Advanced Development of Gemini-DHAP

GeminiTM-Dhap的高级开发 项目总结： 这个直接到第二阶段的项目的具体目标是开发一个离散的、低调的、双重的 荷尔蒙人工胰腺装置GeminiTM-Dhap，采用SFC Fluidics 微流控技术可同时输送双激素推荐的胰岛素和胰高血糖素 算法响应连续的血糖监测仪读数。双子座的吊舱使用的是一个 拥有专利的DualPumpTM Body可独立准确地提供胰岛素和胰升糖素 来自两个不同的水库。安全阀独立设置，安全控制输送 每种激素，并且分配确认传感器通知用户由此产生的任何剂量错误 闭塞或电气/机械故障。第二阶段将侧重于优化和设计 冷冻双子舱，然后将双子舱与CGM和双激素整合 算法应用于DHAP系统，并进行了大量的台式和动物模型测试。该项目将 最终提交一份IDE，为未来的临床试验做准备。贯穿整个项目 证监会将与其大学分包商、已建立的医疗、监管和 制造顾问、符合GMP的吊舱部件制造合作伙伴和食品 和药品监督管理局简化双子座-DHAP的商业化。到年底的时候 第二阶段，SFC Fluidics将处于有利地位，筹集所需的额外资金，以便早日- 阶段性临床试验和随后的关键试验，以获得PMA-Gemini-Dhap的批准。 该项目是对美国国家糖尿病消化肾脏研究所的直接响应 糖尿病、内分泌学和代谢性疾病科 改进的胰岛素和其他胰腺激素输送装置和方法“，尤其是 与2023年相关，因为贫穷导致的Covid 19和其他感染的风险增加 血糖控制。

Advanced Development of GeminiTM-DHAP Project Summary: The Specific Aim of this Direct to Phase II project is to develop a discrete, low-profile, dual hormone artificial pancreas device, the GeminiTM-DHAP, using SFC Fluidics' enabling microfluidic technologies to deliver both insulin and glucagon as recommended by a dual-hormone algorithm in response to continuous glucose monitor readings. The Gemini pod uses one proprietary DualPumpTM body to independently and accurately deliver both insulin and glucagon from two separate reservoirs. Safety valve sets independently and safely control the delivery of each hormone, and a dispense confirmation sensor notifies the user of any dosing errors resulting from occlusions or electrical/mechanical failures. Phase II will focus on optimization and design freeze of the Gemini pod followed by integration of the Gemini pod with a CGM and dual-hormone algorithm into a DHAP system and extensive benchtop and animal model testing. The project will culminate with an IDE submission in preparation for future clinical trials. Throughout the project SFC will collaborate with its university subcontractors, established medical, regulatory and manufacturing consultants, GMP-compliant pod component manufacturing partner, and the Food and Drug Administration to streamline commercialization of the Gemini-DHAP. By the end of Phase II, SFC Fluidics will be well positioned to raise the additional funding necessary for early- stage clinical trials and subsequent pivotal trials to obtain PMA-approval of the Gemini-DHAP. This project is in direct response to the National Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases for “development of improved insulin and other pancreatic hormone delivery devices and methods” and is particularly relevant in 2023 due to the increased risk for Covid 19 and other infections that results from poor glycemic control.