Xeltis said today it completed its 2nd feasibility trial of its bioabsorbable regenerative heart valve technology designed to allow endogenous tissue restoration.
The Swiss med tech firm is designing valves and vessels out of polymers structured as a “porous matrix” designed to be absorbed and leave the patient with its own healthy tissue, the company said.
“The positive results of our second feasibility trial confirm the extraordinary potential of our bioabsorbable technology for a number of different cardiovascular applications. We are confident that bioabsorbable cardiovascular devices will be able to replace most commonly used implantable devices, and that ETR will improve patient outcomes while reducing the economic burden for healthcare systems,” CEO Laurent Grandidier said in a press release.
The study examined children born with only 1 functioning heart ventricle who required a Glenn procedure and were implanted with the Xeltis cardiovascular patch as part of their operations. Results presented no patch-related adverse events, complications or functional impairments, the company said.
“The results of this study are beginning to build clinical evidence about the feasibility of bioabsorbable cardiovascular devices as new therapeutic options in cardiovascular surgery. A year after surgery, all clinical parameters are positive and provide hope that ETR may offer a more definitive solution to a number of cardiac conditions,” study lead Leo Bockeria of Moscow’s Bakoulev Center for Cardiovascular Surgery.
Last December, Xeltis said it closed an over-subscribed Series B round worth about $34 million for the regenerative heart valve technology it’s developing.
Zurich-based Xeltis said the round was led by Amsterdam’s Life Sciences Partners and Paris-based Kurma Partners and included VI Partners and existing shareholders. The proceeds are earmarked primarily for commercialization of the company’s 1st product, a pulmonary valve, and pipeline development, according to a press release.