• FDA granted Humanitarian Device Exemption (HDE) approval for OncoSil device
• First and only U.S. FDA-approved device for distal cholangiocarcinoma (dCCA)
• Annual U.S. market opportunity estimated at A$80 million

OncoSil Medical Limited has announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Device Exemption (HDE) approval for the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA). This approval marks a significant milestone for OncoSil Medical, providing U.S. marketing authorization for the OncoSil device under the HDE framework. The OncoSil device is the first and only U.S. FDA-approved Class III device for the treatment of dCCA, a rare and aggressive cancer with limited treatment options. The approval covers patients with unresectable, non-metastatic dCCA who have limited treatment options, with a median overall survival of approximately 6.7 months. The annual U.S. addressable market is approximately 1,000 patients, representing a potential addressable market of approximately A$80 million per annum.

Annual U.S. addressable market of approximately A$80 million per annum

OncoSil Medical will commence its focused U.S. commercialisation strategy, targeting leading academic cancer centres and specialist hepatobiliary oncology teams, with the Company expecting to launch OncoSil in the U.S. during the second half of FY27.