OncoSil Medical (ASX:OSL) used its 2025 Annual General Meeting to highlight a year of decisive regulatory and clinical progress that positions the company for accelerated commercial growth.
In his first address as Chairman, Dr Thomas Duthy described it as a turning point, marked by “significant regulatory progress, strengthening of our clinical position, targeted commercial expansion, and critical steps taken to strengthen the Company’s capital position.”
A significant milestone was Germany’s approval of a fully funded G-BA clinical trial, an endorsement Dr Duthy said would “broaden access for the OncoSil device across the German public hospital system” and support reimbursement discussions across Europe. The trial is expected to commence in the first half of 2026, creating the conditions for “meaningful revenues” and a significant lift in treatment volumes. Germany also recorded a 40 per cent surge in hospital applications and its first commercial sale in October.
OncoSil also secured full MDR certification in January 2025, removing post-market restrictions and streamlining hospital onboarding in the EU and UK. Dr Duthy described the approval as the result of “years of disciplined investment in quality systems, manufacturing, and clinical validation.”
The company strengthened its clinical evidence base with independent comparative data presented at Digestive Disease Week, demonstrating superior survival outcomes with OncoSil compared with standard radiation therapy. Two global trials, PANCOSIL and TRIPP-FFX, completed recruitment. PANCOSIL’s preliminary results demonstrate the feasibility of percutaneous delivery and a median overall survival of 20.6 months.
To support expansion, OncoSil raised more than $14 million in the financial year 2025 and ended September with $5.9 million in cash, supplemented by R&D tax incentives.