Xeltis, a developer of transformative implants that enable the natural creation of living and long-lasting vessels, has announced 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.
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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.
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, said: “Despite suboptimal performance, 80% of CABG procedures rely on vein grafts – Xeltis has the potential to revolutionise 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.”
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 commercialisation.
Dr Isaac George, surgical director at Columbia University Medical Center, said: “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.”