EOFlow Plans to Support Sinocare’s Glucose Sensor in Its Wearable Artificial Pancreas Solution

[2024-09-10] EOFlow Co., Ltd. (KOSDAQ 294090, CEO Jesse Kim), a company specializing in wearable insulin pumps, announces that with the support of its partner Sinocare it plans to add Sinocare’s continuous glucose monitoring sensor (CGMS) in its wearable artificial pancreas solutions.

As the number of diabetes patients worldwide continues to rise exponentially, the need for effective blood glucose management solutions has become increasingly critical. This demand has led to the development of various medical devices, particularly artificial pancreas (AP) systems that integrate continuous glucose monitors (CGMs) with insulin pumps, using algorithms to automatically regulate insulin levels. While these systems have predominantly been used by patients with Type 1 diabetes, FDA recently approved an artificial pancreas solution for Type 2 diabetes patients, which means that the potential user basis for AP solutions will be expanded by many folds.

While the patch-type insulin pumps are widely sold in the global diabetes market today, most insulin pumps used in AP systems have traditionally been tethered models that are inconvenient to use. However, with the approval of a patch pump AP solution by the U.S. FDA in late 2023 and the approval of EOFlow's EOPatch X patch pump AP system by Korea's Ministry of Food and Drug Safety in early 2024, the market is expected to rapidly shift to patch-type (wearable) AP solutions. To meet this growing demand, EOFlow plans to introduce advanced wearable artificial pancreas solutions with the support of Sinocare.

All current artificial pancreas solutions require usage of two separate devices: a CGM sensor and an insulin pump. However, EOFlow plans to launch "EOPani", which will integrate both the sensor and pump into a single wearable device leveraging the company's proprietary ultra-low-power technology. This innovation will allow for automatic blood glucose regulation with just one patch device worn on the body. With this product concept, EOFlow became the first company in Korea to get research funding from Juvenile Diabetes Research Foundation (JDRF) in 2019, and the first Korean medical device company to receive the FDA's Breakthrough Device Designation (BDD). The technical feasibility of this product was further confirmed through a project supported by the Korean Ministry of Trade, Industry, and Energy in 2020. With the support from Sinocare, the development of this product can finally resume.

EOFlow CEO, Jesse Kim says, "for a fully integrated wearable artificial pancreas device to be commercially viable, the product needs to last for about a week. However, actuator technologies used by other companies are too power hungry for a weekly device light enough to be worn on a body. This is why, realistically, EOFlow is the only company in the world capable of creating such a product.”

Dr. Jiangfeng Fei, head of Sinocare’s continuous glucose monitoring (CGM) division states, “following our recent agreement with EOFlow for the exclusive distribution of our CGM product in Korea, we are now extending our partnership to artificial pancreas space. Sinocare’s extensive expertise in biosensing technologies would allow us to rapidly adapt to meet the complex all-in-one requirements, delivering the advanced, precise glucose sensor essential for a fully integrated AP system."

Since EOFlow already has EOPatch X, a wearable artificial pancreas solution approved by Korean Ministry of Food and Drug Safety, adding a new sensor support can be expected as early as next year. A fully integrated EOPani system will likely require clinical studies that its introduction will take more time.

In their partnership, both companies intend to adopt an open collaboration approach, allowing each company to freely work with other sensor or pump partners. This approach aligns with the current global trend of allowing users greater flexibility in choosing AP components.

Founded in 2002, Sinocare has grown to become the largest manufacturer of blood glucose monitoring devices in Asia and was the first company to be listed in China. Through its continuous innovation in biosensing technology, Sinocare has become the fifth-largest blood glucose monitoring device manufacturer in the world and a market leader in the Point-of-Care Testing (POCT) industry. Notably, Sinocare was the first company globally to develop a CGM product using third-generation electrochemical sensing technology.

Since its launch in April 2023, Sinocare's iCan CGM has achieved remarkable success. It is the fourth CGM brand to receive CE MDR certification and first launched in China. The product has already generated over 200 million Yuan in sales and ranks number three in market share in China, setting new standards in the blood glucose diagnostics industry.

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