- 01Completed 3 validation cycles; 50+ doses produced.
- 02Macquarie Park facility; OncoSil owns tech.
- 03Regulatory approvals underway; production in H2.
OncoSil Medical (ASX: OSL) has completed three manufacturing validation cycles — more than 50 validation doses — of its Class III single-use brachytherapy device to treat unresectable, locally-advanced pancreatic tumours in conjunction with gemcitabine-based chemotherapy.
Conducted with Australian partner Cyclotek, the operational milestone substantially de-risks a key component of OncoSil’s commercial strategy by demonstrating a validated production capability ready to support future market demand, subject to regulatory approval.
OncoSil has established a dedicated manufacturing facility within Cyclotek’s existing Macquarie Park facility at Macquarie University Hospital in New South Wales, and invested approximately $2.1 million in specialised production equipment and proprietary manufacturing processes to build the device.
Australian prevalence of pancreatic cancers is growing at a rate of up to 4,353 new cases per year.
Capital-Efficient Model
Under the terms of the partnership, Cyclotek will provide the manufacturing facility and operational services, while OncoSil will retain ownership of its equipment and processes.
The capital-efficient manufacturing model seeks to support future commercial growth, strengthen supply chain resilience, and improve production economics.
This provides OncoSil with strategic control over manufacturing capability, product quality and supply chain management.
OncoSil has also introduced proprietary Type A finished packaging, ampoules, and POTs.
Together with an expanded network of specialist logistics partners, this has created a scalable manufacturing and distribution platform to support global expansion across existing and new markets.
The ‘Silent Killer’
Pancreatic cancer is the 12th most common cancer in men and 11th most common in women, with around 500,000 new cases detected worldwide every year.
Known as the “silent killer”, it rarely causes noticeable symptoms in its early stages, is typically diagnosed at a later stage, and has a poor prognosis for long-term survival.
OncoSil’s device has been developed as a critical component of revolutionary brachytherapy (or internal radiation) treatment for locally advanced pancreatic tumours unable to be removed surgically due to their size or proximity to blood vessels.
With manufacturing validation now successfully completed, the company is progressing through the final regulatory inspection and approval process.
Commercial production of the device is expected to commence in the second half of this year.
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