Why 3-300 Million?

Bringing our over-the-counter HPV sperm testing kit to market is a complex, multi-stage process. That’s why costs can range from $3 million to $300 million—figures that reflect the real investment required and are neither overestimations nor scams. Here’s a brief explanation of the costs at each stage:

• $300K: From Patent-Pending to Non-Provisional Patent & Pilot Study
  Our invention is currently patent-pending, which means we have filed a provisional patent application to secure an early filing date. However, to fully protect our invention and gain enforceable intellectual property rights, we must file a non-provisional patent application. This step is essential because only a non-provisional patent can lead to an issued patent, giving us the legal authority to defend our innovation. Alongside this, we conduct a pilot study to demonstrate the basic feasibility, safety, and effectiveness of our kit. This foundational phase establishes our intellectual property and provides the initial data needed for further development.

• $1M: FDA Pre-Submission and Mobile App Beta
  Before we can sell our product, we must engage with the FDA through a pre-submission process to clarify regulatory requirements and ensure our product meets all necessary standards. Additionally, we develop a mobile app to support users, requiring investment in software development, user testing, and compliance with privacy and security standards.

• $10M: Manufacturing and Nationwide Distribution
  To make our kit widely available, we need to set up manufacturing processes, implement quality control systems, and establish distribution channels across the country. This phase ensures we can produce our product at scale, maintain high quality, and reach consumers nationwide.

• $100M: Global Rollout and Research
  Expanding internationally means navigating different regulatory environments, building partnerships, conducting large-scale clinical studies, and sharing research data globally. This stage requires significant resources for marketing, logistics, and ongoing research to adapt and validate our product for diverse populations.

• $300M: Scaling and Reaching Every Woman on Earth
  Achieving global access involves massive investments in manufacturing infrastructure, educational campaigns, regulatory approvals in multiple countries, and continuous research. This ensures that our kit is accessible, effective, and trusted by women everywhere.

In essence:
Each stage of bringing our medical device to market requires increasing levels of investment to ensure safety, effectiveness, regulatory compliance, and broad accessibility. These costs are realistic and necessary to take our innovation from a patent-pending concept to a product that can help women around the world. 

HPV is silently damaging fertility, causing miscarriages, and killing women.  It is an epidemic of preventable harm. It’s time we fight back.”