Australian pancreatic cancer device expands global footprint amid local regulatory delays

An Australian-developed device for treating locally advanced, unresectable pancreatic cancer continues to gain international traction, with its resubmission to the Therapeutic Goods Administration (TGA) expected imminently.

The OncoSil device, a single-use brachytherapy device developed by Sydney-based medtech company OncoSil Medical, is approved for clinical use in more than 30 countries. It delivers a targeted intratumoural injection of Phosphorous-32 (32P) in combination with gemcitabine-based chemotherapy, with the radioactive isotope injected directly into pancreatic tumours under endoscopic ultrasound guidance.

Despite its global footprint, the device is yet to gain regulatory approval locally. This comes as pancreatic cancer continues to present one of the greatest challenges, typically diagnosed at an advanced stage and associated with poor long-term survival. Globally, it ranks as the 12th most common cancer in men and the 11th in women, with approximately 500,000 new cases diagnosed annually.

In its Q3 FY2025 update, OncoSil Medical CEO and Managing Director Nigel Lange said, “We are thrilled by the strong uplift seen in OncoSil dose sales of the March 2025 quarter, which was a quarterly record. And the year-to-date growth in dose sales has been equally impressive, which has in turn flowed through to a much higher year-to-date revenue figure. These materially increased dose sales and revenue metrics reflect the increasing confidence in the OncoSil device among clinicians and the real-world impact it is having on patients’ lives.”

The momentum has been further supported by ongoing clinical trials. The company is advancing two key studies – the TRIPP-FFX trial and the PANCOSIL Investigator Initiated Study.

Meanwhile, reimbursement for novel pancreatic cancer therapies remains a key challenge. AstraZeneca’s Lynparza (olaparib), while PBS-listed for breast and prostate cancer, is not reimbursed for metastatic pancreatic cancer, leaving patients to pay $7,000 per month for a private prescription.

Looking ahead, OncoSil’s leadership and governance changes aim to drive the next phase of growth.

“With the support of our expert Advisory Boards, the appointment of highly experienced leaders like Shelley Steyn [Chief Financial Officer] and Lel Smits [Non-Executive Director], and the reinvestment of our R&D tax incentive, we are well positioned to accelerate our growth and deliver meaningful impact to patients worldwide,” Lange said.

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