Australian-based bio-separations and reproductive biotechnology company Memphasys Limited (ASX: MEM) has confirmed that a clinical study on its Felix device (FELIX- ICSI) has enrolled and treated the first couple.
The clinical study is being conducted in collaboration with leading Australian reproductive and fertility services company Monash IVF Group Ltd (MIVF) and Mobius Medical, the appointed Contract Research Organisation managing the study on behalf of Memphasys.
In total, 104 couples will be enrolled across seven MIVF sites. Four of the MIVF sites are now cleared to commence patient recruitment and study enrolment with three more sites to come on stream by August.
All MIVF personnel conducting the study at the chosen MIVF sites have been fully trained in the conduct of the study. The study is scheduled to be completed by end of December 2022, subject to recruitment / treatment rates.
The first patient enrolments into this clinical study are exciting. Memphasys, along with Monash IVF, are confident recruitment and treatment rates will increase especially with the additional three MIVF sites. I look forward to updating the market further as this study progresses,” Alison Coutts, Memphasys Managing Director and CEO, said.
Study overview
The clinical study, which has received ethics approval, will assess the safety and performance of the Felix device vs Swim-Up and Density Gradient Centrifugation for couples suffering from male infertility factors, to isolate sperm from semen prior to its use for ICSI, a common technique used in assisted reproductive technologies.
The clinical study results, together with a comprehensive literature review, will be filed in a formal regulatory submission (conformity assessment application) to the Therapeutic Goods Administration (TGA) in Australia to support the Felix device achieving medical device ARTG inclusion to enable commercial sales in Australia. These clinical data will also support Felix device registrations in other international jurisdictions.