Photo: Dr David Ali, Ashleigh Williams Sophie Popkiss

Since 2021, we have been conducting a clinical study on the performance of the Felix™ sperm separation system in conjunction with the Monash IVF Group Ltd (MVF), a renowned Australian leader in reproductive and fertility services, across ten of its facilities. To ensure efficient management, we’ve engaged Mobius Medical, an esteemed Australian clinical research organisation (CRO), to oversee the project on our behalf.

The visit provided an invaluable opportunity to connect with the dedicated team at Monash IVF who have played a crucial role in advancing our study. We received a comprehensive update on its progress and milestones achieved to date.

The primary objective of the study is to evaluate the safety and efficacy of the Felix™ System compared to conventional sperm separation methods such as Swim-Up and Discontinuous Gradient Centrifuge for isolating sperm from semen prior to intracytoplasmic sperm injection (ICSI) in assisted reproductive treatment (ART)  procedures.

Across these ten Monash IVF sites, approximately 104 couples will participate in the study. Upon completion, the trial results, along with an extensive literature review, will be compiled into a formal regulatory submission to the Therapeutic Goods Administration (TGA) of Australia. This submission will support Memphasys’ application for the approval of the Felix™ System for commercial sale within Australia and aid in regulatory filings in other international markets. Approval by the TGA will potentially expedite the Felix™ Systems global commercialisation process.

David’s visit underscores our commitment to our clinical partners and advancing reproductive medicine through robust clinical partnerships which foster mutual interests and outcomes. We look forward to the continued success of our collaboration with Monash IVF.