The ORIGAMI Female Condom™ (OFC) is a female-initiated, internal condom designed to enhance sensation for both partners, improve ease of use, improve safety, provide direct tactile sensation, minimize slipping and breaking, and to accommodate a range of penis sizes. It replicates a fluid environment for the penis consistent with natural intercourse performance.
Unlike a conventional nitrile female condom, the transparent OFC is fabricated in molded silicone with anatomy-specific design. It validated at 100% biocompatible and non-allergenic in independent pre-clinical lab testing.
The OFC is inserted vaginally before intercourse. It is intended to provide a female controlled strategy for contraception and prevention of HIV/AIDS and STD/STI.
To reach the market the condom must be reviewed by the WHO, the C-Mark (EU), and the FDA (US) to meet regulatory safety requirements. The OFC has completed Phase 1 clinical trials in San Francisco, CA in collaboration with the Women’s Global Health Imperative at RTI, International. Large-scale clinical trials will follow in 2014, to evaluate OFC performance and safety. It is expected to reach the market in late 2015, pending regulatory pre-market approvals.