The British Standards Institute (BSI) has granted the OncoSil System the prestigious European CE marking. This certification validates the OncoSil device and its clinical performance in treating locally advanced pancreatic cancer. Additionally, OncoSil has been designated as a breakthrough therapy, acknowledging its potential to address unmet medical needs.

CE Marking Certification

CE stands for Conformité Européenne, which translates to "European Conformity" in English. A product can lawfully be sold anywhere in the EU and the European Economic Area if it has received CE certification, which is an EU safety directive indicating that a product has passed specific tests.

The CE Marking certification is like a gold star for the OncoSil device. It shows that the device meets high standards for safety and effectiveness. Studies by Oncosil found that patients treated with OncoSil and chemotherapy lived, on average, for 16.1 months – nearly twice as long as those using only chemotherapy.

OncoSil BrachyTherapy Device

The OncoSil device is now officially classified as a "breakthrough device," meaning it brings important benefits to patients facing life-threatening conditions like pancreatic cancer. This recognition covers not only the European Union but also the United Kingdom and the United States.

Clinical Data from PanCO Study

The approval is based on solid evidence from the PanCO study, which compared OncoSil with other standard treatments for pancreatic cancer. Pancreatic cancer is often aggressive and difficult to treat. Until now, options for locally advanced (meaning it hasn't spread to other parts of the body) cases haven't been very effective.

The results showed that OncoSil, when combined with chemotherapy (CT), provided:

• Excellent local disease control: 90.5% control after 16 weeks.
• Prolonged Overall Survival: 16.1 months, almost double that of CT alone.
• Encouraging Surgical Resection Rates: 23.8% compared to 7.7% with CT alone.
• Prolonged Progression-Free Survival: 9.3 months, better than CT.
• Higher Disease Control Rate: 100% disease control and 31.0% overall response.
• Marked Tumour Volume Reduction: Up to 90% reduction at Week 16.
• Significant CA19-9 Tumour Marker Reduction: -77.8%.

Safety and Tolerability

Importantly, the OncoSil device demonstrated an excellent safety profile over an extended study period. There were no major safety concerns or unexpected issues associated with the device or its implantation procedure. This makes OncoSil a valuable treatment option for patients with unresectable, locally advanced pancreatic cancer.

The achievement of CE Marking and the breakthrough therapy designation are pivotal milestones for OncoSil™, an ASX-listed company under the ticker code OSL. This recognition extends across the EU, the UK, and the US, as announced on ASX on 18 March 2020. OncoSil, a first-in-class medical device developed by the company, consists of microparticles containing phosphorus-32 (P-32), a pure beta-emitter radioisotope. These microparticles are implanted directly into a patient's pancreatic tumour through endoscopic ultrasound guidance.

These designations underscore OncoSil's potential to revolutionise the treatment landscape for pancreatic cancer. Despite challenges, including those faced by an ASX-listed company, OncoSil remains steadfast in its commitment to providing a breakthrough treatment option for patients in need.