Female Condoms on Development

 

We have received substantial product information by the producers themselves, FCMi has been made aware several additional female condoms currently being developed

Female Condom

Design & Features

Phase of development

Useful Product Links


Female Condom

ORIGAMI™ Female Condom (OFC)

STRATA Various Product Design

 Origami

 

Design & Features

  • Made of a uniquely formulated polymer to provide high elongation, high tensile strength and long-lasting durability during intercourse.
  • Pre-lubricated with a silicone based lubricant.
  • It is folded “Origami style” and inserted by pushing the folded conical shaped material into the vagina. After insertion, the condom will deploy to its full length during intercourse.
  • An elliptical flange ensures external retention and anatomical conformity, An optional applicator is provided with each OFC for easy insertion.

Product Status

  • Currently the device has completed a Phase I clinical study and is positioned to move to its Phase II study for FDA, CE-Mark, and WHO reviews.
  • It will be available commercially after the Phase 2 is completed and pending regulatory pre-market reviews.
  • Expected to reach the market in late 2015.

Useful Product Links

The ORIGAMI™ condoms website.

Includes videos and press releases related to the development of the OFC female condom.

ORIGAMI is developing new versions female condoms, see end of this page.


Female Condom

ORIGAMI™ OIC (ORGAMI Internal Condom)

 

Design & Features

  • Unique type of condom is an MPT device usable for either vaginal or anal sex protection
  • Made of a non-toxic form of latex with a higher degree of biocompatibility than ordinary latex
  • Does not require an inner ring mechanism or sponge and it does not require any mechanical insertion device

Product Status

  • Pilot Study in South Africa testing it among two sexual groups populations. 
  • If Pilot study succeed,  OIC  will be eligible for Phase II study.

Useful Product Links

The ORIGAMI™ condoms website.

Due to stringent regulatory obstacles the earliest launch date in the US would be 2018-2019, however, the device could be made available earlier with a faster review by the WHO for regions like the Sub-Sahara and Asia.


Additionally, the Gates Foundation is providing support to several innovators to develop the Next Generation of female condoms. For information on these products, FCMi is in discussion with the relevant companies to provide full product profiles in the future.


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