Peripheral and central venous catheters (PVC and CVC) are among the most widely used medical devices in hospitalized patients, with about 1 billion PVC and 10 million CVC being used annually worldwide. Despite implementations of in-hospital measures, catheters are often subject to infection (2-10%) and thrombotic (20-40%) complications, which result in longer hospitalization stay, higher health care costs, or even death. Our research team has developed an innovative bioactive coating that could potentially prevent these complications by conferring anti-infectious and anti-thrombotic properties to coated catheters. Our project provides first proof-of-concept that this coating can be applied to venous catheters. We succeeded to load our coating with a FDA-approved anti-bacterial and anti-thrombotic drug substance and to coat both external and internal surfaces of catheter tubing made of widely used medical-grade polyurethane. We demonstrated progressive release of the drug substance from coated catheter surfaces. Our coating did not induce any toxicity when put in contact with blood. Besides these achievements, the project principal investigator and his main collaborator have founded a spin-off company (CMD-COAT S.A.) with the aim to bring the product on the market. A first market study has been realized, which indicated steadily increasing growth rates for global catheter and coated catheter markets as well as a predominance of coated venous catheters, US geographical segment while Europe has around one sixth of the market. An industrial development plan has been generated with the help of a company specialized in quality management and regulatory affairs. Contacts with industrial partners have been initiated to help evaluating most appropriate business model possibilities. Hence, all this confirmed that the CMD-COAT product is a highly valuable solution to an unmet medical need, with a high market potential. The main goals of the project have been fully achieved.
