Our strategy is to develop our portfolio of innovative products for two large market categories, sexual health and pain to late stage, and then partner with major partners at the optimum time to generate most value.

The objective is to develop products such that each on its own has the potential to generate significant annual revenues. 

 

We are investing in our lead product MED3000 to generate most value for shareholders.

2021 performance

  1. Approval in the EU of MED3000 as a medical device by the Notified Body.
  2. A number of constructive meetings took place with the FDA to confirm the requirements of a further Phase 3 clinical study FM71 which commenced in September 2021.
  3. Agreements signed in China and South East Asia, the Middle East and Latin America.
  4. Manufacturing and internal capabilities strengthened to prepare for the commercialisation and supply of MED3000.
  5. The approval of MED3000 as a Class 2B medical device in the EU means that MED3000 will be the first pan-European topical treatment for ED available without the need of a doctor’s prescription.
  6. Developing its capabilities, infrastructure and expertise to supply and support our new commercial partners around the world including an extension of shelf life from two to three years.

 

2022 priorities and performance

  1. Received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.
  2. Completed Phase 3 study FM71 and received highly positive results meeting all primary and secondary endpoints which will allow a submission to the FDA for marketing authorisation as an OTC De Novo medical device by the end of Q3 2022.
  3. Agreements signed in EU, UK, Switzerland and South Korea as the company continues building a strong global network of licensing and distribution partners and on building a strong brand identity for MED3000.
  4. Specialist corporate advisors have formally commenced the search for a US partner
  5. Support our commercial partners in their own submissions to local regulatory bodies (where required) and any additional clinical studies which will be paid for in all instances by our commercial partners.
  6. Continue to expand our quality, supply chain, manufacturing and commercial capabilities to supply and support our commercial partners
  7. Ensure ED sufferers can have access to MED3000 as quickly as possible and continue to develop other pipeline opportunities.
  8. Completed additional national patent applications in line with normal PCT filing procedure in all key ED markets in order to protect the commercial interests of MED3000. If national patents applications are successful, this will provide patent protection until 2040.