Tape Mechanical Occlusive Device (TMOD)

描述(由申请人提供)：此第二阶段SBIR建议的目的是在10名患者的第二阶段临床试验中优化压力性尿失禁患者的Tape机械闭塞装置(TMOD)的设计。在第一阶段SBIR研究中，通过台架测试、身体尺寸、定位和咬合测量以及动物植入物的测量，证明了该设备在人类中安全有效使用的可行性。拟议的人体研究将为10名受试者中的每一人提供评估和报告疗效和易用性的机会。在第二阶段临床试验结束时，我们预计进入第三阶段临床试验，以获得足够的TMOD设计经验，向食品和药物管理局提交上市前批准申请，允许该设备完全商业化。为进行这项试验而组建的团队在尿路植入物的开发和商业化方面拥有丰富的经验。该团队和顾问认为，与现有的用于管理男性尿失禁的植入式设备相比，这项技术提供了显著的竞争优势。目前，该市场的年销售额超过5000万美元，还可能有助于降低使用吸收产品管理患者的数十亿美元成本。 公共卫生相关性： Tape机械闭塞装置(TMOD)旨在为大约600万患有压力和混合性尿失禁的美国男性提供缓解。TMOD旨在提供比目前用于治疗压力性和混合性尿失禁的技术更多的功能和手术优势。

DESCRIPTION (provided by applicant): The purpose of this Phase II SBIR proposal is to optimize the design of the Tape Mechanical Occlusive Device (TMOD) in a 10 patient Phase II Clinical Trial in men with stress urinary incontinence. The feasibility for using this device in a safe and effective manner in humans was demonstrated by bench testing, cadaveric sizing, positioning and occlusion measurements and in animal implants in the Phase I SBIR study. The proposed human study will afford the opportunity to each of the 10 subjects to evaluate and report on efficacy and ease of use. At the conclusion of this Phase II Clinical Trial we anticipate entering into a Phase III Clinical Trial to gain sufficient experience with the TMOD design to submit a Pre- Market Approval Application to the Food and Drug Administration to permit full commercialization of this device. The team assembled to conduct this trial has extensive experience with the development and commercialization of urologic implants. The team and consultants believe that this technology offers significant competitive advantages over existing implantable devices for managing male urinary incontinence, a market that currently exceeds $50 million in annual sales and could also help reduce the multi-billion dollar cost of managing patients with absorbency products. PUBLIC HEALTH RELEVANCE: The Tape Mechanical Occlusive Device (TMOD) is intended to provide relief to an estimated 6 million US men suffering from stress and mixed urinary incontinence. The TMOD is intended to provide functional and surgical advantages over current technologies used for the treatment of stress and mixed urinary incontinence.