€20.5m · Other round · Healthtech · Eindhoven, Netherlands
Eindhoven-based medtech Xeltis has raised an additional €20.5m in funding to advance aXess, its vascular-access implant for people receiving haemodialysis. New investor Horizon 3 Healthcare led the financing, with the European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, DaVita and other current shareholders participating. Xeltis says the capital will support its European rollout, US pivotal trial, FDA preparation, manufacturing scale-up and two other vascular programmes.
Approval turns a clinical programme into a delivery system
aXess provides the connection used to move blood between a patient and a dialysis machine. The implant begins as a porous, bioresorbable polymer scaffold. Xeltis says the patient’s cells grow into it, while the polymer gradually resorbs and leaves living tissue in place. The product is designed for cannulation after 14 days, giving clinicians an implantable option that aims to reduce prolonged catheter use and the repeat interventions associated with vascular access.
Xeltis received CE marking for aXess in April 2026 and announced its first commercial implantation in Germany in July. That means the European task has moved beyond obtaining approval: the company now has to train clinical centres, support consistent implantation and dialysis workflows, manufacture devices reliably, and build evidence from routine use.
The company reported 12-month data from a 120-patient European pivotal trial across 22 sites, including 79% secondary patency, 1.3 patency-related reinterventions per patient-year and a 3% clinically relevant access-related infection rate. Those company-presented results supported the CE-marking process, but wider adoption will depend on how performance holds across more centres and patients after launch.
One round is financing three linked transitions
The €20.5m round is intended to fund commercial expansion in Europe while Xeltis completes a separate US pivotal trial and prepares an FDA submission. In the US, aXess remains investigational. The regulatory path therefore runs alongside manufacturing scale-up rather than after it: trial devices, commercial European supply and future US demand all rely on repeatable production.
That sequence gives the financing a concrete execution test. Progress is not only another clinical milestone or another hospital launch. Xeltis must show that its scaffold can be produced consistently, adopted within existing dialysis care and supported across markets with different regulatory and reimbursement requirements. The first commercial patient demonstrates that rollout has begun; the more meaningful proof will be repeatable use across participating centres while the US evidence package matures.
The funding also advances XABG, a coronary-artery bypass conduit, and XPAD, a peripheral-artery implant, both in clinical development. They extend the same tissue-restoration platform into other vascular uses, but aXess remains the near-term commercial test. Successful delivery there would establish manufacturing, clinical-support and regulatory capabilities that the wider pipeline can reuse.
