再生医学巨头Organogenesis Holdings Inc（ORGO）近日宣布，已顺利完成与美国食品药品监督管理局（FDA）的关键性会议。双方就Renu®再生细胞技术用于治疗膝骨关节炎疼痛的临床开发路径达成共识。
公司明确表示，将基于会议指导加速推进监管申报流程，计划正式提交生物制剂许可申请（BLA）。这款创新疗法旨在通过细胞再生机制靶向修复膝关节软骨组织，有望为全球数亿骨关节炎患者提供非手术干预新选择。
此次里程碑事件标志着Renu®产品商业化进程取得重大突破。业界分析指出，若获批上市，该产品或将重塑骨科疼痛治疗领域市场格局。受此利好消息影响，公司股价在盘后交易中呈现上扬态势。
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