CSD500 - Condom for Maximum Firmness
CSD500 is a unique condom
CSD500 is a condom developed for use by healthy men to help maintain a firm erection whilst wearing a condom. CSD500 is a lubricated condom with a gel Zanifil®, which contains a low dose of Glyceryl Trinitrate (GTN) in the teat of a standard latex condom which is absorbed through the penis when the condom is used.
CSD500 has 3 clinically proven claims
- Increased penile firmness
- Longer lasting sexual performance
- Improved sexual performance
Futura to focus resources strategically
Significant market potential for the right partner
In 2017, the global condom market was estimated to be worth US$6.8 billion.
Previous research has shown that up to 46% of men have experienced some loss of sensitivity when using a condom during sexual intercourse, which can lead to loss of erection on occasions. This is one reason why some men avoid condoms for either part of or for the duration of sexual intercourse, thereby increasing the risks of unwanted pregnancies and contracting sexually transmitted infections ("STIs").
Futura commissioned a pricing and demand research study by Millward Brown, an internationally respected agency. This research, carried out in the UK and USA, confirmed Futura's confidence in CSD500 as a highly innovative product. The research has been shared with potential licensing partners but the key highlights are:
- CSD500 can command a price premium over existing condoms
- CSD500 is expected to gain a market share in excess of 10% in the markets researched
Regulatory and supply chain strategy
Futura has 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 has just received approval for a 2 year shelf life.
Futura has signed seven licensing and distribution agreements for CSD500 covering more than 27 countries. In the first half of 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). We have been pleased with the continued safety data and encouraged by the positive feedback. Further launches are expected by our distributors in Europe and the MENA region. The in-market experience of the product to date has been consistent with the product's performance and safety profile in clinical studies.
CSD500 is non core moving forward and with development complete Futura will look to maximise income through our distributors. Discussions are ongoing with current and potential further distribution partners on the next steps with the product in a number of markets.
Protecting our IP
We have filed a new patent in connection with the manufacturing improvements we have made 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.