Sydney biotechnology company Memphasys has passed another milestone by enrolling and treating the first couple in its new clinical study, en route to commercialising its unique reproductive technology device, Felix.
It is expected a total of 104 couples will be enrolled for the study, scheduled to be completed by the end of the year, subject to recruitment and treatment rates.
The study’s aim is to assess the safety and performance of Memphasys’ Felix technology platform against two popular sperm selection techniques that isolate sperm from semen before they are used in assisted reproductive technologies.
Felix is a trademarked device that employs bio-separation technology.
It uses electrophoresis and exclusion membranes to separate high-quality sperm from semen for use in-vitro fertilisation, or “IVF”.
Memphasys management believes no other sperm separation method available offers the same combination of speed and quality of isolated sperm.
Felix can process semen samples in as little as six minutes, whilst other methods of sperm preparation take 30 to 60 minutes.
It is also promoted as the first automated sperm separation method for preparing non-DNA damaged sperm samples for IVF clinics.
At present, Felix is not available in Australia.
It is, however, available in India where the company secured breakthrough sales to the Women’s Center in Coimbatore, in the country’s south.
The study is being conducted with leading reproductive company Monash IVF Group and Mobius Medical.
Once its results have been compiled, they will be used as part of a formal regulatory submission to the Therapeutic Goods Administration, or “TGA”, in Australia and other jurisdictions overseas.
If the submission is accepted by the TGA, Felix is likely to get the tick of approval to enable commercial sales in Australia.
The study will span seven sites in Australia, four have already been cleared to start patient enrolment and another three will come on stream by August.
Memphasys’ Managing Director and CEO, Alison Coutts says both the company and Monash IVF were confident recruitment and treatment rates will increase, especially once the three additional Monash sites come on stream.
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