Cardiac Concepts Enrolls First Patients in Pilot Trial in Europe for the RespiCardia(TM) System

By Cardiac Concepts Inc., PRNE
Tuesday, July 6, 2010

Trial Underway for the First Implantable System to Treat Heart Failure Patients with Central Sleep Apnea

MINNEAPOLIS, July 7, 2010 - Cardiac Concepts, Inc., a developer of medical devices to treat Heart
Failure patients who experience breathing disturbances during sleep,
announced today enrollment of the first European patients in a Pilot Clinical
Trial. The purpose of the Pilot Study is to understand the respiratory and
cardiac benefits of the RespiCardia(TM) System when treating a breathing
disorder known as Central Sleep Apnea (CSA) in Heart Failure patients. Prof.
Piotr Ponikowski, Principal Investigator of the Pilot Clinical Trial at The
Medical University/4th Military Hospital in Wroclaw, Poland, commented that
the system was successfully implanted in 2 male patients, ages 57 and 68
years with ischemic cardiomyopathy and symptoms of moderate heart failure.
Despite optimal medical management, both experienced severe sleep breathing
disorders. The trial is a 40 patient study being conducted in a number of
centers worldwide. Implants are expected to begin in the United States in the
coming months.

The RespiCardia System is an implantable device using small, electrical
pulses designed to restore more natural breathing patterns in patients with
sleep disordered breathing. This respiratory management therapy may also
improve Heart Failure and patients' quality of life. The RespiCardia system
is the first implantable device to treat Central Sleep Apnea.

"We are excited to be the first in Europe to bring this new device to
patients. We now understand more about the link between Heart Failure and
Central Sleep Apnea and there is an unmet clinical need for treating this
group of patients. This technology has the potential to improve the quality
of life and potentially the outcomes of those suffering from Heart Failure
and Central Sleep Apnea," said Prof. Ponikowski.

"We are very pleased to achieve this important milestone for Cardiac
Concepts. We look forward to including other centers in our pilot study and
providing physicians with new options to treat Central Sleep Apnea in Heart
Failure patients," said Bonnie Labosky, CEO of Cardiac Concepts, Inc.

About Heart Failure, Central Sleep Apnea and the RespiCardia System:

Heart Failure is a condition in which the heart cannot pump enough blood
to meet the body's needs for blood and oxygen.(1) It is a common disease,
affecting over 25 million people worldwide. Recently, it has been recognized
that Heart Failure patients may suffer symptoms of feeling tired and daytime
sleepiness due to breathing disturbances during sleep. In Heart Failure
patients, a common form of sleep disruption is Central Sleep Apnea that
occurs when the brain is not sending appropriate signals to the diaphragm
that controls breathing during sleep. It is estimated that approximately 40%
of Heart Failure patients will have Central Sleep Apnea.(2) Central Sleep
Apnea can lead to the worsening of Heart Failure and has been shown to be
associated with an increased risk of death.

The RespiCardia System consists of an implantable pulse generator and
leads. It is designed to deliver small, electrical pulses at night during
sleep to restore more regular breathing patterns thus reducing the episodes
of Central Sleep Apnea. The RespiCardia System is not approved for commercial
sale in the United States or Europe.

About Cardiac Concepts:

Cardiac Concepts, Inc. is a privately held company located in
Minneapolis, MN focused on improving the outcomes for Heart Failure patients
by developing an implantable stimulation therapy to treat Central Sleep
Apnea. For more information visit: www.cardiacconcepts.com

Caution - Investigational device. Limited by Federal law to
investigational use.

    Exclusively for Clinical Investigation.

    1. AHA. Heart Disease and Stroke Statistics 2009 Update. American Heart
       Association 2009.
    2. Oldenburg et al. Sleep-disordered breathing in patients with
       symptomatic heart failure: A contemporary study of prevalence in and
       characteristics of 700 patients. Eur J Heart Fail 2007;9:251-7.

Peggy Malikowski, Senior Director of Market Development, +1-952-641-4445, pmalikowski at cardiacconcepts.com, or Kari Larson, Administrative Manager, +1-952-540-4470, klarson at cardiacconcepts.com, both of Cardiac Concepts, Inc.

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