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.
- We have so far performed more than 40 clinical studies with 100,000 patients
- 200 million catheters with our coating have been used for 25 years
- No adverse events related to the coating have been reported
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. At the same time we are 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.