WHO Approves Israeli-developed Circumcision Device

Move paves the way for widespread introduction of Circ MedTech's PrePex in Africa, where the UN organization hopes to perform 20 million procedures by 2015.

A circumcision device developed by an Israeli startup that uses a rubber band instead of a knife was approved on Friday by the World Health Organization, paving the way for its widespread use in Africa to prevent HIV infection.

PrePex, the work of the Israeli-based socially conscious company Circ MedTech, uses a pair of elastic rings to complete circumcision in an average of four and a half minutes without the need for anesthesia, sutures or a sterile setting. The inexpensive device is disposable and requires little training to use.

“The WHO prequalification of PrePex represents an unprecedented opportunity to further the safe and rapid scale up of voluntary medical male circumcision programs," Ambassador Eric P. Goosby, U.S. Global AIDS Coordinator for the U.S. President’s Emergency Plan for AIDS Relief, said, adding, "PEPFAR is ready to support countries that wish to introduce PrePex right away. This announcement will truly help save lives."

The device was approved by the U.S. Food and Drug Administration in 2012 and is certified by the European Union for use by adult men. But its main market is in Africa, where PrePex offers an inexpensive and rapid way of circumcising large numbers of men. Circumcision is estimated to reduce the risk of HIV infection by 60%.

"The significance of the announcement by the U.S. government, the biggest donor in world to the fight against AIDS, is that it is ready to immediately purchase our unique device for any country that asks for it," said Circ MedTech CEO Tzameret Fuerst.

The PrePex device is put into place by a two-person team of trained practitioners and left for a week, during which time it deprives the foreskin of oxygen and causing it to die. The dead tissue either drops off naturally or is easily removed after that period. Each device costs about $20.

Goosby's agency says it has paid for more than two million circumcisions in Africa in the past few years. But the WHO seeks to carry out 20 million circumcisions in Africa by 2015.

The WHO's approval of PrePex, Fuerst said, will permit the device's sale throughout the developing world. She noted that around some 7,000 circumcisions have been performed with PrepEx in Rwanda, Zimbabwe and Uganda, as part of a pilot program funded by the Bill and Melinda Gates Foundation and the U.S. government.

PrePex was developed in 2009, two years after the WHO published research concluding that men in Africa should have themselves circumcised to help prevent the transmission of HIV, the virus that causes AIDS.

Bloomberg
Daniel Tchetchik