Biological separation specialist Memphasys Limited (ASX: MEM) has received positive feedback on the ease-of-use of its Felix Device following the testing of initial shipments by international Key Opinion Leaders(KOL).
Felix is a unique device for quickly separating high quality sperm from a semen sample for use in human IVF procedures.
Memphasys executives who were on hand after Key Opinion Leader sites in Japan, India, Canada, USA and Iran took delivery of the Felix device provided in-person instructional presentations and ran initial tests of the device using clinical samples and received positive assessments on the Felix devices capacities.
Executive Chairman Alison Coutts said early feedback from all of the five Key Opinion Leader sites was positive, with devices proving to be quick and easy to use, while separating sperm with improved average progressive motility than in the semen sample.
“To be on hand when these prominent IVF clinics received and tested the Felix device was such an important and exciting time for everyone involved with the development of the Felix device,” Ms Coutts said.
We were confident on how the Felix device would perform, but to see how easily and quickly it was able to be used and that it performed exactly as expected in various commercial IVF settings was extremely satisfying.
“Based on this positive initial feedback from the sites, we are now eagerly anticipating their commencement of the Protocol A assessments, which they have indicated will commence within weeks.”
Ms Coutts also said a Key Opinion Leader Agreement has now been signed with a prominent New Zealand IVF clinic.
The majority of IVF centres to receive the first Felix devices for the KOL assessment programme are in countries Memphasys believes have a regulatory framework that aligns to the company’s commercialisation objectives of seeking early commercial sales timeframes.
A recently released independent research report concluding these counties will continue to support both a sizable and rising number of IVF procedures each year.
Ms Coutts also revealed Memphasys has commenced the Felix device verification and validation (V&V) process, required to be completed before regulatory registration (if required) and commercial sales in these early target markets can commence, and expects V&V to be completed by mid-CY2020.