For Our Investors

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

  • 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