EINDHOVEN, Netherlands / BOSTON, United States — Xeltis, a Dutch-American MedTech company developing regenerative implants that are gradually replaced by a patient’s own living tissue, has raised €20.5 million in new funding to accelerate clinical development, regulatory approvals, and commercial expansion.
The financing will support the completion of the company’s pivotal U.S. clinical trial, preparation for an FDA submission, expansion of its European commercialization efforts, and continued development of additional regenerative vascular therapies.
The funding round was led by Horizon 3 Healthcare, with participation from the European Innovation Council (EIC), Invest-NL, VI Partners, EQT Life Sciences, DaVita, and existing shareholders.
Regenerative Implants Instead of Permanent Artificial Devices
Founded in 2006, Xeltis is developing a new generation of cardiovascular implants designed to regenerate rather than permanently replace damaged blood vessels.
Its proprietary Restorex® platform uses biodegradable polymer implants that act as temporary scaffolds inside the body. Over time, the implants stimulate the growth of the patient’s own healthy tissue before gradually dissolving, leaving behind fully living blood vessels.
The approach aims to overcome many of the long-term complications associated with conventional synthetic vascular grafts and implants.
Advancing Treatment for Dialysis Patients
Xeltis’ most advanced product, aXess™, is designed for patients requiring hemodialysis vascular access.
The implant has already received CE Mark approval and is being commercially introduced across Europe. Unlike traditional vascular access grafts, aXess™ is intended to become living tissue, potentially reducing infections, complications, and the need for repeat surgical interventions.
The company recently announced the successful treatment of its first commercial patient in Germany and continues expanding the product’s European rollout.
Preparing for the U.S. Market
A major portion of the new investment will be used to complete Xeltis’ ongoing pivotal U.S. clinical trial for aXess™, which has now enrolled more than half of its target participants.
The company plans to use the study results to prepare its submission to the U.S. Food and Drug Administration (FDA)and support its commercial launch in the United States.
According to CEO Eliane Schutte, the financing enables Xeltis to bring its regenerative vascular technology to more patients in Europe while advancing toward regulatory approval in the U.S.
Expanding the Regenerative Medicine Pipeline
Beyond aXess™, Xeltis is also developing additional regenerative cardiovascular products through its XABG and XPADclinical programs.
The company believes its polymer-based tissue regeneration platform has broad potential across vascular and cardiovascular diseases, creating implants that naturally integrate with the body instead of remaining permanent foreign materials.
The latest investment will also support manufacturing expansion as Xeltis prepares for increased commercial demand.
Building Momentum in Regenerative MedTech
The funding follows €50 million secured in 2025 from the European Investment Bank (EIB) and existing investors, as well as earlier investment from Grand Pharma.
Investors believe the company’s technology could significantly improve long-term outcomes for patients requiring vascular access and cardiovascular reconstruction by enabling the body to regenerate its own living tissue.
As regenerative medicine continues to reshape cardiovascular care, Xeltis is positioning itself at the forefront of a new generation of MedTech innovation that combines advanced biomaterials with the body’s natural healing processes.
With fresh funding, growing commercial traction in Europe, and pivotal U.S. clinical trials underway, the company is entering a crucial phase on its path toward bringing regenerative vascular implants to patients worldwide.
