EOFlow Receives CE Mark for Its Innovative Wearable Insulin Pump

EOFlow, a provider of wearable drug delivery solutions, announced on May 25 that it has received CE Mark from the European Union (EU) for its wearable insulin pump ‘EOPatch,’ controller ‘ADM’ and smartphone app ‘Narsha.’ 

Narsha is known to be the world's first commercially approved app that can control insulin injection from a wearable pump.

EOFlow commenced its full product launch in South Korea in March and is now proving its commercial readiness with the CE certification.

EOPatch is Korea’s first and the world’s second wearable disposable insulin pump to be commercially available. People with Type 1 diabetes, advanced type 2 diabetes and gestational diabetes in need of insulin injection can use EOPatch. The product's key advantages include being wireless/tubeless, small and light design that drastically reduces size and weight, waterproof, long wear time (3.5 days) to allow twice-a-week replacement for improved compliance, and faster needle insertion than other solutions for reduced insertion pain.

According to EOFlow, EOPatch has secured competitiveness in many ways, including accurate insulin injection, minimization of insertion error, minimal pain, and lower risks of side effects, complications and low blood sugar level compared to conventional products.

Earlier in 2019, EOFlow signed a 5-year exclusive supply contract worth 150 billion won for EOPatch with Italian pharmaceutical company, Menarini. "With this CE Mark, Menarini can officially launch EOPatch in Europe," a company official said. "EOPatch is now available for sales in countries that honor CE Mark, including Canada, Australia and South America."

"We are very excited to finally receive the CE Mark," said EOFlow’s CEO Jesse Kim. "EOPatch has successfully set its foothold in the domestic market, and we are now looking forward to presenting our wearable insulin pump in the global market."

"We will prove the competitiveness of our products through successful entry into the global market," he added. "We are focusing all our capabilities on ensuring that the production and supply process goes smoothly with the goal of launching them in Europe in the second half of this year."

The CE Mark is Europe’s standard certification that can be obtained only when all requirements of the European Council's guidelines are met in relation to product safety, health, environment and consumer protection. The CE Mark indicates that the product may be sold freely in any part of the European Economic Area.