Tape Mechanical Occlusive Device (TMOD)

描述（由申请人提供）：本II期SBIR提案的目的是在10例压力性尿失禁男性患者的II期临床试验中优化胶带机械封堵器（TMOD）的设计。通过台架试验、尸体尺寸测量、定位和闭塞测量以及I期SBIR研究中的动物植入物，证明了在人体中安全有效地使用该器械的可行性。拟定的人体研究将为10名受试者提供评价和报告疗效和易用性的机会。在本II期临床试验结束时，我们预计将进入III期临床试验，以获得TMOD设计的足够经验，从而向美国食品药品监督管理局提交上市前批准申请，以允许该器械完全商业化。进行本试验的团队在泌尿外科植入物的开发和商业化方面具有丰富的经验。该团队和顾问认为，这项技术与现有的用于管理男性尿失禁的植入式设备相比具有显着的竞争优势，该市场目前的年销售额超过5000万美元，并且还可以帮助减少使用吸收性产品管理患者的数十亿美元成本。 公共卫生相关性： TMOD旨在为估计600万患有压力性和混合性尿失禁的美国男性提供缓解。与目前用于治疗压力性和混合性尿失禁的技术相比，TMOD旨在提供功能和手术优势。

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.