PrePex has been extensively reviewed by the World Health Organization (WHO), with its safety and efficacy validated in a series of comprehensive, rigorous studies. PrePex is Class II CE certified and a sterile version for adults has been cleared by the FDA. In addition, Circ MedTech Ltd. holds ISO 13485 certification.
Clinical studies of the PrePex device for non-surgical male circumcision (MC) were planned using the WHO official Evaluation Framework of Adult Male Circumcision Devices. All studies were executed according to GCP guidelines. Clinical reports on all studies have been submitted to WHO, CDC, PEPFAR, UNAIDS and The Bill and Melinda Gates Foundation.
Three Randomized Controlled Trials (RCT) conducted in collaboration and at Rwanda Military Hospital validated the PrePex device as a literally bloodless procedure that does not necessitate injected anesthesia nor sutures, and can be conducted by nurses in a clean, non-sterile setting. In a WHO audited and peer reviewed randomized controlled comparison study, the device was validated as up to five times faster than the current standard surgical method. PrePex’s simple technology, combined with its adaptability to resource-limited settings, makes it critical to scaling circumcision across Rwanda and sub-Saharan Africa.
Rwanda, Zimbabwe, Uganda, South Africa, Kenya, Botswana, Zambia and Tanzania have completed studies validating the safety, efficacy, acceptability and superiority of PrePex, over the surgical dorsal slit method for male circumcision.
The Rwandan Ministry of Health approved the device for use in Rwanda in March 2011 and initiated a national scale-up of PrePex in 2013. In addition the PrePex Center of Excellence was established in the Rwanda Military Hospital in Kigali, and it now serves as an international training center for PrePex providers from around the world. In addition throughout the years more studies were held in in collaboration with Rwanda military hospital in order to approve the PrePex technic and introduce the device for younger adolescents and boys.