Australian-based bio-separations specialist Memphasys Limited (ASX: MEM) is confident it is on track for first commercial sales of the Felix device in Q4 2020, despite delays caused by Covid-19.
Felix is a unique, automated device for quickly and gently separating high quality sperm from a semen sample for use in human IVF procedures.
The company’s technology has received favourable responses from Key Opinion Leaders (KOLs). With additional data expected in coming weeks as additional sites recommence accepting patients and continuing Felix assessments.
With approximately $2.3m in cash reserves, Memphasys has sufficient funds for KOL assessments, Verification and Validation (V&V) activities, product development and key commercialisation activities.
The company has made important progress as part of the KOL assessment program with positive early data received from initial KOL sites and additional data is expected in coming weeks.
The Australian Government’s recent decision to allow elective surgeries to recommence, including IVF services, has enabled Felix testing at Monash IVF to resume. With IVF services now permitted, Monash IVF is continuing its collaboration with Memphasys, which is considered a high strategic priority for both companies.
The testing initially involves Monash’s participation in the Felix KOL program but also extends to other services to be provided by Monash IVF including validation studies on the final device with clinical samples and assessment of alternative commercial media that could be used with the Felix device.
Some early feedback from the KOL trials has been used to monitor the usability and performance of the Felix device and also ensures appropriate validation of the device.
The Company is successfully progressing Felix product development, with development partner Hydrix continuing to work with Memphasys, ensuring Verification is on track.
W&S Plastics, a major supplier of respirators, had been asked to significantly increase production of respirators to cater for Covid19. Despite this, W&S have kept resources available for Memphasys and are continuing their work on the commissioning of Felix cartridge production. Both W&S (Felix cartridge manufacturer) and SRX Global (Felix console manufacturer) have ‘critical supplier’ status and will remain open during Covid19 constraints.
W&S is in the final stages of preparing to manufacture Memphasys’ proprietary hydrogel membranes (previously made at Memphasys), with technology transfer having been completed.
For this purpose, Memphasys has transferred some specialised equipment to W&S. Whilst Memphasys has made sufficient membranes for the initial Felix KOL assessments, the final quality build cartridges require the membranes to be made and assembled at W&S in a cleanroom environment.
Whilst Memphasys anticipates the overall product development programme will be delayed by approximately three months due to the impact of Covid19 on some suppliers, the delays are not likely to impact expected first sales of the Felix Device, which remains on track for Q4 2020.