About 5 million people in the U.S. have type 2 diabetes, but none of them can use the wearable PAQ insulin infusion device from CeQur. Yet. That’s because the device has not yet received FDA clearance for use in the U.S., though it has received CE approval in the European Union. We wrote about the PAQ last year. A patient wears the device on the belly, and a sub-cutaneous (below the skin) canula delivers a continuous basal dose of insulin automatically. There is no need for separate injections. If an extra bolus dose is required at mealtime, the patient presses a button on the side of the PAQ to deliver additional insulin. The device holds a three-day supply of insulin, after which time a portion is discarded, and the “messenger” unit is transferred to a new device.
In spite of the lack of FDA clearance, the company is expanding their manufacturing capacity in the U.S. The company has announced an expanded facility in Massachusetts that will include a new manufacturing line. The PAQ is designed for high-volume, low-cost production, and the company expects to triple its workforce from 50 employees to more than 150 over the next two years. While the company isn’t making any claims about when the device might be available in the U.S., but clearly they are expecting that to happen sooner than later. Clinical studies already have shown that it’s better at controlling blood glucose levels, and other studies show that it saves money compared to traditional insulin injections.
With so many diabetic patients in this country, a more cost-effective and improved therapy could have an enormous impact. CeQur wants to be the company that delivers on that promise.