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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: 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
SSH News: Statement of Changes in Beneficial Ownership (4) 08/16/2017 07:32:00 PM
SSH News: Quarterly Report (10-q) 08/10/2017 04:05:36 PM
SSH News: Current Report Filing (8-k) 08/08/2017 08:17:23 AM
PostSubject
#818   Not a damn thing. jaytea 08/11/17 10:19:36 AM
#817   What's going on with the one? IXI 08/11/17 10:01:37 AM
#816   Market was nervous yesterday on NK worries should shurtha2000 08/09/17 12:41:20 AM
#815   $CHFS let's go!!!! TheInvincibleBull 08/08/17 08:24:11 AM
#814   * * $CHFS Video Chart 08-03-17 * * ClayTrader 08/03/17 05:21:05 PM
#813   https://seekingalpha.com/pr/16905793-chf-solutions-commences-manufacturing-trans ztraderx 08/03/17 12:30:59 PM
#812   NICE pop WOOT dollardeadline 08/03/17 11:38:14 AM
#811   Looks like Wednesday sucked. infunf 07/22/17 10:39:03 PM
#810   timbeeeeeer! infunf 07/22/17 10:38:00 PM
#809   CHFS a buy confirmed yesterday by american bulls stock1ace1 07/21/17 07:48:48 AM
#808   Chfs ~ .77 x .79 ~ Premarket ! stock1ace1 07/21/17 07:47:02 AM
#807   Chfs @.73~ stock1ace1 07/20/17 10:08:43 AM
#806   Who is he? Tim696969 07/16/17 03:29:51 PM
#805   $OPXA And $CHFS =$$$ 2 best bios 1 BESTTIPSMONEY 07/13/17 11:05:27 AM
#804   Mr. Duhoux has solid relationships with two large Sking87 07/13/17 10:51:11 AM
#803   CHFS https://globenewswire.com/news-release/2017/07/11/1042445/0/en/CHF-Solution BIGANDBAD 07/11/17 08:29:54 AM
#802   * * $CHFS Video Chart 07-07-17 * * ClayTrader 07/07/17 05:26:28 PM
#801   http://ir.sunshineheart.com/ HOLDING THIS FOR AT LEAST A YEAR BIGANDBAD 07/07/17 01:13:53 PM
#800   Boom! Migs123 07/07/17 10:40:45 AM
#799   huge buys kickin in finally shurtha2000 07/07/17 10:38:30 AM
#797   Here she goes... Migs123 07/06/17 10:03:30 AM
#796   Hit my 75 target start buying shurtha2000 07/06/17 10:02:56 AM
#795   This is gonna bounce hard. Shorty has played Migs123 07/06/17 09:59:45 AM
#794   Time for a rally today! Doc Hollywood 07/06/17 09:40:05 AM
#793   No price direction shown in the pre market. Doc Hollywood 07/06/17 09:25:04 AM
#792   25% of the float traded today with a Doc Hollywood 07/05/17 04:00:31 PM
#791   People would be smart to take advantage of Doc Hollywood 07/05/17 01:48:37 PM
#790   Well that is a good scenario. Let's hope Doc Hollywood 07/05/17 01:13:06 PM
#789   Stock was overbought on the FDA and now BIGANDBAD 07/05/17 12:56:31 PM
#788   Yeah, just don't know what it is going Doc Hollywood 07/05/17 11:41:50 AM
#787   might go to 75 doesnt look good shurtha2000 07/05/17 11:40:33 AM
#786   They're definitely taking it for a walk but bcapps66 07/05/17 11:39:23 AM
#785   Time for the MM's to walk this up Doc Hollywood 07/05/17 10:43:50 AM
#784   Thank you...to you as well... georgie18 07/05/17 10:21:03 AM
#783   Amen indeed. Happy belated fourth Goergie! Nobodys Fool 07/05/17 10:17:49 AM
#782   No problem...all stocks are frustrating till their not...CHFS georgie18 07/05/17 10:16:20 AM
#781   Agreed. Thanks for accepting my apology. I'm just Nobodys Fool 07/05/17 10:11:16 AM
#780   And here come the MM's walking it back down Doc Hollywood 07/05/17 09:42:03 AM
#779   Back over a dollar at the moment. That Doc Hollywood 07/05/17 09:35:23 AM
#778   Pre market mildly positive but we have to Doc Hollywood 07/05/17 09:16:11 AM
#777   CHFS... .97...pre market hits... georgie18 07/05/17 09:02:47 AM
#776   It is not oversold it was overbought and georgie18 07/05/17 08:43:55 AM
#775   With the late day reversal on Monday, let's Doc Hollywood 07/05/17 08:40:06 AM
#774   No insult intended. Charts are very helpful, however, Nobodys Fool 07/05/17 08:27:40 AM
#773   Don't insult those that have gained great wealth georgie18 07/05/17 08:20:49 AM
#772   That chart doesn't mean anything. Overbought 4x in Nobodys Fool 07/05/17 08:15:53 AM
#771   CHFS... .93...Chart...Overbought and trading way outside the upper georgie18 07/05/17 08:12:09 AM
#770   Educate yourself on this great company ! http://ir.sunshineheart.com BIGANDBAD 07/03/17 10:02:11 PM
#769   Love the look of the chart after 12:30 BIGANDBAD 07/03/17 07:26:08 PM
#768   Reversing nicely. :) Tim696969 07/03/17 12:59:22 PM
PostSubject