OncoSil Medical (ASX:OSL) has completed three manufacturing validation cycles with partner Cyclotek, producing more than 50 validation doses of its OncoSil device and establishing a dedicated Australian manufacturing capability.
The company invested approximately $2.1 million in production equipment installed at Cyclotek’s Macquarie Park facility in Sydney, a capital-efficient model designed to retain OncoSil ownership of critical manufacturing assets and proprietary processes while leveraging Cyclotek’s infrastructure and operational expertise.
The validated platform incorporates processes and equipment built to quality and regulatory expectations, including ISO 13485, and the company is progressing through final regulatory inspection and approval, with commercial production expected in the second half of calendar 2026, subject to approval.
Nigel Lange, CEO and Managing Director of OncoSil Medical, said, "The successful completion of our manufacturing validation program is a significant operational milestone for OncoSil Medical. Through our strategic partnership with Cyclotek, we have established a scalable Australian manufacturing capability that combines the efficiency of an experienced manufacturing partner with ownership of our specialised production equipment and proprietary manufacturing process. This model strengthens our control over quality, supply and manufacturing capability while supporting improved margins and positioning the Company to meet growing global commercial demand.
"Importantly, completing manufacturing validation substantially de-risks a key component of our commercial strategy by demonstrating that we have a validated production capability ready to support future market demand, subject to regulatory approval. We look forward to commencing commercial production during the second half of calendar 2026 following the completion of the regulatory approval process."
