Showing posts with label Medical. Show all posts
Showing posts with label Medical. Show all posts

Friday, 27 September 2013

Is An Acquisition Of Solta Medical Imminent?

This is my second letter to the board. My first letter went without response or acknowledgement, as did several calls to both Mark Sieckarek and Jack Glenn. I interpret this as further evidence of your unwillingness to properly perform your duties. The Chairman believes hiring a replacement for Stephen Fanning and some marketing tweaks are sufficient. I suggest a bolder strategy is now required. Yes, this may result in some uncomfortable moments in your board meetings but your duties require you to be skeptical of the strategy being presented to you by a Management that has continually failed in its efforts to turn the company around.
I recently listened to Mr. Sieckarek's presentation at the Canaccord Growth conference on August 15, 2013. I had a particular issue with slide 24 where Mark disclosed: "leverage potential." Mark stated that when doing $185M in sales, Solta Medical will generate $0.23/share of net income.

This is exactly what I imagine he presented to this board as reason to either over inflate the true value of the company, to not sell the company and/or reason to continue as an ongoing stand-alone entity. More concerning is the fact that Mr. Sieczkarek is presenting these figures as the interim CEO, the "want to be" CEO (in my opinion), as well as Chairman of the Board, which is an obvious conflict of interest. Per my original letter where I described my personal experience with another company (which resulted in my filing of a 13D with the SEC), this is sadly an almost identical action to what I would expect from another entrenched Management team attempting to further their self serving interests at shareholder expense without challenge from independent directors.

I can only hope you are not blinded to the reality everyone else has seen in the past and lack of any measurable change to positively effect trends for the future. In my first letter to you I described why we no longer have the luxury to "wait and hope" that future earnings trends will be different than past trends. This economy, both in the U.S. and internationally, remains far too fragile to bear false hope on the same people with the same theories and plans to change the dynamics and future results.

This board needs to weigh the risk exposure by continuing along the same failed course of action at shareholder expense. More disappointing to all at the conference was that there was no mentioning the fact that the company has the "mechanisms to explore strategic options" (as stated "somewhere" in the quarterly press release).

Announcing that this strategy will be formally explored by no means indicates the company is desperate for a sale, but simply that it continues to remain undervalued and in order to maximize shareholder value, the board feels it is in the best interest to explore its options. The numbers presented at the conference in my opinion are actually extremely low when in the hands of many suitable acquirers.

This company cannot and should not wait and hope to see if you can correct years of failed efforts to create value for your shareholders. Not only do I personally think this is exercising bad business judgment, but much of the investment community feels the same. They fear exactly what I fear, that there is the chance of continuing operational loss (for internal reasons or circumstances outside company control) as opposed to planned profit. This would financially stretch this company too far which could result in either negotiating the sale of the company from a weak position or a costly attempt to raise capital at levels further depressed from where you already have us today.

While this may or may not be the case, it is your responsibility to mitigate our risk. This is coming from Wall Street professionals, as well as your shareholders. At what point will you recognize you are placing your shareholders and employees in further danger
each and every day you do not form a special committee, hire a professional M&A bank, and announce that to maximize shareholder value you will explore strategic alternatives? The company's history does not provide confidence that the Chairman's business as usual strategy will succeed. I will remind you all again that you have a fiduciary responsibility to use your best business judgment to protect the company and your shareholders.

The obvious remaining factor that keeps everyone positive on the company is that it is extremely undervalued with regard to its product lines, the scalability in the hands of a larger firm, and demand and growth of the aesthetics sector, as well as the margins for profitability.

There is a history of successful acquisitions in your industry, and the time has come to hand Solta Medical off to a company or group that can take this company, the products and its employees to the next level of success.

It is in the best interest of shareholders to explore the potential sale of Solta Medical, Inc. Companies that are looking to make acquisitions through full or partial methods of debt financing are extremely aware of the changing economic climate and rise of interest rates now and going forward. The window for some suitors may be closing should you continue to neglect your responsibilities to maximize shareholder value immediately. The action of the stock and your lack of action is extremely telling, so this is not just my opinion.

