Medical Device Companies to Watch: Xeltis Receives IDE Approval for Initiation of US Pivotal Trial of aXess Restorative Vascular Graft

Xeltis, a pioneering company in restorative vascular graft technology, has announced that it has received an Investigational Device Exemption (IDE) approval from the FDA to initiate a pivotal trial for its aXess vascular graft in the United States. This marks a significant milestone in the development of Xeltis’ innovative solutions aimed at improving treatment outcomes for patients requiring vascular access for hemodialysis.

Analyst Insights: Transformative Technology for Dialysis Patients

Xeltis’ aXess vascular graft is designed to provide a restorative, biocompatible solution for patients who need vascular access for hemodialysis. This technology aims to address the limitations of current options by offering a conduit that can support the body’s natural healing processes and ultimately become a living, self-healing vessel. The aXess graft’s unique design and functionality have the potential to significantly enhance the speed and quality of treatment for dialysis patients.

Hemodialysis is the gold-standard treatment for patients with end-stage renal disease (ESRD). Approximately 100,000 people in the US initiate hemodialysis each year, and over 600,000 patients currently rely on this life-saving procedure. However, traditional methods of vascular access, such as central venous catheters (CVC), have become increasingly popular due to their ease of use and rapid deployment. Despite this, CVCs come with higher risks of infection and other complications.

Xeltis’ aXess vascular graft aims to bridge this gap by providing a safer, more effective alternative that can quickly establish vascular access while reducing the associated risks. This innovation is poised to make a substantial impact on the lives of hundreds of thousands of dialysis patients in the US.

Currently, Xeltis has three clinical-stage products in development, with its vascular conduit being the furthest along in the pivotal stage. With over 600,000 dialysis patients in the US, the market potential for Xeltis’ aXess graft is substantial. The company’s ability to develop a biocompatible, restorative solution that can integrate with the body’s natural healing processes sets it apart in the medtech market.

More on Xeltis

Xeltis is backed by a strong syndicate of medical device venture capital investors and strategic investors. In August of 2023, the company added an additional €12.5 million in funding from the European Innovation Council (EIC) Fund, extending their Series D2 financing round to €44.5 million. The investor syndicate includes Grand Pharma, DaVita Venture Group, EQT Life Sciences, Invest-NL and other international investors.

Xeltis is one of the 150+ emerging medical device companies selected to present at LSI Europe ‘24 this September 16th to 20th in Sintra, Portugal. This premier medtech conference will convene hundreds of medtech companies like Xeltis alongside top medical device investors, global strategics, and more.

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