OncoSil Medical Receives TGA Approval for OncoSil Device in Australia

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OncoSil Medical Receives TGA Approval for OncoSil Device in Australia

Sydney, Australia – 20 May 2026 : OncoSil Medical Limited (ASX: OSL) (“OncoSil Medical” or “the Company”), a medical device company focused on localised treatments for patients with unresectable locally advanced pancreatic cancer (LAPC), is pleased to announce that it has received approval from the Australian Therapeutic Goods Administration (TGA) for the OncoSil™ device for the treatment of LAPC in addition to gemcitabine based chemotherapy. The OncoSil™ device has been included on to the Australian Register of Therapeutic Goods (ARTG).

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 year1. 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.

Nigel Lange, CEO & Managing Director of OncoSil Medical, 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. As an Australian-developed medical technology, achieving approval in our home market is particularly significant and reflects the dedication of our team, investigators and clinical partners over many years. Importantly, this approval provides Australian clinicians and patients with access to a new treatment option for pancreatic cancer and further strengthens the Company’s global commercialisation strategy.”

“This milestone is further supported by the near completion of our new manufacturing facility in Macquarie Park, Sydney, in partnership with Cyclotek, which is expected to strengthen OncoSil Medical’s domestic and global supply chain capabilities as the Company scales commercial operations.”

Professor Nam Nguyen, Head of Endoscopy at the Royal Adelaide Hospital and Clinical Professor at Adelaide University, said:

“Pancreatic cancer remains one of the greatest unmet needs in oncology, and the availability of the OncoSil™ device in Australia is an important advancement for clinicians and patients. For Australian patients suffering from locally advanced pancreatic cancer (LAPC), where treatment options are often limited, access to new technologies such as OncoSil™ is particularly important.

“Based on our extensive experience with the OncoSil™ device, it has demonstrated significant potential value in helping drive patients towards surgical eligibility, which remains one of the most important determinants of long-term outcomes in pancreatic cancer. In addition, the targeted nature of the treatment may provide an important additional survival benefit when integrated into multidisciplinary treatment pathways. TGA approval is a significant milestone that recognises both the innovation and potential clinical value of this therapy.”

Reference:

1.https://gco.iarc.fr/en