Gedea Biotech Secures EU Approval for Antibiotic-Free Vaginal Infection Treatment

Medtech Magazine reports that Lund-based Gedea Biotech has secured CE marking for Phyph, its innovative antibiotic-free treatment for vaginal infections. This certification, issued under the EU Medical Device Regulation (MDR), confirms adherence to stringent safety and performance standards. Consequently, Gedea Biotech gains unrestricted access to the entire European market for its vaginal tablet. Phyph is formulated for both the treatment and prevention of common vaginal conditions, such as fungal infections and bacterial vaginosis, offering a viable alternative to traditional antibiotic therapies. Achieving CE marking marks a pivotal moment for the Skåne-based company as it gears up for the commercial launch of Phyph. This novel approach tackles a prevalent health issue affecting women by providing a non-antibiotic solution. The approval empowers Gedea Biotech to introduce its treatment to a wide European consumer base, signifying a significant advancement in its strategy to bring this unique medical device to market.