Study Reveals Positive Results for Xeltis’ Coronary Artery Bypass Conduit

Xeltis is sharing 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 biorestorative, polymeric conduit that 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. 

“Xeltis is pushing the boundaries of innovation in vascular access solutions,” Dr. Isaac George, surgical director at Columbia University Medical Center, said. “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.”

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 European sites 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, according to the company. With no approved off-the-shelf, small-diameter vascular grafts with good patency rates available, Xabg could potentially 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.

“Despite suboptimal performance, 80% of CABG procedures rely on vein grafts and Xeltis has the potential to revolutionize that,” Xeltis Chief Medical Officer Paulo Neves stated. “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 enrollment and treatment.”

The single arm, human feasibility study in Europe 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 Europe and the United States.

Xeltis is 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 annually. The company’s proprietary endogenous tissue restoration (ETR) platform utilizes an advanced polymer implant that 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, an implantable blood vessel for hemodialysis vascular access. Xeltis’ technology could potentially be applied to other major vascular and cardiovascular diseases.  

Xeltis is based in The Netherlands and United States. 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.

Reference
ⁱ Coronary Artery Bypass Graft Market Growth 2025 to 2035