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Sunshine Heart Inc. (SSH)

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Last Post: 10/15/2014 11:51:52 AM - Followers: 19 - Board type: Free - Posts Today: 0
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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Option Chain for SSH
SSH News: Statement of Changes in Beneficial Ownership (4) 04:41 PM
SSH News: Quarterly Report (10-q) 04:22 PM
SSH News: Statement of Changes in Beneficial Ownership (4) 10/10/2014 04:11:30 PM
SSH News: Statement of Changes in Beneficial Ownership (4) 10/02/2014 04:51:12 PM
SSH News: Statement of Changes in Beneficial Ownership (4) 10/02/2014 04:37:03 PM
News News Alert: Statement of Changes in Beneficial Ownership (4) 10/31/2014 04:41:13 PM
PostSubject
#243   Back into the 4s. Wow matthewverymuch 10/15/14 11:51:52 AM
#242   JACC HF publishing results from 2007-2011 studies. Strong results! RealGenius 10/11/14 11:49:15 AM
#241   Radio ads running again. RealGenius 09/27/14 10:55:42 AM
#240   Want to add a good chunk to my matthewverymuch 08/13/14 05:53:59 PM
#239   Apparently, things are moving forward. The next two matthewverymuch 08/12/14 10:23:47 AM
#238   Happier, yet. Market apparently liked the 2Q update. RealGenius 08/12/14 10:04:52 AM
#237   This could very well be the worst stock matthewverymuch 08/01/14 02:30:30 PM
#236   How about some insider buys once in a while!? matthewverymuch 07/30/14 04:31:50 PM
#235   Boring. Another Form 4 declaring stock options. RealGenius 07/30/14 04:27:49 PM
#234   That is a big catalyst, but i seem matthewverymuch 07/19/14 07:09:52 PM
#233   Next catalyst, Mid-2015 for OPTIONS-HF European P4 post marketing RealGenius 07/19/14 06:57:31 PM
#232   It's all about enrollments matthewverymuch 07/19/14 06:49:07 PM
#231   I'd say easy double by xmas...maybe triple matthewverymuch 07/19/14 06:48:45 PM
#230   $4.85-5 support. Next support? Anyway, easy double in 2 years. Long RealGenius 07/19/14 06:47:33 PM
#229   Likewise matthewverymuch 07/19/14 06:40:09 PM
#228   Adding under $5. RealGenius 07/18/14 02:36:49 PM
#227   Single share trades going through all day long RealGenius 06/25/14 01:11:01 PM
#226   *meant under 6.. matthewverymuch 05/19/14 02:23:22 PM
#225   Man...are we ever going to see 7+ again? matthewverymuch 05/19/14 02:22:44 PM
#224   Spreading the word...one radio market at a time matthewverymuch 04/28/14 11:55:58 AM
#223   No, just a "Sunshine Heart, makers of the RealGenius 04/28/14 11:54:04 AM
#222   Was it an ad looking for trial participants? matthewverymuch 04/28/14 11:51:19 AM
#221   Yes. RealGenius 04/28/14 09:18:52 AM
#220   That's you on stock twits? matthewverymuch 04/28/14 09:12:55 AM
#219   Heard a radio ad for SSH this morning. RealGenius 04/28/14 07:50:55 AM
#218   Oppy likes how things are going. Expect 20-30 matthewverymuch 04/27/14 11:48:17 PM
#217   Trending on StockTwits ... Not sure why. I believe RealGenius 04/26/14 08:19:32 PM
#216   10% in two days. Good times matthewverymuch 04/11/14 04:10:11 PM
#215   PR this morning announcing the presentations (2) at RealGenius 04/03/14 07:50:08 AM
#214   Excert from Preliminary European Data, ... RealGenius 03/28/14 11:48:35 AM
#213   Preliminary Results from the C-Pulse® System European Multicenter RealGenius 03/28/14 11:47:24 AM
#212   Upcoming Poster Presentation: RealGenius 03/28/14 11:44:40 AM
#211   Don't see an SEC filing for $100M, just RealGenius 03/24/14 04:09:25 PM
#210   They filed a 100 million dollar shelf?? What matthewverymuch 03/24/14 11:09:12 AM
#209   S-3 ATM I don't like these on things I RealGenius 03/22/14 01:08:36 PM
#208   It appears that this is going to replace matthewverymuch 03/22/14 09:42:16 AM
#207   Yes. Bad times for this trade, but an RealGenius 03/21/14 04:37:41 PM
#206   The hits keep on coming...what a company matthewverymuch 03/21/14 04:34:32 PM
#205   S-3 filing RealGenius 03/21/14 04:21:49 PM
#204   Open market buys. RealGenius 03/21/14 04:15:40 PM
#203   ISHLT next month. RealGenius 03/21/14 10:40:39 AM
#202   Open market buys from insiders off that $6.10's. RealGenius 03/18/14 12:16:35 PM
#201   Many of the insiders who received stock as RealGenius 03/18/14 12:15:59 PM
#200   6.56 up 10% marcusanimal 03/18/14 11:51:46 AM
#199   Slow enrollment and short sellers have absolutely destroyed matthewverymuch 03/17/14 02:54:15 PM
#198   Anyone know what the insider sales of wiliam matthewverymuch 03/14/14 07:52:45 PM
#197   Never thought I'd get a chance to get novicetrader 03/13/14 03:18:22 PM
#196   Very attainable for SSH to stay on track RealGenius 03/11/14 11:50:45 PM
#195   With 32 sites activated (maybe a few more matthewverymuch 03/11/14 11:16:48 PM
#194   Enrollment numbers are just fine. Most centers involved RealGenius 03/11/14 08:44:37 PM
PostSubject