The significant defeat of the proposed increase in the authorized share count of Solta Medical on June 5, 2013, is clear evidence that shareholders have no confidence in this board. Your sole purpose is to serve shareholder needs and immediate bold action on our behalf is required now.

Of course, you and your management team are certainly allowed to purchase the company on your own accord if you are so inclined to ignore your shareholder requests and needs. In fact, most would welcome your offer measured alongside with the others!

Respectfully,
David Callan
Private Investor
Cc: Joel Bernstein, Esquire

David Callan in the above letter, points out one issue I have taken a serious look at. The issue falls under "best business judgment."

From Wikipedia we read:

The business judgment rule is a United States case law-derived concept in corporations law whereby the "directors of a corporation . . . are clothed with [the] presumption, which the law accords to them, of being [motivated] in their conduct by a bona fide regard for the interests of the corporation whose affairs the stockholders have committed to their charge."

To challenge the actions of a corporation's board of directors, a plaintiff assumes "the burden of providing evidence that directors, in reaching their challenged decision, breached any one of the triads of their fiduciary duty - good faith, loyalty, or due care."

The presumption of best business judgment is making business decisions not involving direct self-interest or self-dealing. Corporate directors act on an informed basis, in good faith, and in the honest belief that their actions are in the corporation's best interest.

It's hard to believe Solta is engaging in best judgment at this time and is engaging in best judgment in this case. Along with Callan, I have to ask "is risking more shareholder value destruction with the same management team in the shareholder's best interest?"

In an article I wrote covering Voce's successful fight in getting Obagi sold, I questioned whether or not Obagi's BOD was acting in the interest of shareholders or self-dealing, mainly because its CEO was also a CEO of another company that had an ongoing contract with Obagi. In Solta's case, I question whether directors are acting in the best interests of shareholders. If Callan decides to engage in legal action, I'm sure he would hire private investigators to look thoroughly at the actions of the BOD of Solta to determine if in fact, they have been self-dealing or not.

Chairman of The Board and Solta "interim" CEO Mark Sieckarek should consider not only Callan's involvement, but Voce Capital's involvement as well in this matter. Sources indicate to me that Sieckarek could be open to a sale of the company, but may be hesitant to hire a specialist investment banker to explore a sale of the company because of the fear of losing employees. Although my source may have been told this by Sieckarek, I have a hard time believing this is in fact a sincere concern. Voce indicates that there are at least three companies with interest in acquiring Solta now, so an acquisition now would mean employees may leave anyways. I believe a fair price of $3.75 to $4 should not be hard to negotiate currently.

Seeing there are potential interested suitors out there now while trying to turn around a company in which the current BOD has overseen years of shareholder destruction may in fact be a violation of legal fiduciary duties. I have to ask myself if Solta really wants to engage in a potential legal battle with both David Callan and Voce Capital. Voce was successful in getting Obagi to sell for a good price, and I have no question that it will succeed here. The question is how much potential pain the Solta BOD wants to endure here before being voted out by shareholders.

In June 2010, Callan filed a 13d with the SEC urging the sale of SRI Surgical (Formely Nasdaq listed STRC). Afterwards, SRI decided to adopt a shareholder rights plan (poison pill) when an unsolicited offer came in only four months later.

Soon after the time the unsolicited offer came in, the stock rallied to trade above $6.00 a share. However, at the time, the CEO and BOD felt that it was not the right time to sell the company. Instead they chose to follow what they described as a "strategic plan" which included the usual realignment and minor shifts in personnel. A year later after their "strategic plan" failed, they agreed to hire an investment bank and sell the company. As a result of their delay, shareholders accepted an offer of $3.70, a far cry from where the stock had traded just a year earlier. While Callan feels Solta is in a much stronger position than SRI was when he called for the sale, he feels the Solta board is obligated to explore an acquisition option while the company is in a desirable position. After years of failure to build shareholder value, the Solta BOD should now be compelled more than ever to maximize shareholder value. Solta is in a position of a revenue upswing, so only fair offers are worthy of consideration. I feel Solta Medical owes it to shareholders and employees to explore this option now, while there is strong interest as Voce has identified. Callan's strong medical device background and financial experience led him to urge the exploration of strategic alternatives in this case, and he hopes another lengthy and costly battle with another BOD is not necessary.

