CeQur Gets FDA OK for Longer Wear of Mealtime Insulin Delivery Patch

CeQur has announced the recent U.S. Food and Drug Administration (FDA) for the wear duration of its Simplicity injection-free insulin delivery patch from three to four days.

The 33% longer wear time replaces up to 12 mealtime insulin injections, over 1,000 less annual injections. The Swiss company cited analysis of over 26,000 subjects in the IQVIA database, which found only 21.3% of type 2 diabetes patients reach the ADA-recommended A1c goal of under 7%.

This announcement follows the early 2021 launch of the FDA-cleared, CE-marked Simplicity bolus-insulin delivery device. CeQur also pocketed $115 million in Series C5 funding later in the year.

Each CeQur Simplicity patch can hold up to 200 units of quick-acting insulin that’s administered in two-unit doses. The company’s real-world studies of Simplicity yielded 1.29% A1c reduction and 94% patient satisfaction.

Because of this demand, the CeQur recently added a fully automated manufacturing line that aims to support 100,000 patients and is fortifying its sales team.

“We are excited to share that there are now ~5000 people with diabetes using CeQur Simplicity for their mealtime insulin delivery,” said CeQur president and CEO Bradley Paddock. “With the 4-day clearance, we hope to make it even easier for people with diabetes to take their mealtime insulin.”