Xeltis announced today that it completed enrollment in an EU pivotal trial for aXess, its restorative vascular access conduit. The study evaluates aXess in adults with end-stage renal disease. Eindhoven, The Netherlands-based Xeltis will conduct the study in 120 subjects across 22 centers in Europe. This study follows 12-month data from a first-in-human EU trial […]
Xeltis
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of arteriovenous grafts (AVG). […]
Xeltis raises $53m Series C round for replacement heart valve programs
Xeltis said today that it closed a Series C round worth more than $53 million (€45 million) for the bioresorbable heart valve technology it’s developing. The Eindhoven, Holland- and Zurich-based company said the round was led by “a global strategic investor,” joined by Ysios Capital, “a number of large private investors,” prior backers LSP, Kurma Partners […]
Xeltis touts preclinical bioresorbable heart valve data
Xeltis today released early data on its bioresorbable heart valves built on endogenous tissue restoration technology, touting potential benefits of the regenerative approach to heart valve replacement. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer […]
Xeltis launches bioresorbable heart valve study
Xeltis said today that it launched the Xplore-I clinical trial of its bioresorbable pulmonary heart valve in pediatric patients undergoing a type of reconstructive surgery to treat congenital heart defects. The Dutch-Swiss company, which won humanitarian use device status from the FDA in March, said the feasibility study is designed to evaluate the 6-month survival rate using the […]
Xeltis wins FDA nod for bioresorbable pulmonary valve
Xeltis said yesterday that the FDA designated the bioresorbable replacement pulmonary valve it’s developing as a humanitarian use device, granted for device designed to treat rare diseases. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure […]
Xeltis snags $3.2m extension for Series B, closes round with $32m
Xeltis said today it brought in an extra $3.2 million (EU €3 million) extension for its Series B financing round, bringing the total up to $32.4 million (€30 million) for its bioabsorbable cardiovascular valve platform. Xeltis’ is designing a platform of bioabsorbable cardiovascular valves and vessels, starting with the pulmonary valve, designed to allow endogenous […]
Xeltis completes 2nd feasibility trial of cardiac valve system
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 […]
Biolase lures Zimmer Dental prez Flynn for CEO role | Personnel Moves
