Australian-based reproductive biotechnology company, Memphasys Limited (ASX: MEM) has confirmed that Vitrolife Japan KK, a subsidiary of the Swedish-based Vitrolife Group (Vitrolife AB), has placed its first order for the Felix System under its exclusive agreement to sell and distribute the device in Japan.
As Japan is an early access market, MEM does not require regulatory clearance to sell Felix in Japan.
The initial order of 150 Felix System cartridges will be directed to five high volume Key Opinion Leader (KOL) client clinics in Japan, as the front end of a product marketing campaign. Vitrolife will provide training on Felix to the KOL clinics and supply ongoing services as part of the agreement.
Felix is a premium, automated device comprising a console with single-use cartridges for sperm preparation in human IVF procedures. The device gently separates sperm from a semen sample in six minutes, using electrophoresis and size exclusion membranes without causing damage to sperm DNA. Felix is MEM’s first commercial product.
Prior to the Vitrolife agreement being established, Memphasys had already established pioneering sales in Japan with one clinic having placed two orders of Felix and looking to place a third. Memphasys had also established a strong working relationship with another KOL clinic, introduced to Memphasys by Vitrolife, which has been undertaking in vitro and subsequently in vivo testing of the Felix system.
In 2020, the Japanese market was estimated at 450,000 cycles. This number has continued to grow following the inclusion of IVF into Japan’s national insurance system in 2022. Currently Memphasys is unable to provide Felix for use under the national insurance system, however it can sell freely to clinics offering private services which are the initial targets.
There are approximately 600 IVF clinics in Japan. A small number operate exclusively with insured patients whilst the majority cater to both the insured and uninsured. Whilst approximately 80% of IVF treatments are inside the insurance system, an estimated 20% are for uninsured privately funded services, for example for aged patients, patients who are otherwise not eligible for insurance or for some specific treatments that are not covered by insurance.
Vitrolife has commenced with five of its high-volume client clinics that service the private treatment market. After establishing the use of the Felix system with these clinics, Vitrolife plans to expand marketing to its next group of client clinics and then continue rollout to other high-volume KOL clients.
Vitrolife will utilise the data from these early user clinics as points of reference for other clinics to build endorsement of Felix further throughout the Japanese market. It is fully expected that the low volume clinics will also follow suit once they become familiar with Felix’s clinical utility.
MEM and Vitrolife are expediting plans to explore the best avenue for participating clinics to obtain full insurance reimbursement for using Felix in their IVF procedures. Once in place these plans will further enhance the Felix presence in the Japanese market.
