OncoSil Medical has received approval from the Australian Therapeutic Goods Administration (TGA) for the OncoSil™ device for the treatment of locally advanced pancreatic cancer (LAPC) in addition to gemcitabine based chemotherapy. The OncoSil™ device has been included on to the Australian Register of Therapeutic Goods (ARTG).
OncoSil™ is a single-use brachytherapy (internal radiation) device used to deliver a pre-determined dose of beta radiation directly into cancerous tissue. It is used in addition to chemotherapy.
The TGA approval represents a major milestone for the Company and opens the way for commercialisation of the OncoSil™ device in Australia. Importantly, this achievement marks the approval of an innovative Australian developed medical technology in its home market and reinforces Australia’s position as a global leader in advanced oncology innovation.
Pancreatic cancer remains one of the deadliest forms of cancer globally, with limited treatment options and poor survival outcomes. In Australia alone, there are approximately 4,353 new pancreatic cancer patients diagnosed each year. The approval provides Australian clinicians and patients with access to a novel treatment option for this highly challenging disease.
The approval is expected to support broader market adoption, strengthen clinician engagement, further validate the growing body of clinical evidence supporting the OncoSil™ device, and will also support future regulatory approvals in additional international markets.
