IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY PROSTHETIC SYSTEMS

摘要 主要的商业利益，iFIT Prosthetics LLC ®与STTR的资金，创造了一个新的经胫骨假体 设备并展示了其安全性、舒适性和功能。与传统的假肢相比， iFIT假肢可在单次手术中轻松安装并对准残肢。由于其巨大的 iFIT装置具有可调节性和定制内衬，是一种舒适的假体， 肢体体积变化。它由注塑成型的先进聚合物材料制成，可以以 与传统设备相比具有显著的成本优势。商业化准备试点（CRP） 计划拨款将在我们业务的关键时刻到来，因为我们准备加速大规模的 这种独特的假体的商业化。这笔资金将使我们能够开发流程， 制造程序完全符合向医疗保险和医疗补助中心销售的规定 服务（CMS），退伍军人事务部（VA）卫生系统，私人保险公司和假肢。我们将完成 生产设备的国际标准（ISO 10328）测试。我们将扩大和完善我们的业务 通过制造新的关节窝尺寸和形状，以适应更广泛的经胫骨和 经股截肢将进行一项为期两个月的前瞻性临床试验， iFIT假体与传统器械相比。为了提高市场的接受度，我们将改进内衬， 增强外插座外观。我们与先进设计概念（ADC）及其 工程团队在开发这种产品方面非常成功。ADC拥有制造 商业化生产iFIT假体的能力。iFIT Prosthetics正处于商业化的风口浪尖， 一种全新的假肢这款新型可调节的模块化和批量生产的特性 该设备为改善获得负担得起的假肢和提高生活质量带来了巨大的希望， 美国和国际上的下肢截肢者。

ABSTRACT The principal business interest, iFIT Prosthetics LLC ® with STTR funding, created a new transtibial prosthetic device and demonstrated its safety, comfort, and function. In contrast to conventionally made prosthetic limbs, the iFIT prosthesis is easily fit and aligned on the residual limb in a single session. Due to its substantial adjustability and customized inner liner, the iFIT device is a comfortable prosthesis that easily accommodates limb volume changes. Made of injection-molded, advanced polymer materials, it can be mass produced at a significant cost advantage compared to conventional devices. This Commercialization Readiness Pilot (CRP) program grant would come at a critical time for our business, as we are ready to accelerate large-scale commercialization for this unique prosthesis. This funding will allow us to develop processes and manufacturing procedures to fully comply with regulations for sales to the Centers for Medicare and Medicaid Services (CMS), the Veterans Affairs (VA) Health systems, private insurers, and prosthetists. We will complete international standards (ISO 10328) testing for the production devices. We will expand and refine our business capabilities by making new socket sizes and shapes to fit a broader range of patients with both transtibial and transfemoral limb loss. A prospective two-month clinical trial with 40 subjects will be conducted to compare the iFIT prosthesis to conventional devices. To enhance market acceptance, we will refine the inner liner and enhance the outer socket appearance. Our close collaboration with Advanced Design Concepts (ADC) and its engineering team has been highly successful in developing this product. ADC has the manufacturing capabilities to produce the iFIT prosthesis commercially. iFIT Prosthetics is on the cusp of commercializing a completely unique new type of prosthesis. The modular and mass produced nature of this new adjustable device holds great promise for improving access to affordable prosthetics and enhancing the quality of life for persons with lower limb amputations in the United States and internationally.