Ann: Positive CE Mark Status Report, page-136

PUBLISHED BYTeam Kalkine

OncoSil Medical Ltd (ASX: OSL) A medical device company
OncoSil Medical Limited (ASX: OSL) has a prime focus on providing localised treatments for patients with pancreatic and liver cancer seeking to improve radiation for cancer patients. OncoSil™ a targeted radioactive isotope (Phosphorus-32), that is implanted directly into a patient’s pancreatic tumours through an endoscopic ultrasound is OncoSil Medical’s lead product.
OncoSil Receives Positive CE Mark Status ReportIn a recent announcement dated 01 November 2019, the company announced on receipt of a positive CE Mark Status Report from the British Standards Institute (BSI) confirming the completion of data analysis presented to Clinical Oversight Committee (COC) for review.To further assess the post market clinical, follow up (PMCF) programme, the CE Mark review process advances to the next and final phase outlining how the OncoSil™ device would be rolled out into the European market by OncoSil.PMS/PMCF plans to be presented in detail to BSI on November 14th.
An Overview of OncoSil DeviceSource:
Company’s ReportOncoSil’s Investment HighlightsOncoSil’s has a clear mission to commersialise groundbreaking implantable radiotherapy treatment for solid tumours with sound science that demonstrated an excellent local disease control, prolonged overall survival, promising resection rates.
In addition, superior outcomes to comparators as well as outstanding safety and tolerability profile.
OncoSil’s clear strategy path include$2 billion market opportunity for improving standard of care in pancreatic cancer.
Aiming for CE Mark for unresectable locally advanced pancreatic cancer.
Post the Grant of US Humanitarian Use Designation (HUD) the company is aiming for US Humanitarian Device Exemption (HDE) for bile duct cancer.
Strong backbone of highly experienced management team.
For supply of commercial quantities, manufacturing and logistics have already been optimised.