Key Highlights

• Board reassessment has identified a potential 510(k) clearance pathway for the Felix™ Sperm Separation System, replacing the previously contemplated De Novo classification route, following the identification of a potential predicate device.

• Memphasys will undertake a Pre-Submission (Q-Submission) engagement with the FDA to seek feedback on the proposed pathway, predicate, and supporting evidence before proceeding to a formal 510(k) submission, targeted for Q1 CY2027.

• The US IVF market was estimated at approximately US$5.9 billion in 2025, representing approximately 20% of global IVF market revenue, with approximately 500 ART clinics and more than 435,000 ART cycles annually.

• The US regulatory program will be ring-fenced and progressed in parallel, with Memphasys' immediate commercial focus remaining on Felix™ adoption across Europe, Australia and New Zealand, Asia, and MENA.

Memphasys Limited (ASX:MEM) announced on 25 September 2026 that a reassessment of its US regulatory strategy for the Felix™ Sperm Separation System has led to the identification of a potentially faster and more cost-effective pathway towards FDA clearance. The Company had previously anticipated pursuing the De Novo classification pathway, as no suitable predicate device had been identified at that time.

Following a Board-directed reassessment, conducted in collaboration with specialist regulatory advisers, Memphasys has identified a legally marketed device it believes may provide an appropriate predicate for Felix™. If accepted by the FDA, this would allow the Company to pursue the 510(k) clearance pathway, which is based on demonstrating substantial equivalence to a predicate device and is generally considered a more established and streamlined regulatory route than the De Novo process.

Next Step: FDA Pre-Submission Engagement

The Company's immediate next step is a Pre-Submission engagement with the FDA, formally known as a Q-Submission. This process enables Memphasys to seek FDA feedback on the proposed predicate, regulatory strategy, testing requirements, and supporting evidence before committing to a formal submission. A formal 510(k) submission is targeted for Q1 CY2027, subject to the outcome of the Q-Submission engagement and the completion of any additional required work.

A Q-Submission is a standard preparatory mechanism in US medical device regulation and does not guarantee FDA acceptance of the proposed pathway. The FDA's response to the Q-Submission will be a critical determinant of whether the 510(k) pathway proceeds as envisioned or requires modification.

US IVF Market Opportunity

The United States represents a significant commercial opportunity for Felix™. Approximately 500 US clinics provide assisted reproductive technology (ART) services, with the latest comprehensive CDC national data reporting 435,426 ART cycles across 457 reporting clinics in 2022. The US IVF market was estimated at approximately US$5.9 billion in 2025, accounting for approximately 20% of global IVF market revenue.

These figures underscore the scale of the addressable market. However, Memphasys clarified that the US regulatory program will be ring-fenced, with no expectation of material short-term Cash Flow impact. The US market opportunity is framed as a Long-term Growth avenue rather than a near-term Revenue driver.

Immediate Commercial Focus and International Traction

Memphasys' stated immediate commercial priority remains unchanged: accelerating Felix™ adoption, cartridge sales, and Recurring Revenue generation in markets where regulatory approvals and commercial infrastructure are already established. The Company is continuing to develop its distributor and clinic network across Europe, Australia and New Zealand, Asia, and the MENA region.

In the context of the September 2026 update, Memphasys also noted that additional repeat orders have been received from existing partners and clinics in Italy, the United Kingdom, and MENA. Repeat orders from established commercial relationships provide an indication of growing clinical adoption of Felix™ in practice, though the Company has not disclosed specific Volume or revenue figures associated with these orders.

About Felix™ and Memphasys Technology

Felix™ is a patented bio-separation system that isolates viable sperm cells for human assisted reproduction using a combination of electrophoresis and size-exclusion membranes. The system is designed to deliver a standardised sperm selection process that the Company asserts reduces cellular stress and DNA damage relative to traditional centrifugation methods. Memphasys' commercial model is focused on contracting recurring cartridge sales through direct and distribution-led channels.

Final Thoughts

The identification of a potential 510(k) pathway represents a strategically meaningful development for Memphasys, given the scale of the US IVF market and the limitations of the previously contemplated De Novo route. However, the pathway remains subject to FDA validation through the Q-Submission process, and a formal submission is not expected until Q1 CY2027 at the earliest. In the interim, investors will be focused on whether Memphasys' existing commercial markets continue to generate revenue momentum from repeat cartridge orders and new clinic onboarding across its established international markets.