Japanese approval for Volpara

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Volpara Health Technologies (ASX:VHT), a digital health company focused on the early detection of breast cancer, has announced the full VolparaEnterprise suite of products has received regulatory approval as a Class II medical device in Japan.

Japan has some 65 million women, screening around 5 million of them each year for breast cancer using mammography, and is seen as a potential important market for Volpara.

It is estimated that Japan has around 3,200 mammography machines, making it one of the world’s largest users of mammography outside the US. Yet the incidence of breast cancer is rapidly increasing in Japan, and is now one of the leading causes of cancer death, accounting for 20.4 per cent of all new cancers.

Volpara said it will launch the products in Japan via Breast Healthcare, its Japanese distributor, supported by its APAC sales team.

The company has research sites installed and active with VolparaDensity software, including Hokkaido Cancer Centre, Niigata Cancer Centre, Hokuto Hospital and Showa University School of Medicine. It formally launched VolparaEnterprise software at the Japanese Association of Breast Cancer Screening meeting held in Tokushima last week.

“We regard Japan as an extremely important market due to its size and density notification discussions, and our track record with leading research institutes,” said CEO Dr Ralph Highnam.

“We also know it has a higher proportion of women with dense breasts compared to the West. A study conducted at Showa University School of Medicine with VolparaDensity software showed approximately 80% of their population had dense breasts, compared to a more typical 40–50% in the West. The study also showed that cancer detection using mammography is very good in fattier breasts, but up to 30% of cancers in extremely dense breasts are being missed. Japan has a growing issue with breast cancer which we believe we can help with.”