- Memphasys (MEM) has enrolled and treated the first couple under a clinical study trialling the safety and performance of its Felix device
- The study is being conducted with reproductive and fertility services company Monash IVF Group and will enrol 104 couples across seven Monash IVF sites
- The study is assessing the Felix device against the swim-up and density gradient centrifugation for couples suffering from male infertility, to isolate sperm from semen
- Memphasys will use the data to submit an application to the Therapeutic Goods Administration (TGA) for its Felix device so it can be sold in Australia
- Company shares are up 5.56 per cent and trading at 3.8 cents as of 12:18 pm AEST
Memphasys (MEM) has enrolled and treated the first couple under a clinical study trialling its Felix device.
The study is being conducted with Australian reproductive and fertility services company Monash IVF Group (MIVF) and Mobius Medical who is the contract research organisation managing the study on Memphasys’ behalf.
All up, 104 couples will be enrolled across seven MIVF sites with four sites now cleared to begin patient recruitment and study enrolment. The other three sites are expected to come on stream by August 1.
Memphasys Managing Director and CEO Alison Coutts said the company is excited to have enrolled the first patients into this study.
“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 the study progresses,” Ms Coutts said.
The clinical study 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 before intracytoplasmic sperm injection (ICSI).
Felix works by combining the electrophoresis (technique used to separate DNA, RNA or protein molecules) with membranes to separate sperm cells from semen for human artificial reproduction.
Memphasys will use the data to submit an application to the Therapeutic Goods Administration (TGA) for its Felix device so it can be sold in Australia.
The company expects the study will be completed by the end of this year, depending on recruitment and treatment rates.
MEM shares were up 5.56 per cent and trading at 3.8 cents as of 12:18 pm AEST.