Australian reproductive biotechnology company Memphasys (ASX:MEM) has completed its first commercial sale of 30 sterile single-use cartridges and console to the Kobe ART Clinic in Japan.

The Felix System is a patented, automated single-use cartridge that gently serperates ‘high-quality’ sperm from a semen sample in 6 minutes for use in human IVF procedures.

The company reports the clinic made the order based on the strong endorsement of Felix in 2 recently published papers by leader global IVF clinics.

It also says Japan represents one of the top 5 addressable markets globally for the Felix System with the potential market opportunity exceeding $100 million.

The Felix System is available for sale in Japan where Memphasys has chosen to initially work with private clinics that only treat self-funded patients following the introduction of the new IVF reimbursement regime in 2022.

Memphasys also reports its Indian Key Opinion Leader (KOL) partner, Coimbatore Women’s Hospital Centre has reported the first live birth of a healthy baby boy using the Felix System. The clinic uses Felix predominantly for males suffering from high sperm DNA fragmentation, which is common and highly correlated with infertility.

KOLS are recognised as the esteemed practitioners of the global IVF sector and a key reference point for the wider IVF community on industry innovation and leadership. The company says they are also traditionally the first buyers of new products in their industry. The Coimbatore Womens Hospital Centre has made multiple orders of Felix Systems.

India also represents one of the top 5 addressable markets globally for the Felix System with the potential market opportunity exceeding $50 million.

Memphasys reports it has had to temporarily suspend sales of Felix in India following changes introduced on 9 August 2022 by Indian regulator, the Central Drugs Standard Control Organisation (CDSCO), to the regulation of all ART clinical processes undertaken in India and to all medical devices sold in India.

The company says it has already acted to address these changes by submitting a voluntary product registration with CDSCO as an internal strategy to sell non-commercial quantities in India. Memphasys is also actively planning to manufacture in India to expedite the regulatory clearance of Felix in India, and to potentially reduce manufacturing costs.

Memphasys is an ASX-listed reproductive biotechnology company focused on developing medical devices, in vitro diagnostics, and new proprietary media.

The company’s Felix System combines electrophoresis with proprietary size exclusion membranes to separate the most viable sperm cells for human artificial reproduction