Australian Manufacturing Facility Achieves ISO 13485
Oncosil Medical Ltd
Key points
- OncoSil Medical's contract manufacturer Cyclotek received ISO 13485 certification
- Certification is a step towards full commercial production by end of 2Q FY27
- Macquarie Park facility aims to enhance production capacity and efficiency
Full summary
OncoSil Medical Limited (ASX: OSL) announced that its contract manufacturer, Cyclotek, has received ISO 13485 certification, marking a significant milestone in the establishment of OncoSil Medical's Macquarie Park manufacturing facility in Sydney. This certification signifies that Cyclotek's Quality Management System meets the international standard for medical device manufacturing. The next step involves adding the Macquarie Park site to OncoSil Medical's existing certification. OncoSil Medical aims to complete this certification process and commence production of the OncoSil device at Macquarie Park by the end of 2Q FY27, subject to regulatory review and approval. The facility is designed to support higher production capacity and efficiency, with a capital intensity of less than 5% at full capacity.
Guidance
Target to commence production by end of 2Q FY27
Outlook
The facility is expected to enhance production capacity, efficiency, and gross margins over time.