Prepex Circumcision Device

Target SDGs

Market Suggested Retail Price

$20.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies, NGOs

Distributors / Implementing Organizations

Circ MedTech Ltd distributes the Prepex device to health clinics and hospitals.

Competitive Landscape

Direct competitors include ShangRing Circumcision Device.

Regions

Africa, Sub-Saharan Africa

Countries

Botswana, Kenya, Lesotho, Malawi, Mozambique, Namibia, Rwanda, South Africa, Swaziland, Tanzania, Uganda, Zambia, Zimbabwe

Manufacturing/Building Method

The Prepex device is mass produced by Circ MedTech, Ltd.

Intellectural Property Type

Patent

User Provision Model

This device is available in health clinics and hospitals for use by surgically trained nurses and/or minimally skilled healthcare workers.

Distributions to Date Status

In 2011, Prepex and the Rwandan Military hospital successfully tested the device and 10,000 procedures were performed.

Design Specifications

The Prepex Circumcision Device consists of an inner ring, elastic ring, placement ring, and a verification thread; there is also a sizing accessory, a template with 5 holes of differing size to guide the selection of ring size. The device works by compressing the foreskin so as to cut off circulation distally, after which the distal foreskin becomes necrotic, allowing easy and bloodless removal.

Product Schematics

Technical Support

Healthcare professionals are trained over a period of 3 days to 2 weeks. A Prepex training program is available to physicians.

Replacement Components

None

Lifecycle

The components are created for single use and disposal.

Manufacturer Specified Performance Parameters

The PrePex device enables non-surgical adult male circumcision.

Vetted Performance Status

Mean time to complete healing was 25.3 days after foreskin removal or 32 days after device placement. The PrePex device was safe and effective as a means of performing bloodless adult male circumcision that can be carried out by nonphysician staff without need for anesthesia, suturing, or sterile settings. The mean PrePex skin-to-skin procedure time is 3.1 minutes. 91 of 92 patients (99%) in the PrePex group were satisfied with the aesthetics of circumcision. Ninety-one of 92 (99%) patients in the PrePex group would recommend the procedure.

Safety

This device is made for single use and disposal. The PrePex device should not be used in cases of phimosis or congenital abnormality.

Complementary Technical Systems

None

Academic Research and References

Compliance with regulations

PrePex is WHO prequalified, FDA cleared and certified CE Mark Class IIa. Circ MedTech is ISO 13485 certified.

Evaluation methods

Randomized, Controlled Intervention Trials, Government-sponsored studies. User feedback, healing time, skin-to-skin procedure time.

Other Information

As of February 2014 PrePex is being used exclusively in 13 priority countries in Sub-Saharan Africa with high HIV prevalence and consequently the device is not yet available elsewhere.