Impulse Dynamics Announces Pivotal Results At the American College of Cardiology Annual Meeting Late-Breaking Session


Long-Term Data Demonstrate the OPTIMIZER(r) System to be Safe and Effective

ORLANDO, Fla., March 30, 2009 (GLOBE NEWSWIRE) -- 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 than 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. 

CONTACT:  Lazar Partners LTD
          Public Relations for Impulse Dynamics, Inc.
          Erich A. Sandoval
          +1-805-667-8402
          Mobile: +1- 917-497-2867
          esandoval@lazarpartners.com