There is a huge commercial opportunity also in Germany with the...

There is a huge commercial opportunity also in Germany with the 84 hospitals on the NUB list, which now, additionally to the trial, can negotiate and ask for reimbursement for treatments conducted outside the trial.

The removal of the red-tape, ie Osprey register

Market penetration across EU and UK markets

Incoming changes:

• OncoSil has now received the UK Conformity Assessment Certificate, removing all post-market restrictions in the UK market, including OSPREY.
• OncoSil is expecting to receive full Medical Device Regulation (MDR) approval in the near term, given confidence by the regulatory authorities in the clinical safety data for the OncoSil™ device.
• Implementation of the MDR is to replace the requirement for the OSPREY Registry in the EU in addition to the UK, resulting in:
  • Removal of administrative burden and the requirement for ethics committee approval, with six months saved to onboard new hospital accounts.
  • Only isotope (³²P) license required at new hospital accounts (all current hospital sites have the required license).
  • Company to save €2 million over three years in ethics approval and patient recruitment-related costs.