Bioresorbable Intravaginal Scaffold Delivering Lauramide Arginine Ethyl Ester as an Adjunct to Antibiotic Therapy for Recurrent BV Prevention
Biomedical Engineering
Daniella Gentile, Zoe Haise, Claire Kennedy, Abby Lupien, Heather Taylor
Abstract
Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide, impacting over 21 million women annually in the U.S. and contributing to increased susceptibility to sexually transmitted infections and adverse pregnancy outcomes. Despite antibiotic treatments such as metronidazole, recurrence rates exceed 50% within six months due to persistent Gardnerella vaginalis biofilms and failure to reestablish healthy Lactobacillus-dominated flora. Addressing this unmet need, Olora Health is developing BVBalance™, an auxetic, bioresorbable vaginal stent designed to disrupt biofilms, restore vaginal microbiota, relieve symptoms, and prevent recurrence for 6–8 months, directly targeting the biological causes of BV persistence and relapse.
The BVBalance™ device integrates three synergistic components: (1) a biofilm-disrupting surface coating using lauramide arginine ethyl ester (LAE) and mild analgesics for rapid symptom relief; (2) a porous auxetic scaffold fabricated from PLGA that conforms to mucosal tissue to maintain patient comfort; and (3) a lyophilized probiotic core delivering Lactobacillus. The insert will both disrupt the biofilm and replenish the healthy vaginal microbiome to bolster the adjunct antibiotic treatment.
Manufacturing utilizes scalable injection molding and aseptic lyophilization under ISO 13485 and GMP standards. Components are sterilized by EtO and sealed in foil/Tyvek pouches with desiccant to preserve probiotic viability. Cost modeling estimates $17 per unit, supporting over-the-counter accessibility. By uniting antibiotic compatibility, probiotic restoration, and mechanical biofilm disruption in one device, BVBalance™ offers a multi-mechanistic, patient-centered therapy. By uniting antibiotic compatibility, probiotic restoration, and mechanical biofilm disruption in one device, BVBalance™ offers a multi-mechanistic, patient-centered therapy. The innovation applies principles of biomedical engineering design—materials science, diffusion modeling, and human factors in order to deliver a comfortable, effective, and clinically translatable solution for recurrent bacterial vaginosis.