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美國新創公司Science Corp宣布將在歐洲開始銷售其視網膜晶片Prima,該植入物已獲得歐盟CE認證,可用於治療因老年性黃斑部病變引起的地圖狀萎縮,為患有此類年齡相關失明的患者恢復部分視力。這是美國腦植入公司首次將產品廣泛提供給患者,標誌著該領域的重要里程碑。

Prima植入物是一塊置於眼球後方的晶片,搭配特製眼鏡使用,能幫助患者恢復部分視覺功能。在《新英格蘭醫學雜誌》發表的臨床研究中,32名晚期黃斑部病變患者中有26人的視力獲得改善,能夠辨識個別字母、數字和單詞。Science Corp計劃今年為數十名患者植入該裝置,明年則增至約200名。

Science Corp總部位於加州阿拉米達,估值達15億美元,已籌集4.89億美元資金,是僅次於馬斯克Neuralink的美國第二大腦植入公司。該公司預計八月在德國完成首例商業植入手術,同時正與美國食品藥物管理局洽談,希望明年在美國市場推出該裝置,並將透過人道主義器械豁免途徑申請上市許可。

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