Periodic Reporting for period 1 - Coati-X (New generation of bioactive coating for intravenous catheters and implantable medical devices to prevent infections and thrombosis)
Berichtszeitraum: 2024-04-01 bis 2025-03-31
Hospital-acquired infections (HAIs) represent one of the most pressing challenges in modern healthcare, with significant implications for patient safety, healthcare costs, and antimicrobial resistance. The widespread use of implantable and insertable medical devices (MDs) such as catheters, valves, and stents has revolutionized the treatment and diagnosis of patients, but it also introduces a high risk of microbial contamination. In intensive care units (ICUs), up to 37% of patients acquire infections during their stay, primarily due to devices like central venous catheters (CVCs). These infections, particularly when leading to sepsis, are associated with mortality rates approaching 20% and impose a significant economic burden on healthcare systems, averaging €30,000 per case.
Antibiotic resistance compounds this issue. As resistant bacterial strains proliferate due to misuse and overuse of antibiotics, effective treatment options become increasingly limited. This problem is not only clinical, but also political and strategic. It is addressed in EU and global frameworks, including the One Health Action Plan, WHO’s Global Action Plan on AMR.
Catheters, the most widely used MDs by volume, are particularly prone to bacterial adhesion, biofilm formation, and protein adsorption, which can lead to both bloodstream infections (incidence up to 9%) and thrombosis (up to 18% in ICU or oncology patients). Yet, no current technology offers a combined, long-lasting antithrombotic and antimicrobial solution with localized delivery, capable of preventing both infection and clot formation at the source.
Our project directly addresses this unmet medical and societal need. We have developed CMD-COAT(TM), a unique, patented bioactive coating based on a multilayered nanogel system. This coating can be applied to a broad range of MDs (e.g. CVCs, pacemakers, heart valve prostheses). The nanogels are crosslinked and can be loaded with multiple active pharmaceutical ingredients (APIs) with antibacterial and antithrombotic properties. The coating ensures a sustained and controlled release over 30 days, while its hydrophilic surface inherently resists adhesion and fouling. This makes CMD-COAT(TM) an all-in-one, preventive barrier against two of the most life-threatening complications associated with MD use.
The overall objective of the project is to bring this breakthrough technology to the medical market through accelerated technological development, preclinical validation, and strategic market readiness. Our consortium brings together CM4Cure, a research team integrating experts in biology, chemistry and cardiovascular medicine (including clinical partners at the University Hospital of Liège), and SCIENCE & STRATEGY SL, a company with proven expertise in innovation management, regulation, and business development in the health and biotech sectors.
In terms of impact pathway, we aim to:
• Validate CMD-COAT(TM) in relevant preclinical models to demonstrate efficacy and safety;
• Engage early with regulatory authorities to define a feasible approval path;
• Develop partnerships with manufacturers and hospitals to facilitate integration into clinical practice;
• Contribute to the reduction of HAIs and thrombosis cases in critical care, ultimately reducing mortality and healthcare costs;
• Support global efforts in fighting antimicrobial resistance by offering a non-antibiotic, preventive solution.
By setting a new standard in medical device safety, CMD-COAT(TM) has the potential to protect thousands of patients, save millions in healthcare costs, and support global goals for safer, more sustainable healthcare systems.
Antibiotic resistance compounds this issue. As resistant bacterial strains proliferate due to misuse and overuse of antibiotics, effective treatment options become increasingly limited. This problem is not only clinical, but also political and strategic. It is addressed in EU and global frameworks, including the One Health Action Plan, WHO’s Global Action Plan on AMR.
Catheters, the most widely used MDs by volume, are particularly prone to bacterial adhesion, biofilm formation, and protein adsorption, which can lead to both bloodstream infections (incidence up to 9%) and thrombosis (up to 18% in ICU or oncology patients). Yet, no current technology offers a combined, long-lasting antithrombotic and antimicrobial solution with localized delivery, capable of preventing both infection and clot formation at the source.
