Memphasys is rapidly hurtling towards commercialising of its “Felix” bio-separation IVF technology with clinical trials set to commence on the assessment of embryo fertilisations in patients at four Monash IVF Australian clinics. 104 couples are anticipated to commence trials in March 2022 with results due by December 2022 that are expected to support regulatory filings and international commercial sales.
Results from the study will be filed in a formal regulatory submission to the Therapeutic Goods Administration or “TGA” of Australia to support Memphasys’ application to have the Felix system approved for sale in Australia and other international jurisdictions.
If the TGA approves the Felix device, commercial sales may be fast tracked in various countries through Asia and the Middle East.
Felix is essentially a medical device that “cleans up” sperm during the IVF process and only allows the better quality specimens to be harvested.
Memphasys has already sold a Felix system to a Chinese key opinion leader for research purposes that the company expects should accelerate interest in further sales, particularly in markets with lower regulatory hurdles such as Japan, India, Canada and New Zealand.
Commercial discussions are already in progress at IVF centres with lower regulatory requirements internationally with commercial sales expected by the company this calendar year.
Memphasys says Felix distinguishes itself from traditional sperm separation technologies by providing a six-minute processing time as opposed to 30 minutes or more for traditional “swim-up” and “centrifuge” methods.
Felix has also shown it can be used on a wider variety of semen samples, it requires less witnesses to be present during separation and it consistently selects cells with low levels of DNA fragmentation according to the company.
Memphasys aims to statistically prove the Felix system is at the very least not inferior to the swim-up and discontinuous gradient centrifuge or “DGC” methods that are the only two other commercial sperm separation techniques currently available.
The study will assess the preliminary safety and performance of Felix’s ability to isolate sperm from semen against traditional swim-up and DGC methods of isolation.
Clinical trails of Felix will be conducted in collaboration with leading Australian reproductive and fertility company, Monash IVF Group Ltd using four of its well-equipped sites. Australian clinical research organisation, Mobius Medical, has been contracted to project manage the trials on Memphasys’ behalf.
Memphasys Chair, Alison Coutts said:
“The study is an important milestone on the path to securing regulatory approval in Australia and, subsequently, in key markets such as the USA. We have already sold a Felix™ System to a Chinese KOL site for research purposes and this trial should accelerate interest in further research sales in the future. It will also supplement the current commercialisation of the Felix™ System in markets with lower regulatory hurdles where sales can occur now, such as Japan, India, Canada, New Zealand.
With analysis from the Australian and New Zealand Assisted Reproductive Database showing one in every 20 babies conceived in 2019-2020 was achieved through IVF, a strong market exists in the assisted reproductive space. If Memphasys can get the tick of approval from the TGA for its Felix device it will be game on for the budding biotechnology company.
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25 Oct 2023
