Sydney, Australia – 30 April 2025: Pancreatic cancer treatment device company OncoSil Medical Limited (ASX:OSL) (“OncoSil” or “the Company”) is pleased to announce that the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) in Germany has officially initiated a European-wide tender process to identify and appoint a Contract Research Organisation (CRO). The selected CRO will be responsible for the design and conduct of the study on behalf of G-BA.
The study will assess the implantation of the OncoSil™ device via endoscopic ultrasound guidance in addition to standard of care chemotherapy versus standard of care chemotherapy alone for the treatment of unresectable, locally advanced pancreatic cancer (LAPC) in a randomised design.
This significant milestone reflects the continued engagement of the G-BA with OncoSil’s innovative technology and marks a critical step forward in the process towards potential inclusion in the German treatment guidelines and statutory health insurance system.
The tender details are publicly available through the G-BA's official channels (https://ted.europa.eu/en/notice/-/detail/260203-2025), which outlines the scope of work and expected timelines for the clinical evaluation. The tender is open for submissions until 11 June 2025. The outcome of this study will form a key component of the evidence required by G-BA to consider a positive reimbursement decision for the OncoSil™ device in Germany.
Nigel Lange, CEO & Managing Director of OncoSil Medical, said: "We are pleased to see the G-BA progressing with the announcement of this tender. It represents a crucial step towards the generation of clinical evidence under the Testing Directive. We look forward to the next steps in this pathway and, ultimately, the commencement of the study."
To read the announcement, please click here
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