Advanced Development of Gemini-DHAP

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.