Phase IIB: Exploratory Clinical trials for The V Needle

血液透析(HD)通常被认为是一种安全、良性的程序。但如果在透析过程中发生静脉针移位(VND)，而机器未能检测到它，几分钟内失血可能是灾难性的，甚至是致命的。据估计，在美国，每周有400名透析患者发生脱臼事件。[3]Hemotek Medical Inc.与我们的临床和医疗设备合作伙伴建立了第一阶段/第二阶段SBIR合作伙伴关系，设计、开发、制造了V-Needle，这是世界上第一个也是唯一一个廉价、针头集成、一次性使用的AV瘘管组，将保护患者免受针头拔出时出血的危险。革命性的V针看起来和感觉上都像传统用于血液透析的标准蝴蝶针，但包括一个独特的“皮肤感应”弹簧加载踏板元件，可以立即检测针头脱出并快速阻断通过针头的流动，极大地限制了取出过程中的失血，并启动了血液透析机泵的关键生命自动关闭程序。它填补了目前尚未满足的有效保护患者免受VND危险的临床需求。FDA规定，Hemotek V针头的510(K)申请必须包括人体临床试验数据，以验证新的VND声称。在这个IIB阶段项目中，Hemotek建议与一家行业领先的透析临床试验提供商和一家全球领先的针头制造商合作，在中心进行所要求的试验。这里提出的多点中心内试验的结果将用于吸引战略投资者，以便在以后通知和支持更困难的家庭/夜间临床试验。该项目的目标是。目标#1：临床样本的制造和验证目标#2：临床研究I：第一人可行性试验目标#3：临床研究II：验证性临床试验(25名患者)创新：Hemotek的510(K)批准的V-Needle将是透析市场上最具创新性的一次性设备之一。与健康相关：在VND发生期间，使用V-Needle自动关闭HD机器，预计将减少与患者受伤或死亡相关的重大和严重事件的频率。商业相关性：通过与世界血液透析领先者合作，Hemotek确保V-Needle最终实现商业化的最大知名度。

Hemodialysis (HD) is generally perceived as a safe, benign, procedure. But if venous needle dislodgement (VND) occurs during dialysis and the machine fails to detect it, within minutes the blood loss can be catastrophic, and even fatal. It is estimated that 400 dialysis patients suffer a dislodgement episode every week in the US. [3] In a Phase I/Phase II SBIR partnership with our clinical and medical device partners, Hemotek Medical Inc. has designed, developed, manufactured and characterized the V-Needle, the world’s first and only, inexpensive, needle-integrated, single-use AV fistula set that will protect patients from the dangers of bleed-out during needle dislodgement. The revolutionary V Needle looks and feels like a standard butterfly needle traditionally used for hemodialysis but includes a unique “skin-sensing” spring-loaded footplate element that can both immediately detect when a needle has dislodged and quickly occlude flow through the needle, dramatically limiting blood loss during dislodgment and initiating a life-saving critical automatic shut-off routine for the hemodialysis machine pump. It fills a currently unmet clinical need of efficiently protecting patients from the dangers of VND. The FDA has stipulated that a 510(k) application for the Hemotek V Needle must include human clinical trial data to validate the novel VND claims. In this Phase IIB project Hemotek proposes to partner with an industry-leading dialysis clinical trial provider and a leading worldwide needle manufacturer to perform the requested trial in-center. Results from the multi-site in-center trial proposed here will be used to attract strategic investors to inform and support more difficult, in-home/nocturnal clinical trials at a later date. The project aims are. Aim #1: Manufacture and Verification of Clinical Samples Aim #2: Clinical Study I: First-in-Man Feasibility Trial Aim #3: Clinical Study II: Confirmatory Clinical Trial (25 patients) Innovation: Hemotek’s 510(k)-approved V-Needle will be one of the most innovative disposable devices in the dialysis market place. Health Relevance: Automated shut off of HD machines during a VND occurrence using the V-Needle is expected to reduce the frequency of significant and serious events related to patient injury or death. Commercial Relevance: By partnering with world hemodialysis leaders, Hemotek ensures that the V-Needle will have maximum visibility for eventual commercialization.