Our project directly addresses this unmet medical and societal need. We have developed CMD-COAT(TM), a unique, patented bioactive coating based on a multilayered nanogel system. This coating can be applied to a broad range of MDs (e.g. CVCs, pacemakers, heart valve prostheses). The nanogels are crosslinked and can be loaded with multiple active pharmaceutical ingredients (APIs) with antibacterial and antithrombotic properties. The coating ensures a sustained and controlled release over 30 days, while its hydrophilic surface inherently resists adhesion and fouling. This makes CMD-COAT(TM) an all-in-one, preventive barrier against two of the most life-threatening complications associated with MD use.
The overall objective of the project is to bring this breakthrough technology to the medical market through accelerated technological development, preclinical validation, and strategic market readiness. Our consortium brings together CM4Cure, a research team integrating experts in biology, chemistry and cardiovascular medicine (including clinical partners at the University Hospital of Liège), and SCIENCE & STRATEGY SL, a company with proven expertise in innovation management, regulation, and business development in the health and biotech sectors.
In terms of impact pathway, we aim to:
• Validate CMD-COAT(TM) in relevant preclinical models to demonstrate efficacy and safety;
• Engage early with regulatory authorities to define a feasible approval path;
• Develop partnerships with manufacturers and hospitals to facilitate integration into clinical practice;
• Contribute to the reduction of HAIs and thrombosis cases in critical care, ultimately reducing mortality and healthcare costs;
• Support global efforts in fighting antimicrobial resistance by offering a non-antibiotic, preventive solution.
By setting a new standard in medical device safety, CMD-COAT(TM) has the potential to protect thousands of patients, save millions in healthcare costs, and support global goals for safer, more sustainable healthcare systems.
During the reporting period, the project achieved several key technical and scientific milestones that significantly advanced the development and readiness of the CMD-COAT(TM) technology for medical device applications:
- Industrial-scale production of CMD-COAT constituents: The main component of the CMD-COAT bioactive coating technology was successfully synthesized and demonstrated in an industrial environment, confirming the scalability and manufacturability beyond the laboratory setting.
- Coating of medical devices: Coated central venous catheters (CVCs) were coated using our proprietary CM-COAT(TM) technology. Importantly, we demonstrated the ability to uniformly coat both the inner and outer surfaces of the CVCs, addressing a key challenge in achieving full-surface protection against infection and thrombosis.
- Validation of testing protocols: Standardized in vitro protocols were developed and validated to evaluate the antithrombotic and antimicrobial performance of coated catheters. These protocols were tailored to the requirements of our industrial partners, ensuring alignment with future product evaluation and regulatory needs.
- Regulatory roadmap development: A regulatory pathway has been established for both EU CE marking and FDA clearance in the United States.
Lab-scale automated coating system: A lab-scale coating machine was designed and developed, enabling automated batch production of coated catheters. This step supports process reproducibility and future scale-up toward pilot and industrial manufacturing.
Quality Management System: Implementation of an ISO 13485-compliant Quality Management System (QMS) is underway, supporting the transition from research to industrial environment.
- Industrial-scale production of CMD-COAT constituents: The main component of the CMD-COAT bioactive coating technology was successfully synthesized and demonstrated in an industrial environment, confirming the scalability and manufacturability beyond the laboratory setting.
- Coating of medical devices: Coated central venous catheters (CVCs) were coated using our proprietary CM-COAT(TM) technology. Importantly, we demonstrated the ability to uniformly coat both the inner and outer surfaces of the CVCs, addressing a key challenge in achieving full-surface protection against infection and thrombosis.
- Validation of testing protocols: Standardized in vitro protocols were developed and validated to evaluate the antithrombotic and antimicrobial performance of coated catheters. These protocols were tailored to the requirements of our industrial partners, ensuring alignment with future product evaluation and regulatory needs.
- Regulatory roadmap development: A regulatory pathway has been established for both EU CE marking and FDA clearance in the United States.
Lab-scale automated coating system: A lab-scale coating machine was designed and developed, enabling automated batch production of coated catheters. This step supports process reproducibility and future scale-up toward pilot and industrial manufacturing.
Quality Management System: Implementation of an ISO 13485-compliant Quality Management System (QMS) is underway, supporting the transition from research to industrial environment.