Memphasys is a reproductive biotechnology company developing solutions for market needs in human and animal fertility and reproduction.

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The Felix™ device for sperm separation

The Felix™ device is an automated electrophoretic system. The Felix™ device separates sperm from raw semen using a proprietary process which combines electrophoresis and size exclusion membranes. Sperm are harvested with exclusion of cellular contaminants such as leukocytes and precursor germ cells.

The Felix™ device consists of two main components: a console, which supplies electrical power, and a sterile disposable cartridge for sperm isolation and selection.

The Felix™ device is the first commercial product to be developed by Memphasys. The Felix™ device is currently being sold in international markets whilst clinical study and/or regulatory processes are underway.

Commercial status

ISO 13485

Memphasys has ISO 13485 certification of its quality management system. This accreditation means that the processes which are used to design, manufacture and market a technology such as the Felix™ device comply with the international ISO 13485 standard.

The Felix™ device also meets IEC 60601 standard and has passed MEA (mouse embryo assay) and HSSA (human sperm survival assay).

The Felix™ device is manufactured in a cleanroom environment and is available for sale in some markets with low level regulatory hurdles (India, Canada, and NZ).  Clinical study and/or regulatory processes are underway for higher regulatory markets.

More information

Clinical Trials

ROSA (Rapid Oxidative Stress Assay)

Oxidative stress is an imbalance between reactive oxygen species and antioxidant protection within the body. This imbalance tends to increase with age and can contribute to serious diseases. Oxidative stress can also severely affect fertility in both humans and animals1.

At present, there is no simple clinical assessment for oxidative stress. Rather, complex laboratory tests and analyses are required and therefore, not often used. Memphasys is developing a point-of-care diagnostic device. The ROSA diagnostic device is being investigated for application for bodily fluids (i.e., semen, blood and follicular fluid) for use in the IVF clinic and physician rooms.

The ROSA diagnostic device will utilise a biochemistry-based assay. Subject to successful optimisation and validation, the ROSA prototype device will be field tested   to demonstrate efficacy and determine market opportunities.

1. Aitken, RJ. (2022) The Infertility Trap. Cambridge University Press

SemPort

Memphasys is developing a system that will allow the transport of intact semen, for up to 3 days at ambient temperature, from the point of collection at an IVF clinic. This will allow a remote full semen analysis at a specialist diagnostic laboratory.

Human sperm are damaged in the freezing and thawing process. Moreover, if sperm are not removed from the seminal plasma, they suffer further loss of viability. Sperm motility, a key semen analysis metric, deteriorates quickly with time. There is a market need to enable the transport of intact semen at ambient temperature to a remote designated diagnostic laboratory for an semen analysis.

Memphasys is in the early proof-of-concept phase with the development of a novel and proprietary “long life” semen medium in conjunction with a prototype “transport” device.

Subject to successful clinical assessments, the market opportunity will be established.