Memphasys Limited (ASX: MEM) has announced the completion of the final patient visit in its pivotal clinical trial for the Felix™ System, an advanced sperm selection technology designed for Assisted Reproductive Technology (ART) procedures. With the last patient visit now completed, all required patient visits and pregnancy outcomes have been recorded. The company is currently focused on data clean-up, ensuring accuracy through data management and source data verification before locking the dataset. This process is expected to take approximately two weeks.
The preliminary trial results remain on track for release to the ASX in early March 2025. The data will be incorporated into the CE Mark submission, facilitating market entry into Europe. Regulatory approvals in Australia and India are expected to follow, with the Therapeutic Goods Administration (TGA) process in Australia likely to be streamlined once CE Mark certification is secured.
Memphasys managing director and chief executive officer, Dr David Ali, highlighted the significance of this milestone, stating that the team is now focused on verifying every data point in preparation for statistical analysis. He emphasised the importance of this meticulous process in ensuring the accuracy and integrity of the results as the company moves towards regulatory approvals and commercial discussions.
The trial data will be shared with both current and potential distribution partners, accelerating commercial discussions related to licensing, manufacturing, and global expansion. The validation from this study is expected to support increased sales by existing distributors in their respective markets.
Memphasys will continue to provide updates as the trial progresses through its final phase.
