OncoSil Medical (ASX:OSL) has marked a significant milestone in its manufacturing strategy, announcing the successful completion of the first 'hot' production test run at its new Sydney facility.
The company said the achievement represents a significant step toward securing full regulatory approval and scaling up the commercial supply of the company’s targeted radiation therapy for pancreatic cancer.
The hot production run involved manufacturing the OncoSil device under standard, real-world production conditions, using commercial-grade equipment, materials, and processes rather than laboratory or trial setups. As the device contains radio-activated Phosphorus-32 microparticles, a hot run is a critical demonstration that the facility can safely and reliably handle radioisotope-enabled manufacturing at a commercial scale.
OncoSil said the successful test is a “risk-managed milestone” that confirms the facility’s capability to produce the company’s already approved therapy for patients with unresectable locally advanced pancreatic cancer (LAPC). It also strengthens the company’s regulatory file as it works through the formal assessment process. Regulatory approval for the facility is expected in the second half of 2026, subject to completion of the remaining requirements.
The milestone forms part of a broader strategy to build internal manufacturing capacity and enhance supply-chain resilience. Once the facility receives full regulatory clearance and ramps to routine operation, OncoSil expects to realise improved manufacturing efficiencies and lower unit production costs—benefits the company anticipates will enhance product margins over time.
CEO and Managing Director Nigel Lange said the hot production run demonstrates the facility’s readiness for the next phase of the company’s growth.
“Successfully completing our first hot production test run marks a significant milestone for OncoSil Medical,” Lange said. “It instils confidence in our manufacturing capabilities and confirms that our Sydney facility is fully equipped to meet future production needs. Crucially, this achievement also plays a key role in advancing our regulatory efforts as we continue working to finalise the outstanding manufacturing-related regulatory requirements.”
The company continues to advance its commercial and clinical programs globally. OncoSil is CE-marked and designated as a breakthrough device in both Europe and the United States. It is already approved in more than 30 countries, with commercial treatments underway across Europe, the UK, Turkey, Israel and other markets.