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Memphasys Raises $1.86 Million to Propel Clinical and Commercial Development of Reproductive Biotech Innovations

Written by Staff Writer | Nov 5, 2024 3:00:12 AM

Memphasys Limited (ASX: MEM) announced today the completion of its Share Purchase Plan (SPP) and Placement Offer, successfully raising $1.857 million to accelerate the development and commercialisation of its reproductive biotechnology portfolio. With these funds, Memphasys is advancing key projects, including the Felix™ System—a breakthrough device for assisted reproductive technology (ART)—and the RoXsta™ oxidative stress measurement tool.

The SPP allowed eligible shareholders to purchase up to $30,000 worth of shares at $0.006, a 20% discount to the recent five-day VWAP. The capital raise also included one-for-one attaching options with each share issued, a feature Memphasys expects will attract continued investor support. Additionally, the company has introduced a Top Up Offer, open until December 13, 2024, aiming to raise an additional $1 million, which would further strengthen its financial position.

Advancing the Felix™ System for Global ART Markets

Memphasys has made significant progress with its flagship product, the Felix™ System, designed to enhance ART outcomes through a novel sperm selection method. The system, which employs a combination of electrophoresis and size-exclusion membranes, isolates the most viable sperm cells to improve ART success rates.

Felix™ is already commercially available in Japan through a partnership with Vitrolife Japan KK, a major player in ART consumables and devices. Japan represents a high-potential market, accounting for roughly 14.5% of global ART demand, with further growth expected upon the anticipated regulatory expansion. Memphasys is targeting additional markets, with distribution agreements already established in Canada and New Zealand, and strategic plans for broader access underway.

 

Nearing Completion of the Australian Clinical Trial

The Felix™ System’s clinical trial in human ART, being conducted across Monash IVF Group sites in Australia, is nearing completion, with over 90% of the required recruitment now achieved. The trial aims to validate Felix™ by comparing it against traditional sperm selection techniques, such as density gradient centrifugation (DGC) and swim-up methods. Key metrics include DNA damage reduction, sperm motility improvement, and overall sperm health—all indicators that directly impact ART success rates.

Expected to conclude by the end of 2024, the trial will provide crucial data needed for regulatory submissions, including the CE mark application slated for the second half of FY25. The CE mark would enable Memphasys to enter the European market, expanding Felix™’s commercial footprint into one of the largest regulated regions for ART. Moreover, a successful trial outcome strengthens Memphasys’ position in ongoing strategic discussions with distributors and partners across the fertility sector, bolstering its case for broader international adoption.

Equine Fertility and the Expansion into Animal Reproductive Markets

Memphasys’ reproductive technology ambitions extend beyond human fertility. The company recently embarked on a three-year equine fertility study in collaboration with the University of Newcastle and EquiBreedUK Ltd, which aims to validate Felix™ in the high-value animal breeding sector. Early results from this study show Felix™ effectively improves the quality of sperm in stallion samples by isolating low-reactive oxygen species (ROS) sperm with enhanced DNA integrity—a crucial factor in reproductive success for equine breeding.

The global equine artificial insemination (AI) market, valued at USD $681 million, is an attractive target, and Memphasys aims to bring Felix™ to this sector within 12 months. The study also paves the way for Felix™ to potentially serve other high-value animal breeding markets, including bovine ART, adding further avenues for commercialisation.

Introducing RoXsta™ for Oxidative Stress Measurement

Memphasys is also developing the RoXsta™ system, a rapid oxidative stress assessment tool with applications in both human fertility and veterinary health. RoXsta™ measures oxidative stress in as little as six minutes and does not require complex laboratory processing, positioning it as a practical, point-of-care solution. Oxidative stress is increasingly recognised as a factor in fertility outcomes, and RoXsta™ is designed to quickly assess stress levels across multiple biological samples, including semen, blood, and saliva. Memphasys has filed a patent for RoXsta™, reinforcing its commitment to protecting the unique aspects of this technology.

What’s Next for Memphasys

With fresh funding secured, Memphasys is set to deliver on several key milestones. The completion of the Felix™ Australian clinical trial will be a crucial step, with upcoming data to support regulatory approvals and fuel global expansion talks. Felix™’s early success in Japan provides a strong foundation, and with distribution agreements now in Canada and New Zealand, broader market reach is in sight.

On the animal health side, the equine fertility study is progressing well, with promising results that pave the way for entry into the global animal breeding market. Meanwhile, RoXsta™ development will focus on establishing performance benchmarks to strengthen its value as a diagnostic tool.

Over the coming months, Memphasys aims to convert these advances into strategic market entries and partnerships, positioning itself as a leader in reproductive biotech across both human and animal sectors.