Australian-based reproduction biotechnology and bio-separations company Memphasys Limited (ASX: MEM) has completed the maiden sale of the Felix device to Diagens Biotechnology Company Ltd.
Felix is a novel automated device for quickly and gently separating high quality sperm from a sample for use in human IVF procedures.
The sale is for delivery to a third party major Chinese reproductive medical research centre, for research purposes. Diagens is a Chinese company that manufactures and distributes proprietary and other products to its network of 500+ assisted reproduction centers and 300+ prenatal diagnosis centers in China.
Memphasys has been collaborating with Diagens for the past 18 months. Diagens has introduced Memphasys to a selection of leading Key Opinion Leader (KOL) clinics in China and is assisting Memphasys with preparing a submission to The National Medical Products Administration (NMPA), the regulatory authority in China, for accessing a potential fast track “Green Channel” regulatory approval to making commercial sales of the Felix device in China.
The transaction via Diagens represents a “pathfinder” sale for MEM, as Diagens is intending to make similar additional sales to other high end Chinese research institutes over the coming months.
These research sales are being offered to premium reproduction medicine research institutes in China. The first order from Diagens, valued at $11,000 and comprising a console plus a starter kit of cartridges, has been shipped and invoiced.
The transaction represents a major milestone for Memphasys, receiving first revenues from the Felix device while also increasing exposure to the Chinese market, the largest IVF market in the world. In 2017, 302,190 IVF cycles were performed in China which is expected to reach up to 842,890 by 2025. In terms of value, the China IVF services market accounted for $957 million in 2018 and it expected to reach $2.7 billion by 2026.
Memphasys remains in regular contact with its KOL partners and in particular the KOLs in early access markets, which provide an opportunity to accelerate commercialisation of the Felix device.
While the sale reflects the first revenues for research purposes, the company said it is seeking to execute first sales for the device to be used clinically, which it anticipates will occur in Q4 2021. Commercial discussions in a number of these low regulatory markets are advanced.