OncoSil Medical has applied to regulators to manufacture its OncoSil device at a Macquarie Park, Sydney facility. The company said it hopes to start commercial production at the facility in the second half of the 2027 financial year.
The company said it had applied to its Notified Body to add Cyclotek's Macquarie Park plant to its existing certification as a critical subcontractor. Cyclotek gained ISO 13485 certification in September. That certification confirmed its quality management system meets the international standard for medical device manufacturing.
OncoSil described the application as the next key step toward manufacturing the device on-site. Production still depends on the Notified Body completing its review and on any other applicable approvals.
The plant combines Cyclotek's existing infrastructure with manufacturing equipment owned by OncoSil and the company's own manufacturing process. OncoSil said this lets it build significant manufacturing capability without the capital cost of a standalone facility. It expects capital intensity to stay below 5 per cent at full capacity.
The company said the plant would greatly increase annual production capacity as it expands commercial activity overseas. It expects higher volumes and efficiencies to cut unit costs and improve gross margins over time. It also expects Australian manufacturing to make global supply more reliable and flexible. OncoSil said the model would give it closer oversight of product quality, manufacturing processes and production planning.
Chief executive and managing director Nigel Lange said the plant was central to the company's growth strategy.
"The regulatory submission represents another important milestone towards commencing commercial production at our Macquarie Park facility. This facility is a critical part of our strategy to build a scalable and capital-efficient manufacturing platform to support our growing global commercial activities. We expect it to significantly increase production capacity, strengthen supply chain resilience and deliver manufacturing efficiencies that have the potential to materially improve gross margins over time.
"We remain focused on completing the regulatory process and bringing this strategically important facility into commercial operation."
The OncoSil device is a single-use form of brachytherapy, or internal radiation. It places phosphorus-32 microparticles directly into the tumour. This delivers a set dose of beta radiation and limits exposure to nearby organs.
In the United States, the FDA approved the device under a Humanitarian Device Exemption. It is used there with systemic therapy for distal cholangiocarcinoma, a rare bile duct cancer, when the cancer cannot be removed surgically and has not spread. In other markets where it is approved, it is used with gemcitabine-based chemotherapy for locally advanced pancreatic cancer that cannot be removed surgically.
The device carries CE marking for the European Union and the United Kingdom. It has Breakthrough Device designation in Europe and the United States. It is approved for sale in more than 30 countries, including Australia. Patients have been treated with it commercially in Spain, Italy, Austria, Germany, Greece, Türkiye, Portugal, Israel and the United Kingdom.