COOLOGICS, a clinical-stage medical device company, has announced the commencement of new, larger multi-center, open-label clinical trials for its innovative product, Vlisse. These trials will begin this month with the objective of gathering sufficient data to secure FDA clearance for the device. The site initiation visits are already scheduled, during which participating centers will receive comprehensive protocol training to ensure immediate enrollment and adherence to study procedures.
The upcoming trials will focus on evaluating the efficacy and safety of Vlisse in treating uncomplicated vulvovaginal candidiasis (VVC), commonly known as yeast infections. Vlisse aims to provide symptom relief through intravaginal cooling. It hopes to reverse Candida albicans from its pathogenic hyphal form back to its commensal yeast form, alleviating the inflammatory response responsible for VVC symptoms.
Participants will undergo a treatment regimen of 30-minute cooling sessions twice daily for three days. Follow-up assessments are planned at seven days and between 28 to 30 days post-treatment to monitor symptom resolution and potential recurrence. The study aims to enroll 69 women to account for potential dropouts, with a target of 55 completing the trial. For seamless data collection and analysis, the trials would be conducted in collaboration with ValidCare, a clinical research organization renowned for its fully digital approach.
This initiative aligns with COOLOGICS’ mission to redefine women’s health by providing innovative, drug-free medical devices that address common gynecological conditions. Kimberly Langdon, MD, COOLOGICS founder, states: “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.”
Kimberly Langdon, MD
A study on Vlisse has demonstrated its effectiveness in alleviating symptoms of VVC through targeted intravaginal cooling. In a pilot clinical trial, five women with symptomatic VVC used the device for 30-minute cooling sessions twice daily for three days. All participants reported their symptoms, including itching, swelling, discharge, redness, and irritation were reduced. 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.
Additionally, an accompanying mouse model study showed that intravaginal cooling reduced immunopathogenic neutrophil infiltration and the presence of fungal hyphae. Since no tissue damage or adverse effects were observed, the safety of the intervention is reinforced. The combination of human and animal data provides compelling evidence that intravaginal cooling can be a viable drug-free alternative to traditional antifungal treatments.
This initial success enabled COOLOGICS to secure funding. This funding, along with a non-dilutive grant, will support the upcoming clinical trials and further product development efforts.
It’s worth noting that Vlisse potential impact doesn’t stop at VVC treatment. Untreated vaginal infections (e.g., bacterial vaginosis and VVC) have been associated with an increased risk of preterm birth (PTB). Genital infections and inflammation contribute to PTBs. Consequently, treatment of yeast and bacterial vaginal infections can lower the chances of PTB. This means Vlisse can serve as a preventative strategy, reducing the incidence of PTBs and improving neonatal outcomes.
COOLOGICS’ initiation of multi-center clinical trials is a step toward obtaining FDA approval for Vlisse. The company is set to meaningfully impact women’s health by offering a drug-free solution for vaginal infections, potentially contributing to the reduction of preterm births.
Media Contact:
Name: Kimberly Langdon
Email: [email protected]
The information in this announcement is intended solely for educational and informational purposes. Vlisse is an investigational device and has not yet received FDA clearance. It is currently being evaluated in clinical trials for safety and efficacy. The statements made regarding Vlisse have not been evaluated by the U.S. Food and Drug Administration. This device is not intended to diagnose, treat, cure, or prevent any disease. Participation in the clinical trial is voluntary and subject to specific inclusion criteria. Individuals should consult with a qualified healthcare provider before considering any new treatment. The results from pilot studies and animal models are preliminary and should not be interpreted as conclusive evidence of safety or effectiveness.
Original Source of the original story >> COOLOGICS Initiates Multi-Center Clinical Trials for Vlisse
