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Positive Results for CeQur SA's PaQ® Insulin Delivery Device


3/1/2013 6:57:45 AM

HORW, Switzerland, Feb. 28, 2013 /PRNewswire/ -- CeQur SA, a company focused on the development and commercialization of simple insulin delivery devices, announced that initial data from a study of the company's PaQ® Insulin Delivery Device were presented today at the 6th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France. The data suggest that PaQ is a safe, highly satisfying alternative to multiple daily insulin injections (MDI) for people with type 2 diabetes – many of whom need new tools to help them achieve better glycemic control.

"This study demonstrated that simple infusion with a device such as PaQ is a valid approach for people with type 2 diabetes who are dependent on multiple daily insulin injections," said Dr. Julia Mader of the Division of Endocrinology and Metabolism, Medical University of Graz, who presented the data. "This is very exciting because it means we will have a new tool to help our patients with type 2 diabetes overcome some of the obstacles that currently prevent them from effectively managing their disease."

Data suggest that approximately 50 percent of insulin-requiring individuals do not achieve appropriate glycemic control.1 Poor glycemic control is associated with additional health-care costs and high risk of disabling complications, including diabetic retinopathy, chronic kidney disease and cardiovascular disease.2 Half of all patients requiring MDIs report that they intentionally skip doses because they consider the injections embarrassing, inconvenient, painful, and/or disruptive to their daily activities.3

PaQ is a discreet, wearable device that provides three days of consistent, basal insulin delivery along with easy, on-demand bolus insulin. The small device comprises a disposable insulin infuser reservoir attached to a reusable insulin monitor.

The 20-patient PaQ study evaluated the ability of people with type 2 diabetes who were on a stable MDI regimen to use PaQ in replacing the daily insulin injections required to control their blood sugar. Study endpoints included glycemic control, patient satisfaction and safety. The study was led by Professor Thomas Pieber, head of the Division of Endocrinology and Metabolism, at the University Hospital in Graz, Austria.

Data presented for the first time today demonstrate that PaQ safely and effectively delivered patients' insulin requirements with a high level of patient satisfaction and acceptance. No severe hypoglycemic events occurred during the study baseline period or while participants were on PaQ. All patients were able to correctly assemble and use PaQ with just one hour of training.

"PaQ was logically designed to address common, specific treatment challenges faced by people with type 2 diabetes," said Professor Pieber. "This study provides encouraging initial evidence that simple devices such as PaQ may help us reduce the incidence and impact of poor glycemic control among these individuals."

The Need for Simple Insulin Infusion

There are currently more than 11 million people in the United States and European Union who are taking insulin injections to manage their type 2 diabetes. Studies suggest that simple continuous, subcutaneous insulin-infusion (CSII) regimens may improve glycemic control and quality of life among these individuals. However, current CSII has not been widely used in T2D to date due to its complexity and cost.

"Our mission is to provide people with type 2 diabetes a simple insulin therapy that can free them from the burden of multiple daily injections so that they can more comfortably and consistently maintain target glycemic values," said James Peterson, founder and CEO, CeQur. "We're extremely pleased that this study provides evidence that PaQ can provide this freedom."

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.

ontact:

Michele Parisi for CeQur

1-925-429-1850

mparisi@biocommnetwork.com

1 Hoerger, T et. al. Is Glycemic Control Improving in U.S. Adults? Diabetes Care 2008, 31:81-86

2 Mohammed, AK et. al. Characteristics Associated with Poor Glycemic Control Among Adults with Self-Reported Diagnosed Diabetes – National Health and Nutrition Examination Survey, United States, 2007-2010. Mor. Mort. Weekly Rprt. 2012; 61:32-37

3 Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010;33:240-5



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