OncoSil is a late stage medical devices company focused on localised treatments for patients with pancreatic and liver cancer.
Recent highlights include the Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (the FDA).
Next steps
Following the approval, the company has initiated its planned global clinical study of OncoSilTM for the treatment of pancreatic cancer, OncoPac-1.
The company is moving quickly to operationalise its clinical program.
Currently ten centres have commenced the Institutional Review Board (IRB) or Ethics Committee approval process in the US, UK and Australia.
In preparation for the commencement of OncoPac-1, the company successfully performed a full hot calibration run of OncoSilTM in August with the Department of Nuclear Medicine, Royal North Shore Hospital, Sydney, which included initial training and calibration of their equipment to ensure dose accuracy of OncoSilTM.
Daniel Kenny, chief executive officer, commented: “This quarter has been a quarter of significant milestones with the receipt of the FDA IDE approval and initiation of OncoPac-1.
"Our success this Quarter is a testament to the hard work and dedication by the whole team.
"We remain dedicated and focussed to achieving our CE Mark and successful enrolment for OncoPac-1 for our shareholders and stakeholders."