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VISIT NEW SITEOncoSil™ receives CE Mark approval
2 minute read
OncoSil Medical Ltd (ASX:OSL) has received CE Marking approval from the British Standards Institute (BSI) for its OncoSilTM device used in the treatment of locally advanced pancreatic cancer (LAPC) in combination with chemotherapy.
OncoSilTM is a first in class 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.
This first approval is a major milestone for OncoSil and allows for the OncoSilTM device to now be marketed and sold within the European Union (EU) and the UK.
Noting ongoing Brexit discussion, the CE Mark granted to OncoSil Medical provides market authorisation also to the UK, as well as the EU.
This is an extremely important, commercially significant development for the company as CE Marking certification is a validation of the OncoSilTM device and its clinical performance.
Clinical studies by Oncosil have demonstrated a median overall survival of 16.1 months in patients treated with OncoSilTM plus chemotherapy (CT) almost double the accepted median overall survival in patients with unresectable pancreatic cancer.
OncoSil chief executive Daniel Kenny said, “Designation of the OncoSilTM 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.
‘’It is worth noting that this activity is unaffected by the COVID19 pandemic,” added Mr Kenny.
However, the COVID-19 pandemic will impact launch preparedness and delay OncoSil’s European launch as management expects disruptions due to limited hospital access in the coming months for new site initiation and training as well as shipping and logistical disruption.
Breakthrough device designation is recognition of importance
In addition to CE Marking approval, the OncoSilTM device has now been officially classified as a “breakthrough device” as defined under EU Medical Device guidance.
In the EU a “breakthrough device” is defined as one that delivers clinical benefit to patients for unmet medical needs which are life threatening, and for which current medical alternatives are insufficient or carry significant risks.
The OncoSilTM device is now officially designated as a breakthrough device in the EU and the UK, and this come shortly after receiving the same designation in the US.
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