OncoSil Medical Ltd has achieved significant expansion and regulatory milestones in Q4 2024, strengthening its position in the global market for locally advanced pancreatic cancer (LAPC) treatment. The company has established strategic distribution partnerships across multiple regions while securing key regulatory approvals that enhance its market access.
Strategic Global Distribution Expansion
The medical device company has forged exclusive distribution agreements with three key partners, significantly expanding its international presence. Al Zahrawi Medical Supplies LLC will distribute OncoSil™ in the UAE, Qatar, Oman, and Bahrain, targeting the rapidly growing GCC healthcare market. In the Nordic region, CardiRad will manage distribution across Sweden, Denmark, Norway, and Finland, leveraging the region's advanced healthcare infrastructure. Additionally, Femto Trade will lead distribution efforts in Egypt, providing a strategic entry point into the MENA region.
Regulatory Achievements and Clinical Progress
OncoSil Medical has secured several crucial regulatory approvals, enhancing its market position. The British Standards Institution renewed the UKCA certificates for OncoSil™ without post-market restrictions, streamlining UK market access. In a groundbreaking development, the German Federal Joint Committee (G-BA) approved a randomized controlled trial under a Coverage with Evidence Development program, making OncoSil the first company to receive such approval in oncology.
The company achieved another significant milestone with MDR certification from BSI, which included the removal of post-market restrictions across the EU and UK. This certification is expected to accelerate market access and optimize operational costs.
Clinical Implementation and Trial Progress
The first OncoSil™ device implantation was successfully performed at Milan's Instituto Nazionale dei Tumori in November 2024, marking an important advancement in European oncology centers. The TRIPP-FFX clinical trial also progressed with the randomization of its first Australian patient at the Royal Adelaide Hospital, bringing the global enrollment to 49 patients.
Financial Position and Growth
OncoSil successfully raised $8 million in new equity through a combination of placement ($7 million) and a Share Purchase Plan ($1 million). The company reported $8.463 million in cash and equivalents as of December 31, 2024, with customer receipts of $0.339 million for the quarter, representing a 45% increase compared to the previous fiscal year's results.
CEO Nigel Lange commented, "This has been an exceptional quarter for OncoSil Medical, marked by significant progress across multiple fronts. From expanding our distribution network in strategic global markets to achieving critical regulatory milestones and advancing our clinical trial initiatives, we have also seen a substantial increase in sales, reflecting the growing demand for our innovative pancreatic cancer treatment."
Corporate Governance Enhancement
The company strengthened its leadership team with the appointment of Ms. Lel Smits as Non-Executive Director. Smits brings extensive experience in governance, strategy, and corporate communications, having advised over 500 ASX-listed companies and earned recognition as Director of the Year by Women in Finance.
