Biological separations specialist Memphasys (ASX: MEM) has signed on the first of a planned number of andrology and in-vitro fertilisation (IVF) clinics to take part in assessments of its Felix sperm separation device.
The company today announced it has signed a memorandum of understanding to appoint Swedish male infertility clinic and andrology centre ANOVA Karolinska as a key opinion leader in the clinical validation of the device ahead of its commercialisation.
ANOVA is based at the Karolinska Institute in Stockholm, which together with the Karolinska University Hospital, is regarded as one of Europe’s premier health facilities.
It is the first of a number of key opinion leaders Memphasys has invited to participate in the clinical studies aimed at assessing and confirming the Felix device’s performance for IVF clinics.
ANOVA will work collaboratively with fertility expert and Felix co-inventor Professor John Aitken to validate the system and confirm its application and efficacy in separating spermatozoa under clinical conditions from a range of human semen samples.
Memphasys hopes the assessments will provide further evidence as to the technical capabilities of the device and broaden its clinical benefits, as well as further refine the company’s commercialisation strategy.
Memphasys executive chairman Alison Coutts said the appointment of the first key opinion leader represented a major milestone in Felix’s commercial development.
“We are recruiting 10-15 of the leading IVF clinics and andrology reference centres in the United States, Europe, Asia and Australia to take part in the Felix assessment under the leadership of Prof John Aitken,” she said.
Choosing good swimmers
Utilising its patented membrane process, Memphasys has spent four years developing and testing the Felix system to separate the most viable sperm in a semen sample for use in IVF.
According to the company, this technology provides unique advantages over current sperm processing methods including an increased probability of pregnancy and birth of a genetically healthy baby as it selects the best quality, least DNA-damaged sperm.
In addition, current laboratory-based methods are considered labour intensive, costly and contribute to sperm DNA damage.
Assessment program and timeline
Memphasys is aiming for the first clinical versions of its Felix device to be available for clinical testing late in the first quarter of 2019.
The assessment programs are projected to take about six months to complete.
CE Mark regulatory approval for the launch of Felix into the European market is anticipated late in the 2019 calendar year, with clinical performance data from the key opinion leader assessments expected to provide support for the launch.
Last month, the company announced it had entered into a collaborative agreement with IVF specialists Monash IVF Group (ASX: MVF) for the commercial development of Felix.
Under the agreement, Monash clinicians and researchers will provide advice on the design and operation of the device.
Meanwhile, Memphasys and its engineering development partner Hydrix are planning to soon commence production of the machined prototypes of the Felix device, which is targeted to begin testing with Monash during the 2018 fourth quarter or 2019 first quarter.
By early afternoon trade, Memphasys stock had climbed more than 34% to $0.043.