DUO Balance is a candidate product intended to become an innovative use-at-home, dual-action, antibiotic-free & acid-free gel aimed to:
- treat the symptoms of vaginal thrush and/or bacterial vaginosis (BV)
- restore hydration to the vagina in case of vaginal dryness and discomfort.
The gel will provide a novel dual action treatment, encouraging the regrowth of a women’s own friendly bacteria, offering a gentler, more personalised and more naturalistic approach in comparison to any existing option on the market.
DUO Balance is expected to be commercialised as a class IIb medical device in compliance with the EU Medical Device Regulation 2017/745 (EU MDR). Indeed, after successfully passing the first in-vitro validation tests, the gel is currently under production and it will be undergoing a clinical investigation for being certified as medical device.
The gel is expected to naturally re-balance the vaginal microbiome without any acid or antibiotic components. Indeed, thanks to its unique patented formulation based on natural ingredients ethically sourced from the oceans, the gel will nurture the "good bacteria" in the vaginal flora with high efficacy and very limited risk of relapses.
Once approved as medical device, DUO Balance will be sold over the counter (OTC) - e.g. in pharmacies, in supermarkets, online - without any need of prescription. The gel will be safe, effective and easy to purchase, helping many women's lives around the world in an unprecedented way.
BiotaLife Healthcare Ltd
Atlas Centre, Fermi Avenue, Harwell Campus, Didcot, Oxfordshire, OX11 0QX, United Kingdom