need for reoperations.

"The conditional approval of our trial is a significant milestone that will not only help further validate our biomedical technology but will also give Xeltis the foundation to accelerate our development of additional life-changing tissue engineering applications, particularly in the large market of heart valves. This is a significant step towards our vision of 'one implant for a lifetime.' I want to thank the University of Zurich for their collaboration in this project," said Laurent Grandidier, Xeltis chief executive officer. "I also want to commend the Xeltis team for achieving quality standards of the highest level intended to meet PEI's stringent requirements, allowing us to take a critical next step in the development of this truly next generation technology."

Xeltis anticipates first patient enrollment in the study in 2012. Results of the trial will be used towards approval by the European Medicines Agency under the Advanced Therapy Medicinal Products regulation.

"The first human study of our vascular grafts is a very rewarding milestone that builds on many years of work dedicated to developing better, long-term solutions for treating heart valve disorders," said Prof. Simon Hoerstrup, Xeltis co-founder, director of the Swiss Centre for Regenerative Medicine (SCRM) and scientific director at the Department of Surgery, University Hospital and University of Zurich. "We are very proud of this achievement as well as the world-class translational research capability we have developed as part of the collaboration between the University and Xeltis."