Memphasys and the Felix™ System trial update

Memphasys (ASX:MEM) has provided an update on its Felix™ System clinical trial and European market strategy. The trial is 90% complete and aims to finish by year-end. The company plans to pursue CE mark registration in Europe, offering a quicker market path.

Summary of Memphasys' strategic moves

Memphasys is nearing the completion of its Felix™ System clinical trial, with plans to finish by the end of the year. The company aims to expedite CE mark registration in Europe, which could take less than a year, allowing for faster market entry compared to the Australian TGA process. This strategic decision positions Memphasys to leverage growth opportunities in the larger European market. The company remains focused on completing its technical file for submission in H2 FY25, regardless of the trial's completion date. Memphasys continues to target commercial expansion in international markets, particularly in Europe, where assisted reproductive technology cycles are significant.

Insights from Memphasys management

Dr. David Ali, Managing Director and CEO, highlighted the significant progress in the trial and the strategic move to prioritize CE mark registration for quicker market entry. The proactive approach aims to mitigate any delays and expand commercial growth potential across larger jurisdictions.