EOFlow, a provider of wearable drug delivery systems (DDS), has announced that it has submitted a 510(k) application to the US FDA for its wearable disposable insulin pump EOPatch. 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 UAE 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.

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.

EOFlow is currently negotiating terms with potential US distributors and aims to conclude a distribution agreement within the first half of 2023.