REDWOOD CITY, Calif.

红木城，加利福尼亚州

,

，

April 2, 2025

2025年4月2日

/PRNewswire/ --

/PRNewswire/ --

Avisi Technologies

阿维西科技

, a clinical-stage ophthalmic device company, today announced encouraging six‐month interim results from the VITA trial evaluating its VisiPlate® device, an ultrathin, multichannel aqueous shunt in study subjects diagnosed with open-angle glaucoma. Data were presented by Eydie Miller-Ellis, MD, as a Top Paper at the American Glaucoma Society Annual Meeting in .

，一家处于临床阶段的眼科设备公司，今天宣布了VITA试验令人鼓舞的六个月中期结果，该试验评估了其VisiPlate®设备，一种超薄多通道房水引流器在被诊断为开角型青光眼的研究对象中的应用。数据由Eydie Miller-Ellis博士在美国青光眼学会年会上作为重点论文发表。

Washington, D.C.

华盛顿特区

Key Trial Data

关键试验数据

The multi‐site VITA trial, a prospective pilot study designed to assess the safety and effectiveness of Avisi Technologies' investigational VisiPlate® device, enrolled and treated 15 subjects (mean age 55.6±17.1 years) with open-angle glaucoma and no prior filtration surgery. Subjects were implanted in one eye at three South African centers.

多中心VITA试验是一项前瞻性试点研究，旨在评估Avisi Technologies公司研发的VisiPlate®设备的安全性和有效性，该试验招募并治疗了15名患有开角型青光眼且无既往滤过手术史的受试者（平均年龄55.6±17.1岁）。受试者的一只眼睛在南非的三个中心接受了植入手术。

Baseline intraocular pressure (IOP) of the cohort averaged 24.1 mmHg (ranging from 18.8 mmHg to 40.2 mmHg), with the study eyes requiring an average of 2.0 glaucoma medications (ranging from 0 to 4 medications). At six months following standalone VisiPlate® implantation:.

该队列的基线眼内压（IOP）平均为24.1毫米汞柱（范围从18.8毫米汞柱到40.2毫米汞柱），研究眼平均需要使用2.0种青光眼药物（范围从0到4种药物）。在单独植入VisiPlate®六个月后：

Mean IOP decreased by 40.4%, to 14.0 mmHg with a corresponding reduction to 0.8 medications.

平均眼压下降了40.4%，降至14.0毫米汞柱，同时用药量减少至0.8种。

78.6% of study eyes achieved a ≥20% IOP reduction on the same or fewer medications, exceeding the study's primary effectiveness endpoints.

78.6%的研究眼压降低了20%或更多，且使用的药物相同或更少，超过了研究的主要有效性终点。

57.1% of study eyes required no IOP-lowering medication.

57.1%的研究眼不需要降低眼压的药物。

The VisiPlate® device demonstrated a favorable safety profile with no subject losing ≥2 lines of best-corrected visual acuity (BCVA), and no need for device removal or additional glaucoma procedures.

VisiPlate® 设备表现出良好的安全性，没有受试者失去≥2行最佳矫正视力 (BCVA)，且无需移除设备或进行额外的青光眼手术。

Device Features

设备特性

Avisi Technologies' VisiPlate® shunt is a unique design made of a patented metamaterial that has been designed to be non-fibrotic and is many times thinner than a human hair. The device is both doctor and patient-centric, designed for ease of implantation, longevity, comfort, and aesthetics. Its multiple, redundant microchannels are engineered to provide healthy aqueous flow while minimizing the risk of blockage, a common challenge with currently available glaucoma surgical solutions..

Avisi Technologies的VisiPlate®分流器是一种独特的设计，由获得专利的超材料制成，该材料被设计为无纤维化，并且比人的头发还要薄很多倍。该设备以医生和患者为中心，旨在实现易于植入、持久性、舒适性和美观性。其多个冗余微通道经过工程设计，能够在提供健康房水流动的同时，最大限度地降低堵塞风险，这是当前可用青光眼手术解决方案常见的挑战。

Dr. Miller-Ellis, Vice President of the American Glaucoma Society and Director of Glaucoma at the

米勒-埃利斯博士，美国青光眼学会副主席兼青光眼主任

University of Pennsylvania

宾夕法尼亚大学

, Scheie Eye Institute, shared her excitement about the positive VisiPlate® performance in

，谢伊眼科研究所，分享了她对VisiPlate®性能表现积极的兴奋之情

Ultrathin Shunt Shows Promising Results in Trial

超薄分流器在试验中显示出可喜的结果

, an article by

，一篇由...撰写的文章

Jim Gallagher

吉姆·加拉格尔

, Senior Managing Editor at

，高级执行编辑 tại

Glaucoma Physician

青光眼医生

. 'I call it 'building a better bleb,' because after trabeculectomy or other filtering surgeries blebs can be very elevated and cause the patient some discomfort,' she noted. 'That tendency of bleb shape is partially attributable to the single lumen outflow of other available stents. If all the aqueous is coming out in one outflow path, then the aqueous force is more concentrated centrally in the bleb, causing more elevation in that area.

