Clinical-stage medical device company Xeltis has completed an oversubscribed €45m in series C financing to advance its programs on aortic and pulmonary valves.
The funding round was led by a global strategic investor with participation from venture capital fund Ysios Capital and a number of large private investors. Existing institutional investors (LSP, Kurma Partners and VI Partners) and private investors also participated in the financing.
The Series C financing will support continuation of clinical activities and acceleration of product and market development for the company's novel aortic and pulmonary valve programs. This is the largest investment round for a private medical device company in Europe in 2017.
"Xeltis is eager to provide patients who need heart valve replacement with a new option offered through our restorative technology, to ultimately improve their lives and reduce healthcare system costs," said Xeltis Chief Executive Officer (CEO) Laurent Grandidier. "This robust financing provides us with the resources necessary to catapult our strategy forward – supporting quick expansion of our aortic and pulmonary valve programs and strengthening our quest to redefine heart valve replacement therapy."
Xeltis' heart valves enable the patient's own body to naturally restore a new heart valve through a therapeutic approach called Endogenous Tissue Restoration (ETR). With ETR, the patient's natural healing system develops tissue that pervades Xeltis' heart valve, forming a new, natural and fully functional valve within it. As ETR occurs, Xeltis implants are gradually absorbed by the body. ETR is enabled by bioabsorbable polymers based on Nobel Prize awarded science.
Ongoing Trial Programs
At TCT 2017, Xeltis announced the latest study results from the Xeltis preclinical aortic valve program during a session dedicated to its innovative technology. The 12-month preliminary aortic valve data showed promising results with good hemodynamic performance and fully functional valves in vivo 12 months after implantation.
The first feasibility clinical trial for Xeltis' pulmonary valve, Xplore-I, is underway in Europe and Asia. In January, the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for Early Feasibility Study (EFS) to implant Xeltis' pulmonary valve in 10 patients. Four prominent U.S. centers are now participating in the clinical trial called Xplore-II.
Previously, Xeltis shared up to 31-month data from a pediatric feasibility study of a vascular graft. The study showed positive functionality results with no device-related adverse events, and significant improvement in patients' general conditions.
Xeltis is currently investigating additional applications of its innovative approach to restore other heart valves and blood vessels.