When I wrote on MAKO Surgical (MAKO)
in the wake of disappointing first quarter results, I mentioned an old
wives tale that says med-tech companies miss in threes. Based on
management's warning that second quarter results would come up short of
lowered expectation, it looks we may have one more yet to go.
Read more here:
MAKO's Blood Is In The Water
Showing posts with label Hansen Medical. Show all posts
Showing posts with label Hansen Medical. Show all posts
Tuesday, July 10, 2012
Monday, September 26, 2011
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.
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.
Tuesday, July 12, 2011
Investopedia: Better Budgets, Better Times For Robots
The healthcare capital equipment market is slowly getting better, as hospitals are starting to pick up spending in the wake of the budget lockdowns forced by the credit crisis and recession. Not only is that good news for major imaging system companies like General Electric (NYSE:GE) and radiology companies like Varian (NYSE:VAR), but also for the burgeoning field of surgical robotics.
Intuitive - Biggest and Best, But Not Home-Free
The go-to name in surgical robotics has pretty much always been Intuitive Surgical (Nasdaq:ISRG), and the company has been exceptionally successful in placing its da Vinci robots in surgery centers around the world. Revenue has rocketed from $227 million in 2005 to over $1.4 billion last year, and the company has established a very profitable recurrent business model.
The challenge for Intuitive is what comes next. Intuitive has done a great job of advertising the benefits that da Vinci can bring to procedures like prostatectomies and hysterectomies, and the company has a strong position in urology and gynecology. The trouble is, Intuitive's shareholder base is ravenous when it comes to demanding growth, and Intuitive needs to start proving that its long-held promise in markets like colorectal, thoracic and cardiology can actually bear fruit. Success will mean hundreds of millions of dollars more in recurrent revenue, but investors will not wait forever.
To read the full piece, please click below:
http://stocks.investopedia.
Intuitive - Biggest and Best, But Not Home-Free
The go-to name in surgical robotics has pretty much always been Intuitive Surgical (Nasdaq:ISRG), and the company has been exceptionally successful in placing its da Vinci robots in surgery centers around the world. Revenue has rocketed from $227 million in 2005 to over $1.4 billion last year, and the company has established a very profitable recurrent business model.
The challenge for Intuitive is what comes next. Intuitive has done a great job of advertising the benefits that da Vinci can bring to procedures like prostatectomies and hysterectomies, and the company has a strong position in urology and gynecology. The trouble is, Intuitive's shareholder base is ravenous when it comes to demanding growth, and Intuitive needs to start proving that its long-held promise in markets like colorectal, thoracic and cardiology can actually bear fruit. Success will mean hundreds of millions of dollars more in recurrent revenue, but investors will not wait forever.
To read the full piece, please click below:
http://stocks.investopedia.
Thursday, April 21, 2011
Investopedia: Intuitive And The Price Of Scarcity
There is a definite lack of exciting growth stories in medical devices these days, and that is certainly part of the attraction of surgical robot maker Intuitive Surgical (Nasdaq:ISRG). Of course, a monopoly position in a potentially huge market and demonstrated improvements in patient outcomes does not hurt either.
The question is, though, will investors continue to willingly pay such a premium for the shares with current growth rates?
A Quarter that Isn't as Strong as It Looks
Intuitive once again surpassed the average revenue estimate, and 18% overall growth is not bad. What's more, instrument revenue growth of 28% was quite good and procedure growth of 30% clearly shows that the daVinci system is gaining share in its targeted procedure base.
On the other hand, system revenue rose less than 8% and the company booked 88 net new placements this quarter - continuing a fairly unimpressive recent trend of net placements. What's more, ASPs fell again - dropping 5% from last year and about 2% from the fourth quarter. Ironically, analysts used to fret when system growth was strong and instrument/procedure growth was not so impressive - now they have it the other way around and are still complaining. (For more, see Med-Tech Choice Is Simply Intuitive.
To continue, please click the link:
http://stocks.investopedia.
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