ASX-listed biotech play Memphasys (ASX:MEM) remains on track for a 2019 commercialisation of its Felix device which separates the most viable sperm in a semen sample for use in human IVF.
The technology behind the device – developed in conjunction with world renowned fertility expert, Prof John Aitken from the University of Newcastle – provides crucial advantages over current sperm processing methods.
It was proven to work in a prior clinical study at Westmead IVF using an early prototype device, which resulted in numerous live births. The Company is now developing a commercial device, Felix, to be used by IVF clinics globally.
Memphasys is targeting Initial sales of Felix device in Europe for late 2019 with additional and substantial recurrent revenue expected from selling the device as single use disposable cartridges.
Meanwhile, Memphasys is in advanced talks with IVF Key Opinion Leaders in the United States, Europe and Australia with a view to having IVF clinics undertake in-vitro assessments using the Felix device.
These agreements for clinical assessment are expected to be entered into during the current quarter, with those clinics to commence testing of the Felix device when the production device is available at the end of first quarter 2019.
The company has also been working closely with a leading Australian IVF company to improve the functionality and ergonomics of the Felix device. This has led to a number of improvements to be incorporated into the final commercial device.
The regulatory plan for obtaining CE Mark, TGA and FDA approval of the Felix system has also been developed.
The plan includes definition of the target markets, which are initially Europe, Australia and the USA (in that order), with the potential for other markets, such as Japan and emerging markets including China and India, to be added.
Shares in Memphasys were last trading at 1.3c on Wednesday.