Investors
Vlisse is the all-natural cure for vaginal infections, providing immediate symptom relief unlike current drugs.
Initial market research indicates that 80% of women would try this product and believe it should be available on the market
US Market Opportunity
VlisseTM Addresses the 3 Major Markets and Unmet Needs in OB/GYN
Go-to-Market Plan
Based on FDA Feedback and Criteria
– Regulatory Pathway: De Novo – Expect FDA Clearance by 2HQ’25
– Low-Moderate Risk Device, Class II
- Design Freeze
- FDA Pre-Submission
- CRO Selected
- Safety Testing
- Manufacturer Selected
- Biocompatibility Started
- Trial Initiated
- Submit for Breakthrough Designation to FDA
- Trial Complete
- Seek Partnerships
- Second Design Freeze
- Bench Testing / DFM
- FDA Submission
- FDA Approval (end of 2025)
Comparable Acquisitions
Investor Overview
- Cooling technology platform treating the three largest markets in OB/GYN (>$32.0 B)
- Strong issued patents (Utility & Design)
- Prevents any other cooling device entry into the market
- Multiple conditions including Bacterial Vaginosis & Preterm Birth
- Selected Contract Research Organizations (CRO)
- Identified three trial sites
- Early exit opportunity – pending clinical trial
- Successful 30 women pilot studies
- Resulting in 100% effectiveness
- Two FDA Pre-Submission meetings
- Confirmed trial protocol
- Class II-Low-Moderate risk
- Referred for Breakthrough Designation
- All-Natural, First Drug-Free, Non-Chemical
IN THE NEWS
Forbes
Coologics’ Revolutionary Temperature-Based Approach To Vaginal Infections
In women’s health, innovation is not just a buzzword but a necessity. Coologics, a forward-thinking femtech company, is at the forefront of this innovation with their platform technology, Vlisse, a patented, drug-free treatment for vaginal infections, including yeast infections and bacterial vaginosis.