Memphasys Advances Global Reach with Felix™ System Trials and Strategic Partnerships

Clinical Milestone Sets Stage for European Market Entry

Memphasys Limited (ASX: MEM) has successfully completed pivotal human clinical trials for its flagship Felix™ System at Monash IVF, a critical step toward securing CE Mark approval. This regulatory milestone is expected to unlock access to the lucrative European assisted reproductive technology (ART) market in the second half of fiscal 2025, positioning Memphasys for accelerated commercialisation.

The Felix™ System, designed for rapid sperm separation, addresses a growing global demand in IVF treatments, with the Asia-Pacific and Middle Eastern markets showing particularly strong growth trajectories. The company’s focus on CE Mark registration reflects a strategic prioritisation of regulated markets to underpin sustainable revenue streams.

Strategic Partnerships Expand Global Footprint

Memphasys has inked a Letter of Intent with Heranova Lifesciences HK Limited to distribute the Felix™ System in Greater China, a market forecasted to nearly double to USD 9 billion by 2030. This partnership includes pathways for exclusive distribution, licensing, and local manufacturing, supported by Heranova’s financing of clinical trials and regulatory submissions. Post-quarter, Heranova commenced in vitro utilisation testing at a major fertility hospital in Chengdu, signalling tangible progress toward market validation.

Additionally, an order from a UAE clinic facilitated by Panacea Medizintech LLC marks Memphasys’ entry into the Middle Eastern market, which is projected to grow at an impressive CAGR of nearly 12% through 2033. These collaborations are instrumental in establishing the Felix™ System’s global presence and demonstrate growing international demand for advanced reproductive technologies.

Diversifying Applications: Equine and Livestock Fertility

Beyond human fertility, Memphasys is advancing the Felix™ System’s application in equine fertility through a three-year study with Equibreed UK Ltd and the University of Newcastle. Supported by prominent Australian stud farms, this initiative aims to position Felix™ as a leader in the equine artificial insemination market, with commercial outcomes anticipated within the next year.

Parallel to this, the RoXsta™ System, which measures oxidative stress to enhance bovine fertility, has received provisional patent approval, reinforcing its intellectual property position. A cattle breeding study launched in New South Wales is underway, with preliminary results expected by February 2025. Positive findings could pave the way for expanded trials and new revenue streams in agricultural biotechnology.

Financial and Leadership Strengthening

Memphasys secured $1.905 million through a placement and share purchase plan during the quarter, providing essential funding to accelerate commercialisation efforts. This capital injection supports ongoing regulatory submissions, clinical trials, and market expansion activities.

Complementing its financial progress, the appointment of Dr. Lindley Edwards as Non-Executive Chairperson brings seasoned expertise in strategic partnerships and financial leadership, bolstering the company’s governance as it navigates growth markets.

Looking Ahead

With regulatory submissions on track and strategic partnerships solidifying its global footprint, Memphasys is well-positioned to capitalise on expanding fertility markets. The company’s dual focus on human and animal reproductive technologies offers diversified growth avenues, while its strengthened leadership and funding base provide a robust platform for the next phase of commercialisation.