UPM’s FibDex® Receives Regulatory Approval and CE Mark

 

UPM (Finland) launched a new advanced wound care product for the European market. FibDex® is the first wound dressing created from wood-based nanofibrillar cellulose to receive regulatory approval and be awarded a CE mark. Nanofibrillar cellulose, which has been shown to be biocompatible with human cells and tissue, forms the core of the dressing. UPM’s proprietary nanotechnology, combined with over a decade of research into nanofibrillar cellulose and a highly professional R&D, has resulted in the development of this unique product.

In clinical trials FibDex was shown to provide a favorable environment for healing to occur. Moreover, FibDex is a one-time only application dressing that peels away from the treatment site once healing has occurred. This makes the process less painful for patients and more efficient from the perspective of the hospital. In patient review scores FibDex was reported to be both comfortable throughout treatment and provide improved scar quality.

FibDex has been developed in collaboration with researchers from the University of Helsinki, Faculty of Pharmacy, as well as with surgeons from the Helsinki Burn Centre, Department of Plastic Surgery, Helsinki University Hospital. Prior to receiving the CE mark, FibDex has undergone vigorous preclinical safety and efficacy tests followed by clinical trials that have centered on the treatment of skin graft donor sites.

FibDex is manufactured from renewable and responsibly sourced Finnish birch wood. "We are thrilled to have been awarded the CE mark and to be able to bring FibDex to the market. We see it as the next natural step on our journey in the Biomedicals business," said Dr. Jane Spencer-Fry, Director, UPM Biomedicals.

"After commercializing GrowDex® hydrogel for cell culture in the life science field, we’ve seen that wood-based materials can offer our customers, researchers and patients many benefits that have been warmly welcomed. UPM continues to advance the research and development of products for the biomedical market and moreover, to maximize the use of renewable and sustainable wood-based raw materials," concluded Jane Spencer-Fry.