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PATH has formed a new product development partnership to advance the Woman’s Condom and expand affordable protection options for women. Under a new four-year, €5.1 million award from the Netherlands Ministry of Foreign Affairs, PATH is coordinating with the Shanghai Dahua Medical Apparatus Company (Dahua), CONRAD, and the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD) on a project called Protection Options for Women (POW).

PATH and Dahua received funding to accelerate development of new, lifesaving reproductive health technologies and to ensure their availability and accessibility in low-resource settings. The partnership will apply a total market approach to create sustainable markets in the public and private sectors for the Woman’s Condom—designed by PATH—at a price affordable to women seeking protection from HIV, other sexually transmitted infections, and unintended pregnancy.

POW will focus first on developing markets in China and sub-Saharan Africa. Our work includes achieving international regulatory clearance, building evidence of product effectiveness, and creating and sustaining advocacy initiatives to raise awareness of, as well as demand for, the Woman’s Condom and promote female condoms worldwide. POW will engage global stakeholders by establishing a technical advisory group to help guide project activities. Ultimately, POW will make the Woman’s Condom available and accessible in developing-country markets worldwide.

Condom passes regulatory hurdle

We are already making progress toward bringing the condom to women in the developing world. In December 2010, the Woman’s Condom, manufactured by Dahua, was granted CE Mark approval, the first regulatory clearance for our new product. The approval certifies the product meets consumer safety standards and can be marketed in countries in the European Union. It demonstrates confidence in the quality of the Dahua product, and it helps pave the way for shipping inventory for clinical studies and facilitates activities in early market development.

In addition, Dahua has submitted an application to the China Food and Drug Administration for clearance to market the Woman’s Condom in China. We expect a response in early 2011.

US studies evaluate condom’s effectiveness

Data to support the effectiveness of the Woman’s Condom are being gathered in two studies in the United States. CONRAD is conducting a performance and failure mode study, and results are expected by the end of 2011. NICHD is conducting a pivotal contraceptive effectiveness study of the Woman’s Condom during 2011 and 2012. Data will be submitted to the US Food and Drug Administration as part of a premarket approval application, the most stringent type of device marketing application required by the agency.

Information and commercial inquiries

For more information about the Woman’s Condom, please contact Patricia Coffey, Woman’s Condom team leader, at womanscondom@path.org. For commercial inquiries, please contact Hua Chen, president of Dahua, at shdahua1@msn.cn.

More information

Posted February 14, 2011.