Bioresorbable Intravaginal Scaffold Delivering Lauramide Arginine Ethyl Ester as an Adjunct to Antibiotic Therapy for Recurrent BV Prevention

Abstract

Bacterial vaginosis (BV) affects approximately 30% of women worldwide, with up to 80% of patients experiencing recurrence within one year of treatment. Current therapies, including antibiotics and over-the-counter treatments, often fail to address the underlying cause of recurrence due to bacterial biofilm formation and disruption of the protective vaginal microbiome. This leads to repeated infections, patient discomfort, and increased healthcare burden.

To address this unmet clinical need, we developed BVBalance, a first-in-class, fully bioresorbable intravaginal device designed to prevent recurrent BV. BVBalance is a soft, expandable insert that integrates seamlessly into existing treatment workflows as an adjunct to antibiotics. The device functions through a three-stage mechanism: (1) immediate symptom relief via hyaluronic acid to improve patient comfort and adherence, (2) biofilm disruption through controlled release of an antimicrobial agent to enhance antibiotic efficacy, and (3) microbiome restoration through delayed probiotic delivery to reduce reinfection risk. The device fully degrades within 2–3 weeks, eliminating the need for removal.

Current work has focused on early-stage in vitro evaluation and prototype development to assess device feasibility, in collaboration with internal and external research partners. Preliminary studies have helped define key design considerations, including degradation behavior, mechanical stability, and planned biofilm-disruption testing.

BVBalance has the potential to significantly improve treatment outcomes by addressing the root cause of recurrence, reducing repeated antibiotic use, and improving patient quality of life. This work demonstrates a novel, patient-centered approach to managing recurrent BV and highlights the broader potential of bioresorbable drug-delivery platforms in women’s health.

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