A device for improving male infertility outcomes
Memphasys aims to establish ‘FELIX’- the first automated, non-DNA damaging lab instrument for sperm separation - as the gold standard method in human IVF clinics for preparing sperm from semen samples
Memphasys (MEM) is a Sydney-based ASX-listed medical device company with unique, patented IP for separating valuable cells and molecules from biological fluids.
For the past 5 years the Memphasys sperm separation research has been undertaken using its CS10 lab instrument developed 10 years ago using the company’s ‘porous Membrane + electrophoresis’ platform technology for separation of cells and molecules.
In this Felix technology development, Memphasys has been working closely with Prof John Aitken and his associates at the University of Newcastle. The cooperation arose after Prof Aitken saw the opportunity to use the company’s cell and molecular separation technology to more gently separate sperm from semen samples for use in IVF.
Above: 'Felix' device cartridge on a stainless steel tray
‘Felix’ for Human Assisted Reproduction
‘Felix’ is Memphasys’ most commercially advanced application, developed with global reproductive medicine expert, Prof John Aitken at the University of Newcastle, selects the best sperm from donor semen samples for use in IVF procedures
Memphasys’ earlier prototype lab device, the CS10, was proven to work (and led to some live human births at Sydney IVF and Westmead IVF in some previously infertile couples). However the CS10 needed substantial change to be suitable for use in IVF clinics. Unlike other sperm processing methods, the CS10 did not damage sperm DNA. In 2016 Monash IVF tested 68 in-vitro patient semen samples with the CS10 and concluded the device “clinically beneficial”.
Lack of sperm DNA damage is more likely to lead to successful pregnancy, to full term babies, and to healthy progeny. The Felix device also provides a much quicker and easier sperm processing method for the IVF clinic than the current laborious lab-based processes. Initially ‘Felix’ will be used for human IVF processes but later it will be applied for use in animal artificial reproduction.
Sealed Cartridge Concept
In the past year Memphasys has developed and validated a new sealed cartridge concept plus the optimum buffers for efficient sperm separation with minimal sperm damage. Currently, with R&D contactors Hydrix, Memphasys has developed a large format research cartridge with a capacity of up to 1.8mls so that the Felix clinical system can process the whole of a typical human semen sample which will make it more appropriate for use in traditional IVF and IUI as well as ICSI.
It has been well documented already in extensive in vitro testing that Felix produces better quality sperm for IVF use (motility, morphology, DNA damage, oxidative stress). The Felix process removes leukocytes from the sperm sample, which has been shown to reduce oxidative stress – a leading cause of DNA damage – and improve fertility outcomes.
Improvement in sperm quality should lead to higher fertilisation rates and successful embryo implants (pregnancies), less spontaneous abortions during pregnancies, and children with less long term neurological and other adverse medical conditions. These expectations will then need to be documented once Felix is in clinical use.
Felix can extract viable sperm from poor sperm samples (high viscosity sperm, testicular sperm samples, severe infertility males), leading to the expectation that these infertile couples may have increased opportunities to have children.
It is anticipated that the Felix procedure will be routinely used in IVF clinics due to its speed, simplicity, and high repeatability for extracting the best sperm in a semen sample – whether the clinic is using traditional IVF or ICSI procedures for subsequent fertilisation. Whilst the ICSI technique (inserting a selected sperm’s DNA into a selected egg) is widespread in some countries (including Australia) at the expense of traditional IVF (a sperm sample is placed with one or more eggs for natural fertilisation to take place), there is a growing push from ICSI back to IVF.
Memphasys is developing a larger Felix cartridge for extracting the sperm from the complete volume of human semen samples. The larger volume will not only be suitable for traditional IVF but also for IUI procedures, which need large volumes of sperm. IUI is a cheaper widely used procedure that often precedes ART in an IVF clinic. IUI is a major potential market extension. Clinical trials will need to be competed to document efficacy in IUI.
New Biologically Safe Polymer Membrane
Memphasys has now developed a new biologically safe polymer membrane and a re-usable next generation Felix cartridge, which MEM and the University of Newcastle researchers are further optimizing. Results of in-house and UoN testing show that this new cartridge works well to separate viable sperm derived from male donors.
Above: Felix schematic showing separation by size, through the membrane, and by charge, through application of electric forces to the fluid.
After this testing with the Felix research prototype is complete and further clinical requirements finalised with our IVF clinical partners, MEM will commence development of the clinical Felix system with its new disposable single-use cartridge using the new polymer membranes.
Memphasys will first produce 15 'fast prototype' Felix devices which will be placed for assessment with IVF key opinion leaders in 15 leading global IVF clinics, in an assessment program coordinated by Prof John Aitken (University of Newcastle). The early in-vitro clinical performance assessment generated will be used in the market launch of the regulatory-approved clinical Felix device. Sales through global distribution partners are anticipated to commence in the major markets in 2019.
The main Felix revenue will be recurrent revenue from sales of the Felix disposable single-use cartridges.
Regulatory advice received indicates that in-vitro trial data comparing Felix with current lab-based sperm preparation treatments can be done using the well-established surrogate measures of sperm quality will be sufficient for regulatory approvals. In vivo pregnancy and birth data will be collected for marketing purposes after the device is approved and adopted for human use.
Memphasys utilizes its proprietary separation technology along with its multiple devices and hydrogel membranes to fractionate biological molecules. The technology relies on the applied electric field and charged biological molecules. The sample and harvest chamber is formed by placing the separation membrane in between two restriction membranes with restricted pores. When electric field is applied the charged molecules of interest migrate to the harvest chamber through the separation membrane based on their charge and size.
HYDROGEL MEMBRANE (SEM IMAGE)
Separation by Membrane Electrophoresis