Memphasys Posts AUD 4.94M Loss as Felix System Hits Clinical and Regulatory Milestones

Financial Performance and Strategic Shift

Memphasys Limited closed the financial year ended 30 June 2025 with a net loss of AUD 4.94 million, an 11% increase from the prior year’s AUD 4.44 million loss. Revenue from continuing operations fell sharply by 94% to just AUD 3,700, reflecting the company’s transition from research and development towards commercial execution. Despite the widening loss, Memphasys is strategically pivoting to focus on commercialising its flagship Felix System, a patented automated sperm separation device designed to improve assisted reproductive technology (ART) outcomes.

Felix System, Clinical Validation and Market Entry

The Felix System achieved a significant milestone with the successful completion of a pivotal Phase III clinical trial in collaboration with Monash IVF, demonstrating superior embryo utilisation rates and safety compared to existing sperm separation methods. Following this, Memphasys lodged its CE Mark application in June 2025, a critical regulatory step that could open access to the European Economic Area and other markets recognizing CE certification, including India and the Middle East.

While awaiting CE Mark approval, expected within 6 to 12 months, Memphasys has initiated direct sales in lower-regulation markets such as Japan, New Zealand, Canada, and the UAE. Early pilot sales in Japan have yielded positive clinician feedback, particularly highlighting the Felix System’s efficiency in reducing sperm preparation time to approximately six minutes. The company is also maintaining its exclusive distribution agreement with Vitrolife Japan KK, while simultaneously pursuing direct sales to accelerate market adoption and establish a commercial foothold.

Expanding Global Footprint and Partnerships

Memphasys is actively engaging with strategic partners and clinics across multiple regions. In China, the company signed a Letter of Intent with Heranova Lifesciences and is conducting clinical utility testing in leading fertility hospitals, although regulatory complexities have led to a strategic deprioritisation in favour of faster-to-market regions. In the Middle East, an initial order from a Dubai clinic underscores growing demand, with further distribution expansion underway pending regulatory approvals.

RoXsta Platform, Diversifying Future Revenue Streams

Alongside Felix, Memphasys is advancing its RoXsta oxidative stress diagnostic platform, which has demonstrated potential across human and animal health applications. The company filed an international patent application in September 2024, with positive novelty findings from the World Intellectual Property Organisation. Pilot studies in livestock fertility and dairy mastitis detection are underway, supported by collaborations with universities and industry partners. The RoXsta Mega Cell High-Throughput Assay device offers rapid, cost-effective antioxidant testing, positioning Memphasys to capture emerging opportunities in oxidative stress diagnostics.

Leadership and Outlook

Memphasys strengthened its leadership team with the appointment of Dr David Ali as permanent CEO and the addition of experienced non-executive directors Dr Lindley Edwards and Marjan Mikel, bringing expertise in corporate governance, commercialisation, and capital markets. The company’s focus is now firmly on driving early revenues, building clinical adoption, and scaling operations to support international expansion of the Felix System, while nurturing the RoXsta platform as a complementary growth engine.