Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CYTAMED (A unique and universal antibacterial coating for prevention of hospital acquired infections associated with the use of medical devices)

Teaser

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...

Summary

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.

Work performed

CytaCoat defined the gap analysis and all actions to be undertaken, with the help from QAdvis - a quality and regulatory consultant firm. We also contacted a notified body and two CRO’s for setting up a clinical trial. In August 2018, CytaCoat published an article in “Materials Science & Engineering C”. This highlighted the technology as well as the clinical results, demonstrating a significant reduction of bacterial colonisation in vivo. CytaCoat got in contact with several manufacturers of medical devices showing interest in the technology. When one of them wanted to test the technology in their preclinical laboratory, we decided to pause the CE mark of the nasal prongs. All the effort was put into providing the manufacturer with the test material by using the dipping technology.

CytaCoat has performed a global market study, where the business plan is focusing on licensing and royalty income, with the emphasis on the medical devices and market volumes of our potential clients. The turnover from licensing is expected to reach €10M in 2025.CytaCoat also participated at business development events, as for example, the Nordic Venture Forum in Copenhagen. We met with investors mostly in Sweden, with the objective to raise funding for scaling up the company on both Business and Research Development. This is necessary to respond to the increased interest that the company is facing.The feedback was positive and we expect to launch a new issue in the beginning of 2019.

Final results

There is a concerted effort to minimise the use of antibiotics in an effort to tackle the ever-growing problem of multidrug resistance. Furthermore, prevention of infections is preferred over curing after the fact since patients may already have compromised immunity when admitted into hospital. Silver agent coating of medical devices, although promising in efficacy, are a dangerous solution for HAI prevention given the risk of substance leakage. Therefore, the market is primed for the introduction of the CytaCoat technology.

The strategy is to sell the technology and defined protocol to medical device manufacturing companies via out-licensing deals. We aim at signing a first contract in 2019 which will take the technology to market in 2020 or 2021.

CytaCoat avoids the use of antibiotics and the ability of bacteria to develop resistance. It has the potential to redefine the way we coat medical devices. By alleviating the burden of HAIs on the health system, CytaCoat will be an invaluable asset to society.

Website & more info

More info: http://www.cytacoat.com.