- Meditech company OncoSil is in the final stages of landing an important CE Mark certification
- A CE approval would let OncoSil sell its namesake cancer treatment in Europe
- The treatment is a medical implant designed to augment radiation treatment for pancreatic and liver cancer
- OncoSil shares have dipped 9.52 per cent today at midday trade, valued at 19 cents each
OncoSil Medical is edging closer to gaining the CE mark approval for its namesake cancer treatment product.
OncoSil’s flagship product is a medical implant designed to deliver a more concentrated radiation treatment compared to standard radiation for cancer patients.
The device is implanted directly into a patient’s tumour and is currently designed specifically for pancreatic and liver cancer.
CE Mark certification for the product essentially means it conforms to European health and safety standards, and as such is eligible for sale and distribution across the European Economic Area.
For OncoSil, the company told shareholders today it is ready to formally submit its OncoSil device to the British Standards Institute (BSI) for CE Mark review, following a meeting regarding the company’s Post Market Surveillance and Post Market Clinical Follow-up plans.
OncoSil CEO Daniel Kenny said the company’s presentation of these plans was well received.
“Based on the discussions held we will now finalise these plans and submit to BSI as soon as possible,” he said.
“We are delighted with the continuing progress with our CE Marking submission.”
With the product now in the final stages of review, OncoSil said it will keep the market updated about developments in the important CE Mark certification.
The OncoSil device was approved for a clinical study in the United States by the Food and Drug Administration in 2016. The study is yet to be conducted.
OncoSil shares have dipped 9.52 per cent at midday trade, trading for 19 cents each in a $119.83 million market cap.