Long-Term Data Demonstrate The OPTIMIZER(R) System to be Safe and Effective

ORLANDO, Fla., March 29 /PRNewswire/ -- Impulse Dynamics (U.S.A.) Inc. announced today findings from the FIX-HF-5 study of its OPTIMIZER System at the 58th Annual Scientific Session of the American College of Cardiology in Orlando, Florida.

Previous studies have demonstrated safety and efficacy of the OPTIMIZER System's cardiac contractility modulation (CCM) signals when applied for three months. The FIX-HF-5 study was designed to test the longer term effects in the largest randomized study to date.

The study met its primary safety endpoint, which was a noninferiority demonstration of the composite of all-cause mortality and all-cause hospitalizations. In terms of efficacy, the results showed that, compared to the control group, patients treated with CCM signals over the other group had significantly improved exercise tolerance as judged by an increase in peak oxygen update (p=0.02) and an improvement in quality of life as judged by a reduction in the Minnesota Living with Heart Failure score (p<0.0001). Although the results did not meet the study's overall primary efficacy endpoint demonstrating improvement in ventilatory anaerobic threshold, it was met in a subgroup of the patients.

"We are pleased to report these longer term data that add to the growing wealth of knowledge showing the potential of CCM as a therapy for heart failure patients with no other options," said Dr. William Abraham, professor of internal medicine and director of the Division of Cardiovascular Medicine, Ohio State University Medical Center.

In a subgroup representing the "less sick" half of the study population (NYHA Class III with ejection fraction 25% and above), the study found even greater improvements not only in peak VO2 (p=0.001) and quality of life (p=0.003), but also in the primary endpoint of ventilatory anaerobic threshold (p=0.03). These effects were largely maintained at twelve months as well.

"This subgroup of the less severely impaired patients appeared to demonstrate an overall greater response rate that those in the control group," noted Dr. Alan Kadish, professor, Division of Cardiology, Feinberg School of Medicine, Northwestern University. "We are particularly encouraged by the findings in this subgroup of patients and look forward to focusing on this subgroup in our next study."

Yuval Mika, chief operating officer of Impulse Dynamics, commented, "The data show that CCM therapy has the potential to be an important new therapy for a greatly underserved group of heart failure patients. We have a clear pathway for further studies of CCM in this population which we believe will have favorable outcomes in the near future."

For a complete copy of the study, please contact Erich Sandoval at 917-497-2867 or esandoval@lazarpartners.com.

About Cardiac Contractility Modulation (CCM) Therapy

Cardiac Contractility Modulation is a new treatment for patients with heart failure. Unlike electrical signals delivered by other cardiac devices, such as pacemakers and implantable defibrillators, CCM signals do not initiate a heartbeat. Rather, CCM signals are intended to modify heart cell function in a manner that improves the strength of the heart muscle, therefore potentially enhancing the heart's overall pumping ability.

About the OPTIMIZER System

The OPTIMIZER System is CE Marked and commercially available in Europe and is currently under clinical investigation at major U.S. research and academic facilities. It consists of a pulse generator and conventional pacing leads which deliver the therapy to the cardiac tissue. The device is implanted in a manner similar to a pacemaker procedure. Unlike conventional pacing methods, however, the OPTIMIZER device utilizes Cardiac Contractility Modulation therapy in which electrical impulses are delivered to the heart after the heart has already initiated its contraction. CCM is designed to increase the forcefulness of the heart's pumping action rather than initiating a new contraction.

About Impulse Dynamics

Impulse Dynamics is focused on the development of electrical therapies for the treatment of heart failure. The company's proprietary technology stems from a scientific discovery regarding the electrical control of tissue function. OPTIMIZER is a registered trademark of Impulse Dynamics. For more information, please visit www.impulse-dynamics.com.

SOURCE Impulse Dynamics (U.S.A.) Inc.

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