Xeltis Raises €20.5M for Regenerative Vascular Implants

Xeltis, a Dutch-US medical technology firm specializing in regenerative vascular implants, has successfully closed a €20.5 million funding round. This significant capital infusion is earmarked to accelerate the commercial rollout of its innovative artificial vessels and valves, which are designed to be replaced by the patient's own living tissue. The investment will also propel the company's pivotal trial for its aXess™ product in the United States towards completion and prepare for its market introduction there.

The financing round saw strong participation from both new and existing investors, underscoring confidence in Xeltis' transformative approach to cardiovascular and hemodialysis access solutions. Leading the investment was new entrant Horizon 3 Healthcare. Key existing backers, including the European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, and DaVita, also contributed, demonstrating continued support for the company's mission.

Eliane Schutte, CEO of Xeltis, expressed enthusiasm for the funding, stating, “This capital injection is pivotal for expanding our vascular access technology to more European patients as we continue our commercial expansion. Crucially, it allows us to advance our aXess™ pivotal trial in the US, readying us for market entry, and to further develop our other promising clinical programs, XABG and XPAD. We are delighted to welcome Horizon 3 Healthcare and deeply appreciate the trust placed in Xeltis by all our investors as we strive to offer vital new alternatives for patients.”

Xeltis' proprietary Restorex® platform utilizes advanced polymer implants that facilitate the body's natural regeneration process. Over time, these implants are absorbed, leaving behind fully functional, living vascular tissue. This regenerative capability addresses a critical unmet need in the millions of patients requiring hemodialysis vascular access or cardiovascular replacements annually, offering a potential for improved long-term outcomes and reduced need for repeat interventions. The global market for cardiovascular devices is substantial, projected to reach over $100 billion in the coming years, with vascular grafts representing a significant segment.

Matt McNamara, Chief Investment Officer at Horizon 3 Healthcare, commented on the investment, noting, “The clinical data Xeltis has generated is exceptionally compelling, highlighting the transformative potential of aXess™ for hemodialysis patients and the broader vascular access market. We are impressed by the company's execution and rapid progress. We are proud to support Xeltis as it navigates US clinical development and European commercialization, while simultaneously advancing its pipeline of regenerative implants.”

This latest funding follows a series of previous capital raises, including a substantial €50 million secured in 2025 from the European Investment Bank and existing shareholders, and a €15 million investment from Chinese firm Grand Pharma in 2022. The current funding will be instrumental in completing the US pivotal trial for aXess™, preparing for FDA submission, and executing the US market launch. It will also support the ongoing European commercial rollout, manufacturing scale-up, and the advancement of the XABG and XPAD programs.

The company recently announced the European launch of aXess™, with the first commercial patient successfully treated in Germany. Concurrently, enrollment in the US pivotal trial for aXess™ is progressing well, having surpassed the 50% completion mark. This dual progress in clinical development and commercialization positions Xeltis for significant growth in the MedTech sector.