The Motley Fool: A Sneaky-Smart Med-Tech Buyer Does It Again

Ever since going out on its own, Covidien (NYSE: COV  ) has had a knack for doing deals that left many analysts and investors scratching their heads initially, only to generate better-than-expected revenue and margin synergies from the deals in the years afterward. Coviden is going back to the well again, buying Given Imaging (NASDAQ: GIVN  ) and further building its efforts in the $3 billion GI market.

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A Sneaky-Smart Med-Tech Buyer Does It Again

Seeking Alpha: For Exact Sciences, Approval May Be The Easy Part

Much as investors may wish it were true, it's not always the case that a great drug, test or medical device meets with real commercial success. Launching new med-tech products always involves an intricate dance between efficacy, patient control (in other words, doctors' "turf"), compliance, cost/benefit, and reimbursement. That could prove to be especially relevant in the case of Exact Sciences (NASDAQ: EXAS) and its non-invasive Cologuard colorectal cancer test.

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For Exact Sciences, Approval May Be The Easy Part

Seeking Alpha: A Med-tech Shopping List For Japanese Companies

Outside of pharmaceuticals and "big iron" applications like imaging, Japanese companies haven't made much impression on the U.S. healthcare market. That may be changing, though. As Japan faces its own aging population and companies look to diversify from traditional industries, healthcare is becoming an increasingly popular sector in corporate Japan.

It's still too soon to call it a real trend, but Japanese companies have recently shown an inclination towards accelerating their diversification by buying established U.S. med-tech names. Asahi Kasei recently announced a $2 billion-plus deal for ZOLL Medical (ZOLL), while a few months earlier Fujifilm stepped up to buy SonoSite (SONO). Though not exactly comparable, Terumo (a Japanese healthcare and device company) acquired CaridianBCT for over $2 billion early in 2011 to strengthen its position in the global transfusion equipment market.

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A Med-Tech Shopping List For Japanese Companies

Seeking Alpha: Exact Sciences Could Be Exactly What Biotech Investors Need

Genomic testing has been a mixed blessing for investors thus far. While progress in the lab and clinic has been significant, the investment picture has followed a pretty familiar pattern - huge enthusiasm (and overvaluation) up front, crushing disappointment, and then general apathy and pessimism. If the pattern continues, a host of commercial successes should begin to appear over the next few years.

One of the more promising molecular diagnostics companies to watch at present is Exact Sciences (EXAS) - a small biotech company in pivotal studies for its non-invasive screening test for colon cancer.

Two Years To The Starting Line
If things go to plan, Exact Sciences should be launching the Cologuard test about two years from now. As of the company's last report, there are 59 sites enrolling patients for its pivotal study, and another 20 or so should come online in the first quarter of 2012.

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Exact Sciences Could Be Exactly What Biotech Investors Need

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.



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