Australian-based reproductive biotechnology company, Memphasys Limited (ASX: MEM), has obtained its first commercial sale of 30 sterile single-use Felix cartridges and console to the prestigious Kobe ART clinic in Japan.
The Felix System is a patented, automated single-use cartridge that gently separates high- quality sperm from a semen sample in six minutes for use in human IVF procedures.
The Clinic made the order based on the strong endorsement of Felix in two recently published papers by leading global IVF clinics.
Japan represents one of the top five addressable markets globally for the Felix System with the potential market opportunity exceeding A$100 million.
The Felix System is available for sale in Japan where MEM 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.
First Live Birth of Baby in India Using Felix
MEM has also confirmed that its Indian KOL (Key Opinion Leader) 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. They are also traditionally the ‘first buyers’ of new products in their industry. The Coimbatore Womens Hospital Centre has made multiple orders of the Felix System.
India also represents one of the top five addressable markets globally for the Felix System with the potential market opportunity exceeding A$50 million.
MEM has had to temporarily suspend sales of Felix in India following changes introduced on 9 August 2022 by the 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.
MEM has already acted to address these changes by submitting a voluntary product registration with CDSCO as an initial strategy to sell non-commercial quantities in India. MEM is also actively planning to manufacture in India to expedite the regulatory clearance of Felix in India and to potentially reduce manufacturing costs.