“我称之为‘构建更好的滤过泡’，因为小梁切除术或其他滤过手术后，滤过泡可能会非常高胀，给患者带来一些不适，”她指出。“滤过泡形状的这种趋势部分归因于其他可用支架的单腔流出。如果所有的房水都通过一个流出路径流出，那么房水的力量会更集中在滤过泡的中央，导致该区域更高胀。”

Our goal is to have a more diffuse outflow of aqueous that's more comfortable for the patient.'.

我们的目标是让房水的流出更加分散，这样患者会感觉更舒适。

Dr. Miller-Ellis also noted that surgeons in the VITA trial found the VisiPlate® surgical procedure to be easier and faster than a standard trabeculectomy, with less involved postoperative management being required.

米勒-埃利斯博士还指出，VITA 试验中的外科医生认为 VisiPlate® 手术比标准的小梁切除术更容易、更快，且需要的术后管理较少。

Expert Commentary

专家评论

Joseph F. Panarelli

约瑟夫·F·帕纳雷利

, MD, Director of Glaucoma Services at NYU Langone Health and Professor of Ophthalmology at NYU Grossman School of Medicine, commented, 'These results are very exciting and I'm anticipating having VisiPlate be a part of my practice in the future. I like the multichannel design and the potential for a straightforward surgery and simpler follow up.

纽约大学朗格尼健康中心青光眼服务部主任、纽约大学格罗斯曼医学院眼科教授评论道：“这些结果非常令人兴奋，我期待未来在我的实践中使用VisiPlate。我喜欢多通道设计以及手术简便和后续处理更简单的潜力。”

If we could have pediatric applications one day, that would be fantastic too.'.

如果有一天我们能有儿科应用，那就太棒了。

Ehsan Sadri

艾山·萨德里

, MD, FACS, FAAO, Founder of Visionary Eye Institute, also shared his enthusiasm stating,

医学博士，FACS，FAAO，Visionary Eye Institute 创始人也分享了他的热情，他表示：

'The six-month VITA trial results for the VisiPlate® aqueous shunt are truly remarkable. A 40% reduction in IOP and over half of study eyes completely off medications—these are the kinds of outcomes we strive for in glaucoma care, especially when achieved through a minimally invasive approach. The metamaterial design and multichannel architecture of VisiPlate® represent a new frontier in safe, sustained IOP control..

“VisiPlate® 房水引流器的六个月 VITA 试验结果确实令人瞩目。眼压降低了 40%，超过一半的研究眼睛完全停止了药物治疗——这些正是我们在青光眼治疗中所追求的成果，特别是当通过微创方法实现时。VisiPlate® 的超材料设计和多通道结构代表了安全、持续控制眼压的新前沿。”

As a surgeon committed to offering the most advanced and patient-centered care, I'm excited about the potential to incorporate VisiPlate® into my practice. Its ultrathin profile, ease of implantation, and impressive safety profile underscore the promise of this technology. I believe VisiPlate® could fundamentally shift how we manage moderate to advanced open-angle glaucoma and open the door to a better quality of life for our patients.'.

作为一名致力于提供最先进和以患者为中心的护理的外科医生，我对将VisiPlate®融入我的实践充满期待。其超薄外形、易于植入以及令人印象深刻的安全性体现了这项技术的潜力。我相信VisiPlate®可以从根本上改变我们管理中度至重度开角型青光眼的方式，并为我们的患者开启更高质量生活的大门。

The paper presented by Dr. Miller-Ellis at the American Glaucoma Society Annual Meeting was the result of a strong international collaboration, with co-authors including

米勒-埃利斯博士在美国青光眼学会年会上发表的论文是强大的国际合作的结果，合著者包括

Jonathan S. Myers

乔纳森·S·迈尔斯

, MD (Chief, Glaucoma Service at Wills Eye Hospital, Professor, Sidney Kimmel Medical College at

，医学博士（威尔斯眼科医院青光眼服务主任，西德尼·金梅尔医学院教授，

Thomas Jefferson University

托马斯·杰斐逊大学

),

),

Lynette Venter

莱内特·文特尔

, MD, MBChB, MMed (Ophth), FC Ophth(SA),

，医学博士，内外全科医学士，眼科医学硕士，南非眼科院士，

Paul Roux

保罗·鲁克斯

, MD (Former Head of the Department of Ophthalmology at

，医学博士（曾任眼科主任

Pretoria

比勒陀利亚

University),

大学），

Petrus Gous

彼得·古斯

, MD (Founder of Pretoria Eye Institute),

，医学博士（比勒陀利亚眼科研究所创始人），

Laura Straub

劳拉·施特劳布

, Morné de Bruin, OD, and

，莫恩·德·布鲁因，OD，和

Eydie G. Miller-Ellis

艾迪·G·米勒-埃利斯

, MD.

