Advanced Sperm Selection Technology Moves Closer to Market

Memphasys Limited (ASX:MEM) has hit a critical milestone in its pivotal clinical trial for the Felix™ System, an innovative sperm selection technology designed for Assisted Reproductive Technology (ART) procedures. With the Last Patient Last Visit (LPLV) now completed, the company is entering the final phase before results are locked in and released.

CEO Confirms Data Lock Timeline

The next major step for Memphasys is the data lock, expected within two weeks. This process ensures all collected data is verified and accurate before statistical analysis begins.

“With all patient data now collected, our team is focused on ensuring every data point is verified and ready for statistical analysis,” said Memphasys Managing Director & CEO, Dr David Ali. “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.”

Memphasys remains on track to release preliminary trial results to the ASX in early March 2025.

Final Quality Checks Underway

Before data lock, the company is conducting a final clean-up phase, which involves data management and source verification. These quality control measures are crucial to ensuring the dataset meets regulatory and scientific standards.

Regulatory Approvals on the Horizon

Once the data is finalised, Memphasys will integrate the findings into its CE Mark submission, a key regulatory step that will enable the Felix™ System to enter the European market.

The company expects regulatory approvals in Australia and India to follow shortly after, with the Therapeutic Goods Administration (TGA) process likely to be expedited due to the CE Mark certification.

Commercialisation and Market Expansion

Beyond regulatory approvals, Memphasys plans to use the trial data to strengthen its position in the ART market. The Felix™ System’s validation is expected to drive interest from distribution partners, paving the way for licensing, manufacturing, and global commercialisation.

“We’re already in discussions with existing and potential distribution partners,” Dr Ali noted. “The completion of this trial will accelerate those conversations and help build confidence in the Felix™ System as a leading-edge technology for ART procedures.”

Memphasys will continue to update the market as the trial progresses through this final stage, with March 2025 shaping up to be a pivotal month for the company’s future in reproductive biotechnology.