OAKLAND, Calif. and TAMPA, Fla., March 6, 2024 /PRNewswire/ -- Koya Medical, today announces topline results from its TEAYS trial. TEAYS (NCT05507346) is a prospective multi-center, randomized cross-over study comparing lower extremity lymphedema treatment effectiveness of Dayspring®, Koya's non-pneumatic compression device (NPCD) with a traditional advanced pneumatic compression device (APCD)..

加利福尼亚州奥克兰市和佛罗里达州坦帕市，2024年3月6日/PRNewswire/--Koya Medical，今天宣布TEAYS试验的topline结果。TEAYS（NCT05507346）是一项前瞻性多中心随机交叉研究，比较了Koya非气动加压装置（NPCD）Dayspring®与传统先进气动加压装置（APCD）治疗下肢淋巴水肿的效果。。

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Dayspring by Koya Medical

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The study met its primary endpoints, achieving statistically significant differences in limb volume reduction, improvement of quality of life, and treatment adherence, all favoring the Dayspring treatment arm over the APCD treatment arm. In limb volume reduction, the Dayspring arm achieved a mean reduction of 369.9mL from baseline compared to that of 83.1mL for the APCD arm.

该研究达到了其主要终点，在肢体体积减少，生活质量改善和治疗依从性方面取得了统计学上的显着差异，所有这些都有利于Dayspring治疗组而不是APCD治疗组。在肢体体积减少方面，Dayspring臂从基线平均减少369.9mL，而APCD臂平均减少83.1mL。

In quality of life, the Dayspring arm achieved 1.01 point improvement on the LYMQOL survey compared to 0.17 point improvement for APCD. In treatment adherence, rate of adherence was reported to be 81% for the Dayspring arm compared with 56% for the APCD. No adverse events were related to either treatment arm..

在生活质量方面，Dayspring arm在LYMQOL调查中获得了1.01分的改善，而APCD则获得了0.17分的改善。在治疗依从性方面，据报道Dayspring组的依从率为81%，而APCD的依从率为56%。两个治疗组均无不良事件。。

Full study results are not yet available. 'Koya is committed to continuing its innovation in this disease space. We are pleased with these topline results and will be conducting sub-analyses of the full data set,' said Thomas Maldonado, MD, Chief Medical Officer. The latest TEAYS trial results add to the growing body of evidence for Dayspring, which has had 7 prior publications to date.

目前还没有完整的研究结果。”Koya致力于在这一疾病领域继续创新。首席医疗官、医学博士托马斯·马尔多纳多（ThomasMaldonado）说，我们对这些最终结果感到满意，并将对整个数据集进行子分析。最新的TEAYS试验结果为Dayspring增加了越来越多的证据，Dayspring迄今已有7篇先前的出版物。

In 2021, Koya Medical became the first company to receive FDA clearance for its non-pneumatic active compression system Dayspring, which provides patients with gradient sequential compression, mobility and ambulation during treatment..

2021年，Koya Medical成为第一家获得FDA批准的非气动主动压缩系统Dayspring公司，该系统为患者在治疗期间提供梯度顺序压缩，活动和行走。。

About LymphedemaAn estimated 20 million Americans live with lymphedema, a progressive, incurable condition where a buildup of protein rich fluid causes painful swelling in the arm, leg, and/or other regions of the body. For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain.

大约有2000万美国人患有淋巴水肿，这是一种进行性的不可治愈的疾病，富含蛋白质的液体积聚会导致手臂，腿部和/或身体其他部位疼痛肿胀。对于大多数人来说，淋巴水肿需要终身维持和各种程度的治疗来控制肿胀和疼痛。

Lymphedema can result from a variety of factors, including cancer, chronic venous disease, infection, and surgery. About DayspringThe Dayspring compression system, available for upper and lower extremity care, is a non-pneumatic treatment that integrates compression, muscle pump activation, and mobility in one easy-to-use solution.

淋巴水肿可能由多种因素引起，包括癌症，慢性静脉疾病，感染和手术。关于Dayspring Dayspring压缩系统可用于上肢和下肢护理，是一种非气动治疗方法，将压缩，肌肉泵激活和移动性集成在一个易于使用的解决方案中。

The Dayspring system includes a low-profile active garment made of soft, breathable mesh using proprietary Flexframe® technology; a rechargeable controller that can be worn on a lanyard; and a mobile app.Dayspring is indicated to treat lymphedema, primary lymphedema, post mastectomy edema, edema following trauma and sports injuries, post immobilization edema, venous insufficiency, venous stasis ulcers, or arterial and diabetic leg ulcers, lipedema and phlebolymphedema and other similar conditions that impact lymphatic flow in the upper and lower extremities.

Dayspring系统包括一件轻薄的活动服装，采用专有的Flexframe®技术，由柔软透气的网眼布制成；可充电控制器，可佩戴在系索上；和一个移动应用程序。Dayspring适用于治疗淋巴水肿，原发性淋巴水肿，乳房切除术后水肿，创伤和运动损伤后水肿，固定后水肿，静脉功能不全，静脉淤滞溃疡或动脉和糖尿病腿溃疡，脂水肿和静脉水肿以及其他影响上下肢淋巴流动的类似病症。

Dayspring is also indicated to reduce wound healing time and treatment and assist in healing stasis dermatitis.About Koya MedicalKoya Medical, a privately held company founded in 2018, is a transformative healthcare company developing breakthrough treatments for venous diseases and lymphedema and personalized care that is unavailable with traditional treatments.Visit Koya Medical www.koyamedical.comLinkedIn at www.linkedin.com/company/koyamedical/SOURCE Koya Medical.

Dayspring还可以减少伤口愈合时间和治疗，并有助于治愈淤滞性皮炎。关于Koya MedicalKoya Medical，一家成立于2018年的私营公司，是一家变革性的医疗保健公司，开发静脉疾病和淋巴水肿的突破性治疗以及传统治疗无法提供的个性化护理。访问Koya Medical www.koyamedical.comLinkedIn，网址为www.linkedin.com/company/koyamedical/SOURCE Koya Medical。