Company
Emulate
Organ-Chip company; submitted a full qualification package for its Liver-Chip to the FDA ISTAND program
Overview
- Funding: Cumulative funding not re-verified ⚠️
- Links: https://www.pharmaceuticalonline.com/doc/emulate-enters-final-stage-of-fda-istand-program-for-human-liver-chip-with-submission-of-qualification-package-covering-both-zo-and-ava-organ-chip-platforms-0001
This profile was compiled from the AI training-data column cards (AI for Science); each column's data view is shown below under "Data profile" (in Chinese).
Data profile · AI for Science
Emulate
Organ-Chip 公司，Liver-Chip 提交 FDA ISTAND 完整资质包
- 数据类型
- 器官芯片毒性与药效
做什么
美国器官芯片（Organ-Chip）公司，用微流控芯片培养人体器官模型做药物毒性与药效评估。
监管进展
2026-09-09 提交 Human Liver-Chip 的完整 ISTAND 资质包，覆盖 Zo 与 Ava 两个平台，进入最后阶段；尚未获批 [1]。截至 2026-10-15，没有一款器官芯片在 ISTAND 完成资质认定。
数据与客户
客户为药企与 FDA 相关合作方。累计融资额未核到可靠来源 ⚠️。产出数据的规模与定价公开材料未查到。
谁在用、用在哪一段
用于临床前毒性（尤其肝毒）判断，配合政策转向减少动物试验，见 fda-modernization-act。同赛道公司见 vivodyne、axiom-bio。
争议与口径
资质认定通过前，其数据在监管决策中的权重有限。
Last compiled: 2026-10-15