SFC Fluidics Inc. Receives $2 Million SBIR Grant to Develop Groundbreaking Dual Hormone System for Diabetes Care

Next Generation Closed Loop System Designed for Broader Type I Diabetes Patient Population

Fayetteville, AR - SFC Fluidics Inc., a medical device company focusing on drug delivery for treatment of Type 1 Diabetes, is pleased to announce that it has been awarded a $2 million Small Business Innovation Research (SBIR) Phase II grant to support advanced development of SFC’s wearable Gemini™ Dual Hormone Artificial Pancreas Pod (Gemini-DHAP). The SBIR grant awarded to SFC Fluidics represents a significant milestone in the development of their dual hormone system as it will enable SFC Fluidics to obtain an IDE for the Insulin and Glucagon delivery system, which will allow SFC to begin clinical trials to support FDA approval.

To address the prevalence of hypoglycemia in T1D management, SFC Fluidics is pioneering the development of a wearable dual-hormone hybrid closed-loop system, which incorporates the glucose-elevating hormone, glucagon, in addition to the glucose lowering hormone, insulin. Although dual-hormone systems are not currently available commercially, research trials have demonstrated that dual-hormone closed-loop treatments are superior to insulin-only treatments in reducing time below range. The Gemini-DHAP will be especially important for patients living with Type 1 diabetes who are hypoglycemic unaware, including adolescents, and for patients who wish to exercise, but don’t out of a fear of hypoglycemia.  

The Gemini Pod, the latest innovation from SFC Fluidics, builds upon the success of SFC’s Panda Pod, which received a Breakthrough Device Designation (BDD) from the FDA. Leveraging the same enabling patented and patent-pending technologies, the Gemini-DHAP will offer improved accuracy over commercially available pumps and instantaneous delivery confirmation, which will mitigate the dangers of silent occlusions. It will control blood sugar using automated insulin delivery, but the Gemini-DHAP will be uniquely able to avoid or correct a low blood sugar event by automatically dispensing glucagon in response to blood glucose trends.

SFC Fluidics remains committed to pushing the boundaries of drug delivery and health monitoring, with a firm belief that their dual hormone system will revolutionize diabetes care and improve the lives of individuals managing T1D.

About SFC Fluidics, Inc.

With a mission to advance healthcare and enhance the quality of life, SFC Fluidics aims to become a recognized global leader in the drug delivery and health monitoring markets. The company's vision is to introduce unique product lines that improve lifestyle and affordability, ultimately transforming the way chronic diseases such as diabetes are managed. To learn more visit sfc-fluidics.com

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Diabeloop SA. and SFC Fluidics Inc. announce development agreement for the United States

SFC Fluidics Inc., developer of an Alternate Controller Enabled (ACE) insulin delivery pod and Diabeloop, pioneer in therapeutic artificial intelligence, are partnering to integrate the SFC ACE insulin pod into Diabeloop’s Automated Insulin Delivery (AID) solution. The agreement includes a full US-adaptation of the system.

A common mission: bring the next generation of diabetes management to patients with type 1 diabetes in the United States.

Fayetteville, AR- Diabeloop is developing interoperable solutions, based on a proprietary self-learning algorithm,  
for diabetes management. Both DBLG1​®​, their first product, and DBL-hu (for highly unstable Type 1  diabetes) have received CE-marking and will be deployed in Europe in 2021. 

The technology developed by Diabeloop - an algorithm hosted in a dedicated handset – wirelessly  communicates with a continuous glucose monitoring device (CGM) and an insulin pump in an AID (closed-loop) system. Diabeloop’s artificial intelligence analyzes glucose data, calculates the proper  dose of insulin to be administered and instructs the pump to deliver it, thus automating the treatment. 

he agreement signed today covers the development of a system integrating the SFC insulin pump as  an Alternate Controller-Enabled​1​ (ACE) insulin pump.  

SFC’s ACE insulin delivery pod (“Panda™”) is intended for the subcutaneous delivery of insulin at set  and variable rates for the management of diabetes mellitus in persons requiring insulin. Its advanced  microfluidic pumping system (ePump®) is designed to provide accurate delivery of extremely small doses of insulin without the resolution limits inherent in other commercially-available delivery devices. SFC believes its technology will effectively eliminate​ 95% of over and under dispenses of insulin.  SFC’s proprietary Dispense Confirmation Sensor (DCS™) represents a differentiating technology that  can detect flow or no flow conditions of insulin in real-time. The DCS will quickly signal a lack of  dispense for any reason. SFC received the US Food and Drug Administration’s breakthrough device designation for its Panda™ insulin delivery pod on November 5, 2020. 

