Clinical evidence

Our strategy is grounded in solid clinical evidence gained over 30 years. With more than 40 clinical studies performed on the coating technology across more than 100,000 patients over the years, the data supports its efficacy in a variety of patient groups, therapeutic areas, and medical devices. Clinical evidence is a strategic advantage and Bactiguard performs studies in collaboration with license partners and well recognized academic institutions where we provide know-how in the areas of clinical research, regulatory affairs, and reimbursement.

40 clinical studies 

✓ 100.000 patients

✓ 230 million catheters with Bactiguard coating

✓ No adverse events

Clinical excellence

Bactiguard’s coating technology of noble metals has been developed and applied to a variety of medical devices. Already in 1986, the first clinical tests were performed and in 1994, a urinary catheter with Bactiguard’s coating technology was approved by the FDA in the US.

Our coating technology has been tried and tested for many different applications. For example, clinical studies show that the risk for catheter-related urinary tract infections decreased 69 percent when the medical devices were coated with Bactiguard’s coating.

Product safety

We must ensure safe products to patients, customers, and healthcare. We comply with all legal and regulatory requirements for clinical trials, product development, production, declarations of goods, sales and marketing. Our MDR and CE labels, like other approvals from government authorities, are indications of quality that demonstrate our ability to maintain a high level of quality throughout our processes.

Clinical studies increase our knowledge

Clinical studies are important for patient safety, to ensure the efficacy of the technology and for the sales process. Combined with our knowledge of regulatory requirements and approval processes, they give us a strategic competitive advantage when negotiating and developing new license agreements. Regulatory processes often take several years, so it is a definite strength if we can shorten them.

Requirements are also getting stricter and the new European MDR regulation will make it more difficult for new products to enter the market if they are not supported by clinical evidence. All our studies are designed according to international and local laws, regulations and ethical principles. They are reviewed and approved by ethical committees and relevant authorities.

These extensive studies have proven that the technology is safe and effective in a variety of patient groups and clinical situations. We also study user-friendliness and patient satisfaction to enable us, for example, to adapt the shape and design of the products.

We are continuously studying new areas of use and applications for our technology, which will pave the way for new products and license applications. In addition to clinical studies, Bactiguard also conducts so-called pre-clinical studies, where knowledge of the technology is increased by using test tubes, cells or bacteria.

As Bactiguard’s technology is applied in new application areas, the need to understand how the surface interacts with different parts of the body increases.

Select publications in scientific journals

PRODUCTSUMMARYREFERENCE
BIP ETT Evac53 percent reduction of VAP in the Bactiguard group compared to control. Delay to onset of VAP.Damas, P. et al. (2022). Annals of Intensive Care, 12(1), 1-10.
BIP ETT39 percent reduction of VAP in the Bactiguard group compared to control. Shorter hospital stay and lower use of antibiotics.Tincu, R. C. et al. (2022). Balkan Medical Journal, 39(1), 75-79.
BIP CVCIn vitro study showing that BIP CVC has good tissue friendliness compared to other coated products.Thorarinsdottir, H. et al. (2022). Scientific Reports, 12(1), 8600.
OrthosynFirst-in-man study with Bactiguard’s technology on orthopedic implants. The study showed an infection rate of 8.6 percent to be compared with literature of similar health-care settings without Bactiguard’s coating on trauma implants.Karupiah, T. et al. (2022). Antibiotics, 11(12), 1763.

Welcome to contact us and our clinical department if you want to know about our clinical data!