DGAP-News: curasan AG / Key word(s): Regulatory Approval
24.01.2019 / 15:35
The issuer is solely responsible for the content of this announcement.
– Clearance of synthetic bone graft material Osbone
– Expanded product portfolio for the Japanese market
Kleinostheim, 24 January 2019 – curasan AG, Germany, a leading specialist for medical products in the field of orthobiologics, has received news that the Japanese Pharmaceutical and Medical Devices Agency (PMA) has approved Osbone for distribution to the local market.
The approval process, which is particularly complicated in Japan, was successfully completed within the expected timeframe.
By this, the Japanese sales partner of curasan AG, Hakuho Co. Ltd., can offer another product in addition to Cerasorb M granules.
Osbone is a purely synthetic material and thus free of risks for allergies and disease transmission. It consists of hydroxyapatite, which has a particularly high porosity, comparable to human bone. Osbone also has a high volume stability and can therefore be loaded immediately. This property is an important criterion for positioning in the market. Competitor products also have this stability, but consist of animal hydroxyapatite.
Preparations for the market launch planned for the end of the first quarter are already underway. Due to the complexity of the introduction and listing processes, no significant revenues are expected in the first year.
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