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Tractivus has developed PHOBOSTech™, a coating technology that prevents bacterial colonization of medical devices. This technology has been implemented in two medical devices, urinary catheters and tracheal stents. These two products have been validated both in vitro and in vivo, showing excellent results compared to commercial gold standards. Currently, both devices are in the manufacturing phase of preclinical batches for subsequent validation.
Tractivus and PHOBOSTech™ have been developed over the years as a solution to the current problems of medical devices. The technology was born as a collaboration between two highly prestigious research groups, GEMAT (IQS) and IDIBELL (Hosp. Univ. De Bellvitge). Tractivus combines the experience of the research groups and a unique solution designed to root out the colonization of the devices through a micro- and nano-structured coating that protects the device from adhesion and bacterial colonization. The team has worked on all aspects of the development: material selection, regulatory strategy, risk reduction, clinical trials, partners, stakeholders... aiming to maximize the success of both the project and the investors.
The global medical device market is vast as it consists of standard devices, medicated devices, and coatings for devices. The competitors are medical device companies such as Bard, Rüsch, Covidien, Coloplast (urinal) or Stening, BESS, Hood Laboratories (tracheal). These companies offer one of these services and/or products. Each product aims to alleviate patients of pain and illness, but most times these devices are the cause of HAIs. Standard medical devices do not protect against infections and have to be replaced regularly for that reason. Coated and medical devices aim to avoid infection and reach the expected life of the device in the body, but they use antibiotics to do so. As previously stated, the use of antibiotics in the medical field is often avoided as it decreases the bodies immunity against AMR bacteria.
A regulatory strategy based on the properties of the structural coating has been defined and, therefore, the classifications of the medical devices are not altered. Aiming to obtain the CE mark through a preclinical validation and a human safety study, we have been carefully study different scenarios. The study / clinical validation is considered to be carried out post-marked CE to present clinical evidences and to be able to introduce the products in the market with guarantees.
The PHOBOSTech™ technology and the resulting products with the described characteristics are protected by patent. Currently, the patent is validated in the EU, Australia and national phases are being processed in the US and the rest of the designated countries. In addition, technology derivatives are being worked on.
Two scenarios are contemplated, a first scenario at the beginning of 2021 - once the CE mark has been obtained, through a capital increase or through the sale of the company - and a second scenario - after carrying out the CE and the post-marked clinical validation through the sale / license of the company.