Key Highlights

• Cyclotek, OncoSil Medical's contract manufacturer, has received ISO 13485 certification for its Macquarie Park Facility in Sydney.

• The certification is a prerequisite for adding Cyclotek as a critical subcontractor to OncoSil Medical's Notified Body (NB) certificate.

• OncoSil Medical is targeting commencement of OncoSil™ device production at Macquarie Park by end of 2Q FY27, subject to regulatory approvals.

• Shares in OSL traded at A$1.11, up 4.23% on the day of the announcement.

OncoSil Medical Limited (ASX:OSL), a medical device company focused on the treatment of locally advanced pancreatic cancer, announced on 9 September 2026 that its contract manufacturer Cyclotek has obtained ISO 13485 certification for its Manufacturing facility located in Macquarie Park, Sydney, New South Wales. ISO 13485 is an internationally recognised quality management system standard specific to the medical device industry, and its attainment by Cyclotek represents a formal checkpoint in the regulatory and quality pathway required before the OncoSil™ device can be manufactured domestically in Australia.

The certification has been described by the company as an important step toward establishing commercial-scale manufacturing at the Macquarie Park site. OncoSil Medical has historically sourced its manufacturing from offshore operations, and the establishment of a domestic Australian facility has been a stated strategic objective. This announcement marks measurable progress toward that objective, though the process remains subject to further regulatory review steps before production can formally begin.

Notified Body Integration: The Next Regulatory Hurdle

Following the ISO 13485 certification, the company's next required step is to formally add the Macquarie Park site as a critical subcontractor to OncoSil Medical's existing Notified Body (NB) certificate. A Notified Body is a conformity assessment organisation designated by a regulatory authority — in this case relevant to the CE marking framework and equivalent international regulatory standards — to evaluate and certify medical devices. The inclusion of Cyclotek under OncoSil's NB certificate would allow the manufacturer to legitimately produce the OncoSil™ device under the company's existing regulatory approvals.

This process adds a layer of procedural complexity and timeline uncertainty. OncoSil Medical has acknowledged that the completion of the certification process is subject to "applicable regulatory review and approval processes," which inherently introduces scheduling risk. The company has not disclosed the identity of its Notified Body, the expected duration of the NB review, or the anticipated costs associated with adding the new manufacturing site to the existing certificate.

Production Timeline and Capacity Ambitions

OncoSil Medical has indicated that it is aiming to commence production of the OncoSil™ device at the Macquarie Park facility by the end of the second quarter of financial year 2027 (2Q FY27). In the context of an Australian financial year running from July to June, the end of 2Q FY27 would correspond to December 2026. The company has also noted that, once operational, the facility will support "significantly higher annual production capacity," though specific production Volume targets or Capital Expenditure figures were not provided in the announcement.

The establishment of domestic manufacturing capacity carries several potential operational advantages for the company, including reduced logistical complexity, potential cost savings over time, and greater Supply chain control. However, the realisation of these benefits is contingent on the successful completion of both the Notified Body review and any other applicable regulatory approvals within the targeted timeframe.

OncoSil™ Device: Clinical and Commercial Context

The OncoSil™ device is a brachytherapy implant designed to deliver targeted radiation to locally advanced pancreatic cancer tumours. The device has received CE mark approval in Europe and regulatory approval in Australia. Pancreatic cancer remains one of the most challenging malignancies to treat, with limited treatment Options and historically poor prognosis, which underpins the clinical rationale for OncoSil Medical's product. The company's commercial footprint spans several markets, and the Australian manufacturing facility is expected to serve as a hub that supports supply to multiple geographies.

As of the announcement date, OncoSil Medical has not disclosed Revenue figures, patient numbers, or hospital adoption rates in conjunction with this manufacturing update. The announcement is a regulatory and operational milestone rather than a commercial or financial one, and investors should assess it within the broader context of the company's commercialisation stage and cash position.

Share Price Performance

On 9 September 2026, at the time of the announcement, OncoSil Medical (ASX:OSL) shares were trading at A$1.11, representing a gain of A$0.045, or 4.23%, on the day.

Conclusion

OncoSil Medical's announcement that Cyclotek has achieved ISO 13485 certification at the Macquarie Park facility establishes a formal regulatory foundation for the next phase of the company's Australian manufacturing strategy. The pathway to commercial production remains conditional on the Notified Body review process, and OncoSil has set a target of completing this process and commencing production by the end of 2Q FY27. The absence of specific production volumes, capital expenditure details, or commercial metrics leaves several financial dimensions of the announcement unquantified at this stage.