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Sunshine Heart Receives Health Canada Approval to Modify Its Ongoing Investigational Study to Use the Next Generation C-Pulse(R) System Driver

Thu, 06/07/2012 - 12:45pm
The Associated Press

Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC), a global medical device

company focused on innovative technologies for moderate to severe

heart failure, today announced that the company has been granted

approval by Health Canada to use its next generation C-Pulse@ Heart

Assist System driver in ongoing clinical studies at Royal Victoria

Hospital. The new C-Pulse driver is designed to provide heart failure

patients with enhanced patient comfort and performance. The C-Pulse

System is a new investigational therapeutic approach based on proven

balloon counter-pulsation technology for the treatment of patients

with Class III and ambulatory Class IV heart failure.

The C-Pulse driver now comes as a single unit that is half the size,

lighter and quieter than the first generation technology. The driver

also features a number of software enhancements. The C-Pulse System is

currently in an investigational study at Royal Victoria Hospital. The

prospective study is designed to evaluate the safety and performance

of the C-Pulse System as a treatment for patients with moderate to

severe heart failure. To date, four patients have been implanted with

the initial C-Pulse System. The company has received Health Canada

approval to expand the number of participants in the trial to 20

patients. All trial participants will receive the new C-Pulse driver,

which will be used in ongoing and future clinical studies.

"We are pleased to have received Health Canada approval of our next

generation C-Pulse driver technology for clinical use," said Dave

Rosa, CEO of Sunshine Heart. "We enhanced the driver based on results

from our feasibility trial and feedback from physicians and patients.

With the reduced size, weight and noise reduction, we expect

improvements in patient quality of life due to enhanced comfort and

performance. We look forward to making this new technology available

to patients enrolled in our clinical studies in Canada in the coming

weeks, as well the United States and Europe thereafter."

The external C-Pulse driver inflates and deflates the balloon which is

secured by a cuff around the outside of the ascending aorta, the main

blood vessel of the heart. The cuff and heart signal sensing wires are

attached to the external C-Pulse driver, which inflates and deflates

the balloon in sequence with the electrocardiogram (ECG) signal to

assist heart function and the pumping capacity of the heart. The

balloon deflects the aorta in a "thumb-printing" manner, which is

intended to minimize aortic wall strain and maximize blood volume

displacement per beat.

About Class III Heart FailureHeart failure is a common condition in

which the heart becomes unable to pump sufficient blood to meet the

body's needs. More than five million people in the United States have

heart failure, resulting in more than 300,000 deaths each year(1).

Heart failure is a progressive condition and typically results from

damage to the heart muscle arising from a heart attack or virus.

Cardiologists use the New York Heart Association (NYHA) classification

system to define the four classes of heart failure; each class is

determined by rating a patient's symptoms to everyday activities and

quality of life. More than 1.5 million U.S. heart failure patients are

in the Class III or moderate heart failure category which is defined

by the limitation of physical activity(2). These patients are

comfortable at rest, but levels of activity regarded as less than

ordinary cause fatigue, palpitation and/or shortness of breath. The

most common treatments for Class III heart failure are drugs,

lifestyle adjustments, family education, device therapy (i.e. heart

failure pacemaker with or without a defibrillator) or surgery. These

standard treatments often do not resolve the progression of heart

failure leaving patients without any additional options, hence the

need for new treatments for patients living with the disease.

About The C-Pulse@Heart Assist SystemThe C-Pulse@ Heart Assist System,

an investigational device, utilizes the proven scientific principles

of intra-aortic balloon counter-pulsation applied in an extra-aortic

approach to assist the left ventricle by reducing the workload

required to pump blood throughout the body, while increasing blood

flow to the coronary arteries. Operating outside the patient's

bloodstream, the novel extra-aortic approach of the C-Pulse technology

offers greater flexibility allowing patients to disconnect as

necessary or desired. The C-Pulse System's potential benefits may help

reverse the heart failure process or maintain the patient's current

condition, which may reduce the need for later stage heart failure

therapies, such as left ventricular assist devices (LVADs), artificial

hearts or transplants.

Caution - Investigational device. Limited by Federal (or United

States) law to investigational use.

About Sunshine Heart@ Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) is

a global medical device company committed to the commercialization of

the C-Pulse Heart Assist System, an implantable, non-blood contacting,

heart assist therapy for the treatment of moderate to severe heart

failure. The C-Pulse System can be implanted using a minimally

invasive procedure and is designed to relieve the symptoms of heart

failure through the use of counter-pulsation technology, which enables

an increase in cardiac output, an increase in coronary blood flow and

a reduction in the heart's pumping load. The Company has completed an

approved U.S. Food and Drug Administration (FDA) feasibility clinical

trial of the C-Pulse System and presented the results in November

2011. Sunshine Heart is a Delaware corporation headquartered in

Minneapolis with a subsidiary presence in Australia. The Company has

been listed on the ASX since September 2004 and on NASDAQ beginning

February 2012. For more information, please visit

www.sunshineheart.com(http://www.sunshineheart.com/).

Forward-Looking Statements Certain statements in this report are

forward-looking statements that are based on management's beliefs,

assumptions and expectations and information currently available to

management. All statements that address future operating performance,

events or developments that we expect or anticipate will occur in the

future are forward-looking statements, including without limitation,

our expectations with respect to product development and

commercialization efforts, results of clinical trials, timing of

regulatory filings and approvals, regulatory acceptance of our

filings, research and development activities, ultimate clinical

outcomes and benefits of our products to patients, market and

physician acceptance of the products, intellectual property

protection, and potentially competitive product offerings. The risk

factors described in our filings with the U.S. Securities and Exchange

Commission (SEC) and ASX could cause actual events to adversely differ

from the expectations indicated in these forward-looking statements.

Management believes that these forward-looking statements are

reasonable as and when made. However, you should not place undue

reliance on forward-looking statements because they speak only as of

the date when made. Sunshine Heart does not assume any obligation to

publicly update or revise any forward-looking statements, whether as a

result of new information, future events or otherwise. Sunshine Heart

may not actually achieve the plans, projections or expectations

disclosed in forward-looking statements, and actual results,

developments or events could differ materially from those disclosed in

the forward-looking statements. Forward-looking statements are subject

to a number of risks and uncertainties, including without limitation,

the possibility that regulatory authorities do not accept our

application or approve the marketing of the C-Pulse Heart System, the

possibility we may be unable to raise the funds necessary for the

development and commercialization of our products, and those described

in our filings with the ASX and SEC. We may update our risk factors

from time to time.

(1)

http://www.nlm.nih.gov/medlineplus/heartfailure.html(http://www.nlm.nih.gov/medlineplus/heartfailure.html)

(2) LSI (Life Science Intelligence) Report, # 0515-1-US-1010-206,

11/2010

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