Problem Approx. 50% of all patients with severe blood stream infections die from the infections, while the remaining 50% incur excessive socio-economic expenses from prolonged hospital stays. In fact, the fourth largest cause of death in the western world is hospital and care acquired infections, most often caused by urinary catheters. Present state-of-the-art, measuring the temperature of a patient, indicates if the patient has an infection, but with approx. 2-3 days delay, and with many possibilities for false positives (increasing temperature can mean other things than infection). Solution The innovation, the Bacticon Catheter, is a catheter impregnation technology based on a new biosensor/biomarker principle based on biomarkers, bio-nanoparticles and nano-channels in a new hybrid material, allowing for an immediate detection. The system is an add-on to existing catheters and is therefore cost efficient and face a faster route through approval procedures, providing much more precise and real-time monitoring. Project The project has three objectives: 1: Technological feasibility study: Verify and adjust an integrated prototype 2: User feasibility study: Verify the product need by conducting a market and user study, a product innovation strategy, partner search, feasibility of concept, benchmarking with other products and a go-to-market strategy. 3: Economical feasibility study: Analyse the economical sustainability of the product Business model The innovation is well suited to be commercialised through the sales and marketing channels of a med-tech company, which is already established in the market place, and where the Bacticon Catheter can be integrated in the existing product portfolio of such med-tech company. BioModics is pursuing this option as priority one. Market The dominating markets are the American market with a 547 M€ urological catheter revenue and Europe with 615 M€. Increasing growth rates are expected, especially in Asia, Europe and US.

Congenital Heart Diseases (CHD) are the most common type of birth defect, affecting more than 1,400,000 newborns annually. About 40% of these children need a stent treatment before they are fully grown, however there is no specific treatment for pediatric patients. The current standard of care is the off-label use of permanent stents designed for adults which is heavily affected by Foreign Body Reaction (FBR), stent migration and breakage. This leads to a high risk of patient mismatch, severe adverse events, high rate of re-interventions and high treatment costs. The StealthStent consortium is developing the world’s first stent explicitly designed for treating CHD in children. The StealthStent is made of an absorbable material that dissolves in 6 months allowing vessel growth and it is coated with a zwitterionic polymer-based coating that prevents FBR. The potential benefits of StealthStent resorbable stent are significant for adults thanks to its enhanced performance against FBR and decreased need for re-interventions. During this project, we will optimise the stent design to improve its radial force for adjusting it to the several types of CHD. We will optimise a zwitterionic polymer which was developed in the former FET-Open Project STARDUST and validated to address FBR but not yet absorbable. The polymer will be applied to an absorbable stent, which for the first time, could solve the unmet growth problem of current stents for children and significantly improve the standard of care for adults. Based on results obtained so far and on the planned development, we expect the StealthStent will reduce the risk of FBR, breakage, and migration to ≤5%. The coated stent will be tested in vitro and in vivo, resulting in a TRL 5 by the end of the project. Simultaneously, we will further develop and constantly update a business plan to outline the roadmap until market entry and we will further develop our go-to-market strategy.

Central venous catheters (CVCs) play a critical role in healthcare and few medical devices are more important and widespread in modern medicine. Catheter-related bloodstream infection (CRBSI) is the most common life-threatening complication of CVCs. Reducing the risk of CRBSI among patients would save costs, reduce length of stay and improve mortality and morbidity. The major challenge of UNICAT is thus to develop a new CVC solution to prevent infection and thrombosis. The project partners will introduce a whole new way of thinking by introducing a disruptive approach which is more than just a coating of devices. A new material will, for the first time, combine ultra-biocompatibility with chemical resistance and desired mechanical properties, to effectively prevent adverse host response, inflammation and infection. A major problem in biomaterials science is that bioresistant materials are inevitably also chemically inert and hence highly difficult to manipulate by traditional wet chemistry. If manipulation (e.g. coating) is achieved, the solution is often unstable and fragile. UNICAT will address this problem by combining two materials using a novel method based on super critical CO2-chemistry. It will result in a hybrid material which is stably formed and combines the best properties of two or more materials. The success criterion is to exceed performance of coatings by producing the first fully biocompatible material to be used as sole robust bulk material of vascular access lines. UNICAT is an international and inter-sector collaborative project comprising R&D activities and secondments between the SME BioModics (BM), the University of Minho (UMinho), the Bar-Ilan University (BIU) and the Simula Research Laboratory (Simula). The consortium has identified the RISE programme as a suitable vehicle for overcoming the identified major challenges and for bridging the knowledge gap, while helping to overcome the financial, technological and intersectoral barriers.