#Xeltis #aXess #Eindhoven #The Netherlands #Hemodialysis

Xeltis: Pioneering Innovations in Hemodialysis Treatment

Xeltis, a leading developer specializing in transformative medical implants, has made significant strides in the field of vascular access for hemodialysis treatments. The company has recently unveiled outstanding results from its aXess EU pivotal trial, a comprehensive study focused on the safety, performance, and patency of its restorative vascular access conduit.

The aXess EU Pivotal Trial

Conducted across 18 locations throughout the European Union, the trial aimed to evaluate the aXess technology in adult patients suffering from end-stage renal disease, necessitating vascular access for hemodialysis. The results have shown robust enhancements in all critical clinical metrics when compared to standard treatment options. Notably, aXess has demonstrated remarkable sustained patency rates, indicating superior long-term effectiveness in maintaining blood flow compared to conventional arteriovenous grafts (AVG).

Key Findings of the Trial

The trial revealed several key improvements:

• - Higher Sustained Patency: aXess outperformed both primary and secondary outcomes significantly, leading to a notable reduction in the need for additional interventions, which is a common necessity with traditional AVG options.
• - Lower Complication Rates: The technology exhibited an impressive reduction in re-intervention rates and maintained a high resistance to infections relative to traditional fistulas.
• - Enhanced Patient Experience: Many participants had faced challenges with prior AVG failures or had dependencies on Central Venous Catheters (CVCs), which further emphasizes the impact of aXess in addressing the needs of high-risk patients.

Eliane Schutte, CEO of Xeltis, expressed her excitement regarding these findings, stating, "This trial validation reinforces our confidence in aXess as the future of hemodialysis vascular access treatment. With its excellent performance on all fronts and being PFAS-free, we are now ready to advance to the next stage, making this technology accessible to those in need."

Collaborative Efforts and Future Directions

The success of the trial was made possible through the dedicated efforts of numerous individuals, from Xeltis' scientists who developed the aXess technology to the clinical professionals and patients who participated in the study. Paulo Neves, Chief Medical Officer, emphasized the importance of collaboration, stating, "This moment is transformative for Xeltis, and we anticipate building upon this momentum as we strategize our commercial pathway.”

An De Vriese, the Coordinating Investigator of the trial and Head of Nephrology at AZ Sint-Jan in Brugge, highlighted the technology's potential, remarking, "Xeltis' technology is truly transformative and heralds a new chapter in sustainable treatment options for patients needing vascular access for hemodialysis."

The ETR Platform Technology

At the core of aXess is Xeltis' proprietary Endogenous Tissue Restoration (ETR) platform, which integrates groundbreaking advancements in polymer technology. This innovative approach allows the implant to be gradually substituted by the patient’s own living tissue, dissolving completely in the process. The clinical safety profile of aXess is unmatched, with only one cannulation-related (partial) explant recorded amongst over 120 patients, paving the way for safe patient procedures.

With just a 0.02% rate of bleeding complications throughout more than 15,000 dialysis sessions, aXess showcases an unprecedented safety and efficacy profile compared to existing treatments. This remarkable technology is not just limited to hemodialysis; it holds great promise for the future management of other major vascular and cardiovascular diseases.

Looking Ahead

As Xeltis prepares to transition towards commercialization, there is also a concurrent pivotal trial underway in the United States, with interim results expected in 2026. This exciting journey signifies a substantial leap forward in addressing the needs of millions of patients requiring hemodialysis access every year.

For more information, please visit Xeltis' official website.

In conclusion, Xeltis is set to disrupt the medical landscape with cutting-edge solutions that improve patient outcomes and redefine standards of care in hemodialysis.