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 has established two outsourced supply chains, one in Europe and one in Asia, TTK Protective Devices Limited ("TTK").
CSD500 is approved by the regulators to be marketed throughout the European Union and a growing number of territories outside of the European Union. 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.
CSD500 has two EU approved manufacturers, our Asian manufacturer TTK has approval for an 18 month shelf life whilst our European manufacturer currently has a 12 month shelf life although we are currently awaiting approval to extend this to at least an 18 month shelf life.
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.
Futura has signed seven licensing and distribution agreements for CSD500 for 36 countries.
In January 2017, Kabey Pharmaceuticals (Kabey) launched CSD500 in Saudi Arabia. Kabey is Futura’s distribution partner for key territories in the Middle East and North Africa (MENA). Further launches are expected by our distributors in Europe and the MENA region.
In addition to out-licensing CSD500 to companies that have the right to 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. We are pleased that the in-market experience of the product to date is consistent with the product’s performance and safety profile in clinical studies.
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CSD500 – Futura Medical plc
