OncoSil Medical (ASX: OSL) says commercialisation of OncoSil in Europe remains on schedule for approval in the third quarter.
In an investor update, the company said that the filing remains on schedule for Conformité Européenne (CE) Mark approval following the recent grant of ISO certification for OncoSil.
"Regulatory advice for CE Mark approval in pancreatic cancer is to also include primary liver cancer as it strengthens its filing position on clinical data and carries no additional risk," the company said. "OncoSil has clinically demonstrated target tumour regression (tumour shrinkage) in both solid tumour indications of pancreatic and liver cancer."
According to the company, successful commercialisation in Europe would facilitate sales in other major markets.
OncoSil is a localised radiation therapy treatment that has the potential benefit of reducing the risk of serious side effects often associated with standard radiotherapy.
As a medical device, it also has a shorter time to market than traditional drugs.
