Australian-based bio-separations company Memphasys Limited (ASX: MEM) confirms it remains on track for first commercial sales of its Felix device in Q4 CY2020 for early markets, with Verification and Validation (V&V) testing entering final stages, which is required before commercial sales can commence.
The Felix device is a novel automated device for quickly and gently separating high quality sperm from a semen sample for use in human IVF procedures.
It consists of a console as well as single-use cartridges which contain the cell separation technology and are used for each IVF cycle. The cartridges combine an electrophoresis technology with size exclusion-based membranes, patented hydrogels, and other polymer membranes to separate sperm cells from semen samples.
Executive Chairman, Alison Coutts, said that ollowing biocompatibility characterisation of the Felix disposable cartridge, better medical grade materials have been adopted for two components. This has made the compliance with biocompatibility regulations more robust.
Final V&V activities are now underway, and the tests required for early market sales are expected to be completed by late November. This initial subset of the full V&V testing requirements allows Felix to be sold in less regulated markets including Japan, Canada, NZ and India.
Although COVID-19 has caused inevitable delays to supply chains with changes to some component suppliers and delayed material, the company is still on track for potential initial sales in less regulated markets before the end of December 2020.
Validation of the cleanroom to ISO7 and ISO8 standards is being completed by the cartridge manufacturer, W&S Plastics. Final production cartridges will be produced in the cleanroom and are scheduled to be sterilized by mid-November, followed by completion of V&V for early markets. Shipments to customers in early markets may then commence by end-December.
Memphasys has now satisfied all legal and regulatory requirements to distribute its Felix device in the market jurisdictions of Japan and New Zealand. This is in addition to Canadian market, where Memphasys has already conformed it has met the legal and regulatory requirements to sell the Felix Device in that market (refer ASX announcement dated 10 July 2020). Commercial sales in one (or more of these) jurisdictions are expected to begin upon the Company completing V&V tests on the final manufactured product, and the Tokyo and Auckland Felix KOL assessment studies have been completed.