FDA Clears ACCU-CHEK Combo Systems

On July 19, 2012 by Cherise Shockley

Media Release via Email

Indianapolis, 18 July 2012

FDA clears Accu-Chek Combo system – Roche’s new interactive insulin pump
system for people with diabetes

The system will be available in the United States in the second half of 2012

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food

and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy. The Accu-

Chek Combo system seamlessly combines a blood glucose meter with an insulin pump, which are able to

exchange data in both directions via Bluetooth wireless technology. The meter not only enables the user to

quickly test blood glucose levels: It allows for operating the insulin pump remotely and by means of an easy-

to-handle bolus advisor it provides support in defining the right amount of insulin. With this the Accu-Chek

Combo system not only supports a more targeted therapy management, but it also allows for a discreet

insulin administration without the need to touch the pump.

“We are very pleased to announce that our new insulin pump system will soon be available for people with

diabetes in the U.S.,” said Daniel O’ Day, COO Roche Diagnostics. “With this clearance we are now looking

forward to launch the second device in the U.S. this year, after the successful clearance of the Accu-Chek

Nano SmartView system in the first quarter. Both launches represent a significant milestone for our Diabetes

Care business.”

According to the 2011 National Diabetes Fact Sheet published by the Centers for Disease Control and

Prevention, more than 25 million people in the U.S. live with diabetes. It is also estimated that 79 million

people live with pre-diabetes in the U.S.

“The Accu-Chek Combo system clearly demonstrates Roche’s dedication to integrated diabetes management

solutions, combining the technical components for blood glucose monitoring, data management and insulin

delivery. This new system is designed to support insulin pump patients in managing diabetes easily and

discreetly in their everyday life,” said Luc Vierstraete, Head of Roche Diabetes Care.

F. Hoffmann-La Roche Ltd


The Accu-Chek Combo system has been launched successfully in several European and APAC(Asia-Pacific)

countries already – including France, Germany, UK, and Australia.

About the Accu-Chek Combo system:

In addition to being discreet and easy-to-use, the Accu-Chek Combo system also features:

Bluetooth technology for two-way wireless communication between the smart meter and the insulin


A full-color display that brings to life blood glucose data, insulin dose information and pump settings;

A bolus advice function on the meter to allow users to easily calculate and deliver a bolus without

touching the pump;

Flexibility to adjust the basal rate to as low as 0.05 units per hour – in increments as precise as 0.01 units;


An insulin cartridge that holds up to 315 units of insulin, the largest capacity among pumps sold in the


About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and

a global leader for diabetes management systems and services. For more than 35 years, the

Accu-Chek brand has been dedicated to enable people with diabetes to live life as normal and active as

possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way.

Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products

and impactful solutions for convenient, efficient and effective diabetes management spanning from blood

glucose monitoring through information management to insulin delivery. The Accu-Chek brand

encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and

education programs – leading to an improved medical outcome.

For more information, please visit www.accu-chek.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with

combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech

company with truly differentiated medicines in oncology, virology, inflammation, metabolism and

CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a

pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing



medicines and diagnostic tools that enable tangible improvements in the health, quality of life and

survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8

billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United

States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai

Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations

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