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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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News News Alert: CHF Solutions, Inc. to Present Healthcare Cost Analysis of Aquadex FlexFlow System Compared to Standard of Care in Heart Fail... 04/26/2018 08:30:00 AM
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#1091  Sticky Note $CHFS FDA 510(k) market cleared and CE marked ash111 03/20/18 03:38:16 PM
#1190   Well, I just did a quick look at ANIA77 04/26/18 11:40:19 PM
#1189   They have a lot of cash at hand myjo 04/26/18 11:26:30 PM
#1188   Net sales doubled between 2016 and 2017.. so ANIA77 04/26/18 09:03:16 PM
#1187   All paid pumpers have puked BS. Market knows myjo 04/26/18 08:52:45 PM
#1186   Look through Ash posts. He is good in ANIA77 04/26/18 08:43:02 PM
#1185   Noticed you here. I have been looking for Citrati 04/26/18 08:27:36 PM
#1184   CHFS another nice update.. no doubt company is ANIA77 04/26/18 11:06:06 AM
#1183   Sooner or later a big firm might acquire ash111 04/17/18 02:10:00 PM
#1182   And yet another agreement in Italy.. CHFS ANIA77 04/17/18 12:09:02 PM
#1181   In one week an agreement in Spain and ash111 04/16/18 02:20:33 PM
#1180   Could see a green close again. Someone is Bakerman_06 04/16/18 02:15:38 PM
#1179   Ma50 break occurred this past Friday, chart: http://stockcharts.com/h-sc/ui?s=C ash111 04/16/18 03:41:20 AM
#1178   when does 1st q earnings come out? MTH4 04/14/18 02:25:24 AM
#1177   Great recent news for CHFS! MTH4 04/14/18 02:24:30 AM
#1176   true. commercial.. ash111 04/12/18 04:25:06 PM
#1175   Shorts are playing with fire here. Company keeps ANIA77 04/12/18 04:21:36 PM
#1174   good close at $3.30. Tomorrow will be wild. aristotelisonassis 04/12/18 04:03:13 PM
#1173   CHFS I warned shorts. solid companies always pays ash111 04/12/18 03:48:06 PM
#1172   broke résistance ash111 04/12/18 03:37:52 PM
#1171   Boom!! aristotelisonassis 04/12/18 03:31:21 PM
#1170   next RKDA which i called at $4.4/sh ash111 04/12/18 02:58:01 PM
#1169   hold on tight ladies and gents. Patience will aristotelisonassis 04/12/18 02:41:39 PM
#1168   could break out in power hour today. Long here! aristotelisonassis 04/12/18 02:16:10 PM
#1167   https://twitter.com/ACInvestorBlog/status/984449023468810240?s=19 ash111 04/12/18 11:41:14 AM
#1166   $CHFS Gets first commercial orders for both Singapore ash111 04/12/18 10:52:43 AM
#1165   EDEN PRAIRIE, Minn., April 12, 2018 (GLOBE NEWSWIRE) buckiii2 04/12/18 08:35:27 AM
#1164   $16m cash,almost zero debt. No dilution. That's a ash111 04/10/18 09:51:30 AM
#1163   Imho though. Roadtojourney 04/10/18 09:41:43 AM
#1162   And then the dilution, making me bagholder again. Roadtojourney 04/10/18 09:41:21 AM
#1161   CHFS very good timing too as the company ash111 04/10/18 09:01:30 AM
#1160   CHFS news again. ANIA77 04/10/18 08:49:00 AM
#1159   will present at The MicroCap Conference on April ash111 04/09/18 10:47:34 AM
#1158   Holding all my shares long and strong! beachkarma 04/06/18 04:17:33 PM
#1157   CHFS green on red market,a strong catalyst. moving ash111 04/06/18 03:19:25 PM
#1156   The market is waiting for more details regarding ash111 04/06/18 01:42:15 PM
#1155   So why is it so undervalued? There must tjguy 04/06/18 11:14:32 AM
#1154   2 analysts set $15 p.t . Since we Rogue Gambler 04/05/18 06:03:08 PM
#1153   * * $CHFS Video Chart 04-05-18 * * ClayTrader 04/05/18 05:05:32 PM
#1152   it usually happens when someone is betting against ash111 04/05/18 02:50:17 PM
#1151   the agreement means that the company’s Aquadex FlexFlow ash111 04/05/18 01:23:58 PM
#1150   Just warning up today. More to come ash111 04/05/18 12:14:35 PM
#1149   long term. next Catalysts, April 9. stay tuned. ash111 04/05/18 09:43:22 AM
#1148   hmmm immediate valuation http://quotes.morningstar.com/stockq/analysis-report?&t=XNAS:CHFS&r ash111 04/05/18 09:31:39 AM
#1147   Hi shortie hope you burn peterus 04/05/18 09:26:07 AM
#1146   Not much interest from the tutes! Hmmmm! > crudeoil24 04/05/18 09:14:57 AM
#1145   Institutions holding only 4% of shares. Short interest crudeoil24 04/05/18 09:13:06 AM
#1144   Nice distribution news in Spain. crudeoil24 04/05/18 09:10:33 AM
#1143   Distribution news... up premarket.. . CHFS ANIA77 04/05/18 08:52:24 AM
#1142   CHFS 3.25 Pm on distribution agreement in spain. ash111 04/05/18 08:51:29 AM
#1141   $CHFS news. CHF Solutions to Present at The ash111 04/03/18 06:35:49 AM
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