Ann: OncoSil Outperforms SBRT in Pancreatic Cancer Outcomes, page-2

Excellent news

This ASX announcement from OncoSil Medical Limited (ASX: OSL) dated 7 May 2025 outlines a major comparative clinical study and its results, with key implications for both medical credibility and potential investor confidence. Here's what's happening:

1. Announcement of Clinical Study Results

OncoSil has released the first comparative analysis showing its OncoSil™ brachytherapy device is clinically superior to Stereotactic Body Radiation Therapy (SBRT) in treating locally advanced pancreatic cancer (LAPC) when used alongside chemotherapy.

Study Overview:

• Study Type: Retrospective, investigator-initiated

• Location: Royal Adelaide Hospital

• Timeframe: March 2015 – August 2023

• Sample Size: 101 patients (42 OncoSil™, 59 SBRT)

• Key Outcomes:

  • Overall Survival: 22 months with OncoSil™ vs. 14 months with SBRT (HR: 1.98; p=0.004)

  • Progression-Free Survival:

    • Local: HR 1.61; p=0.034

    • Distant: HR 1.71; p=0.019

  • Downstaging: 24% (OncoSil™) vs. 4.7% (SBRT); p<0.001

  • Surgical Resection: 22% (OncoSil™) vs. 0%; p<0.001

  • Adverse Events: Lower grade 3 AEs in OncoSil group; no grade 4 or 5 AEs in either group

These findings suggest that OncoSil™ not only improves survival rates but may also convert some previously inoperable cases into operable ones, which is a major advance in cancer treatment.

2. Scientific Recognition

• Presented at: Digestive Disease Week (DDW2025) in San Diego, USA

• Presenter: Dr Amanda Lim (RAH / Beth Israel Deaconess Medical Center)

This international presentation signals growing recognition of OncoSil’s device in leading medical circles.

3. Commercial Implications

• OncoSil Medical is leveraging this new data to accelerate commercialisation of its device.

• Already has CE Marking and Breakthrough Device Designation in:

  • European Union

  • United Kingdom

  • United States

• Approved in 30+ countries with commercial activity already underway in Spain, Italy, and Israel.

This supports both clinical adoption and market expansion, which could have positive financial implications for the company.

4. Strategic Positioning

The study directly compares OncoSil™ with SBRT, which is considered the most precise external beam radiation therapy. Demonstrating superiority over SBRT positions OncoSil™ as a new standard in treating LAPC, particularly for those unsuitable for surgery.

Conclusion

This announcement showcases a significant validation milestone for OncoSil Medical:

• Clinically, by outperforming an industry gold standard (SBRT).

• Commercially, by enabling broader uptake in global markets.

• Financially, by improving its investment proposition with stronger efficacy data and international recognition.