Xeltis Receives FDA IDE Approval for Regenerative aXess Vascular Graft in Hemodialysis Access

Jun 13, 2024 22:15 CST Updated 22:15

Xeltis

Cardiovascular Treatment and Repair Device Developer

Investment in the distanceXeltisAnnouncing its renewable artificial blood vesselaXessApproved by the FDA for IDE research.

Executive Evaluation

"We have already showcased the outstanding 12-month data from our first-in-human study in Europe, and we are looking forward to initiating this pivotal trial in the United States.We are very proud that aXess has the potential to transform the vascular access landscape by halting reinterventions and infections, bringing our unique restorative solutions to hemodialysis patients worldwide.。”

---Eliane Schutte CEO of Xeltis

"Our focus is on improving outcomes for dialysis patients. aXess offers this potential by avoiding reinterventions and complications associated with other vascular access solutions. This pivotal study is important for evaluating and demonstrating that, marking a significant milestone in our U.S. clinical strategy."

---Paulo Neves Chief Medical Officer of Xeltis

FDA ApprovalaXessConduct clinical research (IDE), primarily based onXeltisData from the aXess FIH clinical study conducted in Europe.aaXess FIH Clinical Study RequirementsRecruit up to 110 patients across 25 centers in 9 EU countries. Last yearXeltisPreliminary data from the aXess FIH study presented at VEITH2023 showaXessExcellent Clinical Outcomes

aXess FIH Study Data (First 20 Patients) Shows:

In December,The secondary patency rate is100%、The primary patency rate is78%, infection rate is 0;

To date, these patients have undergone more than 3,500 dialysis sessions.

aXessExcellent clinical data gives hope to dialysis patients and doctors, and also to the FDAaXessClinical and social value, thus gaining FDA approval for IDE research.

aXess

aXessIs a used forRestorative synthetic electrospun blood vessels for arteriovenous hemodialysis access, over time, transform into autologous vessels identical to the patient's own natural blood vessels.

aXessPrepared by electrospinning technology, it thus possesses a dense porous microstructure. Thanks to these porous microstructures, the patient's own tissue can quickly fill into them and eventually form a "living" blood vessel (identical to the patient's own blood vessels).

aXessThe technology adopted is called: Endogenous Tissue Restoration (ETR). ETR is a new treatment method that enables the patient's own body to naturally regenerate new blood vessels or heart valves.

ETR is throughXeltisThe porous structure of the products is made possible by biodegradable polymers, whose base material is developed using Nobel Prize-winning technology.

Application of ETR Technology,XeltisNot limited toaXess, currentlyXeltisIt has been extended to the pulmonary valve, aortic valve, and coronary artery bypass grafting (CABG).

aXess Demonstration

Xeltis

XeltisXeltis AG is a clinical-stage medical device company developing the most advanced polymer-based cardiovascular therapeutic repair devices.XeltisThe repair devices include those used for coronary artery bypass grafting surgery and blood dialysis vascular access, heart valves, and small-diameter blood vessels.

XeltisIt was formed by the merger of two enterprises incubated by Dutch/Swiss universities and currently operates in the Netherlands and the United States.