“We are encouraged that our relationship with Diabeloop continues to progress towards a meaningful  goal of a marketed artificial pancreas in the US”​, commented ​Don Jackson, CFO of SFC​. 

A fully integrated AID system tailored to the US market.

Diabeloop and SFC Fluidics share the vision of advancing diabetes therapy for patients through state-of-the-art technologies and a fully automated approach. SFC Fluidics and Diabeloop continue their relationship, which started with a project initially funded by  the JDRF.  

“JDRF is committed to improving the lives of people with type 1 diabetes by supporting innovations in  diabetes treatments. We are excited to see the partnership between Diabeloop and SFC Fluidics  continue to flourish and look forward to the development of a novel artificial pancreas system that can  improve the health and quality of life of people living with T1D​”,​ said ​Jonathan Rosen​, Ph.D., Associate  Director of Research at JDRF. 

SFC would also like to acknowledge the National Institutes of Health, including the National Institute of Diabetes and Digestive and Kidney Diseases, for help in funding the development of various  aspects of the ACE pod​​.  

The new agreement includes the adaptation of Diabeloop’s algorithm and data visualization platform  YourLoops™, the integration of the SFC ACE insulin pump,​ as well as the application for regulatory approval and the conduct of non-clinical and clinical trials, all following US Food and Drug Administration regulations​​. 

“We are delighted to reinforce our collaboration with this strong partner. The conclusion of this  agreement with SFC Fluidics, Inc. is a real mutual achievement, and for Diabeloop it is an additional opportunity to enter the US market ​”,​ commented ​Marc Julien, co-CEO of Diabeloop​.  

About Diabeloop

Diabeloop’s mission: to relieve people living with Type 1 diabetes from dozens of therapeutic decisions and  reduce their heavy mental burden. Initially conceived from a medical research project, Diabeloop was created in 2015 by Dr. Guillaume Charpentier, now Chief Medical Officer, and Erik Huneker who has co-managed the  company with Marc Julien since 2016. This complementary management team works with experienced  partners, CEA-Leti (a research laboratory) and CERITD (a French research team of diabetologists).  

In 2018, DBLG1​®​ System, Diabeloop’s first medical device for automated diabetes management, obtained CE  marking, followed by DBL-hu, its solution for highly unstable Type 1 diabetes management in 2020.  

A second round of financing of 31 million euros concluded in November 2019 to speed up the international  commercial rollout of the DBLG1​®​ iController and support an ambitious R&D program.  

Today, Diabeloop gathers the personality, the passion and the skills of close to 100 talented individuals who  work hard to improve the quality of life for every person living with Type 1 diabetes.  

About SFC Fluidics, Inc.

SFC Fluidics, Inc. has a mission to advance healthcare and improve quality of life through our enabling  microfluidic technologies. The company’s vision is to become a recognized global leader in drug delivery, with a  focus on insulin, where our unique product lines improve lifestyle and affordability. SFC Fluidics​® is a VIC Technology Venture Development™ portfolio company. For more information, please visit sfc-fluidics.com

SFC Fluidics, Inc. Receives FDA Breakthrough Device Designation

FDA’s BDD program targets novel devices with the potential to provide patients with a more effective treatment for life-threatening or irreversibly debilitating diseases. SFC’s insulin pod promises to substantially improve the lives of patients with diabetes.

FAYETTEVILLE, ARK. (PRWEB) DECEMBER 01, 2020

SFC Fluidics, Inc. (SFC) is pleased to announce that its interoperable insulin delivery pod (the PandaTM), in late-stage development, has been granted Breakthrough Device Designation (BDD) by the Food and Drug Administration (FDA). The interoperable insulin delivery pod is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. SFC’s pod and its indications for use met several criteria designated by the BDD Program, including the promise of providing more effective treatment and offering significant advantages over existing approved or cleared alternatives.

SFC’s advanced microfluidic pumping system (ePump®) is designed to provide accurate delivery of extremely small doses of insulin without the resolution limits inherent in other commercially-available delivery devices. SFC believes its technology will effectively eliminate 95% of over and under dispenses of insulin.

