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Memphasys’ Felix™ Scores Early 500-Cartridge Order Ahead of CE Mark

Healthcare By Ada Torres 3 min read

Memphasys Limited’s partner International Technical Legacy has placed an early order for 500 Felix™ cartridges ahead of anticipated CE Mark approval, signalling strong clinic demand and validating the company’s direct-selling strategy in the Middle East.

  • International Technical Legacy orders 500 Felix™ cartridges before CE Mark approval
  • Order accelerates contractual timeline, with delivery planned for early 2026
  • Order represents A$40,000 to A$75,000 in indicative revenue
  • Direct-selling model drives strong clinic-level demand in Qatar and UAE
  • Potential for initial minimum order to be exceeded based on ongoing engagement

Early Order Signals Market Confidence

Memphasys Limited (ASX, MEM), an Australian reproductive biotechnology company, has received an early order for 500 Felix™ cartridges from its exclusive Middle East partner, International Technical Legacy (ITL). This order comes ahead of the anticipated CE Mark regulatory approval expected in early 2026, marking a significant acceleration of the original contractual timeline.

The early placement and requested expedited delivery underscore strong demand from assisted reproduction technology (ART) clinics across Qatar and the United Arab Emirates. This momentum is a direct result of Memphasys’ hands-on, direct-selling approach, which involves close clinical engagement and operational readiness assessments at the clinic level.

Direct-Selling Strategy Driving Adoption

Unlike traditional distributor-led sales, Memphasys’ direct-selling model embeds clinical and operational leadership within fertility clinics, fostering trust and accelerating the adoption process. This strategy has proven particularly effective in the Middle East, where large IVF operators value detailed product demonstrations, workflow integration, and training sessions.

Assoc. Prof. Hassan Bakos, Director – Clinical Engagement and Growth, led a recent commercial activation program that included hands-on Felix™ demonstrations and procurement planning with senior embryologists and laboratory managers. This groundwork has prepared clinics to be “switch-ready” immediately upon regulatory clearance.

Financial and Commercial Implications

The 500-cartridge order represents indicative gross revenue between A$40,000 and A$75,000, with revenue recognition expected in the December quarter and payment anticipated in the March quarter. While the order is contingent on CE Mark approval, ITL’s confidence in Felix™ is evident in their decision to place the order early and request accelerated delivery.

Memphasys’ Non-Executive Director and Chair of the Commercialisation Committee, Marjan Mikel, highlighted that this disciplined commercial execution validates the direct-selling strategy and signals growing demand ahead of regulatory milestones.

Looking Ahead

CE Mark approval will open sales opportunities not only across the European Union but also in other jurisdictions recognizing CE certification, including the Middle East, India, and Australia. Memphasys continues to deepen clinic engagement in these priority markets, aiming to convert interest into commercial activation swiftly once regulatory clearance is secured.

While the early order is a promising indicator, the company remains cautious, noting that exceeding the minimum contracted order is possible but not guaranteed. Investors and industry watchers will be closely monitoring regulatory progress and subsequent order flow as key signals of Felix™’s commercial trajectory.

Bottom Line?

Memphasys’ early order from ITL validates its direct-selling approach and sets the stage for a pivotal 2026 regulatory milestone.

Questions in the middle?

  • Will CE Mark approval be granted on schedule in early 2026?
  • Can Memphasys sustain and scale clinic-level demand beyond initial orders?
  • How will Felix™ adoption impact Memphasys’ revenue growth and market positioning?