Last year, in a bid to address the country’s low fertility rate, the Japanese government announced that it will cover 70% of the costs of IVF treatments. As people rushed to IVF clinics, companies like biotech company Memphasys (ASX: MEM) saw their time to shine. 

Memphasys offers the Felix System, 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. 

Japan represents one of the top five addressable markets globally for the Felix System with the potential market opportunity exceeding $100 million. The system is now 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. 

In line with that, the Company has announced its first commercial sale of 30 sterile single-use Felix cartridges and consoles to the prestigious Kobe ART clinic in Japan. The clinic made the order based on the strong endorsement of Felix in two recently published papers by leading global IVF clinics. 

Memphasys has not only successfully partnered with clinics, but its Felix System is also already proving its merit. In India, together with its key opinion leader (KOL) in Tamil Nadu—the Coimbatore Women’s Hospital Centre, it has reported the first live birth of a healthy baby boy using the FelixTM System.

The clinic uses Felix predominantly for males suffering from high sperm DNA fragmentation, which is common and highly correlated with infertility. Sperm DNA fragmentation means that there are breaks or damage to the genetic material (DNA) inside a sperm cell. When there’s a lot of this damage, it can make it harder for the sperm to fertilize an egg and can lead to problems with male fertility.

KOLS, or key opinion leaders, are highly respected professionals in the IVF industry who are known for driving innovation and leadership. As the first buyers of new products in their field, they set the standard for the wider IVF community. The Coimbatore Women’s Hospital Centre is one of them for the Company, and it has recently placed multiple orders for the Felix System, a cutting-edge product in the industry.

India is a key market for the Felix System, with the potential for sales to exceed $50 million. However, sales of the product have been temporarily suspended in India due to regulatory changes introduced by the Central Drugs Standard Control Organisation (CDSCO) on August 9, 2022. These changes affect the regulation of all ART clinical processes in India, as well as all medical devices sold within the country. Despite this setback, the Felix System remains a highly sought-after product in the global IVF sector.

Plus, the Company has found a workaround for this. In an effort to sell non-commercial quantities of the Felix System in India, MEM has submitted a voluntary product registration with the Central Drugs Standard Control Organisation (CDSCO). It has announced plans to manufacture the Felix System in India, with the aim of expediting the regulatory clearance process and potentially reducing manufacturing costs. This move demonstrates MEM’s commitment to the Indian market and to providing innovative and cost-effective solutions to the IVF industry.

With its cutting-edge technology and proven track record, the Felix System is a highly sought-after product in the global IVF sector. By pursuing new strategies for entering the Indian market and establishing itself in the Japanese one, MEM is positioning itself for continued success and growth in the years to come.