SFC Fluidics, Inc. Receives FDA Breakthrough Device Designation

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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.

SFC’s highly accurate insulin pod with rapid dispense confirmation.

SFC’s highly accurate insulin pod with rapid dispense confirmation.

“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." -Barry Ginsberg, MD, PhD, Consulting Medical Director for SFC

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.

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