Memphasys (ASX:MEM) has secured CE Mark approval for its Felix automated sperm selection system under the EU Medical Device Regulation, clearing the way for immediate commercial sales across Europe and other CE-recognised markets and marking a key inflection point in the company’s global growth strategy.
The approval unlocks access to an estimated €29+ million annual addressable market, with binding multi-year commercial agreements now activated, including a five-year European supply deal with CFA Italia valued at a minimum of ~$925,000 and a five-year exclusive Middle East and North Africa agreement with International Technical Legacy with minimum contracted purchases of $390,000.
Early cartridge orders placed ahead of contractual triggers indicate emerging clinic-level demand, while operational preparations by Memphasys and its partners position clinics for immediate utilisation.
The CE Mark also enables progression of regulatory pathways in India and Australia under mutual recognition, with approvals expected in July and April 2026 respectively.
Memphasys said the milestone transitions Felix from clinical validation to scalable commercial execution, supporting accelerating revenue growth as the company expands its footprint across Europe, the Middle East and other key IVF markets.