aXess graft demonstrated excellent patency, low rates of infection and re-intervention

Data indicates a significant improvement in performance compared to standard hemodialysis access treatment

EINDHOVEN, The Netherlands – 28 April 2023, Xeltis, a developer of transformative implants that enable the natural creation of living and long-lasting vessels and valves, today presents highly-encouraging six-month data from its first-in-human (FIH) aXess vascular graft trial (NCT04898153) at the 13^th Congress of the Vascular Access Society in Porto, Portugal.

aXess is a vascular access graft for patients with chronic kidney disease (CKD) requiring hemodialysis. In six-month data from the FIH trial, the aXess graft demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary patency). At six months, a 0% infection rate and low re-intervention rates were reported, resulting in a highly favorable safety profile. Hemodialysis was successfully performed through the graft, and compared to current standard of care measures, which typically show lower rates of patency combined with a greater risk of infection or rejection, aXess demonstrated extremely promising results.

The full data will be presented by Matteo Tozzi, Professor of Vascular Surgery, University of Insubria, Italy, in a presentation entitled: aXess Vascular Graft – FIH trial 6-month outcomes today at 09:05 WEST.

Professor Matteo Tozzi, principal investigator in Xeltis’ FIH clinical trial said: “These six-month data are very promising in terms of patency and infection rates and suggest that aXess has great potential to be a game-changing alternative to existing vascular access options, which have a number of significant shortcomings. Xeltis’ vascular access implants, which harness the power of the body’s natural healing processes, could play a vital part in significantly improving the lives of patients requiring hemodialysis.”

Eliane Schutte, CEO of Xeltis commented: “We are thrilled to see these initial data from the aXess FIH trial. The aXess graft has the potential to transform the way hemodialysis patients are treated. Current standard of care procedures are associated with high re-intervention and failure rates and we believe aXess has enormous potential to provide surgeons and patients with a safer and more durable treatment option. We look forward to sharing further data as the trial continues in due course.”

The aXess FIH trial is single arm, non-randomized FIH feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after initial procedure, with full study follow-up visits to be conducted at five years. The aXess pivotal trial is currently enrolling in up to 110 patients across up to 25 sites in nine EU countries.

Notes to editors

About Chronic Kidney Disease

Chronic Kidney Disease (CKD) affects nine percent of the population, with growing prevalence due to cardiovascular disease (diabetes, hypertension, obesity). Patients with CKD have a reduced quality of life due to living with significant constraints and restrictions brought on by disease related manifestations and side effects of treatments. Each year, three million patients with chronic kidney disease need hemodialysis and require vascular access to connect to a dialysis machine.

About the aXess pivotal clinical trial

The EU aXess pivotal trial is a prospective multi-center study evaluating the safety and performance of the Xeltis hemodialysis access graft in patients with end-stage renal disease, who plan to undergo hemodialysis and are deemed unsuitable for fistula creation.

About Xeltis

Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels and valves. Xeltis’ devices seek 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 a within and around it, before gradually being absorbed and leaving new, living and long-lasting vessels and valves in place. Xeltis’ devices currently under clinical development include aXess^TM, implantable blood vessels for hemodialysis vascular access; XABG^TM for coronary artery bypass graft (CABG) surgery; and Xplore 2^TM for pediatric pulmonary heart valve replacement. Xeltis’ technology has high potential to be applied to other major vascular and cardiovascular diseases and represents a transformative technology for vascular and valve implants.

Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, and Ysios Capital, as well as Grand Pharma Group and several public and private investors.