OncoSil Medical has secured the Australian Therapeutic Goods Administration (TGA) approval for its OncoSil device, permitting its use in the treatment of locally advanced pancreatic cancer (LAPC) alongside gemcitabine-based chemotherapy.
The TGA’s decision enables the device’s entry onto the Australian Register of Therapeutic Goods (ARTG), allowing access to clinicians and patients dealing with pancreatic cancer.
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OncoSil is a single-use brachytherapy (internal radiation) device and is utilised for delivering a pre-determined beta radiation dose into cancerous tissue directly.
The company states that around 4,353 Australians are diagnosed with pancreatic cancer annually, and the approval allows the device to be offered as an additional treatment option within the country.
OncoSil Medical expects this authorisation to drive increased clinical adoption and support applications for regulatory approval in other markets.
OncoSil Medical CEO and managing director Nigel Lange said: “Receiving TGA approval is a defining moment for OncoSil Medical and an especially proud achievement as an Australian medical technology company. Having developed this innovative treatment platform in Australia, it is incredibly significant to now secure approval in our home market.
“This milestone not only validates the strength of our clinical and regulatory work but also enables Australian patients suffering from one of the most difficult-to-treat cancers to gain access to a new therapeutic option. We believe this approval will further accelerate clinical adoption and strengthen our global commercialisation strategy.
“Securing TGA approval is a defining milestone for OncoSil Medical and a strong validation of the company’s clinical and regulatory strategy, as a class III device like ours is subject to the most stringent regulatory review process for medical devices.”
