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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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#1091  Sticky Note $CHFS FDA 510(k) market cleared and CE marked ash111 03/20/18 03:38:16 PM
#1275   VA CONTRACT..IN HOUSE MANUFCTG..BULLISH AF $CHFS IHuser 08/30/18 08:40:28 AM
#1274   Moving! beetlejuice 08/23/18 02:13:16 PM
#1273   * * $CHFS Video Chart 07-25-18 * * ClayTrader 07/25/18 05:11:30 PM
#1272   Out @ $1.85 for sizable loss, minimized today. chmcnfunds 07/25/18 10:21:06 AM
#1271   CHFS...$1.83...Pre market on News...Chart linked from $1.50 alert... georgie18 07/25/18 08:55:54 AM
#1270   About time this turned.... more contracts to come! doncamel 07/25/18 08:37:45 AM
#1269   CHFS...$1.63...Hit $1.90 Hod...Chart linked from $1.50 alert...Psar flipped georgie18 07/24/18 07:56:21 AM
#1268   CHFS...$1.68...looking to test the 200ma resistance again on georgie18 07/23/18 11:02:58 AM
#1267   CHFS...$1.66...Psar flipped to a bullish Buy signal... georgie18 07/23/18 09:44:25 AM
#1266   CHFS...$1.70...Chart linked from $1.50 alert... georgie18 07/23/18 09:36:28 AM
#1265   CHFS...$1.50...Oversold Pincher Chart...Macd ready to cross...Williams signaling georgie18 07/23/18 06:40:20 AM
#1264   100% agreement ROCKHard 07/19/18 01:33:10 PM
#1263   What is the CEO's compensation annually, ash? conix 07/18/18 03:22:35 PM
#1262   Management should be replaced asap. ash111 07/18/18 02:51:02 PM
#1261   I sold CHFS awhile back in one account MTH4 07/18/18 12:48:34 PM
#1260   What is the Number #1 reason you are conix 07/18/18 10:48:45 AM
#1259   CHFS chart for the iBox conix 07/17/18 05:06:24 PM
#1258   CHFS chart for the iBox conix 07/17/18 05:06:24 PM
#1257   CHFS News: https://ih.advfn.com/p.php?pid=nmona&article=77851859 chemist72 07/12/18 08:54:45 AM
#1256   I have no idea. See no news and chmcnfunds 06/26/18 10:28:19 AM
#1255   Vow....down by 10% today....does anyone k ow what’s myjo 06/26/18 10:19:50 AM
#1254   Two days of low volume and down over-all chmcnfunds 06/15/18 02:04:33 PM
#1253   Chart showing reversal (MACD cross, SAR flip, PMO chmcnfunds 06/14/18 09:17:02 AM
#1252   Today market is up by 200 points and myjo 06/06/18 12:09:35 PM
#1251   Don't know much about management, but was frustrating chmcnfunds 06/05/18 04:16:58 PM
#1250   If market goes down this pos goes down. myjo 06/05/18 12:16:43 PM
#1249   In @ $2.75. 1st time trading. chmcnfunds 06/04/18 04:13:22 PM
#1248   loosing my patience here. ash111 05/30/18 03:44:39 PM
#1247   Agree.keep holding because such a great company/ products ash111 05/24/18 11:52:47 AM
#1246   So now you agree that this great company myjo 05/24/18 09:43:22 AM
#1245   $chfs solid company, strong balance sheet ( completely ash111 05/22/18 12:43:25 PM
#1244   More green again today.. turning around CHFS ANIA77 05/16/18 02:17:04 PM
#1243   Yesterday CHFS management was interviewed on Fox Business myjo 05/14/18 12:50:25 PM
#1241   This interview today with CHFS should give them MTH4 05/13/18 06:44:09 PM
#1240   Both will do well, I’m in KTOV too, doncamel 05/13/18 06:32:44 PM
#1239   I sold my PIOE but may buy back MTH4 05/13/18 06:31:38 PM
#1238   Hey MTH4! Long time since the PIO* days, doncamel 05/13/18 05:49:28 PM
#1237   Hi Don MTH4 05/13/18 05:48:08 PM
#1235   Vow this is indeed impressive! So if you myjo 05/13/18 04:48:07 PM
#1234   $15 consensus price target https://registrarjournal.com/2018/05/13/zacks-chf-so doncamel 05/13/18 12:42:40 PM
#1233   It closed after hours at 2.78 so from MTH4 05/11/18 10:01:49 PM
#1232   In last 5 days including today when markets myjo 05/11/18 08:11:30 PM
#1231   It would be better for CHFS to wait MTH4 05/11/18 01:34:47 PM
#1230   Just saw from Stocktwits that if CHFS were MTH4 05/11/18 01:12:24 PM
#1229   I sold at $3.50 but decided to start $oldier Hard 05/10/18 11:51:32 PM
#1228   It’s not about whether I’m short or long myjo 05/10/18 07:37:42 PM
#1227   Hi ash I posted this news report coming MTH4 05/10/18 04:22:06 PM
#1226   Great news and thanks for sharing. Long term MTH4 05/10/18 03:23:03 PM
#1225   You must be heavily shorted if you don't ash111 05/10/18 11:19:58 AM
#1224   All this BS doesn’t mean anything for existing myjo 05/10/18 11:05:34 AM
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