Australian-based bio-separations and reproductive biotechnology company Memphasys Limited (ASX: MEM) has reached an important milestone, with the first commercial sales of its Felix System.
Felix is a novel automated device for quickly and gently separating high quality sperm from a semen sample for use in human IVF procedures – for clinical IVF use to the Womens Centre in Coimbatore, India.
The Womens Centre has been a participant in the Felix System Key Opinion Leader (KOL) in vitro study, which is being conducted across 13 leading IVF centres in eight countries.
It was established more than 30 years ago and has a chain of fertility centres located in four regional Southern Indian cities.
It is a holistic facility providing high quality health care catering to a wide range of womens’ health needs including IVF treatments, other fertility and maternal, foetal and neonatal care needs and gynecological services and it also operates a regional andrology reference centre, which has conducted the KOL testing.
This first sale consists of a desk top console, which provides the power to operate the system, and a batch of single-use cartridges. The cartridge processes the semen sample to select sperm with the least DNA damage. One cartridge is used for each semen sample processed, providing separated sperm ready for use in IVF procedures after six minutes’ processing.
The clinic has indicated that orders of further cartridges are likely to be ordered after determining future patient caseloads and how the device will be adopted in its clinical practice.
The Womens Centre will initially utilise the Felix system for IVF cases where the male has demonstrated potential signs of below average sperm quality (low sperm concentration, poor motility, high DNA damage or poor morphology), which according to the Centre represents almost half of male semen samples they deal with.
Executive Chairman Alison Coutts said India is one of the four ‘early markets’ for the Felix system. It accounts for approximately 10% of the global demand for fresh IVF cycles. It classes the Felix System as a laboratory device, permitting early access for sales.
In 2017, approximately 190,000 IVF cycles were performed in the country. This number is anticipated to rise to 587,570 by 2025. One Felix cartridge is used for each semen sample processed, which is required for each cycle.
This is very exciting. It is the first time the Felix System will be put to routine clinical use, to produce embryos for implantation and pregnancies,” Ms Coutts said.
“Whilst it is a small cartridge volume order to begin with, the Felix revenue model is based on the subsequent recurring sales of the cartridges. The Womens Centre have been a great KOL trial partner. They do meticulous work and are deeply interested in assessing the performance of the Felix device. This sale represents a further strengthening of this relationship.
“This sale will provide really useful clinical performance data and should also assist to establish a reference centre in the Indian market for other clinics to observe and potentially become customers themselves.”
Memphasys has advanced commercial discussions with other IVF clinics in the ‘early markets’, including other sites in India, and is confident of securing further clinical sales to other IVF clinics in Q1 2022.