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Sunshine Heart
Corporate Office
 
United States of America
Sunshine Heart, Inc.
12988 Valley View Road
Eden Prairie, MN 55344
 
Phone +1 952 345 4200
http://www.sunshineheart.com
 
 
Dr Elaine Stead
Vice President, Corporate Development
Elaine.Stead@sunshineheart.com
+61 (0) 412 637 023

Sunshine Heart focuses on an innovative cardiac assist therapy to treat heart patients who represent a large and under-served market segment and provide a significant opportunity for the company. Unfortunately, these Class IV patients, despite optimal drug therapy, have persistent symptoms and their options are very limited. Surgical approaches usually involve complex open-heart surgery or heart transplantation.
 
C-Pulse systemSunshine Heart's C-Pulse® Heart Assist System is an innovative approach to assist the heart's function, not replace it and may be implanted using a minimally invasive approach. The C-Pulse Heart Assist System is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure, sometimes also referred to as moderate and severe failure. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life.

C-Pulse

The C-Pulse Heart assist system is designed to treat clinical symptoms associated with Class III and ambulatory Class IV heart failure. These symptoms normally include shortness of breath, dizziness, low blood pressure and fluid retention. Patients associated with Class III and ambulatory Class IV heart failure are typically unable to engage in normal activities, compromising their quality of life. The C-Pulse Heart Assist System may be implanted through a minimally invasive or full sternotomy technique. 

The C-Pulse System's design is based on proven balloon counter-pulsation technology to assist the heart by reducing the workload of the left ventricle. During inflation of the balloon, blood flow is increased to the coronary arteries, thereby providing additional oxygen which is vital to a failing heart. During deflation, theworkload or pumping required by the left heart is reduced. The balloon inflation and deflation is synchronized to the patient's ECG, similar to a pacemaker. Potential benefits of the technology, which are currently being analyzed in clinical trials, are relief of shortness of breath, increased physical activity, and improved cardiac function.

The C-Pulse is designed to improve heart function in three ways:

1

More blood flow from the heart called increased cardiac output

2

More oxygen to the heart muscle, called increased coronary blood flow

3

Less work for the heart, called decreased afterload



Shares Outstanding:6.28M
Free trading shares: 2.62M

Latest news:
 
SYDNEY, AUSTRALIA and EDEN PRAIRIE, MN--(Marketwire -06/07/12)- Sunshine Heart, Inc. (SSH) (SHC.AX), 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 Failure
 
Heart 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.
 
Caution - Investigational device. Limited by Federal (or United States) law to investigational use.
SSH chart



Preliminary Data from european trial, delivered at the 34th Annual International Society for Heart and Lung Transplant April 10th, 2014
Surgical implantation was successful in all patients and does not require cardiopulmonary bypass. Follow-up ranges from 5 days - 6 months with a cumulative follow-up of 493 days. No stroke, myocardial infarction, major bleeding or major infection has occurred due to the device. One patient developed tachycardia with worsening heart failure 12 hours after surgery without stabilization under medication and underwent left ventricular assist device implantation after 5 days.
4 patients improved clinically under the C-Pulse system with three patients improving their functional status by one NYHA class. So far LVEF has increased by an average of 10-15% in the 3 patients with the longest follow-up. One patient is post-op day 7 and has not yet been assessed for efficacy. Conclusion: The C-Pulse system seems to be a promising therapeutic option and may improve cardiac function over time.

