Australian biotech company Memphasys Limited (ASX: MEM) is closing in on a key milestone with its Felix™ System clinical trial, which is now 90% complete. With fewer than 20 patients left to recruit, the trial is on track to wrap up by the end of 2024. The company has also pivoted its regulatory focus towards achieving CE mark registration in Europe, promising a quicker path to market entry compared to the Australian Therapeutic Goods Administration (TGA) process.
Fast-Tracking Progress
Memphasys' flagship Felix™ System, which uses a novel combination of electrophoresis and size exclusion membranes to separate viable sperm for assisted reproductive technologies (ART), is undergoing a clinical trial to demonstrate its superiority over traditional sperm preparation techniques. These methods include Swim-up and Density Gradient Centrifugation (DGC), which are widely used but not without limitations. The trial, conducted in collaboration with Monash IVF Group across multiple sites in Australia, has reached significant momentum, progressing from under 50% completion earlier this year to its current 90%.
With recruitment sites spanning Victoria, New South Wales, Western Australia, and South Australia, and additional patient consents already secured, Memphasys expects the trial to conclude by year-end. The company has also flagged potential contributions from Japan’s Kiba Park Clinic, which could further accelerate the final stages.
A Strategic Regulatory Pivot
Rather than pursuing an initial TGA registration, Memphasys has opted for a CE mark in Europe, driven by strategic advice suggesting this pathway could be completed in less than a year following submission. This approach will allow the Felix™ System to enter the larger European market faster while simultaneously providing a potential springboard for subsequent registration with the TGA.
Memphasys’ Managing Director and CEO, Dr. David Ali, explained the rationale: “Our strategic decision to prioritise CE mark registration puts us in an even stronger position. Regardless of the exact trial completion date, our shortened regulatory timeline is poised to make up for any minor clinical delays and will allow us to enter key markets earlier than initially anticipated.”
With Europe recognised as the global leader in ART treatments, conducting over 1 million IVF cycles annually, the CE mark offers significant commercial advantages. In contrast, the Australian market, while growing, accounted for just over 100,000 IVF cycles in 2021. Memphasys’ move towards CE registration is not only a tactical decision to accelerate time to market but also a step towards accessing larger revenue streams earlier.
Capitalising on Commercial Growth Opportunities
The Felix™ System, Memphasys’ most advanced product, has the potential to transform sperm selection in IVF treatments. By ensuring more viable sperm are used in ART, the system could lead to higher success rates in fertility clinics worldwide. Successful trial outcomes will bolster Memphasys’ case as it seeks regulatory approval and moves towards commercialisation.
The momentum of the Felix™ System trial also comes at a time of heightened interest from potential distributors, strategic partners, and investors. Positive data from the trial will likely accelerate discussions aimed at expanding the product’s reach and securing the necessary backing for global growth.
A Year of Strong Execution
Memphasys has made remarkable strides in 2024, with the Felix™ System trial nearing its conclusion and its regulatory strategy realigned for maximum efficiency. Dr. Ali underscored the importance of these achievements: “We’ve taken every step possible to expedite the Felix™ clinical trial, achieving remarkable progress this year. From less than 50% completion at the start of 2024 to 90% today, we are well on track to wrap up the trial by the end of the calendar year.”
While patient recruitment remains ongoing, the company’s proactive shift towards the CE mark ensures that any minor delays in trial completion will not significantly impact its broader commercial timeline.
Looking Ahead
With the clinical trial expected to close by the end of 2024 and the technical file for CE mark submission slated for H2 FY25, Memphasys is positioning itself for an earlier-than-expected market entry. If all goes according to plan, the Felix™ System could soon be available to European fertility clinics, potentially reshaping the landscape of assisted reproductive technologies.
For investors, Memphasys' accelerated progress and focus on strategic market entry highlight the company's commitment to delivering on its promises and expanding its footprint in the high-demand field of reproductive biotechnology. With the finish line in sight for its clinical trial, Memphasys is primed to unlock new growth opportunities both at home and abroad.
