Nigel Lange, CEO & Managing Director, said:

"This is one of the most important milestones in OncoSil Medical's journey to date. Completing our FDA submission reflects years of dedication from our team and our clinical partners and brings us to the final stage of the regulatory process in the United States.

For patients with distal cholangiocarcinoma, treatment options remain extremely limited. If approved, the OncoSil™ device has the potential to provide clinicians with a new localised treatment option for this challenging disease while establishing our first commercial presence in the U.S.

We recognise that the FDA review process remains ongoing and we look forward to working closely with the Agency as it completes its assessment. Reaching this stage is a testament to the quality of the clinical evidence, the strength of our regulatory strategy and the commitment of everyone who has contributed to the development of the OncoSil™ device."