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Sunshine Heart Inc. (SSH)

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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: Current Report Filing (8-k) 02/16/2017 08:01:43 AM
SSH News: Securities Registration Statement (s-1) 02/14/2017 03:26:46 PM
SSH News: Current Report Filing (8-k) 02/10/2017 06:31:36 AM
SSH News: Sunshine Heart Compliant with Nasdaq Bid Price Requirement 02/10/2017 06:00:00 AM
SSH News: Statement of Changes in Beneficial Ownership (4) 02/09/2017 04:22:08 PM
PostSubject
#508   10K Buyer on level 2 last time i Stockexpertpro 02/08/17 10:43:03 AM
#507   Thanks for that. easymoney 02/08/17 09:51:20 AM
#506   300,000 Shares Sold Naked Short Yesterday Along on Stockexpertpro 02/08/17 09:49:55 AM
#505   Setting up a higher base looks like as easymoney 02/07/17 04:49:39 PM
#504   A little green today. Trying for those $6's!! Lone Wolf 02/07/17 04:42:34 PM
#503   Yep, close above 5.95 that will b perfect. easymoney 02/07/17 02:35:31 PM
#502   You called it! Looking like a nice spirilis 02/07/17 02:29:49 PM
#501   Watching!! ;-) $SSH Lone Wolf 02/03/17 02:09:29 PM
#500   I'm thinking next week Tuesday or Wednesday! Really QUANTUM314 02/03/17 01:57:47 PM
#499   Higher highs today we might b ready for easymoney 02/03/17 11:31:13 AM
#498   Ditto. ash111 02/03/17 11:27:25 AM
#497   Great News Notice how they are holding back Stockexpertpro 02/03/17 11:05:18 AM
#496   the 8k today make sense per this. very ash111 02/03/17 10:35:34 AM
#495   Sunshine Heart adds seasoned commercial executives to board; ash111 02/03/17 10:01:39 AM
#494   Yep, added more today at lows. easymoney 02/02/17 06:16:55 PM
#493   I'm feeling that push is afore us bro! Lone Wolf 02/02/17 06:16:13 PM
#492   Nice ah buy activity 5.75 ash111 02/02/17 05:49:23 PM
#491   5.96 I meant. easymoney 02/02/17 04:48:49 PM
#490   Might see the real deal by Monday on easymoney 02/02/17 04:48:14 PM
#489   SSH 500K Bidder on Level 2 Whats that Stockexpertpro 02/02/17 11:37:32 AM
#488   SSH = Next WINS ?? Stockexpertpro 02/02/17 11:36:16 AM
#487   Man...you always did have good timing on these Lone Wolf 02/01/17 08:57:17 PM
#486   Chart almost there hoping to add lows by easymoney 02/01/17 04:55:14 PM
#485   Totally agree. ash111 02/01/17 09:17:33 AM
#484   Pretty clear to me now they are timing QUANTUM314 01/31/17 05:21:16 PM
#483   A good coverage https://www.equities.com/news/sunshine-heart-ssh-c-pulse-still-has-life-left ash111 01/31/17 05:15:05 PM
#482   Yes, it was. The sneaky patent along with G3TCRUNK3R 01/31/17 04:03:02 PM
#481   ask G3TCRUNK3R, but there are more reasons I ash111 01/31/17 03:20:39 PM
#480   was that patent issued today..news maybe ? zino 01/31/17 03:19:28 PM
#479   SSH all in one DD: still thinking the ash111 01/31/17 02:50:15 PM
#478   I'm long $SSH for 250 shares at 5.50 G3TCRUNK3R 01/31/17 12:43:41 PM
#477   Per risk vs reward SSH is defiantly a buy. ash111 01/31/17 11:53:17 AM
#476   Nice find UP Trend 01/31/17 11:48:43 AM
#475   5.96 break and hold 6.23 next. easymoney 01/31/17 11:42:33 AM
#474   Traction bro!! $SSH Lone Wolf 01/31/17 11:41:16 AM
#473   Small float big news INTL 01/31/17 11:39:20 AM
#472   USPTO PATENT #9555176 - January 31st, 2017 G3TCRUNK3R 01/31/17 11:12:34 AM
#471   Start here in the US I would target Stockexpertpro 01/31/17 11:11:02 AM
#470   CEO Needs to go to work take the Stockexpertpro 01/31/17 11:08:27 AM
#469   Interesting DD. ash111 01/31/17 09:13:36 AM
#468   Huge Potential here Company should contact the Top Stockexpertpro 01/30/17 02:22:13 PM
#467   We have a slightly upwards channel forming here. QUANTUM314 01/29/17 02:36:51 PM
#466   Yep, either way watch it to break today's easymoney 01/27/17 05:41:39 PM
#465   I really thought it would confirm the beginning Lone Wolf 01/27/17 05:40:17 PM
#464   I added, will give it tell Tuesday but easymoney 01/27/17 04:48:35 PM
#463   It's one day...and a Friday...despite the red, volume Lone Wolf 01/27/17 03:32:54 PM
#462   CEO optimistic thru Third Quarter 2016 Conference Call http://files.shareholder. ash111 01/27/17 02:51:14 PM
#461   When can they start duliting the piss out RunningRiot 01/27/17 02:15:38 PM
#460   Would be nice but it's not looking very promising RunningRiot 01/27/17 12:41:51 PM
#459   Watch SSH stair step it's way up to QUANTUM314 01/27/17 11:55:34 AM
PostSubject