EOFlow announced recently that it submitted a 510(k) application to the FDA for its EOPatch wearable, disposable insulin pump.
San Jose, California-based EOFlow submitted its application on Dec. 27, 2022. It aims to enter the U.S. diabetes market, expanding its reach outside Korea.
The company said in a news release that over 600 people in Korea use the EOPatch. Its adoption steadily increased despite no national health insurance coverage since its launch in April 2021. EOPatch features a reservoir size of 2 mL for insulin. The company also has FDA breakthrough device designation on a wearable, integrated artificial pancreas. The wearable, disposable device features a glucose monitoring sensor, insulin pump and automated insulin delivery algorithm.
EOFlow also officially launched the patch pump in Europe in September and obtained United Arab Emirates approval that same month. It picked up Indonesian approval in October 2022 as well. The company’s next step, American clearance, could come following submission, although the company said it does not know when to expect clearance.
EOFlow’s plans for the now-submitted technology
It plans to create a commercial launch plan with its potential U.S. partner as the FDA reviews its submission. EOFlow currently has negotiations ongoing with potential distribution partners in the U.S. It expects to strike a deal within the first half of 2023.
“I am very proud to begin the U.S. clearance process,” said EOFlow founder and CEO Jesse J. Kim. “With this submission, we have taken a major step forward in entering the world’s largest diabetes market. Furthermore, as the 510(k) device shares a common backplane with all EOFlow products, this submission is an important step in our efforts to commercialize extended-wear and closed-loop systems in the U.S.”
EOFlow also recently announced that it developed a seven-da wearable pump prototype. It plans to move it to productization.
This pump has a 3 mL reservoir and utilizes EOFlow’s low-power, high-performance pumping technology. The company dubbed it the “EOPatch 3.0.” EOFlow aims for a 2024 launch.