Australian-based bio-separations and reproductive biotechnology company, Memphasys Limited (ASX: MEM) has confirmed the completion of Verification and Validation (V&V) assessments for early-access markets for the Felix device.
Verification is undertaken to confirm the specified design requirements have been fulfilled. Validation is undertaken to confirm requirements for specific intended use can be consistently fulfilled.
Executive Chairman, Alison Coutts, said passing V&V assessments is a prerequisite before commercial sales may begin. Despite the adverse impact of Covid-19 on the operation of many IVF clinics which has substantially slowed the KOL testing, the company has also received preliminary in vitro KOL assessments on the Felix device’s performance and more data is expected shortly.
Pleasingly, initial results, which consist of 25 in vitro samples per KOL, have been positive and in-line with Memphasys’ expectations. Most importantly, preliminary results have demonstrated the Felix device’s consistent ability to rapidly select cells with low levels of DNA fragmentation.
The results also show that it can be used with a wide range of semen samples, including viscous samples and samples with low sperm counts, poor motility and high DNA fragmentation levels.
Commercial discussions are underway with some of the company’s Key Opinion Leaders (KOLs) in early access markets who have completed the in vitro testing of the performance of the Felix device.
Memphasys is very pleased with the in vitro testing results reported from KOLs to date, especially the DNA fragmentation results, and the consistent feedback about the Felix device’s ease of use and rapid operation. We continue to believe that a maiden commercial sale can be made prior to the end of the calendar year,” Ms Coutts said.