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CE mark and regulatory approval for Wood-based wound dressing

01st July 2019

FibDex, a wound dressing made from wood-based nanofibrillar cellulose has been launched by UPM for European market after receiving regulatory approval and a CE mark. It is manufactured from renewable and responsibly sourced Finnish birch wood.

The core of the dressing is made up of Nanofibrillar cellulose, which is biocompatible with human cells and tissue. UPM’s nanotechnology and professional R&D achieved this product after working into Nanofibrillar cellulose for over a decade.

FibDex showed favorable healing properties during clinical trials and is used for one-time only application that automatically peels away from treatment site after complete healing. Patients reviewed FibDex as a less painful and more efficient dressing for treatment with improved scar quality.

It was developed in collaboration with researchers from Faculty of Pharmacy, University of Helsinki, as well as surgeons from the Helsinki Burn Centre, Department of Plastic Surgery, Helsinki University Hospital. FibDex undergone preclinical safety and efficacy tests followed by clinical trials. The trials were focused on the treatment of skin graft donor sites. After the promising results, it received the CE mark.

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