The funding includes €37.5m ($43.5 million) in funding from the EIB, supported under the European Commission’s Invest EU program, plus €10 million ($11.6 million) from existing investors, including EQT and Invest-NL.
Eindhoven, the Netherlands-based Xeltis plans to use funds to advance its aXess device into commercialization. That includes upscaling production and hiring, as well as supporting the continued development of its broader pipeline.
aXess is the company’s restorative vascular access conduit. Xeltis designed aXess to enable 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). The conduit aims to deliver an improved dialysis patient experience while avoiding reinterventions and complications like infections.
The device utilizes a proprietary endogenous tissue restoration (ETR) platform. Using breakthroughs in polymer technology, it enables gradual replacement by the patient’s own living, healthy tissue. The device then dissolves completely over the course of the process. Xeltis designed it to be highly infection-resistant, plus it can deliver near-immediate cannulation.
More about the use of proceeds for Xeltis
Xeltis said the funds, in addition to supporting aXess, will be used for its broader pipeline of implants. The company plans for further developments using its ETR platform.
Xabg, the company’s coronary bypass conduit and second product in clinical development, previously demonstrated strong 24-month follow-up results, the company said in July. It also continues progressing across other indications in its pipeline.
Funding also comes on the heels of the announcement of clinical data for aXess in September. Results showed that aXess delivered major improvements on all key clinical metrics compared to the standard of care. The aXess EU pivotal trial evaluated adult patients with end-stage renal disease requiring vascular access to start or maintain hemodialysis therapy. The study takes place across 18 sites in Europe.
Xeltis said that the funding, paired with recent clinical results, position it to advance toward commercialization with its first-of-its-kind treatment.
“We are deeply grateful for the continued support of the EIB and our existing investors and proud of the confidence they have shown in Xeltis at this key moment for the company,” Eliane Schutte, Chief Executive Officer, Xeltis. “The EU pivotal trial for aXess has delivered exceptional data, and with this new financing, we now have both the validation and resources to move forward toward commercialization. We are now looking to expand our production facilities and hire the critical staff that we will need to bring aXess to the market and transform vascular access treatment for hemodialysis patients.”
