OncoSil Medical Ltd (ASX:OSL, OTC:OCMLF) has secured US Food and Drug Administration (FDA) approval for its OncoSil™ targeted radiation device to treat distal cholangiocarcinoma (dCCA), giving the company US marketing authorisation and opening an estimated A$80 million annual addressable market.
The FDA granted Humanitarian Device Exemption (HDE) approval for OncoSil in patients with unresectable, non-metastatic dCCA, a rare and aggressive form of bile duct cancer for which treatment options remain limited.
The approval completed its HDE regulatory process and made the device the first and only US FDA-approved Class III device for the treatment of dCCA.
US market opportunity
The company estimates around 1,000 patients each year in the US could fall within the approved indication, representing a total addressable market of approximately A$80 million annually.
Around 8,000 people are diagnosed with cholangiocarcinoma in the US each year, with dCCA estimated to account for 30%-40% of cases.
FDA approval covers patients aged over 21 with dCCA that is both unresectable — either locally advanced or unsuitable for surgery — and non-metastatic, with OncoSil used as an adjunct to systemic therapy.
OncoSil CEO and managing director Nigel Lange described the approval as the most significant regulatory milestone in the company’s history.
“Our attention now turns to successfully launching OncoSil™ in the United States,” Lange said.
“We will work with leading cancer centres and clinical teams to establish treatment sites, advance reimbursement and market access, and build the foundations for sustainable adoption.”
The OncoSil device and dCCA
OncoSil is designed for intratumoural implantation using endoscopic ultrasound guidance, delivering targeted radiation directly into a solid tumour.
dCCA develops in the distal common bile duct near the head of the pancreas and is often diagnosed at an advanced stage. More than 50% of patients are unable to undergo potentially curative surgery, while reported median overall survival for patients with unresectable, non-metastatic disease is approximately 6.7 months.
Treatment typically involves biliary stenting together with systemic therapy and, for selected patients, radiation therapy.
Post-approval study
Under the FDA approval conditions, initial US distribution of OncoSil will be restricted to a maximum of 5 treatment centres participating in an FDA-required Post-Approval Study.
The prospective multicentre study is expected to enrol 30 patients and assess the device’s safety and probable benefit, with participants followed for up to 24 months.
OncoSil expects each patient enrolled in the study to receive a reimbursed treatment, which the company estimates could generate US$1.7 million in revenue in total.
Next steps
OncoSil will now progress a focused US commercialisation strategy targeting leading academic cancer centres and specialist hepatobiliary oncology teams.
The company plans to establish priority treatment centres, engage key opinion leaders and multidisciplinary clinical teams, expand clinician training and advance reimbursement and market-access arrangements ahead of an expected US launch during the second half of FY27.
About OncoSil Medical
OncoSil Medical is a medical device company focused on interventional oncology and targeted intratumoural radiation therapies.
Its OncoSil device uses Phosphorous-32 microparticles placed directly into tumours alongside chemotherapy, with the aim of delivering radiation to the tumour while limiting exposure to surrounding organs.
The device has CE Marking approval in the EU and UK and is approved for sale in more than 30 countries, with commercial treatments already undertaken across several European markets, Türkiye and Israel.