Memphasys has completed the final patient visit in its Felix™ clinical trial, with data lock expected within two weeks and preliminary results slated for early March 2025. This milestone paves the way for CE Mark submission and imminent commercialisation in Europe.
- Last Patient Last Visit (LPLV) achieved, completing all patient data collection
- Data lock anticipated in approximately two weeks following data verification
- Preliminary trial results expected to be released in early March 2025
- CE Mark submission underway to enable European market entry
- Regulatory approvals in Australia and India to follow shortly after Europe
Clinical Milestone Achieved
Memphasys Limited (ASX: MEM) has reached a pivotal milestone in its Felix™ System clinical trial with the completion of the Last Patient Last Visit (LPLV). This marks the conclusion of all required patient visits, including the critical pregnancy outcomes, effectively closing the data collection phase of the study.
The Felix™ System, an advanced sperm selection technology designed to improve Assisted Reproductive Technology (ART) outcomes, has been under rigorous clinical evaluation. The LPLV achievement signals that Memphasys is now transitioning into the final stages of data processing and analysis.
Data Lock and Quality Assurance
Following LPLV, the company is focusing on data clean-up, management, and source data verification to ensure the integrity and accuracy of the dataset. This meticulous process is essential before the data lock, which is expected in approximately two weeks. Once locked, the dataset will be frozen for final statistical analysis, a critical step before public disclosure of trial results.
Memphasys remains on track to release preliminary trial outcomes to the ASX in early March 2025. These results will provide the first comprehensive insights into the clinical efficacy and safety of the Felix™ System, potentially validating its role in enhancing fertility treatment success rates.
Regulatory and Commercial Implications
The clinical data will form a cornerstone of Memphasys' CE Mark submission, a regulatory certification that will enable immediate commercialisation of the Felix™ System across Europe. This is a significant commercial milestone, as CE Mark approval often accelerates market access and adoption.
Following European approval, Memphasys anticipates streamlined regulatory processes in Australia and India, leveraging the CE Mark certification to expedite Therapeutic Goods Administration (TGA) approval and equivalent regulatory clearances. This sequential market entry strategy underscores the company’s global commercial ambitions.
In addition, the trial data will be instrumental in discussions with existing and prospective distribution partners. The validation from the clinical trial is expected to bolster sales efforts and licensing negotiations, potentially expanding Memphasys’ footprint in key fertility markets worldwide.
Leadership Perspective and Next Steps
Dr. David Ali, Managing Director and CEO of Memphasys, emphasised the significance 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."
Investors and stakeholders will be watching closely as Memphasys progresses through data lock and prepares to unveil the trial findings. The coming weeks will be critical in shaping the company’s regulatory trajectory and commercial outlook.
Bottom Line?
As Memphasys locks its trial data, the fertility biotech edges closer to European market entry and global expansion.
Questions in the middle?
- Will the preliminary trial results meet or exceed market expectations for efficacy and safety?
- How quickly will regulatory approvals in Australia and India follow the CE Mark certification?
- What impact will the trial data have on Memphasys’ partnerships and licensing deals?