Seeking Alpha: Can Sunshine Heart Survive To See The Dawn?

The market has turned very hostile toward high-risk small-cap med-tech companies, and Sunshine Heart (NASDAQ:SSH) has long struggled to deliver the sort of progress that would make it easy to argue that the market is being unfair. Although the company has resolved a clinical hold, enrollment rates have been an ongoing long-term disappointment and the company's targets for reimbursed procedures have proven much too optimistic. With that, that company's prospects for finishing its pivotal COUNTER HF trial, let alone advancing a better, fully implantable, version of its technology without exceptionally dilutive/expensive financing has basically vanished.

The company's C-Pulse device does seem to provide benefits and quality of life improvements to the majority of patients who get it, but the ongoing issues with site and patient enrollment would seem to speak to more significant problems at the management and strategic level. At this point, these shares look more like a lottery ticket - there are paths by which these shares could succeed from here (including both buyout and go-it-alone strategies), but between the financing and operational issues, it's also quite possible that further losses are in store for shareholders.

Continue here:
Can Sunshine Heart Survive To See The Dawn?

Seeking Alpha: Sunshine Heart's Path Is Long, But The Rewards Could Be Enormous

In the multiple times I've written about Sunshine Heart (NASDAQ:SSH), I've tried to emphasize the point that this is a "consenting adults" type of stock - the commercial promise of an effective device therapy that can not only halt the progression of heart failure but hold the line (and maybe improve it) is tremendous, but this is an undercapitalized company that still has to establish that the device works and that they can commercialize it.

Looking at other cardiology device companies, I believe there is at least a credible chance that Sunshine can generate $300 million or more in revenue ten years from now, with a gross margin in the 70%s and an operating margin potentially in the 30%s. Discounted back and adjusted for further funding needs, I continue to believe that $7 to $9 per share is a reasonable valuation range for what could well be a high-risk/high-reward story.

Read the full article here:
Sunshine Heart's Path Is Long, But The Rewards Could Be Enormous

Seeking Alpha: Clouds Still Mar Sunshine Heart's Outlook

Development-stage med-tech Sunshine Heart (NASDAQ:SSH) has had a good run up from its mid-December lows, and the company continues to move forward with the clinical development of a device-based approach for congestive heart failure that could mark a real improvement in quality of care. That said, the company continues to see frustratingly slow enrollment and pushback on reimbursement.

Unfortunately, there don't appear to be easy solutions to Sunshine Heart's primary problem - it lacks the resources of major cardiology companies like Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), or St. Jude Medical (NYSE:STJ) that could otherwise support and encourage enrollment. Getting the FDA's permission to run an interim analysis would certainly help, and the shares do appear undervalued, but the company is climbing a steep hill and investors shouldn't kid themselves into thinking that the need for a better treatment for heart failure and the apparent efficacy of Sunshine's C-Pulse system will, on their own, ensure a successful outcome.

Read more here:
Clouds Still Mar Sunshine Heart's Outlook

Seeking Alpha: Will Sunshine Heart Get Schooled If Enrollment Disappoints Again?

Sunshine Heart (SSH) shares have taken a beating since their fall 2013 peak, falling about 60% from their peak on a combination of slow pivotal trial enrollment and a sharp turn away from risky, speculative health care stocks. With Sunshine Heart due to report results tomorrow (May 13), it is a safe bet that investors will be keenly focused on the enrollment figures for the COUNTER-HF study, even though it may be too optimistic to assume that the company's awareness efforts have had a major impact at this point.

Read more here:
Will Sunshine Heart Get Schooled If Enrollment Disappoints Again?

The Motley Fool: New Ideas Offer Hope for Both Heart Failure Patients and Investors

Steep valuations and uncertainty about adoption have created a lot of volatility in the shares of HeartWare International (NASDAQ: HTWR  ) and Thoratec (NASDAQ: THOR  ) , the leading developers of ventricular assist devices or VADs that help seriously ill heart failure patients live longer, better lives. While these companies serve a patient population that is desperately in need of better therapy and can support over $1 billion in revenue, there has always been a bigger market in less seriously ill heart failure patients. Sunshine Heart (NASDAQ: SSH  ) has advanced a very interesting approach for these patients into a pivotal U.S. study, while HeartWare has just recently acquired its own pathway into what could be a multibillion dollar opportunity.

Continue here to The Motley Fool:
New Ideas Offer Hope for Both Heart Failure Patients and Investors

MassDevice: Despite A Long Road Ahead, Sunshine Heart Is Worth A Serious Look

If you've been following the medical device (and/or pharmaceutical) space for a while, you know that congestive heart failure is one of the nastiest, hardest to treat, chronic conditions out there. There's really no way to reverse the disease short of a heart transplant, and the drugs and device therapies available sort themselves out between "largely ineffective" and "effective, but with serious issues".

That's terrible news for those patients who have congestive heart failure, but it leaves a tremendous opportunity for Sunshine Heart (NSDQ:SSH). This small-cap med-tech from Minnesota appears to have an ingenious solution to the problem, one that is based around well-understood principles and relatively simple technology. Although it will be at least four to five years before commercialization in the U.S., and that's only if the pivotal study shows adequate efficacy and an acceptable risk/benefit profile, this is definitely a name to watch in the med-tech space as the company looks to bring a new option to the table for seriously ill CHF patients.

Read the full article here:
http://www.massdevice.com/blogs/massdevice/despite-long-road-ahead-sunshine-heart-worth-serious-look

Seeking Alpha: HeartWare Is Premium-Priced Growth, But Could Still Go Higher

Just in recent memory, investors have had little problem with talking highly-valued med-tech stories like Edwards Lifesciences (EW), Intuitive Surgical (ISRG), and Cepheid (CPHD) and pushing them even higher on their uncommonly strong revenue growth numbers. Along those same lines, I think HeartWare (HTWR) could continue to head higher, despite an already rich valuation, on news of strong share/unit growth. That said, investors would do well to notice that the three aforementioned stocks have all had periods where the stock sold off pretty sharply (and pretty quickly), so HeartWare is not for the faint of heart.

Read more here:
HeartWare Is Premium-Priced Growth, But Could Still Go Higher

Seeking Alpha: Risky Sunshine Heart Looks Very Interesting

I spent close to a decade following small-cap med-tech companies, and in that time I learned to be very skeptical whenever a company talked about having a potential treatment for congestive heart failure. While there are indeed many heart failure patients in the U.S. and EU and there are depressingly few treatment options (particularly for the more serious patients), companies, devices, and technologies have often proved long on hype and hope and short on real-world efficacy and cost benefit.

Maybe, just maybe, Sunshine Heart (SSH) will be different. The dearth of clinical data creates substantial risk here, as does the long timeline to pivotal trial completion and potential FDA approval. Even still, in a med-tech world with few highly promising companies trading at reasonable values, Sunshine is at least worth a look from aggressive risk-tolerant investors.

Please read the full article here:
Risky Sunshine Heart Looks Very Interesting