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3Dプリンタで成形する「カスタムメイド人工骨」をEU諸国で製造・販売3Dプリンタニュース

NEDOプロジェクトにおいて、3Dプリンタで成形するカスタムメイド人工骨CTボーンを開発したネクスト21が、2015年4月30日にオランダXillocとEU諸国における製造・販売に関するライセンス契約を締結した。

» 2015年05月07日 17時00分 公開
[八木沢篤MONOist]
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 新エネルギー・産業技術総合開発機構(以下、NEDO)は2015年5月7日、3Dプリンタで成形するカスタムメイド人工骨CTボーン(以下、CTボーン)を開発したネクスト21が、同年4月30日にオランダXillocとEU諸国における製造・販売に関するライセンス契約を締結したことを発表した。

 CTボーンは、NEDOプロジェクトにおいて、ネクスト21、東京大学、理化学研究所などの研究チームが開発した世界初となる3Dプリンタで製造するカスタムメイド人工骨(関連記事:「世界初」3Dプリンタで人工骨を成形、薬事承認申請)。3Dプリンタを用いた人工骨の成形は骨内部構造の設計も可能で、かつ0.1mm精度で形状再現ができるため、人工骨の成形技術の中でも特に優れた手法だという。また、従来の人工骨のように熱処理を施していないので、自骨への癒合が早く、優れた治療効果を見込めるといった特長を備える。

CTボーン 3Dプリンタで成形したCTボーン(白色部分) ※出典:NEDO

 今回の契約締結を受け、ネクスト21は、欧州での製造販売登録に必要なテクニカルドキュメンテーションを含む製造適合性資料をXillocに提供。その後、Xillocが欧州連合指令93/42EEC(欧州医療機器指令MDD)の登録手続きを行い、登録完了後、EC諸国でのCTボーンの製造・販売を開始する。

3Dプリント人工骨の仕組み 3Dプリント人工骨の仕組み ※出典:NEDO
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