Challenge
Coronary bypasses are the most challenging bypasses given their small diameter (3-5 mm) in combination with high blood pressure. The preferred material to be used for coronary bypass surgery are autologous arteries and especially the left internal mammary artery (LIMA) because of its high long-term patency rate. However, in 80% of the cases at least one graft is harvested from the great saphenous vein (GSV), when arterial grafts are not available or provide insufficient length. The use of the GSV for coronary bypasses has the issue that its patency rate declines fast because of tissue degeneration which frequently leads to acute graft occlusion. Similar issues exist when GSV grafts are used in peripheral bypass surgery.
Opportunity
In Europe and the US alone, ca. 1.6 million coronary and peripheral bypass operations are conducted every year. The associated market value for vascular grafts is approximately 1.2 billion euro. Given the lack of sufficient suitable autologous artery material and the long-term patency challenge with using the venous saphenous, there is a clear need for a high performing artificial alternative. With its innovative artificial vascular graft, ArtiFex aims to provide this alternative and address the large and profitable bypass graft market.
Solution
The ArtiFex vascular graft aims to provide a much better alternative to the venous saphenous and synthetic artificial grafts that are currently in use. It is a multi-layered vascular prosthesis consisting of an outer scaffold mesh made of cobalt-chrome with several layers of cellulose on the inside. The patented cellulose layering is fully permeable for selected cells yet blood tight. Preliminary preclinical tests have shown that the graft becomes like a living artery within 4 weeks as cells and small neo-vessels start to turn the scaffold into living tissue. The cellulose layer is antithrombogenic and does not cause any immune reaction. It targets a high patency rate similar to an artery and better than vein grafts. The graft shows comparable elasticity and burst strength to arteries of a similar diameter. Can be produced well in advance and can be stored at room temperature, ready off the shelf use (no seeding or cell expansion needed).
Status
Extensive patent portfolio with granted patents in numerous regions (including EP, US and China) some additional patents pending. Small scale manufacturing established. Two one month in-vivo studies showed very promising results. A large scale and long-term animal study will start toward the end of 2020.
Meet the team
Associate Professor Dr Bernhard Winkler
Inventor
Cardiovascular/Thoracic Surgeon Associate Professor in cardiac surgery
Prof. Friedrich Eckstein
Inventor
Cardiac Surgeon Professor in cardiac surgery University Hospital Basel
Edmund White
CEO
Medical technology leader with extensive progressive global sales, marketing, clinical and operating experience across both large and small companies in medical technology and contract research organizations at VP and European management levels. Commercialized multiple Class III cardiovascular medical devices both within start-up (Endosense) and global strategics (Medtronic & Biotronik). Two exit strategies Endosense ($350m) to Abbott (St Jude Medical) two years after commercialization & Admedus sales & EU distribution arm to Le Maitre ($15min) four years after CE approval. Led a team of medical device professional working on many Class III cardiovascular clinical projects for sponsors supporting the regulatory process and guiding/helping clients towards the right pathway. Built strong working relationships with worldwide leading KOLs in supporting the adoption of new cardiovascular technologies during my tenure at Biotronik, Endosense & Admedus.
Alessandro Radaelli
Venture partner at NLC
Alessandro joined NLC in April 2022 and brings over 20 years of experience in the MedTech industry. His passion lies in translating clinical needs into meaningful solutions, building purpose-driven 'tribes' of early adopters and taking impactful innovations from idea to business realisation. He has lived in four European countries and has travelled to more than 20 countries with great curiosity for healthcare systems, and the local food culture.