Memphasys Builds Global Momentum with CE Mark Application for Felix™

In a pivotal step toward global commercialisation, reproductive biotech firm Memphasys (ASX: MEM) has lodged its CE Mark application for the Felix™ sperm separation device, positioning itself to crack the lucrative European IVF market—estimated at US$4–5 billion annually.

The CE Mark submission, announced on the last trading day of FY25, ticks a key milestone promised by management and underscores the company’s sharper commercial focus under the leadership of Managing Director Dr David Ali.

“Submitting the CE Mark application on schedule is a clear indicator we are delivering on the commercialisation commitments made to investors,” Dr Ali said. “Our focus is to convert scientific innovation into near-term revenue and scaling into meaningful markets.”

If approved, Felix™ will be able to enter the European Economic Area, opening the doors to more than 500,000 IVF cycles conducted annually across the continent. At an average US$8,000–10,000 per cycle, it’s the single largest assisted reproduction market globally, with growth running at around 5–6% per annum.

Memphasys is gunning for regulatory clearance within six to twelve months, though efforts are underway to expedite the process. A CE Mark would also streamline entry into other significant territories including India, the Middle East, Australia and various parts of Asia-Pacific.

The Felix™ device—which completed Phase III trials in 2024—offers a stark advantage over conventional sperm separation techniques. Clinics can process samples in just six minutes, a dramatic improvement over the 30-minute turnaround typical of centrifuge-based methods. That fivefold time-saving not only boosts efficiency but also helps IVF clinics—often operating near capacity—maximise throughput and better manage scheduling.

Despite the big prize in Europe, Memphasys isn’t sitting idle while the CE process ticks over. Felix™ is already cleared for sale in lower-regulatory markets like Japan, Canada and New Zealand, where the company is actively pursuing a direct go-to-market strategy.

Dr Ali explained the rationale: “While Europe represents a significant future commercial opportunity for Felix™, we are not waiting… We are now gearing up to actively execute structured direct go-to-market plans in these markets.”

Interestingly, Memphasys has chosen to lead with direct sales rather than leaning heavily on distributors—at least in the early stages. It’s a pragmatic move, recognising that distributors aren’t always best-placed to nurture entirely new market segments.

“Following a careful review, the Board has determined that a more direct approach in the initial phases of market entry will provide the best opportunity to build awareness and demonstrate the value of Felix™,” the company said.

The aim is to create a compelling proof of concept with early adopters, paving the way for future distributor-led expansion once brand equity is firmly established.

In Japan, New Zealand and Canada, the company reports active commercial discussions underway with several IVF clinics, although names remain under wraps.

Investors who’ve followed Memphasys’ long and winding R&D path may well see this as an inflection point. Years of lab work and regulatory groundwork are starting to translate into something the market cares about—revenue.

It’s still early days, and regulatory approvals can be fickle beasts. But with Felix™ now officially in the CE pipeline and groundwork laid in multiple territories, Memphasys is finally positioned to make its commercial push felt on a global scale.