Xeltis announces positive data for Xabg, its coronary artery bypass conduit, in EU clinical trial

• Preliminary clinical data from Xabg, Xeltis' coronary artery bypass conduit (CABG), demonstrating positive safety and patency
• In an earlier, separate trial, Xabg recently demonstrated patency with excellent flow in a 24-month trial – the first time ever this duration has been achieved
• Supports potential of Xabg to transform CABG surgery landscape and eliminate need for vein harvesting

EINDHOVEN, Netherlands, 17 July 2025 /PRNewswire/ -- Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces encouraging preliminary data for Xabg, its coronary artery bypass conduit (CABG), demonstrating positive safety and patency among patients with multi-vessel atherosclerotic coronary artery disease.

Xabg is a novel, biorestorative, polymeric conduit which enables continued blood flow in coronary artery disease patients. Developed using Xeltis' proprietary Endogenous Tissue Restoration (ETR) platform based on Nobel Prize winning polymer technology, Xabg has unique regenerative properties, enabling living tissue to replace it over time.

Cardiovascular disease is the leading cause of mortality globally, with coronary artery bypass surgery being the most common cardiac surgery performed worldwide. CABG is an invasive procedure, often requiring multiple painful vein grafts with a high risk of complications. The global CABG market is projected to reach more than $20 Billion by 2035, driven by the growing prevalence of cardiovascular disease[i].

A clinical trial is underway at various sites in the EU with positive, preliminary data demonstrating Xabg to be functioning well with excellent flow in patients. This underscores the potential of Xabg to eliminate the need for vein harvesting and transform the bypass surgery landscape with the goal of longer-term durability. With no approved off-the-shelf, small-diameter vascular grafts with good patency rates available, Xabg has the potential to address this large unmet clinical need of suboptimal conduits in bypass surgery.

In an earlier trial, Xabg recently demonstrated patency after bypass surgery in a patient with excellent flow in a 24-month follow-up, marking the first time any artificial bypass surgery conduit has remained open and functional in humans for this duration. This clinical example provides continued validation of Xeltis' ETR scientific technology in action, redefining the landscape of vascular grafts and solutions.

Paulo Neves, Chief Medical Officer, Xeltis, commented: "Despite suboptimal performance, 80% of CABG procedures rely on vein grafts – Xeltis has the potential to revolutionize that. The encouraging safety and patency data is a major milestone for Xeltis and demonstrates that Xabg has the potential to significantly improve outcomes for patients with coronary artery disease. We are grateful to all those involved in the trial and look forward to continuing patient enrolment and treatment."

Dr Isaac George, Surgical Director at Columbia University Medical Center, added: "Xeltis is pushing the boundaries of innovation in vascular access solutions. The recent 24-month follow-up data is remarkable, the first of its kind to remain open at 24 months and demonstrate excellent flow. This, combined with the safety and patency results in Europe, underscores the potential of Xabg to improve long-term outcomes, reduce the need for reinterventions, and significantly impact patient care and healthcare costs."

The single arm, human feasibility study in the EU will evaluate the preliminary safety and performance of the Xabg technology in patients with multi-vessel atherosclerotic coronary artery disease who are scheduled to undergo elective coronary artery bypass (CABG) surgery.

Xabg is Xeltis' second product in clinical development, following aXess, its restorative vascular access conduit, for which pivotal trials are underway in the EU and US, showcasing the strength of the Company's clinical pipeline as it advances towards commercialization.

About Xeltis

Xeltis 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 endogenous tissue restoration (ETR) 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 clinical development is aXess^TM, 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/

[i] Coronary Artery Bypass Graft Market Growth 2025 to 2035