Xeltis Achieves Breakthrough FDA Status and Begins Pivotal Trial in US

Deal News | Nov 14, 2024 | Ysios Capital

Xeltis, a medtech company based in the Netherlands and the USA, announced that its vascular access device, aXess, has received Breakthrough Device Designation from the US FDA's Center for Devices and Radiological Health. This recognition marks a significant milestone, as aXess is designed to create a permanent, living vessel for hemodialysis vascular access. The designation facilitates accelerated interactions with FDA review teams and expedited market access, indicating aXess's potential to significantly improve patient care by reducing complications like infections and reinterventions. Concurrently, Xeltis has treated the first patient in its pivotal US trial at the Flow Vascular Institute in Houston, Texas, under the supervision of Dr. Karl Illig. With promising early data from European studies, and support from significant investors such as DaVita Venture Group and Ysios Capital, Xeltis is poised for rapid advancement towards commercialization, which crucially for patients means enhanced access to more effective therapies for renal disease.

Sectors

Medical Devices
Healthcare

Geography

United States – The FDA Breakthrough Designation and the pivotal trial for aXess are centered in the US, involving treatments and validations crucial for market entry.
The Netherlands – Xeltis' headquarters are located in the Netherlands, indicating its operational base and part of its research footprint.

Industry

Medical Devices – The article focuses on Xeltis, a company developing transformative vascular implants, which falls under the Medical Devices sector.
Healthcare – Xeltis' advancement with its aXess device represents significant implications in the healthcare industry, particularly in improving vascular access for dialysis patients.

Financials

Participants

Name	Role	Type	Description
Xeltis	Target Company	Company	A medtech company developing transformative implants for vascular and cardiovascular applications.
Ysios Capital	Investor	Company	A venture capital firm investing in the life sciences field, and a stakeholder in Xeltis.
The Food and Drug Administration (FDA)	Regulatory Body	Government	The US government agency providing regulatory oversight, granting the Breakthrough Device Designation to aXess.
Flow Vascular Institute	Clinical Trial Site	Company	The institute in Houston, Texas, where the first US patient was treated as part of Xeltis' pivotal trial.
Dr. Karl Illig	Site Principal Investigator	Person	Vascular Surgeon leading the initial US clinical trials for Xeltis' aXess device.
Dr. John Lucas III	National Principal Investigator	Person	Surgeon overseeing the pivotal US trial for aXess, providing strategic guidance and oversight.