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

Investopedia: MELA Gets A Surprising "Yes"

When it comes to the FDA these days, almost anything is possible. In the last year, the agency has blocked applications that seemed like slam-dunks and granted approvals to long shots. Even though the FDA's position on MELA Sciences' (Nasdaq:MELA) MelaFind during the company's advisory panel meeting could best be summarized as "over our dead bodies," the FDA surprised the market Monday morning by issuing an "approvable letter" to the company, and MELA's stock is likely to soar in the immediate aftermath. (For more on the FDA, and the effect it can have on stock prices, read Pharmaceutical Sector: Does The FDA Help Or Harm?)


Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."

In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.



Read the full piece at the link here:
http://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx

St. Jude Is Fine Today, But What About Tomorrow?

St. Jude Medical (NYSE:STJ) is one of the relatively few large-cap medical technology companies managing to deliver ongoing growth through this tough part of the cycle. Unfortunately for shareholders, there is a great deal of uncertainty about whether St. Jude is going to continue to deliver enough growth to make the stock appealing for the long-haul. 

The Quarter That Was
St. Jude reported total revenue growth of 7% for the third quarter, with the company's large CRM (cardiac rhythm management) business growing at 7%, and the smaller atrial fibrillation and neuromodulation businesses growing 8% and 11% respectively. Relative to "same-store" results from Boston Scientific (NYSE:BSX) and off-calendar comparisons to Medtronic (NYSE:MDT), St. Jude is almost certainly capturing shares in the large and lucrative (but slow-growing) CRM market. That is a good thing, as that is 60% of the company's business.

Please see the link below for the full piece:
http://stocks.investopedia.com/stock-analysis/2010/St.-Jude-Is-Fine-Today-But-What-About-Tomorrow--STJ-BSX-MDT-AGAM-ABMD-THOR-ZOLL1021.aspx

Shopping Time In Medical Technology?

The following has been posted on Investopedia:
http://stocks.investopedia.com/stock-analysis/2010/Shopping-Time-In-Medical-Technology-MDT-VOLC-ZOLL-ABMD-THOR0506.aspx.

It is a little strange for me to see ATS Medical get a bid. We banked that company when I was just a junior analyst at Piper and the CEO/founder, Manny, was (and still is) a one-of-a-kind guy. ATSI has always been something of a sad lesson for me; sad in that it proves that the best technology/product doesn't always win and that the company with the better marketing is more likely to win. 

In any event, it's always fun to speculate on who may be next to go out in the space. I hope you enjoy the piece.  


Amidst the paper blizzard of earnings releases, a little deal in the med-tech world took place. Medical device giant Medtronic (NYSE:MDT) announced that it was buying small cardiology company ATS Medical (Nasdaq:ATSI) for about $370 million in cash and assumed debt. The deal will bring some quality heart valve technology to Medtronic and cash to long-suffering shareholders of ATS Medical.


Buy The TechnologyThe ATSI deal is a relatively minor one in the bigger scheme of things, but it does at least highlight one type of deal that could be increasingly attractive - tucking in a small company that has good technology, but has not been able to leverage it effectively. Following this mold, investors should look for companies that have acknowledged quality technology, but for whatever reasons have not been able to deliver the growth that investors want.

You can read the rest at Investopedia: http://stocks.investopedia.com/stock-analysis/2010/Shopping-Time-In-Medical-Technology-MDT-VOLC-ZOLL-ABMD-THOR0506.aspx.