OncoSil Medical Achieves Record Quarterly Dose Sales in Q3 FY25
OncoSil Medical Limited (ASX:OSL)
Key Highlights
• Record quarterly dose sales reported in the March 2025 quarter, on the back of continued growth in clinical adoption of the OncoSil™ device
• Advisory Board Meetings in UK and Germany define strategic pathways for OncoSil™ device
• OncoSil Medical receives $1.05m R&D tax incentive
• Ms Lel Smits appointed to OncoSil Medical Board of Directors as Non-Executive Director
• OncoSil Medical receives MDR Approval
• 120 German Hospitals are now entitled to negotiate fee for OncoSil™ device
• OncoSil appoints Ms Shelley Steyn as Chief Financial Officer
OncoSil dose sales hit record levels in Q3 FY25
Reflecting continued growth in clinical adoption of the OncoSil™ device, the number of OncoSil doses sold during Q3 FY25 increased by 233% on a prior corresponding period (Q3 FY24) basis. This represented a quarterly record.
On a year-to-date (YTD) basis, dose sales rose by 83% over the nine months to end-Q3 FY25. This uplift underpinned a 135% uplift in YTD revenues.
This nine months to end-Q3 FY25 revenue figure already exceeds the revenue for all of FY24, highlighting the sustained uplift in commercial sales of the OncoSil™ device across key target geographic markets over FY25 to date. Given that (1) revenue reported in OncoSil’s financial statements reflect cash received and (2) that there are variable payment terms across hospitals and distribution partners for OncoSil dose sales, there is typically a lag between these sales and cash receipts. In the light of this lag, the strong increase in FY25 sales is expected to be more fully reflected in upcoming quarters’ revenue figures.
Advisory Board Meetings in UK and Germany Define Strategic Pathways for OncoSil™ device
In January 2025, OncoSil Medical held an Advisory Board meeting in London, UK, bringing together leading experts in pancreatic cancer. A key target deliverable of this meeting was strategic guidance on advancing the OncoSil™ device, leveraging existing clinical experience, and exploring its potential in broader indications such as borderline resectable and metastatic disease. Discussions focused on emerging trends in pancreatic cancer treatment, fostering collaboration with academic and research institutions, and enhanced alignment on future clinical development.
Another Advisory Board meeting was subsequently held in February 2025, this time in Germany. This meeting, which was with key clinical and industry experts, helped define the strategic roadmap for the OncoSil™ device in the German market. Meeting participants explored the most effective ways to deliver this objective, including potential support for the German Federal Joint Committee (G-BA) study and the overall clinical approach. Key target results from the meeting were an understanding of the current landscape, an alignment on study priorities, and identification of opportunities to strengthen OncoSil’s position within the German healthcare system. The meeting provided valuable guidance to support the Company’s continued progress in this key market.
A $1.05m R&D tax incentive booked in Q3 FY25
OncoSil Medical received a research and development (R&D) tax refund of A$1,050,896 in Q3 FY25, the latter under the Australian Government’s R&D Tax Incentive program (see OSL ASX announcement dated 8 January 2025). This refund recognises the Company’s eligible R&D activities undertaken during the 2024 financial year and will support the ongoing development of its commercial-stage device, which is designed to deliver targeted radiotherapy for pancreatic cancer.
Ms Lel Smits appointed to OncoSil Medical’s Board of Directors
In mid-January 2025, Ms Lel Smith was appointed to the OncoSil Medical Board as a Non-Executive Director (see OSL ASX announcement dated 15 January 2025). Ms. Smits brings extensive experience in governance, strategy, risk oversight, and corporate communications. She has advised over 500 ASX-listed companies and currently serves on the Board of the Australian Shareholders’ Association.
An award-winning entrepreneur and two-time Women in Finance Director of the Year (2024, 2022), Ms Smits began her career as a finance journalist, including time as a foreign correspondent on Wall Street. She holds a Master of Arts in Journalism (UTS), a Diploma of Investor Relations (AIRA), and is a graduate of the AICD Company Directors Course.
OncoSil Medical Received MDR Approval
In late January 2025, OncoSil Medical received Medical Device Regulation (MDR) certification from BSI, the EU Notified Body (see OSL ASX announcement dated 28 January 2025). This approval lifts previous post-market restrictions and underscores the growing clinical evidence supporting the safety of the OncoSil™ device.
With these restrictions removed, OncoSil can now streamline the initiation of commercial treatments by bypassing local ethics and hospital governance approvals. This simplification is expected to accelerate market access across the EU and UK, shorten sales cycles, and significantly expand the device’s reach.