SFC’s proprietary Dispense Confirmation Sensor (DCS™) represents a differentiating technology that can detect flow or no flow conditions of insulin in real-time. The DCS will quickly signal a lack of dispense for any reason. Currently available insulin pumps struggle with occlusion detection, especially at low doses. Some insulin pump systems cannot identify an occlusion for 20 hours or more, a very dangerous condition for patients. The DCS technology can detect an occlusion in six minutes or less.

Improved accuracy, precision, and resolution of dosing along with real-time confirmation of insulin delivery will allow dosing schemes and alert/alarm settings to be customized by a physician for each patient.

Barry Ginsberg, MD, PhD, Consulting Medical Director for SFC Fluidics stated, “This pod is truly a breakthrough in its safety, immediately detecting the common blockages to pump flow and preventing traumatic insulin overdosing. It also provides exceptional dose accuracy. As we progress to the next level of integrated diabetes care, these features will allow improved therapy of diabetes, resulting in better blood glucose control and fewer diabetes complications.”

“SFC is honored to receive the Breakthrough Device Designation. Being recognized by the FDA as the developer of a potentially game-changing device demonstrates promise for the future of our company’s role in improving diabetes therapy,” added Anthony Cruz, CEO of SFC Fluidics.

This work was supported in part by funding from JDRF, the leading global organization funding type 1 diabetes research.

SFC would also like to acknowledge the National Institutes of Health, including the National Institute of Diabetes and Digestive and Kidney Diseases, for help in funding various aspects of product development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About SFC Fluidics, Inc.    
SFC Fluidics, Inc. has a mission to advance healthcare and improve quality of life through our enabling microfluidic technologies. The company’s vision is to become a recognized global leader in drug delivery, with a focus on insulin, where our unique product lines improve lifestyle and affordability. SFC Fluidics® is a VIC Technology Venture Development™ portfolio company. For more information, please visit https://www.sfc-fluidics.com/ or follow us on Twitter: @sfcfluidics.

SFC Fluidics® Partners with PercuSense and Diabeloop to Improve Diabetes Care

JDRF funding will advance integration of an insulin delivery pump with a continuous glucose monitor and a control algorithm into a single pod artificial pancreas.

FAYETTEVILLE, AR – SFC Fluidics, Inc. (SFC) has partnered with two companies, Diabeloop SA and PercuSense, Inc., as part of the Industry Development and Discovery Partnership that was awarded to SFC Fluidics in 2018 by JDRF.

JDRF is sponsoring this project for the development of a single integrated pod artificial pancreas (AP) system for people with type 1 diabetes (T1D). By accelerating the development of a next-generation miniaturized and user-friendly AP system, JDRF will further its goal of reducing the daily burden for people with T1D while improving their overall health outcomes. State-of-the-art AP systems such as this are especially important for children and young adults with T1D who want to achieve better outcomes while living as normal a lifestyle as possible.

The AP system currently under development will consist of an insulin pump and continuous glucose monitor (CGM) that are housed in a single on-body pod. The pod will be controlled wirelessly via a proprietary closed-loop algorithm running on a handheld device. For the past year, SFC has focused on the optimization of its proprietary insulin pumping technology and platform. The key features of SFC’s insulin pump include best-in-class accuracy and precision at very small dose volumes, a two-valve safety system, and a dispense confirmation sensor. PercuSense will contribute its cutting edge CGM that features calibration-free glucose detection. PercuSense is dedicated to the development of a simple inserter and low-cost manufacturing. Diabeloop, a pioneer in diabetes management, will contribute a machine-learning control algorithm to automate insulin delivery.

“We are very excited to work with excellent technical and business partners such as PercuSense and Diabeloop. We look forward to the challenge and opportunity of creating a fully automated, miniaturized, integrated AP system for patients with diabetes. Our system will simplify and improve efforts to enhance glycemic control and free people with T1D to lead a more active and carefree lifestyle,” said Tony Cruz, CEO of SFC Fluidics, “SFC Fluidics is grateful for the opportunity granted by this collaborative funding from JDRF.”

“Our mission at Diabeloop is to bring innovation to families affected by diabetes. Therefore, we are delighted to be part of this highly promising technological project and equally honored by JRDF support,” commented Marc Julien, co-CEO of Diabeloop.

“We are very happy to see SFC making progress and establishing the partnerships necessary to make these next-gen automated insulin delivery systems a reality. By teaming up with leaders in the fields of continuous glucose sensing and insulin delivery algorithms such as PercuSense and Diabeloop, SFC is laying a solid foundation to maximize their chances of success and ensure high performance of these products,” said Jaime Giraldo, Scientist at JDRF.

