OncoSil Medical (ASX: OSL) has announced its OncoSil device has been granted CE Marking approval by the British Standards Institute (BSI) for the treatment of locally advanced pancreatic cancer (LAPC) in combination with chemotherapy.
The company described this first approval as a major milestone that allows for the OncoSil device to be marketed and sold within the European Union and the UK.
OncoSil is an innovative medical device comprising microparticles containing phosphorus-32 (P-32), a pure beta-emitter radioisotope, implanted directly into a patient’s pancreatic tumour via endoscopic ultrasound guidance.
It said studies have demonstrated a median overall survival of 16.1 months in patients treated with OncoSil plus chemotherapy - almost double the accepted median overall survival in patients with unresectable pancreatic cancer.
According to OncoSil CEO and managing director Daniel Kenny, “Designation of the OncoSil device as a breakthrough device is a validation of our platform technology which can be used to treat multiple solid tumour types such as liver, biliary duct and of course pancreatic cancer.
“Having secured CE Marking approval, our focus is now on multiple registration filings in jurisdictions which recognise CE Marking certification. This activity is unaffected by the COVID19 pandemic.
“The COVID-19 pandemic will impact our launch preparedness and delay our European launch as the Company expects disruptions due to limited hospital access in the coming months for new site initiation and training as well as shipping and logistical disruption.
"We would like to thank our shareholders for their support through this long but ultimately rewarding journey.”