The ORIGAMI IP portfolio represents the most innovative ideas for barrier prevention in nearly a century. Generous research and development funding from the National Institute of Allergies & Infectious Disease (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the Bill & Melinda Gates Foundation has supported the company’s R&D and four Phase I human trials.
The ORIGAMI Condom brand will submit its clinical and pre-clinical data to the WHO, the C-Mark (EU), and the FDA (US) for regulatory reviews and pre-market approvals (PMA) in 2015. Clinical research was conducted for The ORIGAMI Male Condom (OMC), in collaboration with co-investigator Ron Frezieres, VP and Director of Research at the California Family Health Council, Los Angeles, CA; the ORIGAMI Female Condom (OFC), in collaboration with Dr. Ariane van der Straten, Director of the Women’s Global Health Imperative at RTI, Intnl., San Francisco, CA; and the ORIGAMI Anal Condom (OAC), the first dedicated condom ever designed and tested for anal sex, in collaboration with Dr. Ken Mayer, Director of Clinical Research at The Fenway Institute, Boston, MA.
The company has successfully advanced the prospects for innovative condom devices through its groundbreaking, anatomy-specific condoms and their unique functional applications. The new materials and fabrication methods have developed a next generation of condoms that were never before proposed or tested for human use.