Cardiola Collaborates With Leading German Cardiac Center In Study Of Its Muscular Counterpulsation (MCP)-Based M.Pulse(R) System For Non-Surgically Treating Chronic Heart Failure Patients At Home

Published: Jan 29, 2010

WINTERTHUR, Switzerland, Jan. 26, 2010-Cardiola AG announced today it is collaborating with The Heart and Diabetes Center North Rhine-Westphalia, Ruhr University of Bochum, Bad Oeyhausen, Germany, in a study of the Company's CE-Marked m.pulse® system. The study's purpose is to investigate the utility of "Muscular CounterPulsation" ("MCP") in patients with early-stage heart failure.MCP was previously only available in a clinical setting. Now, m.pulse® is the world's first and only device enabling chronic heart failure (CHF) patients to receive MCP therapy at home. Principal investigator for the study is Univ.-Prof. Dr. med. Dieter Horstkotte.

"We are extremely pleased to be collaborating with one of the leading heart centers and interventional cardiologists in Europe," said Christof Lenz, Cardiola's CEO and former Global Innovation Manager at Siemens Medical. "Under the supervision of the clinical investigating team, early-stage heart failure patients will be able to use our m.pulse® system at home on a prescribed schedule and will be evaluated to determine the impact of m.pulse® treatment on their symptoms of CHF. It has been well-documented clinically that MCP-the proprietary technology platform of our patented m.pulse® device-is a safe and effective therapy designed to improve the hemodynamic function of a failing heart," Lenz added. "While m.pulse® is already CE-Marked and safety has been established, this study is intended to offer additional clinical evidence of m.pulse® as a well-validated, affordable and non-surgical treatment option that patients themselves can perform in their own home."

Previously the Company announced that data from a study presented at last year's Annual Congress of the Swiss Society of Cardiology concluded that "MCP is safe and efficient for improving cardiac function" non-surgically in patients with coronary artery disease (CAD). In the study, peripheral resistance of CAD patients was decreased by 22%; end-diastolic pressure was reduced by 18%; and stroke work was reduced by 16%. Additionally, there was a 12% increase in cardiac index. Equally important, all of these hemodynamic effects were less marked in the study's control patients.

Cardiola's m.pulse® device, based on Muscular CounterPulsation (MCP) technology, is approved in Europe for treating CHF as a non-surgical, at-home therapy. Battery-powered m.pulse®, the size of a cell phone that the patient attaches to his belt for about 45 minutes per treatment, is synchronized to his cardiac cycle to stimulate the muscles of the calves and thighs to make them contract in the resting phase of the heart. This well-established Muscular CounterPulsation action results in increased blood flow to the heart muscle while decreasing the heart's workload. MCP was previously only available in a clinical setting. Now, m.pulse® is the world's first and only device enabling CHF patients to receive MCP therapy at home.

Chronic Heart Failure is among the world's most prevalent diseases and the cause of numerous other serious clinical disorders. Approximately 17 million people currently suffer from CHF in Europe, the U.S. and Japan. Some six million of these patients are classified as NYHA (New York Heart Assn.) classes II and III with systolic dysfunction, the primary patient population for m.pulse® with Muscular CounterPulsation from Cardiola.

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