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.

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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.

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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.

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http://www.massdevice.com/blogs/massdevice/despite-long-road-ahead-sunshine-heart-worth-serious-look

MassDevice: Not A Lot Of Bargains Among Med-Tech Stocks

Medical technology stocks of all stripes have been enjoying a pretty exceptional run in the market, as healthcare has actually been 1 of the leading sectors in the recent rally. Unfortunately for investors, however, revenue, profits, and free cash flow have not been improving at the same rate, and the number of real bargains in the market has shrunk noticeably. While there are still a few opportunities that look undervalued, investors are increasingly finding themselves faced with a limited menu of attractive options.

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http://www.massdevice.com/blogs/massdevice/not-lot-bargains-among-medtech-stocks

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.

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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.

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Risky Sunshine Heart Looks Very Interesting

Hottest Device Stocks Of 2010

2010 was a tough year for medical device stocks. Investors faced up to the reality that a popular myth - that people do not meaningfully change their health care consumption because of the economy - is just not true. Investors also had to digest the impact of a suddenly much more industry-unfriendly FDA, which is imposing new (and in many cases unspecified) standards regarding safety and the trade-off with efficacy.


All in all, the medical device industry lost about 5% in 2010, just barely missing the bottom 10 list of underperformers. In fact, in broad terms, banks (which includes many subcategories), biotechnology, solar and for-profit education were the only ones separating medical devices from the bottom.

That said, it was not all doom and gloom in the sector. In fact, many medical device companies not only outperformed the industry but did quite well in absolute terms. Here are some of the notable performers of the year. (For a quick refresher, check out A Checklist Of Successful Medical Technology Investment.)

Growth Is Growth
NxStage Medical (Nasdaq:NXTM) does not get all that much attention, but this company has brought to reality what many companies have tried (and failed) to develop for at least two decades - an at-home hemodialysis system that actually works in both a technical and practical sense. NxStage is not profitable yet, but the company is posting double-digit growth (annualizing over $100 million). On top of that, sell-side analyst interest is picking up, and institutional investors are becoming a bigger player in the stock. All of that has fueled a better than 200% jump in the stock over the last year.  

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http://stocks.investopedia.com/stock-analysis/2010/Dec---Hottest-Device-Stocks-Of-2010-NXTM-DXCM-EW-VOLC-HRC-VAR-BSX1220.aspx