OncoSil Medical files for 45-day FDA review

• OncoSil Medical has submitted its final documentation to the United States Food and Drug Administration to complete its device application.
• The company's shares rose 7.28% to close at $0.81 following recent regulatory milestones.
• The commercial application aims to grant the business access to the largest medical device market in the world.

Medical device developer OncoSil Medical (ASX:OSL) has completed its Humanitarian Device Exemption application submission to the U.S. Food and Drug Administration for its brachytherapy platform, initiating an expected 45-day review period.

The milestone marks the transition into the official review phase after years of clinical preparation by the company and its partners.

"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," said OncoSil Medical CEO & Managing Director Nigel Lange.

If the regulator grants approval, the company stated the device would become the first Class III medical device indicated specifically for treating distal cholangiocarcinoma in the United States.

Following the announcement, the OncoSil Medical share price was up at $0.81.

The business recently expanded its European footprint by joining a major academic research consortium to evaluate repeat device implantations.

The company stated that the approval pathway would establish an important commercial platform for future growth.