Globally in 2030, ~5.4 m people with end-stage kidney disease (ESKD) rely on lifesaving kidney replacement therapies. ~68% of these ESKD patients depend on haemodialysis to stay alive. To transport blood to the dialysis machine and vice versa, haemodialysis requires a high-flow vascular access site. The current standard is a surgically created arteriovenous fistula (AVF), a connection in the patient's arm between a major artery and a vein.
However, haemodialysis access is fraught with debilitating side effects. Common complications include loss of access patency, heart failure, compression bleeding risk, steal syndrome and aneurysm. The source of these complications lies in the continuously high blood flow in the access conduit. The complications lead to recurrent surgeries (averaging around ~1.5 surgeries per year), mean costs at USD ~15 k per patient annually, and a profound reduction in patient quality of life.
Current vascular access solutions address only a small part in the spectrum of complications. We set us apart from other vascular access solutions by tackling the core issue of vascular access: the continuous high blood flow. Our revolutionary and novel device connects the artery and vein only during dialysis. At all other times it is closed, and normal circulation is restored. Our device, the Dynamic AVF will set the new gold standard for haemodialysis, by allowing the high blood flow only when needed and thus reducing complications.
We have proven functionality of our device in an in vivo goat model and are now starting biological impact assessments as part of an early-stage de-risking program. In parallel, we are continuing development of our prototype, and target first-in-human testing by 2026. Following a structured medical device development process, we aim to secure regulatory approval in both the US and Europe and to enter these markets in 2029, with the appropriate investments and workforce in place.
An experienced and ambitious international team from the fields of nephrology (prof. dr. Joris Rotmans), vascular surgery (dr. Koen van der Bogt), medical device engineering and design (ir. Nick White and ir. Ruairi Duffy), clinical research (em. prof. dr. Adam Cohen) and business development (ir. Toon Stilma and Alexandra Klijn), supported by a high-profile advisory board (prof. dr. Jeffrey Lawson, prof. dr. Robert Robbins, ir. Koen Besteman and ir. Tim Horeman) and in collaboration with industry partners, is ready to start the venture and build on the ground-breaking academic work.