Xeltis has raised an additional €20.5m to expand its vascular implant programmes in Europe and the US.
The commercial-stage medtech company, based in the Netherlands and the US, develops artificial vessels and valves that are gradually replaced by patients’ own healthy tissue.
Its Restorex platform uses an advanced polymer implant that is transformed into the patient’s own tissue before being gradually absorbed, leaving new living vessels in place.
Xeltis said the technology could reduce repeat procedures and address the limitations of current treatments for millions of patients who need haemodialysis vascular access or cardiovascular replacements each year.
Haemodialysis filters waste and excess fluid from the blood when the kidneys cannot do so. Vascular access provides a route into the bloodstream for treatment.
Its most advanced product, aXess, is an implantable blood vessel for patients who need vascular access for haemodialysis.
The device has received CE Mark approval and is being commercially deployed across Europe.
Xeltis recently announced the treatment of the first commercial patient in Germany.
The company is also enrolling patients in a US pivotal trial of aXess, which is now more than halfway complete.
A pivotal trial is a late-stage clinical study designed to provide key evidence for regulators considering whether to approve a medical product.
Xeltis plans to use the funding to complete the trial, prepare a submission to the US Food and Drug Administration and prepare for bringing the product to the US market.
The capital will also support the European rollout of aXess, increased manufacturing capacity and the continued clinical development of the company’s XABG and XPAD programmes.
Eliane Schutte, chief executive of Xeltis, said: “This fundraising not only enables us to bring our groundbreaking vascular access technology to more European patients, as we continue our successful commercial rollout, but also enables us to advance our aXess™ pivotal trial in the US, prepare for US market launch and continue our other exciting clinical programmes, XABG and XPAD. We welcome our new investor Horizon 3 Healthcare and thank them, and our existing investors, for their confidence in Xeltis as we look to bring much-needed alternatives to patients.”
The funding was secured from new and existing shareholders and led by new investor Horizon 3 Healthcare.
The European Innovation Council, Invest-NL, VI Partners, EQT Life Sciences, DaVita and other existing shareholders also participated.
Matt McNamara, chief investment officer at Horizon 3 Healthcare, said: “The data generated by Xeltis to date has been highly compelling and underscores the potential of aXess™ to transform the haemodialysis access landscape and improve patient outcomes. We are impressed by the company’s strong execution and rapid progress and are proud to support Xeltis as it advances aXess™ through US clinical development and European commercialisation, while continuing to expand its broader pipeline of transformative implants.”
The latest round builds on €50m secured from the European Investment Bank and existing shareholders in 2025.
Xeltis also raised €15m from Chinese pharmaceutical company Grand Pharma in 2022.
Founded in 2006, the company is developing its implants as alternatives to current vascular access treatments and replacement blood vessels and valves.
Xeltis said its technology could also be applied to other major vascular and cardiovascular conditions.
The funding will support the next stage of the company’s clinical, regulatory and commercial plans in Europe and the US.
