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Sydney-based medical device company OncoSil Medical (ASX: OSL) has completed the submission of its Humanitarian Device Exemption (HDE) application to the US Food and Drug Administration (FDA) for its OncoSil device for the treatment of distal cholangiocarcinoma, a form of bile duct cancer.
The FDA is expected to complete its review within 45 days, with approval set to make OncoSil the first and only FDA-approved Class III medical device for the condition and hand the company its first US commercial regulatory clearance.
Distal cholangiocarcinoma (dCCA) affects fewer than 8,000 patients annually in the United States, qualifying the device for the HDE pathway, which is designed to bring treatments to market for rare diseases and conditions that would otherwise lack viable commercial incentives for full-scale clinical trials.
The filing follows a 9 June announcement that the FDA had confirmed all outstanding questions relating to the application had been satisfactorily addressed and moved it to the final review stage, requesting only final device labelling and any post-market study updates.
OncoSil is a brachytherapy device that delivers targeted radiation directly to tumours via phosphorus-32-impregnated microparticles implanted under endoscopic ultrasound guidance. It is designed to be used alongside standard chemotherapy for locally advanced, unresectable disease.
"This is one of the most important milestones in OncoSil Medical's journey to date," says CEO Nigel Lange.
"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 US.
"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."
The HDE submission caps a period of accelerating regulatory and commercial momentum for the company.
On 20 May, OncoSil secured Therapeutic Goods Administration approval in Australia for the use of its device in the treatment of locally advanced pancreatic cancer, broadening its approved indications beyond its existing European CE Mark.
On the commercial front, OncoSil reported dose sales up 60 per cent year-on-year in the third quarter of FY26, with the number of commercially active treatment centres rising 56 per cent to 28.
The company has also been selected for the EU-funded PALACROS consortium, which will sponsor the PULSE Phase II clinical trial across 120 patients.
OncoSil has estimated the consortium arrangement will save the company approximately $9 million compared with the cost of a self-sponsored study.
Shares in OncoSil were trading 19 per cent higher today at $1.17 at 12.52pm.
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