• Australian TGA submission lodged, approval expected by April 2026
• Indian CDSCO submission lodged, regulatory outcome anticipated in 6 months
• Regulatory approvals represent final step toward full commercialisation in Australia and India

Memphasys Limited (ASX: MEM) has formally lodged regulatory submissions for the Felix System with both the Australian Therapeutic Goods Administration (TGA) and India's Central Drugs Standard Control Organisation (CDSCO). These submissions follow the Company's successful CE Mark approval for Felix and were undertaken in line with guidance previously provided to the market. In Australia, Memphasys has lodged its submission seeking inclusion of the Felix System on the Australian Register of Therapeutic Goods (ARTG), with TGA approval expected by April 2026. In India, the Company has lodged its submission with the CDSCO, with the review process expected to take approximately six months from submission. Both regulatory pathways leverage the clinical data, manufacturing standards and quality systems underpinning CE Mark approval and represent the final regulatory steps required to unlock commercial execution in these jurisdictions. Memphasys is also progressing the requirements necessary to enable immediate commercial sales of the Felix System in the United Kingdom under the current UK transition framework, without the need for a UKCA mark at this time. The Company has executed a non-exclusive supply agreement with Andrology Center group company Andro Diagnostics, Coimbatore, under its go-direct commercial strategy, with activation of this agreement contingent on CDSCO approval. With regulatory submissions now lodged, Memphasys is positioned to transition Felix into full commercial deployment across multiple large, regulated markets.

The Company has executed a non-exclusive supply agreement with Andrology Center group company Andro Diagnostics, Coimbatore, which includes a minimum Year 1 commitment of 1,800 Felix cartridges, increasing to at least 2,700 cartridges in Year 2.

With regulatory submissions lodged, commercial readiness progressing and market entry pathways advancing across multiple jurisdictions, Memphasys believes Felix is entering a new phase of global commercial execution. The Company is positioned to activate its existing formal supply agreement in India upon receipt of CDSCO approval, while advanced commercial negotiations are underway in Australia and the United Kingdom.