CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to commercializationaXess™ reduces the need for vascular access interventions enabling more streamlined kidney care delivery EINDHOVEN, The Netherlands, April 21, 2026 (GLOBE NEWSWIRE) — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces that it has received the CE mark for aXess™, its restorative vascular access conduit for hemodialysis treatment, marking a significant regulatory milestone and the Company’s transition from a clinical-stage to a commercial-stage organization. The CE mark was granted following evaluation of all data including Xeltis’ European clinical pivotal trial results and was achieved in just 84 working days from submission, well ahead of schedule, reflecting the strength and completeness of the clinical evidence package. Built on Nobel Prize-winning science, aXess™ leverages Restorex™ materials, which triggers the body’s natural healing response to transform into the patient’s own tissue to form a living vessel for reliable vascular access. aXess™ is designed to reduce long-term catheter dependence and access issues – helping shift the hemodialysis journey for patients with end-stage kidney disease from repeated interventions toward more seamless care delivery and improved quality of life. Achieving CE mark approval represents a pivotal commercial inflection point for Xeltis, signaling the transition from clinical validation to market entry. The successful and timely completion of the CE marking process serves as a clear signal to clinicians, investors and strategic partners of the product’s readiness for real-world use. With CE marking in place, Xeltis can commercialize across European markets, enabling clinicians to confidently deploy aXess™ and allowing patients to benefit from an innovation that meets high standards of safety, performance and clinical evidence. Eliane Schutte, Chief Executive Officer of Xeltis, commented: “Receiving CE mark approval for aXess™ is a defining moment for Xeltis and a strong validation of our revolutionary restorative technology platform and the outstanding dedication of the entire Xeltis team. For patients undergoing hemodialysis, this milestone means we can offer a more reliable, long-lasting access option that can improve quality of life while reducing the burden of ongoing procedures. Achieving CE mark in just 84 working days underscores the strength of our clinical data and marks our transition from a clinical-stage company to a commercial organization.” Steve Phillips, Chief Strategy Officer of DaVita, said: “At DaVita, we’re committed to advancing technologies that meaningfully improve outcomes and elevate the care experience for people living with kidney disease. This milestone for Xeltis represents meaningful progress toward better clinical results and a more patient centered care experience.” Fred Colen, Chairman of the Board of Xeltis, added: “The Xeltis Board of Directors is very pleased with the performance of the Xeltis team under the leadership of CEO Eliane Schutte, to deliver on the promise of the exceptional Xeltis Technology Platform, to obtain the European CE Mark approval in record time, under the stringent European MDR regulations. Approval to start commercialization for its first application, access for dialysis patients addressing key limitations of existing treatment options in clinical use, is further testament to the promise of this technology.” Ferdinando Lamagna, Spokesperson at The British Standards Institution said: “At BSI, it is a pleasure to support MedTech organizations that bring meaningful innovation to the sector and ultimately benefit patients. Xeltis demonstrated a high level of preparation and a collaborative approach throughout the conformity assessment process, which progressed in an efficient and well-structured manner, with effective coordination between the parties. As a result, certification of this Class III implantable device was achieved within a notably short timeframe, taking into account the scope and complexity of the assessment, including a full Clinical Evaluation Consultation Procedure per MDR Article 54. We congratulate the Xeltis team on this important achievement and look forward to continuing our collaboration to support innovation in patient care.” The Xeltis team will be presenting its 12-month data at The 48th Charing Cross Symposium, London, UK, from 21-23 April 2026. Contacts XeltisEliane Schutte, CEOAlexander Goemans, CFOinfo@xeltis.com Optimum Strategic CommunicationsNick Bastin, Eleanor Cooper, Aoife Minihan +44 (0) 208 078 4357xeltis@optimumcomms.com   About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary Restorex™ platform utilizes an advanced polymer implant which regenerates the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place. Xeltis’ most advanced product currently under commercial development is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: https://xeltis.com/