Memphasys achieves key milestone with clinical validation of Felix fertility device
Memphasys (ASX: MEM) has published positive data from a pivotal clinical trial of its Felix electrophoresis-based sperm separation device for use in assisted reproduction.
The trial validated the ability of the Felix device to meet and exceed industry benchmarks and found it to be non-inferior to the “swim-up” technique but statistically superior to DGC (density-gradient centrifugation), the world’s most commonly used sperm preparation method.
The company conducted the trial, which confirmed the device to have best-in-class performance in sperm selection for human fertility treatments, in partnership with Perth-based clinic Monash IVF Australia.
Improved embryo utilisation
Felix also demonstrated a positive primary endpoint of improved embryo utilisation compared with swim-up and DGC.
Specifically, the number of embryos utilised divided by the total number of embryos created, a benchmark of assisted reproduction cycle success.
Felix also proved significantly faster at isolating high-quality sperm than the other techniques, providing a time-based economic and operational benefit to users.
Rigorous study
Memphasys chief executive officer David Ali said the Felix trial was the most rigorous study ever conducted for a sperm separation device.
“The successful completion of this clinical trial marks a defining moment for Memphasys and the rigour of the trial sets Felix apart from any other sperm separation technology on the market,” he said.
“Our device has demonstrated comparable or superior performance to traditional methods and has achieved the ultimate benchmark of improving embryo utilisation rates—we are now in a strong position to accelerate our market expansion.”
Global markets
Memphasys plans to apply for CE Mark certification, which would allow it to sell Felix into Europe, Australia and India, as well as markets recognising the certification including Japan, Canada, the US and Switzerland.
The company has existing distribution agreements with Vitrolife Group for Japan, Canada and New Zealand and with Heranova Lifesciences HK for Greater China, facilitating research and development sales into the United Arab Emirates through Panacea Medizintech.
“The validation of our technology is expected to translate into accelerated sales, particularly in Japan, where Vitrolife has been conducting utilisation testing for over a year,” Mr Ali said.
“In the meantime, we will continue to advance commercial discussions with new and existing strategic partners, reinforcing Felix as the most rigorously validated and innovative sperm separation device available in the market today.”