，医学博士。

Next Steps

下一步

The VITA trial is now complete. Full 12-month results will be announced at a future date.

VITA试验现已完成。完整的12个月结果将在未来公布。

About VisiPlate®

关于VisiPlate®

The investigational VisiPlate® aqueous shunt is Avisi Technologies' flagship 'minimally invasive bleb surgery' (MIBS) device. Made from non-fibrotic nanotechnology-enabled metamaterials, it works by wicking pent-up aqueous humor from the inside of the eye to a secondary drainage zone via a network of interconnected microchannels, rather than a large tube.

VisiPlate® 房水引流器是 Avisi Technologies 公司的旗舰“微创滤过泡手术”（MIBS）设备。它由非纤维化纳米技术赋能的超材料制成，通过一个相互连接的微通道网络将眼睛内部积聚的房水引流至次级排水区，而非依靠大管径导管。

The device is engineered to lower IOP  while maintaining patient comfort and aesthetics. It is an investigational device and is not yet available for sale..

该设备旨在降低眼压，同时保持患者的舒适度和美观性。它是一种研究性设备，尚未上市销售。

About Glaucoma

关于青光眼

Glaucoma

青光眼

is the leading cause of irreversible blindness worldwide and currently has no cure. In glaucoma patients, excess fluid builds up within the eye, increasing pressure on the optic nerve and leading to permanent vision loss. Glaucoma is a group of diseases, the most common of which are primary open-angle glaucoma (POAG) and angle-closure glaucoma..

是全球不可逆失明的主要原因，目前尚无治愈方法。在青光眼患者中，眼睛内多余液体积聚，增加对视神经的压力，导致永久性视力丧失。青光眼是一组疾病，其中最常见的是原发性开角型青光眼（POAG）和闭角型青光眼。

POAG, the most prevalent form of glaucoma, often has no early warning signs or symptoms. It occurs when the eye's drainage system (trabecular meshwork) becomes clogged, preventing normal fluid outflow and leading to elevated eye pressure. Without diagnosis and treatment, POAG can cause gradual vision loss over time..

原发性开角型青光眼（POAG）是最常见的青光眼类型，早期通常没有警示信号或症状。它发生在眼睛的排水系统（小梁网）被堵塞时，阻止了正常的液体流出，导致眼压升高。如果不进行诊断和治疗，POAG会随着时间的推移逐渐引起视力丧失。

About Avisi Technologies

关于Avisi科技

Avisi Technologies

阿维西科技公司

is a clinical-stage medical device company committed to advancing vision care through innovative ophthalmic solutions. The company's portfolio includes state-of-the-art treatments for glaucoma and other ocular conditions. These include its flagship VisiPlate® aqueous shunt, a sustained drug delivery platform, and a device to treat mild glaucoma.

是一家临床阶段的医疗设备公司，致力于通过创新的眼科解决方案推动视力保健的发展。该公司产品组合包括青光眼和其他眼部疾病的先进治疗方法。其中包括其旗舰产品VisiPlate®房水引流器、持续药物输送平台以及用于治疗轻度青光眼的设备。

Avisi Technologies' VisiPlate device has been recognized as a promising new technology by numerous organizations, including the National Science Foundation, the Glaucoma Research Foundation, SXSW, Johnson & Johnson JLABs, Medtech Innovator Accelerator, UCSF Rosenman Institute, and the .

Avisi Technologies的VisiPlate设备已被多个组织认可为一项有前途的新技术，这些组织包括美国国家科学基金会、青光眼研究基金会、SXSW、强生JLABs、Medtech Innovator Accelerator、UCSF Rosenman研究所等。

University of Pennsylvania

宾夕法尼亚大学

, among others. Avisi has been funded by early-stage venture capital investors, angel investors, and research grants from the National Science Foundation. For more information, visit

，以及其他。Avisi 已获得早期风险资本投资者、天使投资人和国家科学基金会研究基金的资助。欲了解更多信息，请访问

avisitech.com

avisitech.com

.

。

SOURCE Avisi Technologies

来源：Avisi Technologies

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