Memphasys identifies regulatory pathway to US$5.9B market

• Memphasys identified a potential 510(k) clearance pathway for its Felix Sperm Separation System.
• The regulatory adjustment opens direct access to the US$5.9 billion American fertility sector.
• The company intends to engage in pre-submission feedback while progressing international sales.

Memphasys (ASX:MEM) has identified an expedited 510(k) pathway to seek clearance for its Felix Sperm Separation System in the US$5.9 billion US market.

The board previously anticipated needing a De Novo classification pathway, but recent reassessments identified a legally marketed predicate device.

The company stated that the strategic shift allows it to pursue an established pathway based on substantial equivalence.

Memphasys Executive Chairman David Tasker said, "The board's reassessment of our US regulatory strategy has identified a potentially faster and more direct pathway for Felix into a US$5.9 billion IVF market representing around 20% of the global market.”

Memphasys will now undertake a pre-submission engagement with the United States Food and Drug Administration to seek formal feedback.

Following the announcement, the Memphasys share price was unchanged at $0.005.

The US market represents a major long-term commercial target, hosting around 500 clinics and over 435,000 annual treatment cycles.

While advancing its US programme in parallel, Memphasys stated that its immediate commercial focus remains on driving adoption across Europe, Australia, Asia, and MENA.