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SSH News: Statement of Changes in Beneficial Ownership (4) 09/20/2017 04:25:27 PM
SSH News: Amended Statement of Beneficial Ownership (sc 13d/a) 09/20/2017 04:23:20 PM
SSH News: Proxy Statement (definitive) (def 14a) 09/08/2017 07:06:50 AM
SSH News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 08/18/2017 04:38:16 PM
SSH News: Amended Statement of Beneficial Ownership (sc 13d/a) 08/17/2017 06:02:59 AM
News News Alert: CHF Solutions Signs International Distribution and Services Agreement with Singapore-based TRANSMEDIC Pte Ltd. 12/13/2017 08:00:00 AM
PostSubject
#1017   80% gain this week for CHFS. watch nokomis 12/11/17 01:50:53 PM
#1016   Don't post any more on message boards! Waste makingbiigdough 12/11/17 11:56:55 AM
#1015   Seems to be holding, needs more volume to reb329 12/11/17 11:24:12 AM
#1014   CHFS how high will it go is the nokomis 12/11/17 11:14:45 AM
#1013   CHFS macd crossover is very bullish. Due for nokomis 12/11/17 10:40:22 AM
#1012   Looking forward to Monday, I have about 1500 reb329 12/10/17 02:44:08 PM
#1011   He took a 13.1% Stake in the company. Dlicious1 12/09/17 03:49:39 PM
#1010   Appreciate the response. What exactly is a 13.1 Ducatijc80 12/09/17 03:02:35 PM
#1009   Li Chiang just took a 13.1 stake in Dlicious1 12/09/17 12:39:55 PM
#1008   Any other thoughts on this one? Another insane Ducatijc80 12/09/17 10:19:28 AM
#1007   Looking good, might run hard Monday reb329 12/08/17 07:34:29 PM
#1006   gonna be a big winner,,,the POP is coming johnnyzice 12/05/17 10:00:51 PM
#1005   Back in at $4, lets see what happens reb329 12/05/17 10:09:06 AM
#1004   Lol! No QServus 12/03/17 10:48:16 AM
#1003   filled just now @ 3.72 Next week ++ nokomis 12/01/17 11:37:44 AM
#1002   CHFS under 4 going into next week Dec. nokomis 12/01/17 10:45:46 AM
#1001   Round 2!! +$$ Leezee Life Strategies 11/30/17 10:51:00 AM
#1000   Man almost bought at 4.4, thinking about just fortunebuilder1959 11/30/17 10:46:20 AM
#999   volume has arrived... Tdash 11/30/17 10:36:59 AM
#998   looks like everyone still waiting for that next pop Tdash 11/30/17 10:33:05 AM
#997   4.4 next then 4.9 if I recall. easymoney 11/29/17 11:51:41 AM
#996   same here, bought in for the bounce. This thestreetlawyer 11/29/17 11:50:47 AM
#995   Took a starter today. easymoney 11/24/17 02:09:08 PM
#994   Not millions this will bounce soon QServus 11/24/17 07:28:22 AM
#993   Millions left to dump. Think eod could be FloatCleaver 11/22/17 01:18:56 PM
#992   Good and bad. Bad: gonna dip some more Good: good QServus 11/22/17 01:10:47 PM
#991   Gonna nibble here. CHFS @ $4.45 Lone Wolf 11/22/17 12:09:30 PM
#990   What's the today's news mean? more shares going IXI 11/22/17 10:40:32 AM
#989   CHFS buy 4.46 stocktrademan 11/22/17 10:21:23 AM
#988   No new 52 week low? FloatCleaver 11/22/17 10:17:31 AM
#987   Maybe, temporarily. QServus 11/22/17 10:16:39 AM
#986   4 million shares to dump. I’m thinking 4, FloatCleaver 11/22/17 10:15:47 AM
#985   Offering is at $4.50 which means it will QServus 11/22/17 10:14:44 AM
#984   Where would you buy it? FloatCleaver 11/22/17 10:13:58 AM
#983   Sure you can QServus 11/22/17 10:10:09 AM
#982   Not worth trading down here? FloatCleaver 11/22/17 10:09:46 AM
#981   Oh yeah thanks Q Yo-Yo 11/22/17 09:26:41 AM
#980   This stock was a pump and dump. It QServus 11/22/17 09:25:40 AM
#979   Why so low it closed @$7.88 offer it Yo-Yo 11/22/17 09:25:05 AM
#978   Offering at $4.50 So this stock is done QServus 11/22/17 09:22:45 AM
#977   Dang what happened here smh Yo-Yo 11/22/17 07:47:51 AM
#976   Oh yea. Too little shares to go around QServus 11/17/17 04:59:16 PM
#975   Tried shorting this all day through TDA....not available bcapps66 11/17/17 04:58:15 PM
#974   WOW you are one lucky trader on this NotRichYet2 11/17/17 07:55:54 AM
#973   Yikes! Under $11 QServus 11/17/17 07:23:02 AM
#972   No Buddy out Long Time... was in at europtiger 11/17/17 05:50:05 AM
#971   Many like you have , now it has NotRichYet2 11/16/17 11:52:34 AM
#970   I am Glad i nailed the upmove and europtiger 11/16/17 11:48:37 AM
#969   What you are seeing now as far as NotRichYet2 11/16/17 11:28:32 AM
#968   FIRST do some good DD on this company NotRichYet2 11/16/17 11:21:33 AM
PostSubject