Memphasys Secures CE Mark Approval for Felix(TM) System, Marking Commercial Inflection Point and Activating Global Growth Strategy

Chapter One Advisors

HIGHLIGHTS

• CE Mark approval achieved for the Felix™ System under EU MDR, unlocking full commercial deployment across Europe and other CE-recognised international markets.
• Immediate Access to ~A$50+ million (€29+ million) Felix™ Addressable Market
• Binding, multi-year commercial agreements now activated, including:
  • a five-year European commercial agreement with CFA Italia valued at a minimum of ~A$925,000, and
  • a five-year exclusive Middle East & North Africa (MENA) agreement with International Technical Legacy (ITL) with minimum contracted purchases of A$390,000.
• Early cartridge orders already placed ahead of contractual triggers, providing tangible evidence of clinic-level demand.
• Company-led partners’ preparation see clinics ready for immediate utilisation, with business development capability rapidly expanding to support scale-up across Europe and the Middle East
• Indian CDSCO and Australian TGA regulatory pathways to now progress under CE Mark mutual recognition, expected in July and April 2026 respectively.

Memphasys Limited (ASX: MEM) (“Memphasys” or the “Company”) is pleased to announce that it has been granted CE (Conformité Européenne) Mark approval for its Felix™ automated sperm selection system.

The CE Mark confirms that Felix™ complies with the European Union Medical Device Regulation (EU MDR 2017/745), enabling commercial sale and clinical use across the European Economic Area (EEA) and other jurisdictions, such a Qatar, that recognise CE certification.

This approval represents a defining milestone for Memphasys - transforming Felix™ from a clinically validated technology into a globally deployable commercial product and marking the Company’s continued transition into a revenue-scaling phase. 

About Memphasys

Memphasys Limited (ASX: MEM) is an Australian-based reproductive biotechnology company commercialising the Felix™ System, a patented bio separation technology that isolates the most viable sperm cells for human assisted reproduction.
By combining electrophoresis and size-exclusion membranes, Felix™ delivers a fast, gentle and standardised sperm selection process that enhances sperm quality and reduces laboratory time. The system replaces traditional centrifugation, which can cause cellular stress and DNA damage, offering clinicians a superior, repeatable alternative.
Memphasys’ commercial strategy focuses on building contracted sales through direct and distribution-led channels, scaling production to improve margins, and establishing Felix™ as a new global standard in sperm preparation for ART procedures. 

David Tasker
Managing Director
Chapter One Advisors
Tel: +61 433 112 936
E: [email protected]