Sydney-based reproductive technology specialist Memphasys has inked an exclusive five-year distribution deal with Vitrolife Japan KK – a subsidiary of the world-renowned Vitrolife Group – to sell and distribute its patented Felix system in Japan.
Vitrolife is a global provider of medical devices, consumables and genetic testing services dedicated to the human IVF and reproductive health market. The company, listed on the NASDAQ Stockholm exchange with a market capitalisation of $3.06 billion, has manufacturing sites in Sweden, Denmark and the United States and a direct presence in 25 countries, with its products and services available in more than 125 countries.
Interestingly, Vitrolife predominantly markets its own products and only selectively promotes others, seemingly handing Memphasys a significant signal of support for its innovative Felix system. And stomping a foot in the door of the lucrative Japanese health sector is certainly also nothing to be sneezed at.
The automated Felix device uses single-use cartridges for preparing sperm for human IVF procedures. The device gently separates sperm from a semen sample using electrophoresis and size exclusion membranes without causing damage to sperm DNA.
Japan’s birth rate, in a country with 125 million people, fell below 800,000 last year for the first time – reflecting the worldwide phenomenon of a decline in the number of babies being delivered. The statistics prompted the Japanese government last year to add IVF to its national insurance system, in addition to committing to an annual 3.2-trillion-yen (AU$37.4 million) investment to help curb the downward trend.
With more than 600 clinics and hospitals offering infertility treatment, Japan is seen as a leader in the field. In 2020, the Japanese market was estimated at 450,000 cycles, a number set to only grow courtesy of the inclusion of IVF in the national insurance system.
The five-year exclusive deal for Memphasys formalises a long-standing relationship between the duo, with Vitrolife supporting the development of the Felix device from its embryonic phase and providing its media for use in the Felix clinical trials.
Under the agreement, Vitrolife will provide marketing, sales and training, with an initial focus on key clinicians and high-volume clinics in Japan’s private health sector. Additionally, Vitrolife will work with Memphasys to build clinical data sets over time to position the Felix system to receive full insurance coverage in Japan.
Memphasys chief executive officer Alison Coutts said: “We are thrilled to have reached this agreement to collaborate with Vitrolife, a recognised leader in the global fertility sector. This strategic collaboration enhances the availability of cutting-edge fertility treatment for men in Japan, a major IVF market, where population levels have been on the decline for many years.”
Ms Coutts believes the agreement marks a significant milestone in the global commercialisation of Felix, which boasts speed as a key advantage. The company says it can process semen samples in just six minutes, while other sperm-separation methods, such as density gradient centrifugation (DGC), can take up to 10 times more.
A recent peer-reviewed study that appeared in the Journal of Assisted Reproduction and Genetics, which is an official journal of the American Society for Reproductive Medicine, concluded that, “The Felix device is a positive technical development capable of isolating suspensions of highly-motile spermatozoa exhibiting low levels of DNA damage in a fraction of the time taken by conventional procedures such as DGC”.
The research, supported by Memphasys, was conducted across five key opinion leaders in Australia, China, Sweden, India and the US. Notably, four of the five centres reported a “significant improvement” in the DNA integrity of the sperm relative to the DGC method.
Back at home, Felix is currently involved in a series of clinical studies and regulatory processes as the company seeks Australia’s coveted Therapeutic Goods Administration (TGA) tick of approval. The device is currently available for sale overseas in certain markets, including Canada and New Zealand.
Securing the exclusive distribution deal with an IVF powerhouse of Vitrolife’s standing is no small feat for a small Australian-based biotech company. With a global network at its fingertips, Memphasys could soon be humming to the tune of remarkable Australian songwriters Kev Carmody and Paul Kelly ... from little things big things grow.
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By Helen Barling