Case in point

BlackBerry (BBRY) recently received an offer of $4.7B, or roughly $9 a share from Fairfax Financial Holdings, a Canadian insurance firm.

BlackBerry's BOD had ample opportunity over a year ago to sell its company for a much higher price. Now, long-term shareholders of BlackBerry may be getting the shaft here, as it's my opinion BlackBerry should have been actively seeking to be acquired last year, when many companies were in a prime position to engage into a merger/acquisition due to continued lower interest rates and sector consolidation.

Many companies in BlackBerry's market segment have made several key acquisitions over the last year. BlackBerry could have, and should have, been one of these acquisitions, but management was "stubborn" and did not use its best judgment in my opinion to do what was best for its shareholders. Instead, it believed it could "turn the company around" and increase shareholder value, in which it failed miserably.

The current domestic economic conditions still see interest rates at record lows. Many larger companies in Solta's segment have taken advantage of this with levered/debt financed buy-outs of smaller companies.

Valeant (VRX) has aggressively expanded itself recently through various smaller acquisitions, making around 25 levered/debt financed deals a year since 2010. These are mainly focused on specialized high-margin markets, lately with its focus on the aesthetics market.

Valeant's recent strategy has been to buy high-margin healthcare product businesses that are strong in emerging markets - for example, Asia. In these markets, customers tend to pay directly for products and services rather than relying on government health plans.

Allegan (AGN) might be interested in acquiring Solta. Allegan is the well-known maker and seller of Botox, with a global market forecast to reach $2.9 billion by 2018, and the entire global market for facial aesthetics predicted to reach $4.7 billion. Solta recently announced a new product called the Thermage Total Tip 3.0. Thermage uses radiofrequency technology to non-invasively help smooth and contour the skin, as well as temporarily reduce the appearance of cellulite, in a single treatment with little to no downtime. The Thermage Total Tip is effective for facial treatments because it delivers uniform, volumetric bulk heating. Targeted, uniform, bulk heating could allow dermatologists to treat patients effectively while maintaining patient comfort.

I believe Allegan is one of the three interested companies in Solta as mentioned in a letter from Voce released July 19th of this year. Another potential bidder for Solta could be Nu Skin Enterprises Inc. (NUS). Nu Skin develops and distributes anti-aging personal care products and a wide range of skin-care systems and treatment products, including Spa Systems, Body Spas, Body Shaping Gels, Dermatic Effects Body Contouring Lotion and Transformation anti-aging skin care systems.

Nu Skin had a very good 2nd quarter this year which seems to be a common theme among companies in the beauty and skin care segment. Nu Skin is also seeing accelerated growth in Asia as the conference call comments confirm:

Turning our attention to a few geographic markets, greater China's growth obviously continues to be very strong. Sales in the second quarter in Mainland China were $198 million. And as we announced a few weeks ago, we're pleased that China recently approved 5 additional direct-selling licenses, which will become increasingly important as our business develops throughout China. We continue to invest to sustain growth in this market and are committed to working to ensure our long-term success there. From what we're seeing, we believe that the market continues to have significant upside potential.

Our north Asia region also had a very strong quarter. South Korea generated an impressive 54% quarterly gain in local currency and continues its long run as a stellar market for us. And Japan had another solid quarter with 5% revenue growth. The weakness of the yen against the dollar is obviously hurting our reported results, but we feel good about the direction of our business in Japan and we believe that North Asia can be a $1 billion market for us in the next few years.

In my opinion, the Asian market is where Solta's products can really generate significant revenues and profits moving forward.

Solta is on track to do around $190M in revenues over the next year. There is no question the company under different management can be very successful. This would include every single BOD member being replaced, along with hiring a well-known competent CEO. The current BOD has been present in the past and current destruction of Solta shareholder value; therefore they are responsible as the captains of the Solta ship.

