Memphasys (ASX:MEM) has reached a major commercial milestone with the Therapeutic Goods Administration granting approval for its Felix System ahead of schedule, clearing the way for immediate sales and clinical deployment across Australia.
The reproductive biotechnology company announced that Felix has been formally included on the Australian Register of Therapeutic Goods, securing regulatory clearance around two months earlier than previously anticipated. The accelerated approval materially shortens Memphasys’ time-to-market and brings forward revenue-generating activity in a jurisdiction the company views as strategically important and with high regulatory scrutiny.
Australia represents a significant initial commercial opportunity for Felix, with more than 60,000 fresh IVF cycles performed annually, where the system has direct clinical application.
The approval builds on existing regulatory momentum, following CE Mark certification in Europe and compliance in selected international markets.
Chair Lindley Edwards said the early approval validated both the technology and the company’s execution capability, highlighting the strength of Memphasys’ regulatory strategy, manufacturing readiness and quality systems. Just as importantly, the decision allows the company to accelerate engagement with IVF clinics and convert advanced commercial discussions into revenue sooner than expected.
Memphasys has been progressing commercial negotiations with Australian clinics and potential distribution partners in parallel with the regulatory process. With ARTG inclusion now secured, those discussions can move directly into execution, supporting the company’s strategy of building an installed base of Felix systems and establishing scalable, recurring cartridge revenues linked to procedure volumes.
The commercial acceleration is further underpinned by a recently completed capital raise, with Memphasys securing firm commitments to raise $800,000 through a share placement. The funding, backed by new and existing sophisticated, professional investors, will be directed toward expanding Felix's commercial execution, including scaling the direct sales model, building cartridge manufacturing capacity to meet growing demand, progressing regulatory approvals in key markets, and strengthening working capital.