Memphasys Advances Felix™ CE Mark, Boosts Sales in Japan, Validates RoXsta™ Assay

Regulatory Milestone Opens European Market

Memphasys Limited (ASX – MEM), a reproductive biotechnology company, marked a significant step forward in its commercial journey by submitting the CE Mark application for its flagship Felix™ sperm separation system. This regulatory milestone, expected to culminate in approval within the next 6 to 12 months, will grant Memphasys access to Europe’s lucrative in vitro fertilisation (IVF) market, valued at approximately $5 billion annually.

The Felix™ system leverages proprietary bioseparation technology to isolate the most viable sperm cells, promising improved outcomes for assisted reproduction. With over half a million IVF cycles conducted annually in Europe, the potential market impact is substantial.

Strategic Pivot to Early-Access Markets

Rather than waiting for CE approval, Memphasys has strategically pivoted to direct sales in lower-regulation jurisdictions including Japan, New Zealand, the United Arab Emirates, and Canada. This approach has already yielded repeat sales in Japan, where the Felix™ device is now in clinical use. Advanced commercial discussions are underway in other territories, supported by active clinical engagement and education initiatives.

This early market penetration strategy allows Memphasys to build critical clinical data, foster early adopter relationships, and refine its commercial messaging; all while retaining greater margin control ahead of broader distributor partnerships post-CE Mark approval.

RoXsta™ Platform Validated for Diverse Applications

Alongside Felix™, Memphasys is advancing its RoXsta™ oxidative stress diagnostic platform, which measures antioxidant capacity in biological fluids. The recently validated RoXsta™ Mega Cell assay can process 96 samples per hour, offering rapid, cost-effective testing for human fertility, livestock reproduction, and elite sports performance.

Trials with cattle, athletes, and fertility labs have confirmed the assay’s commercial viability. Notably, a large-scale bull fertility study is in preparation with a global veterinary pharmaceutical partner, and early-stage mastitis detection trials have shown promising results in collaboration with Charles Sturt University and the University of Newcastle.

Financial and Operational Foundations Strengthened

To support these initiatives, Memphasys completed a $1.275 million capital raise during the quarter, providing runway for regulatory activities, market entry, and further development of the RoXsta™ platform. Concurrently, the company has initiated a comprehensive manufacturing and supply chain review aimed at reducing costs, ensuring CE compliance, and scaling production to meet anticipated demand.

Corporate governance also saw changes with the appointment of Marjan Mikel as a Non-Executive Director, bringing valuable medtech and commercialisation expertise, while Michael Atkins resigned post-quarter due to other commitments.

Looking Ahead

Memphasys enters fiscal year 2026 poised to expand Felix™ sales across direct and partnered markets, explore new RoXsta™ partnerships, and optimise its cost structure. While early revenues remain modest, the company’s disciplined execution and strategic market entries set a foundation for growth and shareholder value creation.