According to the European Centre for Disease Prevention and Control (ECDC), 1 in 18 patients in a European hospital acquire Healthcare-Associated Infections (HAIs); infections that occur during the process of care in a hospital/healthcare setting. The root cause of most HAIs is colonisation and formation of microbial biofilms on the surface of medical devices that are in lengthy contact with patients, such as catheters, endotracheal tubes or nasal prongs. These biofilms are not accessible to antibiotics or the patient’s immune system, and are reservoirs and entryways of bacteria to the organism causing life-threatening infections. Prior to the formation of biofilms, bacteria need to attach to the device surface, and then to proliferate on it (colonize). Antimicrobial resistance is extremely serious and has been defined as one of the biggest threats to global health by the World Health Organisation.
Key strategies to tackle HAIs either involves the use of antimicrobial substances or the use of silver (and similar) agents on the surface of medical devices as a preventative measure. The use of antibiotics is complicated by the development of antimicrobial resistance - the ability that some microorganisms (mainly bacteria) acquire to become resistant to antimicrobial agents used for therapy or prophylaxis ; while silver agents are known to release active silver ions in moisture, body fluids, and secretion that are harmful to the body and fast being abandoned for use in most countries. Hence, there is a pressing need for an antibiotic-free preventative measure against HAIs that is both efficacious and safe to use.
CytaCoat has developed a unique, stable and universal antimicrobial coating for prevention of Healthcare-Associated Infections (HAIs) related with the use of invasive and non-invasive medical devices. This strong chemical bond in the antibacterial coating provides stability and prevents the release of components with potential toxic or accumulation effects in the patient. This avoids the use of antibiotics and the ability of bacteria to develop resistance.
The objective of the SME Instrument phase 1 project has resulted in defining a business plan to bring CytaCoat to market in 2020. The feasibility assessment was divided into three sections: 1) Clinical feasibility – defining the CE mark requirements and clinical development plans that roadmap the launch of the product on the market. 2) Market feasibility – identifying the market, product positioning, competitor analysis, optimal pricing, stakeholders (e.g. potential license-taking medical device manufacturing companies) and regulatory landscape. 3) Dissemination and Business Plan Development and Formulation – formulation of the final business strategy, business model and commercialisation plan.
