OncoSil Medical (ASX:OSL) has provided an update on its CE Mark application for OncoSil™.
OncoSil™ is a targeted radioactive isotope (Phosphorous-32), implanted directly into a patient’s pancreatic tumours via an endoscopic ultrasound.
Treatment with OncoSil™ is intended to deliver more concentrated and localised beta radiation compared to external beam radiation.
Update
OncoSil said that based on information received from BSI, the company has advised that CE Certification for the pancreatic cancer indication will now be granted subject to the following conditions:
- Provision of supplemental data from 20 locally advanced pancreatic cancer patients supporting the existing safety and clinical performance data already reviewed; and
- OncoSil Medical agrees to undertake a Post Marketing Clinical Follow-up program.
The 20 patient supplemental data request from BSI is consistent with the request received from the US FDA prior to granting an Investigational Device Exemption (IDE) in July 2016.
The company is well positioned to provide the supplemental data from its Global Pancreatic Clinical Study program.
Daniel Kenny, chief executive officer, commented:
"After a lengthy and complex review it is clear that the company is now well on its way to obtaining the CE Mark this year.
"I am pleased with the progress that the OncoSil team has made over the past 12 months in securing the IDE from the FDA, and the on-boarding of top tier recruitment sites in Australia, UK and the US.
"OncoSil is well positioned to collect the supplemental data quickly and to finalise our post marketing follow up program to secure the CE Mark in 2017."
The CE Mark review for the Primary Liver indication (HCC) is ongoing.