October 27, 2015
Kuraray Co., Ltd.
Kuraray Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President: Masaaki Ito) hereby announces that AFFINOS, a bioresorbable bone-graft substitute that the Company has created using Beta-tricalcium phosphate (β-TCP), will be on the market from November 2, 2015.
In Japan, autologous bone-graft has been the predominant method used to treat bone defects and other conditions requiring bone grafting. However, in the interest of reducing the pain on patients while enhancing quality of life, development efforts have focused on creating artificial bone-graft materials capable of substituting for autologous bone-graft.
In 2009, Kuraray released REGENOS, a bone-graft substitute medical device made of hydroxyapatite. Building on this achievement, Kuraray has been developing AFFINOS to accommodate growing demand associated with bone regenerative medicine for bioresorbable implant materials that can be replaced by living bone. AFFINOS helps round out the Kuraray’s product lineup, and its introduction will boost Kuraray’s operations in the bone-graft substitutes market.
|Compressive Strength||more than 8 MPa (in the direction of unidirectional pores); more than 1.5 MPa (in the direction perpendicular to unidirectional pores)|
|Classification||Specially controlled medical device (Class IV)|
|General name||Bioresorbable bone-graft substitute|
|Marketing approval number||22600BZX00536000|
|Marketing approval holder||Kuraray Co., Ltd.|
|Type||Granular, cube, cuboid and cylinder|
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