Memphasys Limited (ASX: MEM) has achieved key milestones for the Verification and Validation (V&V) process for its unique Felix device, a unique device for quickly separating high quality sperm from a semen sample for use in human IVF procedures.
The purpose-built clean room nearing completion at W&S facility
Executive Chairman, Alison Coutts, said the V&V process, which needs to be completed before any commercial sales can occur, is on track to be completed by mid-CY2020.
Once the V&V activities are concluded, Memphasys is planning to start a clinical trial in Q3 2020.
Ms Coutts said that as Felix is a novel device, its safety and efficacy will need to be clinically demonstrated to satisfy regulators in high regulatory jurisdictions, including Australia, the USA and Europe.
This trial is not expected to be required in countries previously identified as early commercial target markets, where it is believed commercial sales can occur on completion of the Verification and initial Validation phase, including Japan, India, New Zealand and Canada.
Memphasys recently announced it had received very positive feedback from Key Opinion Leader (KOL) sites in a number of key target countries.
“We have been buoyed by the initial feedback from KOL sites to our Felix device,” she said.
“However, to be able to sell these devices to these sites, or any other IVF clinics globally, requires the successful verification and validation of the product.
We are well advanced with the V&V process and as it progresses we will be focussed on completing the KOL assessments and securing distributors, where necessary, in the markets believed to have a regulatory framework that aligns to the company’s commercialisation objectives of seeking early commercial sales timeframes.”
Ms Coutts said Memphasys is working with Monash IVF to establish a clinical trial protocol.
A meeting with the Therapeutic Goods Administration (TGA) of Australia has confirmed that, as expected, a clinical trial will be required for Felix to gain regulatory certification. The trial will focus on the safety and efficacy of Felix and its performance against existing sperm separation techniques. The trial is expected to be performed by Monash IVF in Q3 of 2020.
