OncoSil™ receives CE Mark approval
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.
Where to invest $1,000 right now
Short-term positions in small, early stage ASX companies,
with high potential and near term price catalysts.
Focusing on resource exploration, early-stage tech, and biotech.
Exceptional opportunities across a broad range of
early-stage growth sectors with strong management.
Seeking 1,000% plus returns across medium to long-term holds.
Longer-term positions in a variety of sectors.
Seeking strong management where traction
is established and have entered into a growth phase.
Like this article? You may like...
S3 Consortium Pty Ltd (CAR No.433913) is a corporate authorised representative of LeMessurier Securities Pty Ltd (AFSL No. 296877). The information contained in this article is general information only. Any advice is general advice only. Neither your personal objectives, financial situation nor needs have been taken into consideration. Accordingly you should consider how appropriate the advice (if any) is to those objectives, financial situation and needs, before acting on the advice.
Conflict of Interest Notice
S3 Consortium Pty Ltd does and seeks to do business with companies featured in its articles. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this article. Investors should consider this article as only a single factor in making any investment decision. The publishers of this article also wish to disclose that they may hold this stock in their portfolios and that any decision to purchase this stock should be done so after the purchaser has made their own inquires as to the validity of any information in this article.
Publishers Notice
The information contained in this article is current at the finalised date. The information contained in this article is based on sources reasonably considered to be reliable by S3 Consortium Pty Ltd, and available in the public domain. No “insider information” is ever sourced, disclosed or used by S3 Consortium.
