Science Corporation’s vision-restoring chip wins EU approval
Science Corporation’s vision-restoring chip wins EU approval
Science Corporation 的视力恢复芯片获得欧盟批准
Science Corporation, a startup developing novel brain-computer interfaces (BCI), won approval from Europe’s medical device regulator to begin selling a device that restores vision lost from age-related macular degeneration. The company said the device, called PRIMA, also received a designation from the US Food and Drug Administration that is the first step toward an expedited regulatory review, which could see the device used to treat two rare kinds of blindness.
Science Corporation 是一家开发新型脑机接口（BCI）的初创公司，近日获得了欧洲医疗器械监管机构的批准，可以开始销售一种用于恢复因年龄相关性黄斑变性而丧失视力的设备。该公司表示，这款名为 PRIMA 的设备还获得了美国食品药品监督管理局（FDA）的认定，这是迈向加速监管审查的第一步，该设备未来有望用于治疗两种罕见的失明症。
Millions of people around the world suffer from age-related macular degeneration, which destroys the light-sensitive cells at the back of the eyes, making it difficult to read and recognize faces. To use the device, patients suffering from this loss of vision undergo an hour-long outpatient procedure that plants a small chip in back of their eye. Then they wear camera-equipped glasses that transmit a view of the world to the chip.
全球有数百万人患有年龄相关性黄斑变性，这种疾病会破坏眼底的光敏细胞，导致患者难以阅读和识别人脸。为了使用该设备，视力受损的患者需要接受一个小时的门诊手术，将一枚微型芯片植入眼底。随后，患者佩戴配有摄像头的眼镜，将外界影像传输到芯片上。
Max Hodak, Science Corp.’s founder and CEO, says the product gives functional vision to people who have lost it. “One of our patients in France finished a 300-page novel a little while ago, and sent us the book,” Hodak told TechCrunch. “We have a sketch on the wall [that] one of our patients drew of the Sydney Opera House. There are videos of patients playing crossword puzzles and filling in Sudoku.”
Science Corp. 的创始人兼首席执行官 Max Hodak 表示，该产品能为失去视力的人提供功能性视觉。“我们的一位法国患者不久前读完了一本 300 页的小说，并把书寄给了我们，”Hodak 告诉 TechCrunch。“我们的墙上挂着一位患者画的悉尼歌剧院素描。还有视频显示患者在玩填字游戏和数独。”
Hodak is known as the co-founder and former president of Neuralink, Elon Musk’s BCI startup. He left in 2021 to start Science Corp., with plans to develop a novel BCI based on a hybrid of silicon chips and living cells. But first, the company had to prove out its processes and develop a sustainable business. “The thing that the space needs is a company making $100 million a year of revenue,” Hodak said. “There’s this risk that the whole thing enters a winter, and so we think it’s important to build a sustainable business as we develop these longer-term technologies.”
Hodak 是埃隆·马斯克（Elon Musk）旗下脑机接口初创公司 Neuralink 的联合创始人兼前总裁。他于 2021 年离职并创立了 Science Corp.，计划开发一种基于硅芯片与活细胞混合的新型脑机接口。但首先，公司必须验证其工艺并建立可持续的业务。“这个领域需要的是一家年收入达到 1 亿美元的公司，”Hodak 说。“整个行业存在进入‘寒冬’的风险，因此我们认为在开发这些长期技术的同时，建立可持续的业务至关重要。”
Hodak and his colleagues believe that sustainable business will be restoring vision to the blind, specifically patients whose conditions stem from problems with the light-detecting cells at the back of the eye. After exploring multiple approaches, they determined that Pixium, a French company that developed the PRIMA technology, had the right path forward and acquired the firm in 2024. Science Corp. used its internal platform to build out the documentation and evolve the product to prepare it for regulatory approval and commercialization.
Hodak 和他的同事们认为，这种可持续的业务将是为盲人恢复视力，特别是那些因眼底光感细胞问题而导致失明的患者。在探索了多种方案后，他们认定开发 PRIMA 技术的法国公司 Pixium 拥有正确的路径，并于 2024 年收购了该公司。Science Corp. 利用其内部平台完善了文档，并对产品进行了升级，为监管审批和商业化做好了准备。
Each PRIMA device is expected to cost in the hundreds of thousands of dollars; Science Corp. and its medical partners in Europe are currently in discussion with healthcare providers over reimbursement. The company is laying the groundwork to begin offering PRIMA in Germany, where its clinical trials were held, and could see the first procedure in September.
每台 PRIMA 设备的成本预计在数十万美元；Science Corp. 及其在欧洲的医疗合作伙伴目前正在与医疗服务提供商讨论报销事宜。该公司正在为在德国提供 PRIMA 服务奠定基础，其临床试验就是在德国进行的，预计首例手术最早可能在 9 月进行。
Science Corp. expects to continue improving the vision capabilities of PRIMA with a new chip, and the form factor of its glasses, which currently require a battery-pack to operate. The goal is to offer something like Meta’s AR glasses, but the power and compute requirements for PRIMA are more significant. Science Corp. is also working with Dr. Murat Günel, chair of Yale Medical School’s Department of Neurosurgery, to develop procedures for human trials of a directly implanted bio-hybrid brain sensor.
Science Corp. 计划通过新芯片继续提升 PRIMA 的视觉能力，并改进其眼镜的外形——目前的眼镜仍需外接电池组才能运行。他们的目标是提供类似 Meta AR 眼镜的产品，但 PRIMA 对功耗和计算能力的要求更高。此外，Science Corp. 正在与耶鲁大学医学院神经外科系主任 Murat Günel 博士合作，开发直接植入式生物混合脑传感器的临床试验流程。
Hodak says bringing PRIMA to market is “the most important thing for the company, because we don’t get to do the bio hybrid stuff long term if you don’t have a great vision business. That’s what’s really financing the rest of it — that’s the thing that investors know how to build spreadsheets around.”
Hodak 表示，将 PRIMA 推向市场是“对公司而言最重要的事情，因为如果没有一个出色的视力业务，我们就无法长期从事生物混合技术的研究。这才是真正为其他项目提供资金的来源——这也是投资者知道如何通过财务模型进行评估的项目。”