The US Food and Drug Administration (FDA) has granted OncoSil Medical a humanitarian device exemption (HDE) approval for its namesake platform in the treatment of a rare type of bile duct cancer.
As per the HDE, the OncoSildevice is authorised to treat distal cholangiocarcinoma (dCCA). The technology works by delivering targeted beta radiation therapy directly into tumours via injection, which destroys cancer cells while protecting nearby healthy organs. The HDE for dCCA follows the platform’s EU clearance for locally advanced pancreatic cancer in 2020.
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Around 10,000 patients in the US are diagnosed with dCCA each year, according to the Cholangiocarcinoma Foundation. The cancer is associated with poor survival outcomes, with median overall survival (OS) as low as 6.7 months, given the cancer often grows silently and is diagnosed late, with palliative stenting, standard chemotherapy, and general radiation providing limited effectiveness.
Under the terms of the Australian company’s HDE, the device’s US rollout will initially be restricted to a maximum of five treatment centres, with appropriately trained practitioners, as part of an FDA-mandated post-approval study (PAS).
OncoSil’s multicentre, prospective PAS will evaluate the safety and potential benefit of its device in the approved patient population of adults aged 21 and above with unresectable and non-metastatic dCCA. Expected to enrol 30 patients, the study will follow enrolled patients for up to 24 months, with the final study protocol and associated requirements of the PAS expected to be confirmed with the FDA in due course.
OncoSil anticipates launching its namesake device in the US in Q2 of fiscal year 2027 (FY27).
OncoSil’s CEO, Nigel Lange, said: “FDA approval of the OncoSil device under the HDE pathway represents the most significant milestone in OncoSil Medical’s history and a transformational moment for our company. Most importantly, it provides a pathway making OncoSil available for patients with dCCA in the US, where there remains significant unmet clinical need.
“Our attention now turns to successfully launching OncoSil in the US. 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.”
