Yes, I have been adding to my position over the last week. I think we will break through resistance today of $10.60 and head back towards the $11.50 to $11.75 area and then the EU trial data on Oct. 28 sends us parabolic. EU trial data will be a HUGE catalyst.
With regard to safety: although this is a non-surgical procedure in and of itself, there are several risks that have been exhibited. First, there is great risk of thromboembolism from the newly created low flow areas within the left ventricle, even with chronic system anticoagulation. Other known issues are the creation of left ventricle arrhythmias by the suture line and overly aggressive stroke volume reduction.
Keep in mind when comparing C-Pulse with other devices/therapies that it's a minimally-invasive procedure where a pre-sutured cuff is attached to the left ventricle in order to alleviate the heart's cardiac load, thereby enabling it to work more effectively and efficiently while the heart so to speak, "rests." This is why they've been able to show such dramatic improvement, with several patients having already been reported as "weaned" completely from the device due to lack of heart failure symptoms. This is particularly significant as the device is for moderate to severe (Class III and ambulatory Class IV heart failure) - so patients with fairly severe symptoms. Another important point to note is that C-Pulse is non-blood contacting. That is, it's located outside of the bloodstream (safer this way). Lastly, this device can be disconnected so that patients can live temporarily free of therapy in order to do every day activities such as take a shower, go for a walk, or go swimming, if they so choose. In addition to C-Pulse's efficacy to-date, safety has also been a key differentiating factor, with no strokes, clots, bleeding or heart attacks seen in the feasibility study.
BioVentrix's product is essentially used to "shut off" damaged areas of the left ventricle such that only the healthy, functioning areas are actionable. It's used only for patients that have ischemic heart failure, which is limiting compared to C-Pulse in terms of market size. The procedure is not a standalone; it's generally done in association with surgery for a cardiac event (heart attack, etc.). You can look at it as a non-surgical (less invasive) approach to Batista's procedure. This was a surgical ventricular reduction therapy, which you may know, showed both early and late failure. Another comparison is to look at Acorn and Paracor's therapies, which are essentially passive approaches that do not seem to help with later stage heart failure patients.
Not to mention the Revivent technology is a complete joke compared to the C-Pulse System.
That's only 10 trading days away. Why anybody would sell, short or be on the sidelines before then is beyond comprehension and downright stupid. From a technical standpoint, the recent selling has been on very light volume and today's reversal and positive close is very bullish. A close above MA (50) of $10.57 tomorrow would be extremely bullish.
Consolidation for the next 7 to 10 days followed by a breakout to the $16 - $18 level. European data can can send us much higher than that. October will be an exciting month. I bought a bunch of call option contracts today.
RSI is back above 50. MACD and Slow Stochastics have cycled down and are just starting to move back up again. Consolidation for a several weeks prior to today's break out. Typically the longer the consolidation period, the longer the new uptrend will last. EU clinical trial data coming soon. Overall a VERY bullish scenario moving forward.
The consolidation phase is over and the uptrend has resumed. Now we head back towards $13.80 and when we take that out the next resistance point is $17.33 followed by $22.90. Or we just go parabolic when European data is released in October and blow through all of these.
Management's timing was perfect. As far as dilution, shares outstanding was 12.38M, public float 7.34M, another 3.8 million shares won't make a darn bit of difference in regards to dilution as the shares outstanding and public float still remain miniscule. And now we have $40 million in the bank. We got rid of all of the nervous nellies and day traders last week. We continue to consolidate nicely leading up to European data in October when we go parabolic. Keep your cool people, this will be one of the most lucrative investments ever in my opinion.
Exactly! I'm glad someone else realizes how Wall Street works. I would not be surprised to see SSH back to it's recent high of $13.80 by the end of next week.
$16 - $16.50 between now and mid November. Although if EU clinical data is stellar, we could double from here as I've seen happen so many times before.
EDEN PRAIRIE, Minn., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (SSH) today announced that the company is scheduled to present a corporate update at the following upcoming investor conferences for the balance of 2013:
2013 Credit Suisse Healthcare Conference
Presentation: Tuesday, November 12, 2013 at 9:30 AM MST at The Phoenician in Scottsdale, Arizona. Breakout session to immediately follow presentation at 10:00 AM MST
Presenting: Jeff Mathiesen, Chief Financial Officer
2013 Canaccord Genuity Medical Technology & Diagnostics Forum
Presentation: Thursday, November 14, 2013 at 3:30 PM EST at the Westin Grand Central in New York, New York
Presenting: Jeff Mathiesen, Chief Financial Officer
Barclays Select Series 2013: Growth Conference
Presentation: Tuesday, November 19, 2013 at 8:20 AM EST at 745 7th Ave in New York, New York (Club Room I)
Presenting: Kevin Bassett, Senior Vice President of Technology and Operations
Piper Jaffray 25th Annual Healthcare Conference
Presentation: Tuesday, December 3, 2013 at 1:30 PM EST at the New York Palace Hotel in New York, New York (Rutherford Room)
Presenting: Dave Rosa, Chief Executive Officer
Oppenheimer 24th Annual Healthcare Conference
Presentation: Wednesday, December 11, 2013 at 2:10 EST at the Crowne Plaza Hotel in New York, New York
Presenting: Jeff Mathiesen, Chief Financial Officer
About the C-Pulse(R) Heart Assist System
The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the United States, Canada and countries that do not recognize the CE mark approval, utilizes the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices (LVADs), artificial hearts or transplants. It may also provide relief from the symptoms of Class III and ambulatory Class IV heart failure and improve quality of life and cardiac function. Based on the results from our feasibility trial, we also believe that some patients treated with our C-Pulse System will be able to stop using the device due to sustained improvement in their condition as a result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to Investigational use.
About Sunshine(R) Heart
Sunshine Heart, Inc. is a medical device company focused on developing, manufacturing and commercializing the C-Pulse System for treatment of Class III and ambulatory Class IV heart failure. Sunshine Heart has completed an approved U.S. Food and Drug Administration (FDA) feasibility clinical trial of the C-Pulse System and presented the results in November 2011. In March 2012, the FDA notified the Company that it could move forward with an investigational device exemption (IDE) application. Sunshine Heart received unconditional approval from the FDA in November 2012 to initiate its pivotal trial. In July 2012 Sunshine Heart received CE Mark approval for its C-Pulse System in Europe. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with a wholly owned subsidiary in Australia. The Company has been listed on the NASDAQ Capital Market since February 2012.
Certain statements in this release are forward-looking statements that are based on management's beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including, without limitation, future clinical trial activities and results including patient enrollment in trials. These forward-looking statements are subject to numerous risks and uncertainties, including, without limitation, the possibility that our clinical trials do not meet their enrollment goals, meet their endpoints or otherwise fail, that regulatory authorities do not accept our application or approve the marketing of the C-Pulse System, the possibility that we may be unable to raise the funds necessary for the development and commercialization of our products, that we may not be able to commercialize our products successfully in the European Union and the other risk factors described under the caption "Risk Factors" and elsewhere in our filings with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements because they speak only as of the date when made and may turn out to be inaccurate. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. We may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.
For further information, please contact:
Blueprint Life Science Group
Chief Financial Officer
Sunshine Heart, Inc.
available nowadays. Maybe you should try one of them.
Should be a nice catalyst on Monday to push us higher and resume the uptrend. Recent news has been ALL POSITIVE. Market makers have been shaking the tree to get cheap shares before they run it up heading into Monday and beyond.