SAN JOSE, Calif. , Dec. 27, 2022 /PRNewswire/ -- EOFlow Co., Ltd. (KOSDAQ: 294090) (EOFlow or the Company), a provider of wearable drug delivery systems (DDS), announced today that it submitted a 510(k) application to the U.S. FDA for its wearable disposable insulin pump EOPatch on December 27.
EOFlow plans to enter the US, the world's largest diabetes market, with its current disposable wearable insulin pump the 'EOPatch'.
EOFlow has said that the number of accumulated EOPatch users in Korea has been steadily increasing and is over 600 although the product has not been covered by the national health insurance since its domestic launch in April 2021. It was also reported that the monthly average number of new users increased 78 percent compared to previous sales from Huons in three months from August to October, when it began to conduct its own marketing and sales in Korea.
As EOFlow begins to expand its market reach outside Korea, the Company officially launched EOPatch in Europe in September 2022; obtained the U.A.E. approval in September 2022, and Indonesia approval in October 2022. The 510(k) filing is the latest move from the Company on its global expansion plan.
A 510(k) is a premarket submission made to the FDA to demonstrate that the submitted device is as safe and effective, that is, substantially equivalent, to a legally marketed device.[1] An EOFlow official said that they just submitted FDA 510(k) application, but the expected clearance date was still unknown. The Company official also commented that the commercial launch plan with its potential partner will be strategically crafted in lieu of the FDA clearance schedule.
The Company is currently negotiating terms with potential U.S. distributors and aims to conclude a distribution agreement within the first half of 2023.
EOFlow's founder and CEO, Mr. Jesse J. Kim said, "I am very proud to begin the US clearance process. 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 US."
Earlier in November, EOFlow announced that it had developed a 7-day wearable pump prototype and is moving it to productization. Completing various tests with the samples that have a 3ml reservoir and can operate for 7 days based on EOFlow's ultra-low-power, high-performance pumping technology, the Company declared the 'EOPatch 3.0' to be the next-generation product aiming for a 2024 launch. However, it is the 'EOPatch' with the reservoir size of 2ml that filed to the FDA this time. The company also has a Breakthrough Device Designation from FDA on a wearable integrated 'artificial pancreas' solution which is a wearable disposable device that has a glucose monitoring sensor, an insulin pump and automated insulin delivery algorithm integrated.
Forward-Looking Statement:
This press release contains forward-looking statements regarding future operating and financial performance. The predictive information may be affected by future management and contains inherent uncertainty. Actual future performance may differ significantly from the predictive information due to these uncertainties. These forward-looking statements are based on management's current beliefs, assumptions and estimates and are not intended to be a guarantee of future events or performance. Any details are subject to change without prior notice due to changes in market conditions and operation strategies in the future. The Company and its employees will not be liable for any losses incurred from utilizing the information contained in this press release.
[1] U.S. Food & Drug Administration Premarket Notification 510(k) https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k |
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