Endoscopy-assisted intracochlear access via ultrasharp-microneedles

项目总结/摘要 到2050年，全球将有多达25亿人患有听力损失或平衡障碍， 内耳中有潜在原因的部分。这包括由于年龄、噪音和药物导致的听力损失 以及各种平衡障碍，这些疾病总共折磨着大约三分之一的人， 65和751。目前不可能无创伤地医疗进入内耳，进行诊断和 耳蜗听力和平衡障碍的治疗不精确，依赖于排除其他潜在的 可使. Haystack Medical，Inc.正在开发技术，为临床医生提供安全，直接进入 用于诊断目的的内耳。该产品被称为内窥镜辅助介入治疗， Ultrasharp-micronEedles（EarCure）。创始团队一直在共同努力解决这个问题， 跨学科的研究小组出了哥伦比亚大学在过去的十年。在这段时间里， 撰写了12篇期刊文章，并申请了11项专利，其中2项已获得批准，9项正在申请中。的 该团队发明并开发了精密微针技术，并进行了安全性研究， 通过精致的圆窗膜到达内耳。他们现在正在把这个工具变成一个设备 它提供了常规的，安全的内耳通道，以获得有价值的诊断数据。 Haystack Medical设想该产品将成为一种常规工具，用于诊断 听力损失和平衡障碍的根本原因，并帮助制定最佳课程或精确治疗， 患者为此，在STTR第一阶段项目中，EarCure将用于进入人的内耳 尸体的颞骨，只穿过鼓膜，形成一个像耳管一样小的洞 快速愈合。此外，EarCure将用于从内耳内抽取1微升液体， 足以用于诊断目的，因此证明了该设备的可行性。 在计划的项目第二阶段，该团队预计将进入临床试验，并开始翻译 这是一种接触患者的工具。EarCure的潜在市场包括所有患有听力疾病的患者 和/或平衡障碍，其根源在内耳。 仅在美国，诊断听力和平衡障碍的市场规模就超过50亿美元， 因为内耳症状而寻求治疗的人数。Haystack希望该设备能够 通过医院销售，并作为其他一次性医疗器械报销。该公司预计将 寻求微针和驱动装置的510（k）许可，如果FDA认为 该器械与同品种器械存在显著差异。

PROJECT SUMMARY / ABSTRACT Up to 2.5 billion people worldwide will suffer from hearing loss or balance disorders by 2050, with a significant portion having underlying causes in the inner ear. This includes hearing loss due to age, noise and medications as well as various balance disorders, which in total afflicts approximately one in three people between the ages of 65 and 751. Atraumatic medical access into the inner ear is presently not possible, making diagnosis and treatment of cochlear-based hearing and balance disorders imprecise, relying on exclusion of other potential causes. Haystack Medical, Inc. is developing technology to provide clinicians with safe, direct access into the inner ear for diagnostic purposes. The product is called Endoscopy-Assisted intRacochlear aCcess via Ultrasharp-micRonEedles (EarCure). The founding team has been working together on this problem as an interdisciplinary research group out of Columbia University for the past decade. In this time, they have authored 12 journal articles and applied for 11 patents, 2 of which have been granted and 9 are pending. The team has invented and developed precision microneedle technology and carried out safety studies where they reach the inner ear through the delicate round window membrane. They are now turning this tool into a device that provides routine, safe access to the inner ear for valuable diagnostic data. Haystack Medical envisions this product to become a routine tool that will be used to diagnose the underlying cause of hearing loss and balance disorders, and help craft the best course or precise treatment for patients. For this purpose, in this STTR Phase I project, EarCure will be used to access the inner ear of human cadaveric temporal bones, only going through the tympanic membrane, making a hole as small as an ear tube for rapid healing. Furthermore, EarCure will be used to draw 1 µL amount of fluid from inside the inner ear, enough for diagnostic purposes, therefore demonstrating feasibility of the device. In the planned Phase II of the project, the team expects to enter clinical trials and begin translation of the tool to reach patients. The potential market for EarCure consists of all patients suffering from hearing and/or balance disorders with root causes in the inner ear. In the US alone, the market size for diagnosing hearing and balance disorders is greater than $5B, due to the number of people who seek treatment because of inner ear symptoms. Haystack intends the device to be sold through hospitals and reimbursed as other disposable medical devices. The company expects to pursue 510(k) clearance of the microneedle and actuation device, and will pursue a PMA if the FDA considers this device to be significantly different from predicates.