OncoSil Medical (ASX:OSL) has capped a significant year with major regulatory approvals, clinical trial progress, and expanding commercial traction for its brachytherapy device in pancreatic cancer.
In January, the company achieved Medical Device Regulation (MDR) certification in Europe, lifting previous post-market restrictions and simplifying the initiation of treatment across the EU and UK. That milestone was followed by approval from Germany’s Federal Joint Committee (G-BA) for a pivotal trial. This decision not only strengthens OncoSil’s reimbursement prospects in Germany but also provides a reference point for other European markets.
Clinical momentum accelerated throughout the year. By June, recruitment in the company’s TRIPP-FFX and PANCOSIL studies had reached 99 and 95 per cent, respectively, with both studies completing enrolment in July. At the same time, German hospitals significantly increased their applications for temporary reimbursement of the OncoSil device, highlighting growing institutional confidence.
Evidence of OncoSil’s clinical benefit also deepened. A comparative analysis presented at Digestive Disease Week in San Diego in May showed that patients with locally advanced pancreatic cancer treated with OncoSil achieved a median overall survival of 22 months compared to 14 months with stereotactic body radiation therapy (SBRT). Progression-free survival and safety outcomes also favoured OncoSil, reinforcing its potential role in improving treatment outcomes.
Commercial traction mirrored the regulatory and clinical progress. More than 30 patients were treated in Spain during the year, while new distribution agreements extended OncoSil’s reach into the Nordic region, Egypt, and Gulf Cooperation Council countries. Revenue increased 127 per cent to $1.17 million, driven by stronger device sales, with approximately 60 per cent from direct sales and the remainder through distributors.
The company reported a net loss of $15.1 million, compared with $11.9 million in 2024, as employee and trial costs rose. Cash reserves stood at $5.1 million at 30 June 2025, supported by more than $14 million raised through placements and share purchase plans, alongside a $1.05 million R&D tax incentive. A 1-for-400 share consolidation was also completed in June to streamline the capital structure for future investor engagement.
OncoSil also strengthened its leadership and governance. New appointments included Non-Executive Directors Lel Smits and, in July, Thomas Duthy, both bringing deep experience in governance, communications, and healthcare capital markets. Shelley Steyn, Chief Financial Officer, joined the company in May, bolstering its financial leadership.
Chief Executive Nigel Lange said the year’s achievements positioned OncoSil at a genuine inflection point. “With MDR certification achieved, key trials fully recruited, and sales growing across multiple regions, we are entering FY26 with the strongest foundation in the company’s history,” he said.
Chairman Douglas Cubbin echoed the sentiment, describing 2025 as a transformational year. “We now have the platform to accelerate adoption, expand reimbursement, and demonstrate the true impact of OncoSil as a meaningful new option for patients with pancreatic cancer.”
Looking forward, OncoSil will focus on deepening commercial uptake in Europe, supporting reimbursement negotiations, and advancing its regulatory pathway in other markets, including the US, where a Humanitarian Device Exemption application for bile duct cancer is pending with the FDA. Preliminary data from the PANCOSIL study are expected later in 2025, while results from the TRIPP-FFX trial are anticipated in early 2026.