Xeltis Secures €20.5M for US FDA Approval

Xeltis, a Dutch medical device innovator, has successfully closed an additional €20.5 million funding round, propelling its novel vascular access technology, aXess™, closer to U.S. regulatory approval and market entry. This significant capital infusion, spearheaded by new investor Horizon 3 Healthcare, underscores robust confidence in the company's mission to revolutionize hemodialysis vascular access.

The financing round saw participation from a strong syndicate of existing backers, including the European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, and DaVita, alongside the new lead investor. This latest funding builds upon the substantial €50 million secured in 2025, providing Xeltis with the necessary financial runway to navigate the critical next stages of its development and commercialization strategy.

Proceeds from this round are earmarked for several key initiatives. A primary focus will be the completion of the ongoing pivotal trial for aXess™ in the United States, a crucial step towards securing Food and Drug Administration (FDA) clearance. Concurrently, the funds will support the preparation for a U.S. market launch and facilitate the ongoing commercial rollout of aXess™ across Europe. The company also plans to scale its manufacturing capabilities and advance its promising XABG and XPAD programs through clinical development.

The market for vascular access devices is substantial, with millions of patients requiring hemodialysis annually. Current solutions often face limitations, including high rates of complications and the need for repeated interventions. Xeltis' proprietary technology aims to address these unmet needs by enabling the creation of living, long-lasting vessels, potentially reducing patient morbidity and healthcare costs. The global vascular grafts market is projected to experience significant growth, driven by an aging population and the increasing prevalence of cardiovascular diseases.

The recent successful treatment of the first commercial patient in Germany with aXess™ marks a significant milestone, validating the technology's clinical application and paving the way for broader European adoption. This commercial momentum, combined with the progress in the U.S. pivotal trial, which has now exceeded 50% enrollment, positions Xeltis for a transformative period. The company's approach, which focuses on transforming implants into the patient's own tissue, represents a paradigm shift in regenerative medicine for vascular applications.

Eliane Schutte, CEO of Xeltis, expressed enthusiasm for the new partnership and the strategic implications of the funding. She highlighted the company's commitment to bringing its innovative technology to more patients globally. Matt McNamara, Chief Investment Officer at Horizon 3 Healthcare, commented on the compelling data generated by Xeltis, emphasizing the potential of aXess™ to significantly improve patient outcomes in hemodialysis. This investment signals strong conviction in Xeltis' ability to execute its ambitious clinical and commercial plans.