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?
Showing posts with label Cyberonics. Show all posts
Showing posts with label Cyberonics. Show all posts
Tuesday, May 13, 2014
Thursday, February 6, 2014
Seeking Alpha: Depression Likely The Biggest Incremental Driver For Cyberonics
Watching Cyberonics (CYBX)
evolve over the years has been pretty compelling. I was part of a
sell-side research team that covered the stock in the late 90s and early
00s and followed the company as it struggled to gain the acceptance of
the FDA, physicians, and patients, not to mention overcome a
particularly aggressive CEO. In more recent years, the company has
settled into a solid growth trajectory driven by incremental market
penetration and a very strong replacement cycle, while delivering
impressive margins.
The question is what comes next. While I do believe the company's core addressable market in developed countries (epilepsy) remains significantly under-penetrated, I don't see that changing rapidly or dramatically. That puts even more significance on the under-developed opportunity in depression, where the company has only a limited opportunity to drive real change. Although these shares aren't all that expensive relative to other growth med-techs on the basis of multiples, it's going to take either accelerated penetration in epilepsy or upside in depression to drive a higher intrinsic fair value.
Continue here:
Depression Likely The Biggest Incremental Driver For Cyberonics
The question is what comes next. While I do believe the company's core addressable market in developed countries (epilepsy) remains significantly under-penetrated, I don't see that changing rapidly or dramatically. That puts even more significance on the under-developed opportunity in depression, where the company has only a limited opportunity to drive real change. Although these shares aren't all that expensive relative to other growth med-techs on the basis of multiples, it's going to take either accelerated penetration in epilepsy or upside in depression to drive a higher intrinsic fair value.
Continue here:
Depression Likely The Biggest Incremental Driver For Cyberonics
Saturday, February 9, 2013
Seeking Alpha: EnteroMedics May Get Approval, But Will It Get Sales?
Friday was not a good day for EnteroMedics (ETRM)
shareholders. Although it would be a stretch to say that there was a
real expectation that this company had a high-potential weight loss
solution in its hands (the market cap was about $125 million prior to
Friday's news), there were definitely some analysts and investors who
thought that the company's VBLOC therapy and Maestro system had
potential in treating morbidly obese individuals.
While the company's ReCharge study was a technical failure, there was evidence of efficacy from the device and the safety profile was pretty clean. Even so, convincing the FDA to approve this system may not even be the biggest issue for the company. The bigger issue is whether the company can sell physicians, insurance companies, and ultimately patients on the device.
Continue reading here:
EnteroMedics May Get Approval, But Will It Get Sales?
While the company's ReCharge study was a technical failure, there was evidence of efficacy from the device and the safety profile was pretty clean. Even so, convincing the FDA to approve this system may not even be the biggest issue for the company. The bigger issue is whether the company can sell physicians, insurance companies, and ultimately patients on the device.
Continue reading here:
EnteroMedics May Get Approval, But Will It Get Sales?
Friday, March 23, 2012
Seeking Alpha: Can Uroplasty Drive Adoption Of Its Better Mousetrap?
A lot of investors seem to think that all a company has to do to succeed in health care is develop a better therapy and the patients and docs will magically appeal. Unfortunately, that's never been true - strong clinical data and large under-served patient populations certainly help make a good story, but strong marketing often matters quite a bit.
That seems particularly relevant in the case of micro-cap med-tech company Uroplasty (UPI). The company's Urgent PC neurostimulation system for overactive bladder really does seem like a viable alternative in the $3 billion market it serves, but adoption has been slow and the company still has a lot yet to prove.
Read the full article here:
Can Uroplasty Drive Adoption Of Its Better Mousetrap?
That seems particularly relevant in the case of micro-cap med-tech company Uroplasty (UPI). The company's Urgent PC neurostimulation system for overactive bladder really does seem like a viable alternative in the $3 billion market it serves, but adoption has been slow and the company still has a lot yet to prove.
Read the full article here:
Can Uroplasty Drive Adoption Of Its Better Mousetrap?
Tuesday, March 13, 2012
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.
Please follow this link for more:
A Med-Tech Shopping List For Japanese Companies
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.
Please follow this link for more:
A Med-Tech Shopping List For Japanese Companies
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, December 28, 2010
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.
Please follow the link:
http://stocks.investopedia.
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.
Please follow the link:
http://stocks.investopedia.
Friday, November 19, 2010
MELA Sciences' New Device - Will It Be Approved?
On Thursday, would-be medical device manufacturer MELA Sciences (Nasdaq:MELA) got its day in front of an FDA advisory panel. Despite an unrestrained barrage from the FDA regarding the utility, safety and efficacy of the company's investigational device, MelaFind, the panel nevertheless gave an equivocal vote on the device. In the final tally, the panel voted that the device was safe and effective, and very narrowly voted that its potential benefits outweighed the risks.
Will The Panel Sway a Skeptical FDA?
Here again is the time and place for the boilerplate notice that although the FDA often does follow the advice of its panels, it is not obligated to do so and has in the past issued decisions contrary to the panel's vote. This seems to be an example of another case where that is likely.
The link below leads to the full article:
http://stocks.investopedia.
Will The Panel Sway a Skeptical FDA?
Here again is the time and place for the boilerplate notice that although the FDA often does follow the advice of its panels, it is not obligated to do so and has in the past issued decisions contrary to the panel's vote. This seems to be an example of another case where that is likely.
I have worked in the medical device industry as a securities analyst and consultant for nearly 15 years, and I have never seen the FDA object to a device with as much rigor as they directed toward the MelaFind. There have certainly been debates and disagreements in the past; panels for medical device makers like Cyberonics (Nasdaq:CYBX) and Therasense (now part of Abbott Labs (NYSE:ABT)) featured some intense disagreements and pointed barbs, but nothing quite like this.
The link below leads to the full article:
http://stocks.investopedia.
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