SFC FLUIDICS, INC. — Department of Health and Human Services SBIR Phase II: 200

Description

Development of a Low Profile Dual Hormone Patch Pumpwith Novel Occlusion Sensor Project SummaryThe Specific Aim of this project is to develop a discretelow profiledual hormone drug delivery system using SFC Fluidicsenabling microfluidic technologiesA DualPumpwill be developed in which one proprietary ePumpbody will independently and accurately deliver both insulin and glucagon from two separate reservoirsLatching safety valve sets will independently and safely control the delivery of each hormone and a dispense confirmation sensor will notify the user of any dosing errors resulting from occlusions or electrical mechanical failuresPhase II will see the integration of all components into an accuratediscretelow profile wearable podextensive benchtop testing and initial testing in swineThe end goal of Phase II is production of a DualPump module that has been introduced to the FDA and is ready to be integrated with all other components required for a dual hormone artificial pancreasDuring Phase IIBSFC Fluidics will work with manufacturers of continuous glucose monitorscontrol algorithms and stable drug formulations to develop an FDA approvedrobustand reliable dual hormone artificial pancreas Project NarrativeThe proposed DualPump APTM system will improve glycemic control as compared to an insulin only Artificial Pancreas by providing the ability to correct a hypoglycemic conditionThe DualPump AP will have the necessary safety features and low dose precision to meet the need for insulin and glucagon delivery for people with Typediabetesespecially childrenadolescentsand individuals that are hypoglycemic unaware