These anticipated operational efficiencies are projected to deliver substantial cost savings over the next three years, which will be reinvested into strategic growth initiatives. Additionally, MDR certification enables OncoSil to re-submit its application to the Australian Therapeutic Goods Administration (TGA), further advancing its commitment to global patient access and improved outcomes.
120 German Hospitals entitled to negotiate fee for OncoSil
In February 2025, Germany’s Institute for the Hospital Remuneration System (InEK) has authorised 120 hospitals to negotiate funding for the OncoSil™ device under the NUB innovation program—up 43% from 84 hospitals in 2024 (see OSL ASX announcement dated 4 February 2025). This reflects growing demand and recognition of the OncoSil™ device in the German healthcare system.
OncoSil was granted “Positive Status 1” under the NUB program in 2021. In October 2024, the G-BA approved a directive to test the treatment method involving endoscopic injection of 32P-labeled microparticles for advanced pancreatic cancer. This was followed by Ministry of Health approval in January 2025.
Ms Shelley Steyn appointed as OncoSil’s Chief Financial Officer
In March 2025, The Board of OncoSil Medical announced the appointment of Ms Shelley Steyn as its Chief Financial Officer, effective 5 May 2025 (see OSL ASX announcement dated 18 March 2025). Ms Steyn’s appointment strengthens OncoSil’s leadership team as the Company advances its strategic priorities in a key phase of its development. She brings over 17 years of experience in senior accounting, financial analysis, and audit roles.
She joins from Flynn Global ANZ and has held positions at Sirtex Medical, Deloitte, and Grant Thornton. Ms Steyn holds a Bachelor of Commerce, a Postgraduate Diploma in Accounting, and is a Chartered Accountant.
OncoSil Medical CEO & Managing Director Nigel Lange, said:
“We are thrilled by the strong uplift seen in OncoSil dose sales of the March 2025 quarter, which was a quarterly record. And the year-to-date growth in dose sales has been equally impressive, which has in turn flowed through to a much higher year-to-date revenue figure. These materially increased dose sales and revenue metrics reflect the increasing confidence in the OncoSil™ device among clinicians and the real-world impact it is having on patients’ lives.
We also made significant strides from an operational perspective over initial part of calendar 2025. This period has seen OncoSil realise some major regulatory, commercial, and strategic milestones that have strengthened its global position. These achievements included the receipt of MDR approval, and a further expansion in hospital access in Europe. All this while we have continued to successfully progress our allimportant TRIPP-FFX trial and PANCOSIL Investigator Initiated Study, both of which are critical to advancing the clinical evidence base and supporting further market expansion.
With the support of our expert Advisory Boards, the appointment of highly experienced leaders like Shelley Steyn and Lel Smits, and the reinvestment of our R&D tax incentive, we are well positioned to accelerate our growth and deliver meaningful impact to patients worldwide.”
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About us:
About OncoSil Medical
OncoSil Medical Limited (ASX:OSL) has developed a cancer treatment device, the OncoSil™ brachytherapy device, which is a critical component of a revolutionary brachytherapy treatment for locally advanced unresectable pancreatic cancer. This type of cancer is the 12th most common cancer in men and the 11th most common cancer in women across the globe, with some 500,000 new cases of pancreatic cancer detected every year. With pancreatic cancer typically diagnosed at a later stage, it has a poor prognosis for longterm survival.
The OncoSil™ device delivers a targeted intratumoural placement of Phosphorous-32 (32P) in the treatment of locally advanced unresectable pancreatic cancer. This occurs via injection directly into a patient’s pancreatic tumours under endoscopic ultrasound guidance and takes place in combination with gemcitabine-based chemotherapy.
The OncoSil™ device that has already received breakthrough device designation in the European Union, United Kingdom and United States for the treatment of locally advanced unresectable pancreatic cancer in combination with chemotherapy. CE Marking has additionally been granted for the OncoSil™ device, which can be marketed in the European Union, United Kingdom.
While clinical trials involving the OncoSil™ device continue to occur, the Company is simultaneously moving to commercialise this unique medical technology. It is currently approved for sale in 30+ countries including European Union, United Kingdom, Türkiye and Israel, with initial commercial pancreatic cancer treatments using the device already undertaken in Spain, Italy and Israel.
To learn more, please visit: www.oncosil.com
Contact details:
For further information, please contact:
Mr. Nigel Lange
CEO & Managing Director
E: [email protected]
T: +49 30 300 149 3043
Mr. Christian Dal Cin
CFO & Company Secretary
E: [email protected]
T: +61 3 9824 5254
Investor relations
Ms. Julia Maguire
The Capital Network
Media and Investor Enquiries
E: [email protected]
T: +61 2 7257 7338