OncoSil Medical has received US Food and Drug Administration approval for its OncoSil device to treat patients with unresectable, non-metastatic distal cholangiocarcinoma, giving the Australian medical-device company a pathway into the world’s largest healthcare market.
The approval, granted under the FDA’s Humanitarian Device Exemption framework, is the most significant regulatory milestone in OncoSil’s history and clears the way for commercialisation of the targeted radiation treatment in the United States.
OncoSil said the device is the first and only FDA-approved Class III device for distal cholangiocarcinoma, a rare and aggressive cancer affecting the lower section of the bile duct near the pancreas. The indication covers adults aged over 21 years whose disease cannot be surgically removed and has not spread to distant parts of the body, with the treatment used alongside systemic therapy.
The device delivers Phosphorus-32 microparticles directly into a tumour through an injection performed under endoscopic ultrasound guidance. The company argues that this intratumoural approach can deliver a concentrated dose of radiation to the tumour while limiting exposure to surrounding organs.
For patients with unresectable disease, the need for additional treatment options is substantial.
OncoSil cited a reported median overall survival of about 6.7 months for people with unresectable, non-metastatic distal cholangiocarcinoma.
More than half of patients are unable to undergo potentially curative surgery, while disease progression can cause repeated bile duct obstruction, stent blockage, infection and hospital admissions that may interrupt systemic treatment.
Chief executive Nigel Lange said the decision was transformative for the company and would allow eligible US patients to access an additional treatment option in an area of significant unmet need.
“This approval marks the beginning of an exciting new chapter for OncoSil Medical as we work to make a meaningful difference to patients facing this challenging cancer,” he said.
The Humanitarian Device Exemption pathway applies to devices intended for rare diseases or conditions affecting no more than 8,000 people annually in the United States. Unlike the conventional premarket approval route, the framework does not require the same demonstration of effectiveness. Instead, the FDA must determine that the device does not pose an unreasonable or significant risk and that its probable benefit outweighs the risks associated with use.
OncoSil estimates that about 8,000 people are diagnosed with cholangiocarcinoma in the United States each year. Distal cholangiocarcinoma is estimated to represent 30 per cent to 40 per cent of those cases, with the company identifying a potential eligible population of about 1,000 patients annually.
Based on an assumed selling price of US$55,000 per device and an Australian dollar to US dollar exchange rate of 0.70, OncoSil estimates the addressable US market at about A$80 million a year.
The approval comes with an FDA requirement for a post-approval study, initially limiting the device's use and distribution to a maximum of five treatment centres staffed by appropriately trained practitioners. The multicentre prospective study is expected to enrol 30 patients and follow them for up to 24 months to assess safety and probable benefit in the approved population.
OncoSil expects patients treated through the study to receive reimbursed treatment, which it estimates could generate US$1.7 million in revenue.
The company plans to focus its US launch on leading academic cancer centres and specialist hepatobiliary oncology teams. It expects to launch the device in the second half of financial year 2027, subject to establishing and activating priority treatment sites, training clinicians, engaging key opinion leaders and progressing reimbursement and market-access arrangements.
OncoSil already has marketing authorisation in the European Union and United Kingdom and says the device is approved for sale in more than 30 countries, including Australia, Turkey, Saudi Arabia and Israel.
