# Advanced Development of Gemini-DHAP

> **NIH NIH R44** · SFC FLUIDICS, LLC · 2024 · $944,944

## Abstract

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.

## Key facts

- **NIH application ID:** 10892876
- **Project number:** 5R44DK137702-02
- **Recipient organization:** SFC FLUIDICS, LLC
- **Principal Investigator:** Forrest Payne
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $944,944
- **Award type:** 5
- **Project period:** 2023-07-25 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10892876

## Citation

> US National Institutes of Health, RePORTER application 10892876, Advanced Development of Gemini-DHAP (5R44DK137702-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10892876. Licensed CC0.

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