Australian bio separations company Memphasys (ASX: MEM) is boasting a rapidly accelerating development program for its Felix device, a unique technology aiming to separate viable sperm in a semen sample for improved human IVF procedures.
The next major milestone for the company will be to conduct in-vitro clinical assessment of its technology with international key opinion leaders (KOLs) in fertility clinics globally, and it has just announced another five KOLs have signed-up to test the device.
Memphasys has how signed a total of 12 KOLs to participate in trials – meeting its stated goal of attracting 10-15 leading IVF clinics and andrology reference centres in the United States, Europe, Asia and Australia.
Significantly, one of Australia’s largest and most successful providers of assisted reproductive services, Australian based Monash IVF is amongst the latest batch of organisations agreeing to trial Felix.
The addition of Monash IVF demonstrates a deepening engagement between the two groups, with \Monash IVF recently taking an equity stake in Memphasys as part of a 2018 collaboration agreement.
Memphasys has also announced that it has completed its first protocol document, which has been distributed to the KOLs, stipulating the assessment processes to be used.
KOLs will be testing Felix against their current preferred IVF sperm preparation techniques, typically involving either the “Density Gradient Centrifuge” or “Swim-Up” method.
The company reports that the finalisation of protocol assessments and ethics approvals remain on track for end of June 2019 quarter.
Commenting on the recent signings and its advancement off the Felix decide towards commercialisation, Memphasys executive chairperson Alison Coutts said:
I am pleased with what our company has recently achieved in the product development and commercialisation of the Felix device with the assistance of Prof John Aitken.
“We are meeting our key milestones within the timeframe that we have set out and remain on target to deliver Felix devices to KOLs for assessment program to commence in September Quarter 2019,” she said.
Memphasys has completed the manufacture of hand-assembled CNC-made, fully functional pre-production devices and 20 cartridges for use in the clinical trials.
The IVF innovator has now shortlisted subcontract manufacturers for larger scale production and is working through a process to identify and finalise a contract with the chosen subcontractor.
