Earlier this month, EOFlow, an emerging medical device company with offices in Seoul, South Korea and San Jose, California, announced that its closed loop Automated Insulin Delivery, the EOPancreas System, received Breakthrough Device Designation by the U.S. Food and Drug Administration. This designation grants priority review to companies with promising new technology in chronic disease care. “The Breakthrough Device designation will assist us in developing clear design and development milestones in concert with the FDA, greatly accelerating our ability to commercialize this important new technology,” says Luis Malave, the president of EOFlow.
The upcoming EOFlow closed loop system, the EOPancreas, combines a continuous glucose monitor with an insulin patch pump, and is set to rival the tubeless OmniPod. The system is designed to primarily for people with Type 1 diabetes.
The EOPancreas System contains a unique, connected architecture, allowing it to benefit from Artificial Intelligence (AI) algorithms running on a private, validated cloud – termed EOCloud – to allow customization of the closed loop control for each user.
“EOFlow was founded to democratize wearable drug delivery solutions by providing intelligent, connected solutions for patients managing chronic conditions at globally-competitive price points”, according to Jesse Kim, founding CEO of EOFlow, “and we see the Breakthrough Device designation as an important validation of our business model.”
The EOPancreas System is being developed with the support JDRF to address the continuing global challenges associated with diabetes management through lowering the barriers to blood glucose control for people living with Type 1 diabetes.
Currently, in addition to the EOCloud, the system consists of the following:
The EOPatch, a small, lightweight, waterproof, tubeless patch pump that adheres to the skin. The reservoir will hold 200 units of insulin, and lasts for three days. It is fully disposable, and the cannula is a 30-gauge stainless steel needle designed to minimize occlusion.
The ADM (Advanced Diabetes Manager) is a smartphone-like color touch screen that allows for easy operation (Android OS). It can save up to 8 basal programs and 8 bolus preset programs. The ADM keeps track of important data such as Patch insulin infusion status, history, and blood glucose trends. It also monitors for Patch use time, battery status, and abnormal conditions such as occlusion, and promptly notifies the user.
CGM: DiabetesMine reports that “there isn’t a lot of detail out there publicly, but we’re told the EoPancreas will be integrated with existing CGM technology. Specifically, the company has reached an agreement to use the CT-100B CGM sensor made by China-based POCTech.“
A commercial launch is expected in 2021.