About SFC Fluidics, Inc.      
SFC Fluidics, Inc. has a mission to advance healthcare and improve quality of life through our enabling microfluidic technologies. The company’s vision is to become a recognized global leader in drug delivery, with a focus on insulin, where our unique product lines improve lifestyle and affordability. SFC Fluidics® is a VIC Technology Venture Development™ portfolio company. For more information, please visit sfc-fluidics.com or follow us on Twitter: @sfcfluidics.

About Diabeloop SA
Diabeloop is a young company developing disruptive technological innovations to automate the treatment of T1D. Created in 2015 in Grenoble by Erik Huneker and Dr. Charpentier, Diabeloop and CEA-Leti work within a joint research laboratory to accelerate product development. The company is co-managed by Marc Julien and Erik Huneker and employs approximately 50 people. Diabeloop received first round funding of 13.5 million Euros in 2017 and second round funding is ongoing. For more information, please visit diabeloop.com.

About PercuSense
PercuSense is focused on developing next generation continuous sensing platforms that enable prediction, intervention, and prevention in chronic diseases and acute conditions including diabetes management and in-hospital monitoring. PercuSense’s unique technology enables low cost, glucose plus multi-analyte sensing to bring affordable and actionable continuous monitoring to the market while greatly improving usability through its integration into a single sensing and delivery site. For more information, please visit percusense.com.

About JDRF
JDRF is the leading international nonprofit fighting to cure T1D while also helping those with T1D live healthy lives today. Supported by hundreds of thousands of donors, JDRF raises, invests and drives more funds to T1D research than any organization in the world. As a result, JDRF has played a key role in major T1D advances – drug, device, cell research – that have improved lives and brought us closer to our ultimate goal of a cure. JDRF is mission-driven and serves as an aggressive advocate and educational support for the T1D community. JDRF has staff and volunteers across the United States, has five international affiliates, funds research in more than 20 countries and supports insulin-aid efforts in the U.S. and around the world. Visit jdrf.org to learn more.

SFC Fluidics, Inc. Receives SBIR Phase II Funding to Develop a Dual Hormone Patch Pump for Patients with Diabetes

Miniaturized system will allow accurate insulin and glucagon dosing in a discreet, low profile patch pump for patients with Type 1 diabetes.

FAYETTEVILLE, Ark. – September 20th, 2018 – SFC Fluidics® is pleased to announce that it has been awarded a $1.4 million grant to support development of a dual hormone patch pump for patients with diabetes.

There are 4 million insulin-dependent Type 1 diabetics worldwide and this number is expected to increase over time. The challenges of maintaining proper glycemic control are particularly difficult for young patients who understandably dislike the multiple needle sticks required for measuring blood glucose levels and delivering the appropriate doses of insulin or glucagon. SFC’s proposed patch pump system will have the necessary safety features and dose accuracy to allow automated insulin and glucagon dosing to achieve fine-tuned glycemic control in patients with Type 1 diabetes.

SFC Fluidics’ proprietary ePump® system can control the delivery of both insulin and glucagon in a discreet patch pump that is the same size as the insulin-only patch pumps currently on the market. A second proprietary feature of the proposed system is a flow confirmation sensor that determines whether dose administration has occurred as expected in real-time. This sensor will quickly alert to any problems within the patch pump such as occlusions, leaks, depleted drug supply, accidental misloading, and any mechanical/electrical failure. According to Dr. Forrest Payne, the Principal Investigator on the project, “The suite of patents and patent applications that covers SFC Fluidics’ system - from the pump to the valves to the sensors - will allow for development of a next generation dual-hormone patch pump that combines safety, convenience and small size with excellent accuracy and precision.”

“We think the proposed system will be especially attractive to adolescents with Type 1 diabetes and will serve the broader diabetic community as well. What’s more, we see the dual hormone drug delivery system as a vital part of a future state-of-the-art artificial pancreas,” remarked Greg Lamps, SFC’s Vice President of Product Realization.

SFC Fluidics, Inc. has a mission to advance healthcare and improve quality of life through our enabling microfluidic technologies. The company’s vision is to become a recognized global leader in the drug delivery and health monitoring markets where our unique product lines improve lifestyle and affordability. SFC Fluidics® is a VIC Technology Venture Development™ portfolio company.

The described research is supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, under Award Number 2R44DK110972-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Contact: Ashley Shemain

Vice President, Marketing & Business Development

479.527.6810

ashemain@sfcfluidics.com