Swedish company Gedea Biotech has announced that its lead product pHyph has received CE-marking under the EU Medical Device Regulation (MDR) for the treatment of bacterial vaginosis (BV).
pHyph is an antibiotic-free vaginal tablet designed to both treat BV and promote a healthy vaginal microbiome.
Approval under the MDR provides pHyph unrestricted access to the European market.
BV affects nearly one in four women globally and is often treated with antibiotics, which can disrupt the vaginal microbiome and lead to recurrent infections or yeast overgrowth. The need for antibiotic-free treatments has been expressed by patients and doctors and confirmed by market research. pHyph is a clinically proven, antibiotic-free treatment that also promotes a healthy vaginal microbiome.
“We need more antibiotic free treatment options for BV because current treatments often lead to side effects, recurrent BV or even resistant bacteria,” said Phillip Hay, consultant in sexual health at a London teaching hospital.
“pHyph is interesting because it works on the level of the microbiome; treating bacterial vaginosis, reducing symptoms and contributing to long-term vaginal health.”
CE-marking under MDR requires comprehensive clinical evaluation and review by a notified body, confirming that the product is safe, effective, and ready for market.
“This approval confirms the efficacy and safety of our product and opens up a large market opportunity in Europe. The novel, antibiotic free mode of action will improve treatment of bacterial vaginosis for millions of women and reduce use of antibiotics, and our ambition is to make pHyph available in pharmacies in the first markets in 2026,” Hay said.
Gedea is currently in discussions with pharmaceutical partners for the launch of pHyph in European markets.
The company said MDR approval for pHyph secures access to the European market with a value estimated at approximately €200m within the EU alone and supports regulatory approval in markets in Asia and North America.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
