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Sunshine Heart Inc. (SSH)

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Last Post: 1/23/2017 1:24:28 PM - Followers: 42 - Board type: Free - Posts Today: 3

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
[email protected]
+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
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SSH News: Statement of Ownership (sc 13g) 01/20/2017 11:18:18 AM
SSH News: Amended Statement of Ownership (sc 13g/a) 01/19/2017 06:03:15 AM
SSH News: Statement of Changes in Beneficial Ownership (4) 01/17/2017 04:25:18 PM
SSH News: Statement of Changes in Beneficial Ownership (4) 01/17/2017 04:13:34 PM
SSH News: Current Report Filing (8-k) 01/13/2017 09:01:54 AM
PostSubject
#428   600k after Friday's Sabby's stake in Sunshine Heart ash111 01/23/17 01:24:28 PM
#427   Market Cap 3 Million Float 600k Stockexpertpro 01/23/17 12:17:55 PM
#426   This reversed in the $5's and remains a jones99 01/23/17 05:55:34 AM
#425   Hard to tell. A lot of short trades. dontforgetme 01/21/17 12:52:47 AM
#424   Bottom $5? QUANTUM314 01/20/17 10:35:20 PM
#423   Thank you for your info. dontforgetme 01/20/17 01:55:10 PM
#422   if issue more shares the answer is yes. ash111 01/20/17 01:53:36 PM
#421   You think they are gonna dilute? dontforgetme 01/20/17 01:49:50 PM
#420   As I mentioned before, company need Cash.they can ash111 01/20/17 01:22:47 PM
#419   At this history low and the 4 times dontforgetme 01/19/17 11:49:26 PM
#418   ver possible, low float, might be manipulated by MMs. dontforgetme 01/19/17 10:29:51 PM
#417   This thing might rip tomorrow QUANTUM314 01/19/17 07:40:05 PM
#416   sure you did wilburb 01/19/17 04:56:22 PM
#415   Dip n dip. RunningRiot 01/19/17 12:13:56 PM
#414   Agreed. No one should ever buy this stock. RunningRiot 01/19/17 12:12:46 PM
#413   SSH I wont be surprised if an offering ash111 01/19/17 11:41:12 AM
#412   Sold it all at the market and went Stockexpertpro 01/19/17 11:26:44 AM
#411   ya dang this sucks sold for a HUGE Stockexpertpro 01/19/17 11:25:33 AM
#410   pump only.check their balance sheet.i tried to warned earlier: ash111 01/19/17 11:21:40 AM
#409   There ya go. jaytea 01/19/17 10:04:06 AM
#408   Dip n Rip ???? zino 01/19/17 09:49:28 AM
#407   if we get volume....can see 15-20 fast !!!! zino 01/19/17 09:21:00 AM
#406   SSH 8.8 not going down yet. Maybe squeeze PAC 01/19/17 09:16:40 AM
#405   SSH Saby Equity Owns 72% Link Stockexpertpro 01/19/17 08:53:53 AM
#404   They're going to be feeling it this morning!! Lone Wolf 01/19/17 08:52:55 AM
#403   Yeah I see that too, reminds me of Capitalvaluetrade 01/19/17 08:23:57 AM
#402   Looks like this had a short attack at Lone Wolf 01/19/17 08:15:38 AM
#401   SSH Pre-Market Volume 70,000+ Already more than yesterdays Capitalvaluetrade 01/19/17 08:00:26 AM
#400   SSH looking strong, these post RS plays, sure Capitalvaluetrade 01/19/17 07:09:29 AM
#399   $9.50 hit....29 trades so far on the day...damnnnn....most Lone Wolf 01/19/17 06:06:40 AM
#398   SSH $9.95 p/m ClearlyStocks 01/19/17 04:54:09 AM
#397   #post-split-low-float-squeeze [SMART MONEY] 01/18/17 09:32:00 PM
#396   SSH..any reason for A/H spike,don't see any news out? novicetrader 01/18/17 08:25:13 PM
#395   I know, right! ;-). Shhhhh indeed! LoL Lone Wolf 01/18/17 06:50:55 PM
#394   It will break out 9 before the close dontforgetme 01/18/17 06:03:44 PM
#393   Break $9 and yes it's SHOOOOWTIME!!!!! 867moneytime 01/18/17 05:52:23 PM
#392   ?$SSH $9 its showtime!? ClearlyStocks 01/18/17 05:40:00 PM
#391   Low Floater No Brainers In This Market !!!! zino 01/18/17 05:30:04 PM
#390   LMAO!!! SHEEPWOLF 01/18/17 05:28:52 PM
#389   Lol....reminding myself I bought when stock was up zino 01/18/17 05:28:51 PM
#388   I love it... [SMART MONEY] 01/18/17 05:27:25 PM
#387   $$$$$ Great buy Zino $$$$$ zino 01/18/17 05:26:16 PM
#386   ssh im trying to accumulate [SMART MONEY] 01/18/17 05:15:59 PM
#385   SSH $8.90 from $7.40 within a few min. ClearlyStocks 01/18/17 05:15:58 PM
#384   $SSH: 50DMA=8.84..COULD JUST RUN BUCK WILD AFTER THAT BREAKOUT!! SHEEPWOLF 01/18/17 04:55:29 PM
#383   SSH called $7.40 on twitter. Tiny float after 1/30 ClearlyStocks 01/18/17 04:35:48 PM
#382   Hugggeeee 600k float going to run hard. SSH QUANTUM314 01/18/17 04:30:36 PM
#381   Horray dontforgetme 01/18/17 03:59:57 PM
#380   Could do a DRY$ zino 01/18/17 02:28:44 PM
#379   I just bought in...glta here zino 01/18/17 02:27:17 PM
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