Meets Deadlines and is Preparing for Regulatory Submission, FELIX(TM) Clinical Trial Completed
Sydney, Feb 24, 2025 AEST (ABN Newswire) - Memphasys Limited (
ASX:MEM) (IG7:FRA) is pleased to announce successful completion of the data lock for the pivotal Felix(TM) clinical trial. This marks a critical milestone in ensuring the accuracy and integrity of the trial data through rigorous data management and source data verification processes; and follows MEM's approval of the final data management and statistical analysis plans.
Key Highlights:
- Following final quality check and data validation, data lock has been completed for the pivotal Felix(TM) clinical trial
- Felix(TM) clinical trial data ready for statistical analysis, following MEM's approval of the final data management and statistical analysis plans
- Preliminary trial results remain on track for release in March 2025
- CE Mark submission planned for June 2025
- Market entry into Europe, Australia and India is planned soon after CE Mark approval
Completion of the data lock involved an extensive process of data clean-up, meticulous data management, and rigorous source data verification, all aimed at ensuring the accuracy and integrity of the trial results.
The data will now be incorporated into the CE Mark submission, which is a vital step in the Company's efforts to gain access and approval in the European market. Following CE Mark approval, market entry into other jurisdictions, such as Australia and India, will follow shortly thereafter.
Preliminary trial results remain on track for release in March 2025. This is a significant step towards the eventual commercialisation of the Felix(TM) System, which has shown great promise in the clinical trial to date.
Memphasys Managing Director & CEO, Dr David Ali said:
"We are extremely pleased with the progress made in completing the data lock for the Felix(TM) clinical trial. This milestone ensures that we are on track to meet our timelines for releasing preliminary trial results and advancing towards the CE Mark submission. We are excited for the future of Felix(TM) and I look forward to updating you on the imminent release of preliminary results."
About Memphasys Ltd
Memphasys Limited (ASX:MEM) specialises in reproductive biotechnology for high value commercial applications. Reproductive biotechnology products in development include medical devices, in vitro diagnostics, and new proprietary media. The Company's patented bio separation technology, utilised by the Company's most advanced product, the Felix(TM) System, combines electrophoresis with proprietary size exclusion membranes to separate the most viable sperm cells for human artificial reproduction.
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