• Felixâ„¢ System approved by the Therapeutic Goods Administration (TGA) and included on the Australian Register of Therapeutic Goods (ARTG)
• Approval granted approximately two months ahead of previously guided timeframe
• TGA registration enables immediate commercial sale and clinical deployment of Felixâ„¢ across Australia

Memphasys Limited (ASX: MEM) has announced that the Felixâ„¢ System has received approval from the Australian Therapeutic Goods Administration (TGA) and has been successfully included on the Australian Register of Therapeutic Goods (ARTG). This approval has been granted approximately two months ahead of the company's previously guided timeframe, representing a material acceleration of Memphasys' Australian commercial rollout. The early approval reflects the strength of the company's regulatory, manufacturing and quality systems, and underscores Memphasys' ability to execute to plan - and ahead of schedule. With ARTG inclusion now secured, Memphasys is immediately authorised to market and sell the Felixâ„¢ System in Australia, deploy Felixâ„¢ consoles into IVF laboratories, and supply Felixâ„¢ cartridges on a recurring per-procedure basis. Australia represents a strategically important initial market, with more than 60,000 fresh IVF cycles performed annually where Felixâ„¢ has a direct clinical application. The earlier-than-expected approval enables Memphasys to capitalize on these opportunities earlier than expected and accelerate advanced commercial discussions with Australian stakeholders, including IVF clinics and potential distribution partners.

Memphasys is entering a phase of accelerated commercial execution in Australia following the earlier-than-anticipated TGA approval.

Memphasys will continue to update shareholders as Australian commercial agreements are finalised and as further regulatory and commercial milestones are achieved internationally.