First-of-its-kind titratable glaucoma therapy system aims to optimize reduction of intraocular pressure (IOP)

首次推出的可滴定青光眼治疗系统旨在优化眼压降低（IOP）

CAMPBELL, Calif., Sept. 6, 2023 /PRNewswire/ -- Myra Vision, a Shifamed portfolio company, announced today it has initiated its first-in-human clinical study of the Calibreye™ System, a next generation glaucoma drainage device with titratable outflow control designed to achieve optimal reduction of intraocular pressure (IOP) for moderate to severe glaucoma patients.

加利福尼亚州坎贝尔，2023年9月6日/PRNewswire/--Shifamed投资组合公司Myra Vision今天宣布，它已启动该口径的首次人体临床研究™系统，具有可滴定流出控制的下一代青光眼引流装置，旨在实现中重度青光眼患者眼内压（IOP）的最佳降低。

The prospective, non-randomized open-label feasibility study aims to evaluate the clinical procedure, safety, and overall performance of the Calibreye System in open angle glaucoma patients. .

前瞻性，非随机开放标签可行性研究旨在评估口径系统在开角型青光眼患者中的临床程序，安全性和总体表现。 .

The Calibreye System is engineered to put outflow control in the hands of glaucoma specialists, giving them the opportunity to provide personalized therapy while minimizing complications. Once implanted, the Calibreye shunt is designed to allow non-invasive in-office increases or decreases in outflow as a patient's individual treatment needs change..

Calibreye系统旨在将流出控制放在青光眼专家手中，使他们有机会提供个性化治疗，同时最大限度地减少并发症。一旦植入，口径分流器被设计成允许非侵入性的办公室增加或减少流出，因为患者的个人治疗需要改变。。

'Managing glaucoma remains increasingly challenging as the condition progresses to moderate and severe stages,' commented Dr. Rohit Varma, Founding Director of Southern California Eye Institute in Los Angeles, CA. 'Unlike other glaucoma drainage devices, the titratable outflow of the Calibreye System has the potential to achieve personalized optimal IOP in our patients, with simple, in-office adjustments.

加利福尼亚州洛杉矶南加州眼科研究所创始主任Rohit Varma博士评论说：“随着病情发展到中度和重度阶段，管理青光眼仍然越来越具有挑战性。”与其他青光眼引流装置不同，口径系统的可滴定流出有可能在我们的患者中实现个性化的最佳眼压，只需简单，办公室调整。

I believe this is a transformative advance in the management of our patients with moderate and severe glaucoma.'.

我相信这是我们中重度青光眼患者管理的变革性进展。

Glaucoma, a leading cause of irreversible blindness, affects an estimated 66M people worldwide.1 More than one third of patients have moderate to severe glaucoma, which requires significant reductions in IOP. Traditionally, these glaucoma patients have been treated with surgery, including trabeculectomy and tube shunt implants.

青光眼是导致不可逆失明的主要原因，影响全球约660万人.1超过三分之一的患者患有中度至重度青光眼，这需要显着降低眼压。传统上，这些青光眼患者已经接受手术治疗，包括小梁切除术和管分流植入物。

Recent advances in less invasive surgical devices offer simpler and safer treatment options. While these devices have demonstrated an improvement in complication rates, achieving the IOP reductions necessary for the moderate to severe glaucoma patient population remains challenging..

微创手术装置的最新进展提供了更简单和更安全的治疗选择。虽然这些装置已经证明并发症发生率有所改善，但实现中度至重度青光眼患者群体所需的IOP降低仍然具有挑战性。。

'I am pleased to be a part of these initial cases and am impressed by the early performance of the Calibreye System,' stated Dr. Iqbal Ike K. Ahmed, Director, Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center and Director, Glaucoma & Advanced Anterior Segment Surgery (GAASS) Fellowship, University of Toronto.

“我很高兴成为这些初始病例的一部分，并且对Calibreye系统的早期表现印象深刻，”Iqbal Ike K.Ahmed博士，John a.Moran眼科中心Alan S.Crandall青光眼创新中心主任和多伦多大学青光眼与高级前段手术（GAASS）奖学金主任。

'In my opinion, the Calibreye System was implanted using a familiar and established technique. I look forward to following these patients to observe the performance of the implant and the ability to adjust outflow, if needed, over time.'.

“我认为，Calibreye系统是使用熟悉和成熟的技术植入的。我期待着跟踪这些患者，观察植入物的表现以及随着时间的推移调整流出量的能力。

'This first-in-human experience marks an important milestone as Myra transitions to a clinical stage company,' stated Robert Chang, President and Chief Executive Officer of Myra Vision. 'I would like to thank the entire team for their seamless execution and our clinical advisors for their expertise in guiding these initial cases.

Myra Vision的总裁兼首席执行官Robert Chang说：“这是人类第一次经历，标志着Myra过渡到临床阶段公司的一个重要里程碑。”我要感谢整个团队的无缝执行和我们的临床顾问在指导这些初始病例方面的专业知识。

We look forward to gaining additional insights as we advance our goal of bringing personalized glaucoma care to the surgical armamentarium for patients with moderate to severe glaucoma.'.

我们期待着获得更多的见解，因为我们的目标是为中度至重度青光眼患者的手术设备提供个性化的青光眼护理。

Myra Vision and the Calibreye System will be highlighted as part of the company presentations beginning at 8:50 am CET on Thursday, September 7, 2023, during the Ophthalmology Futures European Forum in Vienna, Austria.

在2023年9月7日星期四上午8:50，奥地利维也纳眼科期货欧洲论坛期间，Myra Vision和Calibreye系统将作为公司演示文稿的一部分突出显示。

About Myra Vision, Inc. Myra Vision, a privately held portfolio company of Shifamed LLC, is developing a novel technology that is designed to allow safe outflow control to achieve maximum reduction of intraocular pressure (IOP) while also reducing complexity and complication rates. To learn more about Myra Vision, please visit www.myravision.com..

关于Myra Vision，Inc.Myra Vision是Shifamed LLC的私营投资组合公司，正在开发一项新技术，旨在实现安全的流出控制，实现眼压（IOP）的最大降低，同时降低复杂性和并发症发生率。要了解有关Myra Vision的更多信息，请访问www.myravision.com。。

About Shifamed, LLC. Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives.

关于Shifamed，LLC。由连续企业家Amr Salahieh创立，Shifamed LLC是一家高度专业化的医疗创新中心，致力于开发解决方案，加快上市时间，降低风险，增加影响力，并开辟通往患者能够走向世界的道路领导更长，更健康的生活。

To learn more about Shifamed, please visit www.shifamed.com..

要了解有关Shifamed的更多信息，请访问www.Shifamed.com。。

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1Market Scope 2019.

1市场范围2019。

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SOURCE Myra Vision, Inc.

资料来源Myra Vision，Inc。