CeQur announced recently that the FDA granted 510(k) clearance for its Simplicity system for an extended wear duration. Clearance extends the wear time for the wearable mealtime insulin delivery patch from three to four days. It marks a significant advancement for what the company says is the longest wearable insulin delivery patch, which provides diabetes discretion, additional convenience and injection-free dosing.
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Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.
Simplicity, a wearable, disposable bolus insulin delivery system, was developed as, essentially, a wearable insulin pen. CeQur began a pilot commercial launch for the FDA-cleared and CE-marked device in early 2021. In April 2021, the company raised $115 million to support that launch and scale up manufacturing.
CeQur said it has a fully automated manufacturing line to support 100,000 patients. It also increased the size of its sales force to ensure wider availability for Simplicity.
“We are excited to share that there are now ~5000 people with diabetes using CeQur Simplicity for their mealtime insulin delivery,” said Paddock. “With the 4-day clearance, we hope to make it even easier for people with diabetes to take their mealtime insulin.”
