Futura's condom products are aimed at improving the sex lives of healthy men and women. In 2006, the global condom market was worth US$3.1 billion. Our distribution partner SSL International plc, the makers of Durex® are the global leader with a 30% market share.
CSD500, the Condom Safety Device, will be a condom to be used by healthy men to help maintain a full erection during intercourse whilst wearing a condom.
In 2007, Futura announced positive results from a user study of CSD500. 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.
In the UK, a government report from the Health Protection Agency has shown that in the last 10 years new cases of syphilis have increased by 1130%, HIV by over 300%, gonorrhoea by 45% and chlamydia by 166%. The ‘safe sex’ message is not getting through and this may partly be linked to the fact that some healthy men can experience a loss of sensitivity when using a condom. This in turn can contribute to a partial loss of erection during intercourse and therefore discourage some men from always wearing a condom during intercourse.
Market research conducted by Futura showed that up to 22% of healthy men can sometimes suffer a partial loss of erection during intercourse when wearing a condom. This may in part explain the growing trend of men to be reluctant to practice safe sex. The Directors believe that CSD500, by helping men maintain a full erection when wearing a condom, may help promote condom usage and compliance.
Market research commissioned by Futura has shown that the product has significant commercial potential:
- 88% of existing condom users would be interested in purchasing CSD500
- 49% of non-condom users would be interested in purchasing CSD500
In November 2008, CSD500 received a positive regulatory opinion relating to the pharmaceutical aspects of the dossier. This positive opinion marked a pivotal step towards European marketing authorisation for CSD500, which will be sold under the Durex® brand by SSL International plc (“SSL”).
The EU Competent Authority's opinion forms a key part of the process to permit the award of the CE mark, the regulatory approval mechanism for this class of medical device in Europe. The award of the CE mark will allow CSD500 to be marketed throughout all EU member states.