SARASOTA, Fla. (Oct. 16, 2025) – People living with end-stage kidney disease require safe and dependable hemodialysis access. Common complications with existing dialysis access include infections, blood clots, and stenosis (narrowing of blood vessels). Sarasota Memorial’s Kolschowsky Research and Education Institute is now exploring a new treatment option in a clinical study aimed at providing a safer, more reliable access point for dialysis patients.
Led locally by vascular surgeon Jason Wagner, MD, the multi-center study sponsored by Xeltis is testing the safety and effectiveness of aXess, a restorative vascular access conduit. Developed using Xeltis’ proprietary Endogenous Tissue Restoration platform, which utilizes Nobel-prize winning breakthroughs in polymer technology, aXess is designed to safely integrate with the body. Over time, natural healing allows the patient’s own tissue to regenerate before gradually being absorbed and replaced, thus forming a new, natural, and long-living blood vessel. Over the course of the process, the aXess conduit dissolves completely, leaving behind a natural, stronger dialysis access point, comprised of the patients’ own cells and vascular tissue.
The study will enroll up to 140 patients at 20 sites. Eligible participants are 18 years or older, have end-stage kidney disease, are expected to need dialysis within the next six months, and are suitable for placement of an aXess conduit. Recent clinical results have showed aXess delivers major improvements on all key clinical metrics compared to the standard of care, including superior sustained patency and fewer interventions.
For more information or to find out if you are eligible to participate in the local study, contact the research team at (941) 917-2225 or researchinstitute@smh.com. For information about the trial, click here.
About the Kolschowsky Research and Education Institute
Located on the flagship Sarasota Memorial Hospital-Sarasota campus, the Kolschowsky Research and Education Institute serves as a premier hub for medical research and clinical innovation. With dedicated space for research, clinical innovation and graduate medical education, the Kolschowsky Institute provides a collaborative learning environment for physicians, nurses, researchers and students studying new treatments and mastering the latest tools and techniques in patient care. Through state-of-the-art simulation labs, hands-on training programs, and a robust portfolio of clinical studies, Sarasota Memorial and the Kolschowsky Institute play a vital role in advancing medical knowledge, improving patient outcomes, and shaping the future of healthcare in the region. For more information, click here.
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 aXessTM, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. For more information, click here.