Coologics, Inc. has partnered with Validcare to conduct a multi-center prospective study involving 160 women. The research will evaluate the Vlisse vaginal cooling device (VCD) against standard treatments for vulvovaginal candidiasis (VVC), with findings intended to support an FDA market approval submission.
Clinical Context
Dr. Kim Langdon, Coologics’ founder and Chief Medical Officer, emphasized the clinical need: “Millions of women suffer from VVC annually” and existing pharmaceutical therapies often prove slow and unreliable. Dr. Keith Aqua, overseeing study sites, reported that all of his patients experienced complete success with Vlisse treatment.
Study Design & Execution
The research employs hybrid data collection—combining in-office investigator assessments with remote participant monitoring. Validcare provides comprehensive CRO services spanning protocol development, investigator recruitment, and patient enrollment through database lock.
Enrollment is planned for the first half of 2024, with database lock targeted before year-end. Validcare’s streamlined data management protocols aim to accelerate final dataset delivery compared to traditional CRO approaches.
About Coologics
Coologics is a biotech firm founded in 2019, partnering with Project MedTech for clinical development and commercialization.