In a pivotal step towards commercialisation, Memphasys (ASX: MEM) has announced the completion of the Last Patient Last Visit (LPLV) in its clinical trial for the Felix™ System, an advanced sperm selection technology designed to improve outcomes in Assisted Reproductive Technology (ART) procedures.
With all required patient visits and pregnancy outcomes now finalised, the company is moving swiftly towards data lock, expected within the next two weeks. This marks a crucial transition from data collection to analysis, setting the stage for the release of preliminary trial results in early March 2025.
Tightening the Data Before the Home Stretch
Memphasys' immediate focus is on data clean-up and verification—a meticulous process ensuring accuracy before statistical analysis begins. Given the high stakes in ART technologies, this step is essential for regulatory approvals and commercial adoption.
Dr David Ali, Managing Director & CEO of Memphasys, emphasised the importance of this phase:
“With all patient data now collected, our team is focused on ensuring every data point is verified and ready for statistical analysis. It’s a meticulous process, but a necessary one as we prepare for regulatory approvals and commercial discussions. We look forward to sharing the trial results very soon.”
Dr David Ali
Regulatory Pathway and Commercial Ambitions
Once the trial data is locked and analysed, Memphasys will submit the findings as part of its CE Mark submission, a crucial step for launching the Felix™ System in Europe. Approvals in Australia and India are expected to follow, with the Therapeutic Goods Administration (TGA) likely to expedite its decision once the CE Mark is in place.
Memphasys is also keen to leverage the trial results in commercial discussions with current and prospective partners. Strong data validation could accelerate licensing and manufacturing deals, expanding the technology’s reach into global fertility markets.
What’s Next?
The coming weeks will be pivotal for Memphasys, with investors and industry stakeholders keenly awaiting the early March 2025 data release. If successful, the Felix™ System could significantly improve ART outcomes, making sperm selection faster, safer, and more effective.
Memphasys has promised further updates as it moves through this final phase, but for now, all eyes are on the impending trial results—and the potential market impact that follows.
