Latest Oncosil Medical News

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

OncoSil Medical has gained Saudi FDA approval for its OncoSil™ device, enabling full reimbursement and commercial access in Saudi Arabia, the Middle East's largest healthcare market.

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

OncoSil Medical secures a spot in the PALACROS consortium, advancing its OncoSil™ device through a cost-efficient Phase II trial targeting unresectable locally advanced pancreatic cancer.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

OncoSil Medical has secured a pivotal ethics committee approval in Italy, reclassifying its OSPRItaly registry and enabling a streamlined procurement process that could double the number of authorised hospitals using its OncoSil™ device by mid-2027.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

OncoSil Medical’s interim OSPREY Registry data show strong safety and promising survival outcomes for its targeted radiotherapy device in unresectable locally advanced pancreatic cancer, surpassing historical benchmarks.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Oncosil Medical Ltd’s OSLOE securities have been suspended from trading by the ASX due to non-compliance with listing rules, raising questions about the company’s next steps.