ALAMEDA, Calif.--(BUSINESS WIRE)--Science Corporation, a leader in brain-computer interface (“BCI”) technology, has announced the preliminary clinical trials results for its PRIMA retina implant. The results showed that the implant restored real 'form vision' in patients who had lost their central visual field, allowing them to execute useful, high acuity tasks like reading or recognizing faces.

加利福尼亚州阿拉米达（商业新闻短讯）--脑机接口（“BCI”）技术的领导者科学公司宣布了其PRIMA retina植入物的初步临床试验结果。结果表明，植入物恢复了失去中央视野的患者的真实“形式视力”，使他们能够执行有用的高视力任务，如阅读或识别面部。

After receiving a PRIMA implant, patients were able to read with a clinically meaningful improvement including the ability to recognize letters..

接受PRIMA植入物后，患者能够阅读，并具有临床意义的改善，包括识别字母的能力。。

“The results demonstrate a milestone in the treatment of severe vision loss caused by geographic atrophy due to age-related macular degeneration. For the first time it was possible to restore real form vision in a retina that has deteriorated due to age-related macular degeneration,” said Professor Frank Holz, MD, Scientific Coordinator of the PRIMAvera study.

PRIMAvera研究的科学协调员Frank Holz教授说：“研究结果表明，在治疗因年龄相关性黄斑变性引起的地理萎缩引起的严重视力丧失方面，这是一个里程碑。首次有可能恢复因年龄相关性黄斑变性而恶化的视网膜的真实视力。”。

“Prior to this, there have been no real treatment options to improve vision for these patients,” added Professor Holz, who is Chairman and Professor, Department of Ophthalmology, at the University of Bonn, Germany..

“在此之前，还没有真正的治疗选择来改善这些患者的视力，”德国波恩大学眼科系主席兼教授霍尔茨教授补充道。。

Max Hodak, Science Corp CEO, added: “To my knowledge, this is the first time that restoration of the ability to fluently read has ever been definitively shown in blind patients. This represents an enormous turning point for the field, and we’re incredibly excited to bring this important technology to market over the next few years.”.

科学公司（Science Corp）首席执行官马克斯·霍达克（Max Hodak）补充道：“据我所知，这是盲人患者首次明确显示出流利阅读能力的恢复。这代表了该领域的一个巨大转折点，我们对在未来几年将这项重要技术推向市场感到无比兴奋。”。

The study was designed to demonstrate PRIMA’s safety and efficacy to reach European market approval (CE mark). PRIMA, owned and manufactured by Science Corp, is based on original research done at Stanford University and later by Pixium Vision, which was acquired by Science Corp.

该研究旨在证明PRIMA的安全性和有效性，以达到欧洲市场认可（CE mark）。PRIMA由Science Corp拥有和制造，基于斯坦福大学的原始研究，后来由Science Corp收购的Pixium Vision进行。

Clinical Trial of 38 Patients

38例患者的临床试验

The PRIMA clinical trial, called PRIMAvera, is a clinical study with 38 patients suffering from geographic atrophy (GA), who were implanted with the PRIMA retinal system to restore vision. Geographic atrophy is an advanced form of age-related macular degeneration (AMD) where the central area of the retina, and thus the patient’s sight, has deteriorated..

PRIMA临床试验称为PRIMAvera，是一项针对38名患有地理萎缩（GA）的患者的临床研究，这些患者植入了PRIMA视网膜系统以恢复视力。地理萎缩是年龄相关性黄斑变性（AMD）的一种高级形式，视网膜中央区域因此患者的视力恶化。。

A Meaningful Improvement of Visual Acuity

有意义的视力提高

The results show a meaningful improvement of visual acuity when using the system. Patients show a notable improvement in their letter acuity while using the PRIMA implant to read a series of letters; some are able to read longer text.

结果表明，使用该系统时视力有了显着提高。当使用PRIMA植入物阅读一系列信件时，患者的字母敏锐度显着提高；有些人能够阅读更长的文本。

Preliminary Results

初步结果

The visual acuity of all participating patients was measured at 6 and 12 months post implantation via logMAR scoring (zero logMAR indicates normal vision, positive values indicate poor vision), and it demonstrated clinically significant improvement:

通过logMAR评分在植入后6个月和12个月测量所有参与患者的视力（零logMAR表示视力正常，正值表示视力不佳），并显示出临床显着改善：

A 23 letter (4.6 lines) mean improvement at 12 months post implantation compared to baseline.

23个字母（4.6行）意味着植入后12个月与基线相比有所改善。

A 59 letter (11.8 line) maximum improvement in the patient with the best response.

59个字母（11.8行）最大程度地改善了患者的反应。

A success was defined as 10 letters (2 lines) of improvement.

成功被定义为10个字母（2行）的改进。

The mean natural visual acuity without using PRIMA remained stable after implantation, which suggests a good safety profile.

植入后，不使用PRIMA的平均自然视力保持稳定，这表明安全性良好。

Additional details from the trials can be found here: link.

试验的其他细节可以在这里找到：链接。

The PRIMA System

PRIMA系统

The PRIMA system is a visual prosthesis which consists of a photovoltaic implant—totally cableless and autonomous—surgically implanted under the retina, a special pair of glasses with a camera and built-in projection system, and a pocket processor that processes the image for clarity and magnification..

PRIMA系统是一种视觉假体，由完全无电缆的光伏植入物和视网膜下的自主手术植入物组成，一副带有相机和内置投影系统的特殊眼镜，以及一个处理图像以获得清晰度和放大率的袖珍处理器。。

Additional Background

其他背景

According to the United States National Institute of Health, there are about one million cases of GA in the US, and about 160,000 new cases occur per year. The American Academy of Ophthalmology estimates that over eight million people are affected worldwide with GA. The most significant risk factors are increasing age and family history..

根据美国国立卫生研究院的数据，美国约有100万例GA病例，每年约有16万例新病例发生。美国眼科学会估计，全世界有800多万人受到GA的影响。最重要的危险因素是年龄和家族史的增加。。

About Science Corporation:

关于科学公司：

Science Corporation is a leader in the field of brain-computer interface (BCI) technology, and the emerging field of neural engineering broadly. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility.

科学公司是脑机接口（BCI）技术领域的领导者，也是神经工程领域的新兴领域。我们致力于恢复那些没有治疗选择的衰弱患者的生活质量，创建旨在恢复视力，认知和活动能力的设备。

To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry. We are headquartered in Alameda, California with additional offices in Research Triangle Park, North Carolina and Paris, France..

为了支持整个行业的进步，我们通过Science Foundry为其他人提供最先进的组件和垂直集成的基础设施。我们的总部位于加利福尼亚州的阿拉米达，在北卡罗莱纳州的三角研究公园和法国巴黎设有办事处。。