E!115695/COD15 Antimicrobial coated breakaway variable lumen connector for intravenous therapy

Healthcare associated infections (HAI) represents a major public health problem, both in the economic sense, and measured in the additional patient suffering caused by the infections. HAI is particularly prevalent where invasive medical devices are used, hence hitting the weakest patients the hardest. In USA alone, the Centre for Disease Control has estimated that the direct cost of HAI surpasses 28 billion USD/y. In addition, HAI must be treated with antibiotics, not only prolonging the hospitalization period for the patient, but also driving the global resistance crisis. Amicoat has in the ARCHER project integrated its antimicrobial technology into a medical device manufactured by our project partner with the purpose of reducing the infection risk connected with the application of this device. The integration have taken place through the development of a novel impregnation technology, and Amicoat have assisted its partner through the development of this novel antimicrobial medical device.

Amicoat and Tada have successfully incorporated AMC-109 into the silicone membranes of the ReLink connector forming a new AM-ReLink. The final prototype was using an industrial and scalable method, was subjected to sterilization and performed according to the requirements. If commercialized, the new product may be an important addition to the companies respective portfolios.

AM-ReLink is a highly novel self-sterilising breakaway connector for IV therapy. Our connector consists of two reconnectable parts with double safety valves, to be placed between the IV tube and the catheter, using the standard Luer-Lock fitting. The safety valves and all other surfaces of the connector in contact with the IV fluid are impregnated with our antimicrobial coating technology based on synthetic mimetics of antimicrobial peptides (AMPs). These integrated components will constitute an attractive and unique product for the IV therapy market. For licensing the ARCHER’s project technology, we will target large and specialised multi-national original equipment manufacturers (OEMs), dominants actors in the market primarily based within the EU and the US that offer their solutions to the global medical device marketplace. Target users of AM-ReLink are divided into: healthcare personnel (public and private) delivering IV therapy and the patients receiving it (i.e., 80% of hospitalized patients). AM-ReLink will target the EU and the US markets for IV therapy. Every year more than 1 billion IV catheters are used in Europe and the USA which corresponds to a minimum of 3.8 billion IV tubes. The demand for IV tubes, in our target markets, is expected to grow at an average CAGR of 6.1% from 2016 to 2021 [6]. Factors influencing the growth of the IV market include increasing cases of chronic conditions, aging population, steady rise in surgical procedural volumes and increasing product demand in developing markets. Consequently, we estimate AM-ReLink ’s SAM at €11.4bn for 2020. Within 5 years the Consortium will target up to 3.38% of the market, resulting in sales of 75 million devices by 2029 and cumulative income of €61.4mn. AM-ReLink will take a leading position at a market valued at €33.5bn in Europe and US.