OncoSil Medical Secures MDR Approval, Unlocking EU Market Potential
OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.
- Received Medical Device Regulation (MDR) certification from BSI
- Post-market restrictions lifted, simplifying commercial treatment initiation
- Projected cost savings to be reinvested in growth and strategic initiatives
- Accelerated market access across EU and UK with shorter sales cycles
- Opportunity to re-submit for Therapeutic Goods Administration (TGA) approval in Australia
Regulatory Breakthrough for OncoSil Medical
OncoSil Medical Limited (ASX:OSL), a company specialising in pancreatic cancer treatment devices, has announced a significant regulatory achievement with the receipt of Medical Device Regulation (MDR) certification from BSI, the EU Notified Body. This certification not only confirms the robust clinical evidence supporting the safety of the OncoSil™ device but also lifts existing post-market restrictions that had previously constrained the company’s operations.
Operational and Commercial Implications
The removal of post-market restrictions is expected to have a transformative impact on OncoSil’s commercial activities. By eliminating the need for local ethics and hospital governance approvals, the company can now initiate treatments more efficiently, reducing administrative burdens and accelerating patient access. This streamlined process is anticipated to shorten sales cycles and expand the device’s reach across key European markets, including the EU and UK.
In addition, the operational simplifications are projected to generate significant cost savings over the next three years. OncoSil plans to reinvest these savings into growth initiatives and further strategic development of the OncoSil™ device, positioning the company for sustained commercial momentum.
Strategic Expansion and Market Access
With MDR certification in hand, OncoSil is also poised to re-engage with the Australian Therapeutic Goods Administration (TGA) by re-submitting its application for approval. This move aligns with the company’s broader mission to improve global patient outcomes by expanding access to its innovative brachytherapy treatment for locally advanced unresectable pancreatic cancer.
CEO Nigel Lange highlighted the milestone’s significance, stating that the approval underscores the strength of OncoSil’s clinical data and safety profile. He emphasised that the lifting of restrictions will enable the company to focus on commercial growth and accelerate market penetration, particularly in Europe and potentially Australia.
Clinical and Market Context
The OncoSil™ device delivers targeted intratumoural radiation therapy using Phosphorous-32, combined with chemotherapy, offering a novel treatment option for a cancer type with historically poor prognosis. Pancreatic cancer ranks among the most challenging cancers globally, with approximately 500,000 new cases annually and limited long-term survival rates.
Already approved in over 30 countries, including the EU, UK, Türkiye, and Israel, OncoSil has commenced initial commercial treatments in Spain, Italy, and Israel. The MDR approval is expected to accelerate this commercial rollout and enhance patient access across Europe.
Looking Ahead
As OncoSil Medical moves forward with its expanded regulatory clearance, the company stands at a critical juncture to capitalise on its clinical advancements and regulatory momentum. The next phases will involve scaling commercial operations, navigating the Australian regulatory landscape, and continuing to build evidence that supports broader adoption of its device.
Bottom Line?
OncoSil’s MDR approval clears a major hurdle, setting the stage for accelerated growth and renewed Australian market ambitions.
Questions in the middle?
- How quickly can OncoSil translate MDR approval into increased sales and market share in Europe?
- What are the prospects and timeline for successful TGA approval in Australia following this milestone?
- How will OncoSil reinvest cost savings to sustain innovation and competitive advantage?
