CSD500 - Condom for Maximum Firmness
CSD500 is a condom developed for use by healthy men. The product incorporates a unique erectogenic gel (known as "Zanifil® gel") to help men maintain a firmer erection during intercourse whilst wearing a condom.
How does it work?
Zanifil® gel contains a low dose of Glyceryl Trinitrate located in the teat of a standard latex condom which is absorbed through the penis when the condom is used. Zanifil® gel has been clinically proven to provide a firmer erection, maximise the natural size of an erection and enable a longer lasting sexual experience.
Clinically proven claims
In a double blind clinical study comparing CSD500 against a standard condom, 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 against a standard 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. A good safety and tolerability profile was also reported for CSD500.
Regulatory and supply chain strategy
Futura has already achieved ISO 13485 certification and is well advanced in establishing two outsourced supply chains, one in Europe and one in Asia.
In October 2013, Futura was awarded the CE mark certificate for CSD500. The award of the CE mark means that CSD500 can be marketed in all 28 European territories. In addition, a number of other non-European territories also recognise the CE mark process, thereby facilitating registration. Further regulatory approvals have been obtained including several in the Middle East and North Africa (MENA) region - the first approvals for markets outside the EU. Regulatory filings have also been made in further countries in the MENA region, Asia and South America.
The CE mark certificate currently covers one of these supply chains, with the second supply chain expected to come on stream in 2016 following regulatory clearance. Futura's virtual business model remains unchanged and the Company will therefore not be directly involved in manufacturing, packaging, warehousing or any other discipline associated with integrated businesses.
CSD500 currently has a shelf life of one year, however, following extensive technical development work for CSD500, we expect to significantly extend the shelf life beyond this during 2016. Regulatory submissions have been made in Europe for approval of the modified manufacturing process to extend the shelf life, which is expected mid-2016. This is an important requirement for our commercial distribution partners.
Protecting our IP
We have filed a new patent in connection with these manufacturing improvements which, if granted, would extend the commercial value of the product for a further ten years to 2033. To protect the unique intellectual property of CSD500, patents have already been granted in 37 consumer markets, including the key commercial territories in Europe and the US. In addition, Zanifil® has been trademarked in many countries throughout the world and will be displayed on all packaging containing CSD500 condoms.
Commercialisation strategy on track
Futura has signed eight licensing and distribution agreements for CSD500 covering many key territories. This out-licensing work continues in order to give CSD500 the strongest possible global distribution platform. In total, the rights to CSD500 have been licensed in 39 countries.
In addition to out-licensing CSD500 to companies that will launch the product under their own brand names, we have also created our own condom brand, Blue Diamond® which is being used by some of our licensing partners. Blue Diamond® is now available online and in store in the Netherlands and Belgium. We are pleased that the in-market experience of the product to date is consistent with the product's performance in clinical studies.