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美国新创公司Science Corp宣布将在欧洲开始销售其视网膜晶片Prima,该植入物已获得欧盟CE认证,可用于治疗因老年性黄斑部病变引起的地图状萎缩,为患有此类年龄相关失明的患者恢复部分视力。这是美国脑植入公司首次将产品广泛提供给患者,标志著该领域的重要里程碑。

Prima植入物是一块置于眼球后方的晶片,搭配特制眼镜使用,能帮助患者恢复部分视觉功能。在《新英格兰医学杂志》发表的临床研究中,32名晚期黄斑部病变患者中有26人的视力获得改善,能够辨识个别字母、数字和单词。Science Corp计划今年为数十名患者植入该装置,明年则增至约200名。

Science Corp总部位于加州阿拉米达,估值达15亿美元,已筹集4.89亿美元资金,是仅次于马斯克Neuralink的美国第二大脑植入公司。该公司预计八月在德国完成首例商业植入手术,同时正与美国食品药物管理局洽谈,希望明年在美国市场推出该装置,并将透过人道主义器械豁免途径申请上市许可。

US startup Science Corp has announced that its retinal chip, the Prima implant, has received the CE mark in Europe, enabling it to treat geographic atrophy caused by age-related macular degeneration. The device, which sits on the back of the eye and works with specialized glasses, restores partial vision to patients suffering from this advanced form of blindness—marking the first commercially available product from a US brain-implant company.

Clinical research published in the New England Journal of Medicine demonstrated that the Prima implant improved vision in 26 out of 32 patients with advanced age-related macular degeneration, specifically enhancing form vision so patients could identify individual letters, numbers, and words. The company plans to implant the device in dozens of patients this year and approximately 200 next year, with the first commercial implantation expected in Germany in August.

Science Corp, valued at $1.5 billion with $489 million in funding raised, is the second most valuable US brain-implant company after Elon Musk's Neuralink. Beyond the retina implant, the company is developing brain-tissue interfaces using engineered neurons. It is currently in discussions with the US FDA to bring the device to market next year through a humanitarian device exemption pathway, which offers a streamlined approval process for products serving a small patient population.

2026-07-23 (Thursday) · ff39684746f9e21cb5f31ebdacdc6fc10ed7e165