OncoSil Medical device clears US FDA review

• The United States Food and Drug Administration granted humanitarian device exemption approval for the OncoSil device.
• The OncoSil Medical share price moved following the regulatory announcement.
• The company aims to launch the medical device in the United States during the second half of fiscal year 2027.

OncoSil Medical (ASX:OSL) received approval from the United States Food and Drug Administration for its OncoSil device to treat distal cholangiocarcinoma with an annual U.S. addressable market valued at approximately $80 million.

The regulatory decision completes the business regulatory process and provides marketing authorisation in the United States for the targeted radiation therapy device.

"[The approval] provides a pathway making OncoSil available for patients with dCCA in the United States, where there remains significant unmet clinical need," said OncoSil Medical CEO and Managing Director Nigel Lange.

The company stated that the annual addressable market covers approximately 1,000 patients in the United States who face limited treatment options.

OncoSil Medical plans to launch the device in the United States during the second half of fiscal year 2027.

Following the announcement, the OncoSil Medical share price was down at $1.20.

The medical device company focuses on developing targeted radiation therapies for difficult-to-treat cancers using selected placement of microparticles alongside chemotherapy.