OncoSil’s MDR Approval and German Hospital Expansion Set Stage for Market Acceleration
OncoSil Medical has reported a remarkable 233% increase in dose sales for Q3 FY25, alongside significant regulatory approvals and strategic expansions that position the company for accelerated growth.
- Record quarterly dose sales up 233% year-on-year in Q3 FY25
- Year-to-date revenues surged 135%, surpassing full FY24 figures
- Received $1.05 million R&D tax incentive supporting ongoing development
- Achieved EU Medical Device Regulation (MDR) approval, easing market access
- Expanded German hospital access with 120 facilities authorized to negotiate fees
Record Dose Sales Signal Growing Clinical Adoption
OncoSil Medical Ltd (ASX: OSL) has delivered an impressive performance in the March 2025 quarter, reporting a 233% increase in dose sales compared to the same period last year. This surge marks a quarterly record for the company and underscores the growing clinical acceptance of its OncoSil™ brachytherapy device, designed for patients with unresectable locally advanced pancreatic cancer (LAPC).
Year-to-date dose sales have risen by 83%, driving a 135% uplift in revenues over the first nine months of FY25. Notably, the revenue generated in this period already exceeds the total revenue recorded for the entire FY24, highlighting sustained commercial momentum across key geographic markets.
Strategic Advisory Boards and Market Expansion
OncoSil convened advisory board meetings in the UK and Germany early in 2025, gathering leading pancreatic cancer experts to chart strategic pathways for the device. The UK meeting focused on leveraging clinical experience and exploring broader indications, including borderline resectable and metastatic disease. Meanwhile, the German meeting concentrated on positioning OncoSil within the German healthcare system, aligning on study priorities, and supporting regulatory initiatives such as the Federal Joint Committee (G-BA) study.
These engagements have been pivotal in expanding OncoSil’s footprint, particularly in Germany, where 120 hospitals are now authorized to negotiate fees for the device under the NUB innovation program, up 43% from 84 hospitals in 2024. This expansion reflects increasing recognition and demand within one of Europe’s largest healthcare markets.
Regulatory Milestones and Financial Strength
In January 2025, OncoSil secured Medical Device Regulation (MDR) certification from BSI, the EU Notified Body. This approval removes previous post-market restrictions, allowing the company to bypass local ethics and hospital governance approvals, thereby accelerating market access across the EU and UK. The operational efficiencies anticipated from this milestone are expected to generate significant cost savings over the next three years, which will be reinvested into growth initiatives.
Financially, the company received a $1.05 million R&D tax incentive refund for eligible activities undertaken in 2024, bolstering its development efforts. The quarterly cash flow report shows a cash balance of $5.44 million at quarter-end, with ongoing investments in research, development, and commercial operations.
Leadership Enhancements to Support Growth
OncoSil has strengthened its leadership team with the appointment of Ms Lel Smits as a Non-Executive Director and Ms Shelley Steyn as Chief Financial Officer, effective May 2025. Ms Smits brings extensive governance and strategic expertise, while Ms Steyn adds over 17 years of financial leadership experience. These appointments align with the company’s ambitions to scale operations and navigate the complexities of global market expansion.
CEO Nigel Lange highlighted the significance of these developments, noting that the strong sales growth and regulatory achievements reflect increasing clinician confidence and the real-world impact of the OncoSil™ device on patient outcomes. He emphasized the company’s commitment to advancing clinical trials, including the TRIPP-FFX and PANCOSIL studies, which are critical to expanding the evidence base and supporting further market penetration.
Bottom Line?
With robust sales momentum, regulatory clearances, and strategic leadership in place, OncoSil is poised to accelerate its global impact in pancreatic cancer treatment.
Questions in the middle?
- How will the lag in revenue recognition affect upcoming quarterly financial results?
- What are the timelines and expected outcomes for the TRIPP-FFX and PANCOSIL clinical trials?
- How might expanded hospital access in Germany influence OncoSil’s market share and pricing power?