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正海生物(300653.SZ):“鈣硅生物陶瓷骨修復材料”完成首例受試者隨機入組
格隆匯 08-02 20:07

格隆匯8月2日丨正海生物(300653.SZ)公佈,公司的研發項目“鈣硅生物陶瓷骨修復材料”(公司2021年年報中使用名稱為“3D打印生物骨修復材料”)於近日完成首例受試者隨機入組,正式進入臨牀試驗。

為解決種植修復中的牙槽骨骨量不足對治療效果的影響,探索有效的改善骨量不足的方法,並將各種骨移植材料應用於種植修復中一直是口腔種植學的熱點。人工骨修復材料作為自體骨移植的替代品,可避免自體骨的骨量有限、二次傷害、潛在併發症等問題,為種植牙修復治療提供了更多的選擇。

“鈣硅生物陶瓷骨修復材料”屬於人工合成骨修復材料,是經過三維打印成型、高温燒結制備而成的生物陶瓷,具有與天然松質骨類似的仿生多孔結構,從原料來源上看,將區別於公司已上市的生物材料來源產品“骨修復材料(國械注準20153170391)”,有利於進一步豐富公司產品管線。

公司“鈣硅生物陶瓷骨修復材料”臨牀試驗的開展,對豐富公司口腔領域產品管線具有積極意義,公司將按照國家醫療器械註冊的相關規定和要求開展臨牀試驗,待臨牀試驗成功後按程序申報註冊。

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