COOLOGICS, a Cleveland-based clinical-stage medical device company, announced this month the initiation of multi-center, open-label clinical trials for Vlisse, its innovative intravaginal cooling device designed to treat vulvovaginal candidiasis (VVC), commonly known as yeast infections.
The trials aim to gather sufficient data to secure FDA clearance for the device, which offers a drug-free alternative to traditional antifungal treatments. Site initiation visits are already scheduled, with participating centers set to receive comprehensive protocol training to ensure immediate enrollment and adherence to study procedures.
Novel Mechanism of Action
Vlisse employs a unique approach to treating VVC by utilizing targeted intravaginal cooling. The device is designed to reverse Candida albicans from its pathogenic hyphal form back to its commensal yeast form, thereby alleviating the inflammatory response responsible for VVC symptoms.
"We've always been committed to developing solutions that target the underlying causes of vaginal infections. That's why our focus is on non-pharmacological interventions. We intend to reduce the reliance on antifungal medications," stated Dr. Kimberly Langdon, founder of COOLOGICS.
Trial Design and Methodology
The upcoming clinical trials will evaluate both the efficacy and safety of Vlisse in treating uncomplicated VVC. The study protocol includes:
- Treatment regimen: 30-minute cooling sessions twice daily for three days
- Follow-up assessments: 7 days and 28-30 days post-treatment
- Target enrollment: 69 women (accounting for potential dropouts)
- Completion goal: 55 participants
- Primary endpoints: Symptom resolution and clinical cure
The trials will be conducted in collaboration with ValidCare, a clinical research organization known for its fully digital approach to data collection and analysis.
Promising Preliminary Results
A pilot clinical trial has already demonstrated encouraging results for Vlisse. Five women with symptomatic VVC used the device according to the protocol, and all participants reported reduction in symptoms including itching, swelling, discharge, redness, and irritation. Notably, improvements were observed after only three uses, and by the 30-day follow-up, all patients had achieved complete symptom relief and demonstrated clinical cure.
Supporting these clinical findings, an accompanying mouse model study showed that intravaginal cooling reduced immunopathogenic neutrophil infiltration and the presence of fungal hyphae. No tissue damage or adverse effects were observed in either the human or animal studies, reinforcing the safety profile of the intervention.
Broader Implications for Women's Health
Beyond treating VVC, Vlisse may have additional benefits for women's health. Research has shown that untreated vaginal infections, including bacterial vaginosis and VVC, are associated with an increased risk of preterm birth (PTB) due to genital infections and inflammation.
By providing an effective treatment for vaginal infections, Vlisse could potentially serve as a preventative strategy against PTB, improving neonatal outcomes. This broader impact aligns with COOLOGICS' mission to redefine women's health through innovative medical devices that address common gynecological conditions.
Funding and Future Directions
The initial success of Vlisse has enabled COOLOGICS to secure funding, including a non-dilutive grant, to support the upcoming clinical trials and further product development efforts. The company views these multi-center trials as a crucial step toward obtaining FDA approval.
It's important to note that Vlisse is currently an investigational device that has not yet received FDA clearance. The statements regarding its efficacy have not been evaluated by the U.S. Food and Drug Administration, and the device is not yet approved to diagnose, treat, cure, or prevent any disease.
As the trials progress, COOLOGICS aims to establish Vlisse as a viable drug-free alternative to traditional antifungal treatments, potentially transforming the standard of care for vulvovaginal candidiasis and contributing to improved women's health outcomes.
