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Sunshine Heart Inc. (SSH)

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Last Post: 4/20/2017 6:00:22 PM - Followers: 38 - 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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SSH News: Sunshine Heart Announces Closing of $9.2 Million Underwritten Public Offering and Full Exercise of Over-Allotment Option 01:03 PM
SSH News: Sunshine Heart Announces Closing of $9.2 Million Underwritten Public Offering and Full Exercise of Over-Allotment Option 01:00 PM
SSH News: Amended Statement of Beneficial Ownership (sc 13d/a) 04/20/2017 04:45:47 PM
SSH News: Initial Statement of Beneficial Ownership (3) 04/20/2017 04:42:14 PM
SSH News: Statement of Changes in Beneficial Ownership (4) 04/20/2017 04:25:16 PM
News News Alert: Sunshine Heart Announces Closing of $9.2 Million Underwritten Public Offering and Full Exercise of Over-Allotment Option 04/24/2017 01:03:10 PM
PostSubject
#626   $1.03 Aftermarket! !!!!!! Goldmind 04/20/17 06:00:22 PM
#625   Wow!!!!!!! Goldmind 04/20/17 05:47:27 PM
#624   Major of company buy 1.3m shares!!!!!!!!!! Weeeeeeeeee Goldmind 04/20/17 05:09:59 PM
#623   $4 coming !!!!!!!! Goldmind 04/20/17 05:09:18 PM
#622   Please sell now!!! Goldmind 04/20/17 11:48:04 AM
#621   Sell now!!!!! Company is bankrupt out of money: ( Goldmind 04/20/17 11:44:53 AM
#620   News!!!!!! Company has been delisted. Sell now !!! Goldmind 04/20/17 11:21:58 AM
#619   I'm out Goldmind 04/20/17 09:43:37 AM
#618   Goldmind, I bought back in @ 0.915 late pennyvestor 04/19/17 04:21:29 PM
#617   I'm in ;) Goldmind 04/19/17 03:32:38 PM
#616   Says they are selling stocks with warrants, doesn't Muddy_m0ney 04/19/17 01:59:57 PM
#615   Who's buying? jablome 04/19/17 10:23:10 AM
#614   Howdy! $SSH GoodWill 04/19/17 09:11:04 AM
#613   Howdy! $SSH GoodWill 04/19/17 09:10:56 AM
#612   Notice of effectiveness posted... Muddy_m0ney 04/19/17 07:31:22 AM
#611   Here it is bottom area 1.70 volume starting T1aris 04/04/17 02:06:41 PM
#610   Where do you think is bottom here? artman 03/29/17 01:45:27 PM
#609   Out at 2... adios... glta BuildingCoin1 03/29/17 09:58:47 AM
#608   Out and moving on. GL all no shorts 03/29/17 09:35:05 AM
#607   Get an extension and drop an offering. How QUANTUM314 03/29/17 09:29:04 AM
#606   The 5mill offering from 3/21 is finished, but no shorts 03/29/17 09:25:42 AM
#605   Fak QUANTUM314 03/29/17 08:53:56 AM
#604   They f'ed us. 18million offering per the s1 no shorts 03/29/17 08:22:46 AM
#603   S1 out as well.... no shorts 03/29/17 07:43:20 AM
#602   Nice find on NEWS joe! BuildingCoin1 03/29/17 07:35:50 AM
#601   Nice timing on that extension. Could bring volume today. no shorts 03/29/17 07:33:56 AM
#600   https://globenewswire.com/news-release/2017/03/29/946240/0/en/Sunshine-Heart-Rec Joecanada13 03/29/17 06:29:14 AM
#599   Anyone else happen to realize the closing price QUANTUM314 03/29/17 01:14:35 AM
#598   March 23, 2017, the Series C Convertible Preferred QUANTUM314 03/29/17 12:54:28 AM
#597   Warrant Exercise Agreement On February 15, 2017, we QUANTUM314 03/29/17 12:11:00 AM
#596   Thanks BC. SPORTYNORTY 03/28/17 10:32:27 PM
#595   Well I'm all loaded up. Gonna be an Joecanada13 03/28/17 09:35:24 PM
#594   The reality of stocks is that you can DFDBTB 03/28/17 08:48:24 PM
#593   LoL. Sorry bud. Tout SSH all Lone Wolf 03/28/17 08:23:15 PM
#592   Lol that's hilarious Joecanada13 03/28/17 07:41:58 PM
#591   I got suspended from stocktwits for alerting this QUANTUM314 03/28/17 07:19:45 PM
#590   Game on Sport... helluva close! BuildingCoin1 03/28/17 04:06:14 PM
#589   Nice.. BuildingCoin1 03/28/17 03:43:31 PM
#588   SQEEZE EM no shorts 03/28/17 03:40:11 PM
#587   Big bids showing up. Saw a 50k on 2.05 no shorts 03/28/17 02:26:07 PM
#586   These MMS are loading this is going to launch QUANTUM314 03/28/17 02:23:45 PM
#585   Short squeeze into power hour. Low float rocket potential. no shorts 03/28/17 02:01:20 PM
#584   Hoping so got in at 2.00. These low QUANTUM314 03/28/17 01:31:56 PM
#583   Volume picking up... nice my friend... BuildingCoin1 03/28/17 01:26:25 PM
#582   Thank You, Thank You. SPORTYNORTY 03/28/17 01:24:27 PM
#581   Finally a bounce here huh? Had to Lone Wolf 03/28/17 01:23:31 PM
#580   Nice call on bottom SPORTY!!! BuildingCoin1 03/28/17 01:23:14 PM
#579   Looking good... BuildingCoin1 03/28/17 01:03:39 PM
#578   Let's get this moving! Giving it a nice no shorts 03/28/17 01:01:53 PM
#577   BEAST MODE ENGAGED! DFDBTB 03/28/17 12:40:45 PM
PostSubject