Memphasys Felix

Felix is an innovative technology for use in ART, which aims to improve the chances in achieving a successful pregnancy for infertile couples. It utilises Memphasys’s proprietary cell and molecular separation technology in the separation of sperm from semen samples for use in IVF procedures. The key challenge in developing this device was to evolve a proven concept, fit for research and animal testing, into a commercially viable instrument that would conform with regulatory requirements and bio-compatibility standards; and at the same time, deliver a design intended to be compact, intuitive, reliable, and laboratory friendly.

In developing the instrument and cartridge, a core focus was workflow optimisation. Designed for use in laminar-flow enclosures, the product development process incorporated regular usability testing and analysis with experienced laboratory staff at Monash IVF. Likewise, the disposable cartridge, together with packaging, labelling, and Instructions for Use (IFUs) were all optimised via structured reviews with end-users. The final design solution is a robust and compact instrument with single-button operation. A logical sample-in, sample-out workflow produces fractionated sperm in six minutes. This compares favourably to the current methods, which require multiple sample-handling steps, and processing time of up to 60 minutes.

Currently, 1 in 6 Australian couples will experience infertility, with poor sperm quality a factor in approximately 50% of infertility cases. There is no standard method for preparing sperm for IVF, and techniques, costs, and times vary in existing methods. Pregnancy success rates vary substantially, with labour intensive processing steps that can inadvertently select DNA-damaged cells, reducing the effectiveness or passing on genetic damage. Felix aims to extract the highest quality sperm from a sample, including poor quality sperm samples, through a consistent, controlled series of steps. It intends to increase the likelihood of couples successfully conceiving and giving birth.

The Felix system addresses the key issue of male infertility. ▪ Current failure rate to achieve a live birth through any single IVF cycle is around 80% and there is no guarantee of success even with multiple attempts. ▪ It is estimated that 1 in 3 men over 40 years old is affected by infertility ▪ Sperm quality measured by DNA damage is the key concern ▪ No meaningful advances in male sperm preparation treatments since the advent of IVF The Felix system processes sperm, through the disposable cartridge, in a single step. This is in stark contrast to conventional ART procedures where sperm samples are required to undergo multiple handling and positional changes, the complexity and frequency of which significantly increases the possibility of processing errors, including sample mix-up and chain-of-custody breakage; which in the IVF sector would be a catastrophe. Felix’s simple one-stop-processing approach provides avenues to avoid this possibility and thereby safeguard both the integrity of the sperm sample and its donor.