10130079Scale up manufacture and final product testing of biomimetic coated tampon to improve the vaginal microbiome and prevent bacterial vaginosisClosedGrant for R&DInnovate UKThe global prevalence of Bacterial Vaginosis (BV) among women of reproductive age is 1 in 3 (WHO), caused by an overgrowth of pathogenic bacteria in the vaginal microbiome. 58% of these women suffer chronically, experiencing recurrence within 6-12 months. Vaginal microbiome dysbiosis is linked to increased risk of: infertility; miscarriage; ovarian and cervical cancer; STIs and HIV; endometriosis; and pelvic inflammatory disease. Menstruation is a period of heightened vulnerability to vaginal microbiome dysbiosis because: the alkaline pH of period blood (7.4) disrupts the healthy acidic pH of 3.8-5.0; hormonal fluctuations cause an increase in vaginal microbial diversity; and standard tampons and period care products trigger dysbiosis. The vaginal microbiome is around 9% of a woman's total bodily microbiome and our solution is a tampon that is coated with our patented milk&iron(r) technology, specifically designed to restore the health of the vaginal microbiome. Our functional tampon both manages the flow of a woman's monthly period whilst the milk&iron(r) prebiotic coating is beneficial to the vaginal and vulval microbiome and contributes to the normal, healthy functioning of the vaginal mucosa. The tampon is 100% organic, pesticide free and 100% plastic free. The milk&iron(r) coating is also GOTS (Global Organic Textile Standard) organic audited and certified. Clinical studies have demonstrated that the bioactive ingredient in our milk&iron(r) coating is beneficial to the vaginal microbiome and restores a healthy acidic pH to support commensal, beneficial bacteria to outcompete the pathogenic bacteria associated with BV and vaginal dysbiosis. Our milk&iron(r) is a highly differentiated way of delivering wellness to the body. This project will facilitate our first scaled manufacturing run and final product safety & biocompatibility testing, as well as a structured PPIE programme (ahead of a phase 1 RCT after the project), rendering us ready to launch to market to potentially improve the lives of 18 billion menstruating women and AFAB people globally.