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- Australian medtech OncoSil Medical (OSL) has announced its OncoSil device has received European CE Marking approval
- The device is designed to treat locally advanced pancreatic cancer (LAPC) in combination with chemotherapy
- Studies have shown the OncoSil device extends the patient’s survival rate, reduces tumour volume, and is safe to apply
- This approval comes off the back of OncoSil being classified as a breakthrough device
- This means it has been recognised as something that can fulfil an unmet medical need and potentially save a patient’s life
- Unfortunately, the COVID-19 pandemic is set to impede the device’s official launch, as hospital access becomes increasingly limited.
- OncoSil is up 24.1 per cent following today’s news and shares are trading for 16.8 cents each
Australian medtech OncoSil Medical (OSL) has announced its OncoSil device has received European CE Marking approval.
The device is designed to treat locally advanced pancreatic cancer (LAPC) in combination with chemotherapy.
Essentially, the OncoSil device comprises microparticles containing phosphorus-32 (P-32), which is a pure beta-emitter radioisotope that is directly implanted into a patient’s pancreatic tumour through endoscopic ultrasound guidance.
This approval is a major milestone and validation for OncoSil and means the device can now be marketed and sold within the European Union and the United Kingdom.
“Designation of the OncoSil 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,” CEO and Managing Director Daniel Kenny said.
A breakthrough device
On March 18, OncoSil announced its device of the same name was officially classified as a breakthrough device by the U.S. Food and Drug Administration (FDA). Following today’s CE Marking approval, it is now also classified as a breakthrough device in the EU and U.K.
A breakthrough device delivers clinical benefit to patients for unmet, life-threatening medical needs. These devices offer an alternative, innovative treatment to replace current insufficient and risky treatments.
Studies have shown a median overall survival of 16.1 months in patients treated with OncoSil in combination with chemotherapy. This extension compares to between nine and 11 months of the current median overall survival rate.
The company’s PanCO study delivered compelling results, including a reduction in the tumour volume.
Overall, treatment with OncoSil resulted in a median maximal volume reduction of 52 per cent from baseline. At 16 weeks, the median tumour volume reduction was 38 per cent population. Additionally, a number of patients showed significant tumour volume reductions; up to 74 per cent at week eight and up to 90 per cent at week 16.
The OncoSil device has also proved to be safe to use with no evidence of significant safety concerns, or unexpected or serious toxicities associated with the device or the implantation procedure over a prolonged timeframe.
Unfortunately, the current COVID-19 pandemic is set to impact the launch of the device, as a result of limited hospital access in the next few months for new site initiation and training, as well as shipping and logistical disruption.
OncoSil is up 24.1 per cent following today’s news and shares are trading for 16.8 cents each at 11:47 am AEDT.
