CSD500, the Condom Safety Device will be a condom to be used by healthy men. The product will incorporate an erectogenic compound to help men maintain a full erection during intercourse whilst wearing a condom. The gel is to be licensed under the trademarked brand name of Zanifil®.
By applying the CSD500 condom, a pharmacological dose contained within the teat of the condom will be delivered to the penis. This will result in increased local blood flow which in turn will lead to improved rigidity, tumescence and duration of an erection.
Discussions with EU regulatory authorities have confirmed that the product will be classified within the EU as a Class III medical device with an ancillary medicinal substance. This classification will allow the product to be sold throughout Europe in the same way as conventional condoms.
Futura has signed a global distribution agreement with the world's largest branded condom manufacturer and distributor, SSL International plc ("SSL" - makers of the Durex® condom range) for the lifetime of the patents.
Futura recently announced positive results from a user study of CSD500. The study, equally funded by Futura and its marketing and distribution partner SSL International plc (SSL), successfully met its primary endpoint. Of those who expressed a preference a significant proportion of both men and women reported improvements in the firmness of the man’s erection during intercourse when using CSD500, compared to using a normal condom, a result that was highly statistically significant. Furthermore, of those who expressed a preference, a significant proportion of both men and women also felt that CSD500 increased the penis size and a significant proportion of women reported a longer lasting sexual experience with CSD500. The quality of the study results has reinforced our confidence that CSD500 has significant commercial potential.
The study included 108 healthy couples, the men of which had at some time experienced a loss or partial loss of erection whilst using standard condoms. A good safety and tolerability profile was reported for CSD500.
The results of this clinical trial have been accepted by the Competent Authority as supporting the proposed product claims and therefore no further clinical trials are anticipated. Discussions continue to resolve the outstanding issues and enable the Notified Body to issue the CE Mark for the product.
CSD500 is expected to receive marketing approval this year, after which it will be launched and marketed by SSL as a Durex-branded condom. SSL is currently carrying out the detailed preparatory work for CSD500’s EU marketing launch, including the selection of the product’s brand name within the Durex® portfolio and the product’s logo and packaging. Once launched, Futura will receive royalty payments from SSL based on product sales.
To protect Futura’s revenues from CSD500. Futura has secured patent protection, or is proceeding to obtain patent protection, in 36 consumer markets, including the principal territories within Europe as well as the USA and Canada.
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