OncoSil 'fast-track' review for CE Mark confirmed for October

Company News

OncoSil Medical (ASX: OSL) has announced that it has been scheduled for a Conformité Européenne (CE) Mark Fast Track review for OncoSil.

OncoSil is a localised radiation therapy treatment with the potential benefit of reducing the risk of serious side effects often associated with standard radiotherapy.

According to the company, the review has been scheduled following the submission of the CE Mark Design Dossier for pancreatic and primary liver cancer in July.

The 'fast-track' review will assess the company’s design dossier and make a recommendation in respect of the CE Mark for OncoSil. It will take place in the UK over four days commencing early October. Upon completion, a determination will be made to either recommend the granting of CE Mark certification for OncoSil, or ask the company to provide additional information.

CE Mark is the mandatory regulatory designation required to commercially market and sell OncoSil in the EU.

"A CE Mark for OncoSil would also facilitate commercialisation and sales in other major markets, including Australia, Canada, and Singapore," said the company.

According to OncoSil CEO, Daniel Kenny, “I am delighted with the progress of our CE Mark process for the commercialisation of OncoSil. The filing is the culmination of an intensive eight months of work by the technical team. We now look forward to meeting with the regulator, and to securing CE Mark for OncoSil and being in a position to offer a new treatment option for the dreaded diseases of pancreatic cancer and liver cancer.”