IMMEDIATE FIT USING INNOVATIVE TECHNOLOGY PROSTHETIC SYSTEMS

摘要 主要的商业利益，iFit Prosthetics LLC®，由STTR资助，创造了一种新的经胫骨假体 并展示了它的安全性、舒适性和功能性。与传统制造假体形成对比 对于残肢，iFit假体可以很容易地安装并在一次治疗中对齐残肢。由于它的实质性 IFit装置具有可调性和定制的内衬，是一种舒适的假体，很容易容纳 四肢体积改变。它由注塑成型的先进聚合物材料制成，可以一次批量生产 与传统设备相比，具有显著的成本优势。此商业化就绪性试点(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 这种独一无二的假肢的商业化。这笔资金将使我们能够开发流程和 生产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)健康系统、私营保险公司和假肢医生。我们将完成 生产设备的国际标准(国际标准化组织10328)测试。我们将扩大和完善我们的业务 通过制造新的插座尺寸和形状来满足更广泛的经胫骨和胫骨骨折患者的需求 经股动脉的肢体丧失。将对40名受试者进行为期两个月的前瞻性临床试验，以进行比较 IFit假体与传统设备相比。为了提高市场认可度，我们将改进内衬，并 增强外部插座的外观。我们与先进设计概念公司(ADC)及其 工程团队在开发该产品方面取得了巨大的成功。ADC拥有制造 商业生产iFit假体的能力。IFit假体即将实现商业化 完全独特的新型假体。模块化和批量生产的性质，这一新的可调式 该设备有望改善人们获得负担得起的假肢的机会，并提高患者的生活质量 在美国和国际上有下肢截肢的人。

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.