Memphasys’ EU Ambitions Hinge on CE Mark Approval and Market Uptake

Strategic Contract Upgrade and Territory Expansion

Memphasys Limited (ASX, MEM), a reproductive biotechnology company, has secured a significant upgrade to its existing distribution agreement with International Technical Legacy (ITL). The contract value has been raised from A$325,000 to A$390,000, reflecting strong demand for Memphasys’ Felix™ System, a pioneering technology designed to improve sperm preparation in assisted reproduction.

Crucially, the agreement’s territory has been expanded to include Turkey, a major hub for in vitro fertilisation (IVF) within the European Union. This marks Memphasys’ first contracted revenues in the EU, a milestone that positions the company strategically within one of the world’s largest and fastest-growing fertility markets.

Turkey, A Gateway to the European IVF Market

Turkey’s IVF sector is notable for its volume and growth, with over 100 clinics performing more than 40,000 cycles annually. The country’s competitive treatment costs and status as a medical tourism destination make it an attractive market for Memphasys. By securing exclusive commercialisation rights through ITL across 15 Middle East and North African (MENA) countries plus Turkey, Memphasys is effectively bridging its established regional presence with a foothold in Europe.

This expansion is timely, as the company awaits CE Mark approval, a regulatory milestone expected within nine months, that will enable commercial sales across the EU. The CE Mark submission is progressing positively, and management expresses confidence in achieving approval on schedule.

Building a Scalable Revenue Model

The upgraded agreement includes binding minimum orders for Felix™ cartridges, triggered automatically upon CE Mark approval. Memphasys will supply initial consoles free of charge to new clinics, supporting adoption and facilitating a direct selling business model. This approach lays the foundation for a scalable, recurring revenue stream aligned with the company’s razor-and-blade consumables strategy.

Following initial orders, pricing and minimum purchase commitments will be negotiated for the remaining term, providing revenue certainty while allowing upside potential if market uptake accelerates. This model reflects a mature commercial strategy designed to balance risk and growth.

Global Expansion and Future Prospects

Beyond the ITL agreement, Memphasys is advancing negotiations in New Zealand, Japan, and India, aiming to secure volume-based contracts that will contribute to meaningful revenues in fiscal year 2026. This dual-track commercialisation strategy, combining partnerships with established distributors and direct sales in select markets, helps diversify revenue streams and build global momentum for Felix™.

CEO Dr David Ali highlighted the significance of the ITL addendum, emphasizing the strong clinician demand driving the expansion and the strategic importance of entering the EU market. As Memphasys prepares for regulatory approval and broader commercial rollout, the company is well-positioned to capitalize on growing global demand for advanced reproductive technologies.