, Nov. 27, 2012
/PRNewswire/ -- CeQur SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that the PaQ®
Insulin Delivery Device has received CE Mark approval. PaQ has demonstrated the safety and efficacy required for marketing in Europe.
PaQ is a discreet, wearable device that provides three days of consistent, basal insulin delivery as well as easy, on-demand bolus insulin for individuals with type 2 diabetes. The small device comprises a disposable insulin-infuser reservoir attached to a reusable insulin monitor. PaQ is simple to use, making it easy to train patients to start and stay on insulin therapy.
"This regulatory achievement demonstrates the quality of both the PaQ device and the internal processes we've put in place to move this unique, important product through development and into the marketplace," said James Peterson, founder and CEO, CeQur.
Currently more than 30 million people in the European Union have diabetes. Many of these individuals manage the disease by taking multiple, daily insulin injections. According to a recent publication, half of all patients requiring multiple daily injections intentionally skip doses because they consider the injections embarrassing, inconvenient, painful and/or disruptive to their daily activities. Adhering to prescribed insulin therapy regimens is important, because tight glucose control is vital to reducing the risk of long-term type 2 diabetes complications. Studies indicate that simple, continuous insulin-infusion regimens may improve glycemic control and quality of life among individuals with type 2 diabetes.
CeQur recently announced the successful completion of a clinical study conducted with the University Hospital Graz, Austria, evaluating the ability of PaQ to replace insulin injections among people with type 2 diabetes. Study endpoints included glycemic control, patient satisfaction and safety. CeQur expects to share initial results early next year.
About CeQur SA
CeQur® is dedicated to developing and commercializing advanced insulin delivery devices that make it easier for people living with type 2 diabetes to adhere to therapy and stay in control of their disease. The company is headquartered in Horw, Switzerland, with operations in Nordborg, Denmark and Marlborough, Massachusetts.
CeQur was established in January 2008. The company's lead product candidate is the PaQ Insulin Delivery Device, a novel, wearable device that provides freedom from multiple daily injections. More information can be found at www.cequrcorp.com.
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Edelman SV, Bode BW, Bailey TS, et al. Insulin pump therapy in patients with type 2 diabetes safely improved glycemic control using a simple insulin dosing regimen. Diabetes Technol Ther 2010;12:627-33.
IDF Diabetes Atlas
Michele Parisi for CeQur
SOURCE CeQur SA