Australian Lifesciences company OncoSil Medical (ASX:OSL) has provided an update on its Conformité Européenne (CE) Mark application for its OncoSilTM localised radiation treatment for cancer.
Last month the company was granted a Fast Track review by the European regulator to assess its CE Mark application for OncoSil™ in pancreatic and primary liver cancer (HCC).
OncoSil has advised that the Fast Track Face-to-Face review phase has been completed, and it now awaits the final outcome of the review as the Notified Body continues its assessment over the coming weeks.
The company was pleased with the review meeting and anticipates that the Notified Body will make a decision in respect of the CE Mark for OncoSil™ in November.
A CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil™ in the European Union, and would also facilitate regulatory approvals, commercialisation and sales of OncoSil™ in other major markets, including Australia, Canada, and Singapore.
How OncoSil™ works
OncoSil™ is an implantable nuclear medicine (radiotherapy) device that has been successfully piloted in pancreatic and liver cancer.
The device is inserted directly into the centre of the tumour using well established technology.
OncoSil™ has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer.
Buyers and users of OncoSil™
The devices would be purchased by governments, national health services, or individual hospitals.
The next step is that the surgeons involved need to be trained and certified to use OncoSil's device.
Every physician or surgeon involved in using the device would have to be certified or trained by OncoSil, which would be part of its license requirements.
OncoSil would therefore require clinical adoption from both medical and radiation oncologists, along with GI surgeons and liver surgeons to cover the two indications.
OncoSil makes key appointments
Last week OncoSil made two new key appointments in preparation for the commercialisation of its OncoSil™.
The appointments include David James as global head of manufacturing operations, and Greg Rogers as manufacturing engineering manager.
James brings more than 20 years’ experience, including six years with leading cancer treatment company Sirtex Medical (ASX:SRX) as global operations manager.
Rogers has more than 27 years experience in leadership, operations, quality control and change management roles in the medical device and diagnostics sectors.
Broker valuation
Wilson HTM recently initiated coverage on OncoSil with a Speculative Buy rating and a price target of A$0.35.
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