MDR Approval received for OncoSil™ Device

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MDR Approval received for OncoSil™ Device

Sydney, Australia – 28 January 2025: OncoSil Medical Ltd (ASX: OSL) (OncoSil or the Company), a medical device company focused on localised treatments for patients with locally advanced pancreatic cancer (LAPC), is pleased to announce that it has received Medical Device Regulation (MDR) certification from BSI, the EU Notified Body. The certification includes the lifting of existing post-market restrictions. This milestone highlights the growing robust clinical evidence supporting the safety of the OncoSil™ device and marks a significant step forward for the company.

The removal of these post-market restrictions will have a transformative impact on OncoSil’s operations. By eliminating local ethics and hospital governance approvals, OncoSil simplifies the initiation of commercial treatments, enabling smoother operations and allowing teams to focus on advancing commercial activities. The removal of operational constraints is projected to yield significant cost savings over the next three years, which will be reinvested in growth initiatives and strategic advancements of the OncoSilTM device. Simplified approval pathways further accelerate market access, shortening sales cycles and expanding the reach of the OncoSil™ device across the EU and UK, enhancing patient access and driving commercial success.

MDR certification also provides a critical opportunity to re-submit our application to the Therapeutic Goods Administration (TGA) for approval in the Australian market, aligning with our commitment to improving global patient outcomes.