Lund, Sweden – September 2, 2025 – Gedea Biotech, an innovative Swedish life science company, today 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
- Novel, antibiotic free, safe and effective treatment for bacterial vaginosis can be made accessible to millions of women
- Facilitates ongoing partnering discussion
Meeting an urgent medical need
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 clearly 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, says Dr. Phillip Hay, Consultant in Sexual Health at a leading 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, Phillip Hay continues.
A major regulatory milestone
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.
Gedea is currently engaged in active discussions with several established pharmaceutical partners for the launch of pHyph in European markets:
-We are very pleased with the strong interest and high quality of the partners we are in dialogue with, adds Annette Säfholm. The MDR approval for pHyph secures future-proof access to the European market which value is estimated at approximately €200 million within the EU alone and supports regulatory approval in several important markets in Asia and North America.