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Advanced Development of Gemini-DHAP

Award Number: R44DK137702
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/25/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $944,944 )
2024	2024	SFC FLUIDICS, INC.	535 W RESEARCH CENTER BLVD	FAYETTEVILLE	AR	72701	WASHINGTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	6/28/2024	NON-COMPETING CONTINUATION	$944,944
2024	2023	SFC FLUIDICS, INC.	535 W RESEARCH CENTER BLVD	FAYETTEVILLE	AR	72701	WASHINGTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/13/2023	NEW	$0
														Subtotal = $944,944

Issue Date FY: 2023 ( Subtotal = $1,000,000 )
2023	2023	SFC FLUIDICS, INC.	535 W RESEARCH CENTER BLVD	FAYETTEVILLE	AR	72701	WASHINGTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/24/2023	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $1,944,944

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Advanced Development of Gemini-DHAP

Award Number: R44DK137702

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/25/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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