Voce was in the process of replacing Obagi's BOD before it decided to finally cave in and sell its company. We can expect Voce to engage in the same tactics here with Solta. As I consider David Callan a personal friend, I also know his views line up with Voce's. The Solta BOD needs to fully understand its fiduciary duty to its shareholders it has continually wrecked. When a company agrees to be a publicly traded one, it has legal responsibilities it must adhere to. Both David and I feel that if the company chooses to continue forward and not officially hire an investment banker, it would not be using its best judgment.

Voce has stated that if it's necessary, it would force a sale of the company.

From Voce's last letter we read:

While we continue to believe Solta's assets are attractive, the only way to unlock their value is in the hands of a more successful operator; fortunately, there are several that are interested and shareholders can share in at least some of that value now through a strategic premium. By comparison, even if one were to believe meaningful stand-alone improvements were possible, the time and risks involved would have to be discounted heavily before concluding shareholders were better served waiting for those to potentially materialize versus taking the certain value in a sale today. During that time, one would also need to account for the risk that Solta's exit options might narrow as industry consolidation proceeds around it. Finally, anyone pining for the "good old days" should remember there are now 30% more shares outstanding versus a year ago. Getting back there is not only operationally, but mathematically, much more difficult now.

The only thing that has increased the stock price this year has been the expectation the Company would be sold. Recall Solta touched $2.89 not that long ago - solely on take-over speculation. Attempting to rebuild the stock through a complex turnaround, at the hands of a dubious leader, in the hope of then selling the Company off of a marginally higher base is worth neither the time nor the risks. We agree with the final assessment of yet another research analyst who said: "SLTM's stock performance is more heavily linked to take-out prospects, which very well may be SLTM's best option given that a turnaround as a stand-alone - even under new leadership - could prove challenging and lengthy. The decision to appoint Mr. Sieczkarek as CEO was disappointing enough, but we were appalled by his statements during the conference call. Mr. Sieczkarek made clear that his true intention is to become Solta's permanent CEO and, not coincidentally, that the Company will not explore a sale unless it is forced to do so. If necessary, that's exactly what we shall do.

Voce would likely force a sale by first applying pressure for a special shareholder meeting to vote out the entire current BOD of Solta. Solta's BOD cannot afford to wait until the official shareholders meeting next year considering interest rates may be significantly higher, along with a possible downturn in economic conditions by that time. At the very least, if an unsolicited offer has been made, the company has a duty to reveal this information publicly and let shareholders decide if any such offer is fair or not. By not exploring a sale now, it's my opinion the entire Solta BOD places itself in legal peril.

Conclusion

Sieczkarek and the board has a decision to make here. They can risk moving forward with Solta independently and most likely fail, get the boot from the BOD, and face potential legal battles and/or personal lawsuits. Or, sell and let shareholders decide on offers now as the current economic conditions are favorable. Sieczkarek also needs to consider his future prospects, as failure with Solta would likely mean he would be hard-pressed to find a new job, let alone to sit on any BOD again. However, selling Solta would likely gain him favor with many in the industry, and assure him continued employment in the sector.

Sieczkarek needs to take a closer look at what happened with SRI and BlackBerry while considering his fiduciary responsibilities to his shareholders and his future in the industry. In other words, put his ego aside and do the responsible thing as he is required to by law.

It's a virtual certainty that if Sieczkarek chooses to wait until next year's required shareholder meeting, he, along with the rest of Solta's BOD will be voted out and replaced at that meeting. Additionally, if the share price of Solta has significantly dropped by then, the entire Solta BOD would likely be facing numerous lawsuits. I am continually baffled with these types of corporate executives "not getting it." As Voce as mentioned, there is strong interest and sector consolidation, meaning the time is now to negotiate a deal that is satisfactory for the majority of Solta shareholders.

The majority of Solta's shareholders seem to want a sale now based on those I have spoken with. I call on Sieczkarek do the best thing for him and shareholders, and to carefully consider the possible negative outcomes if he fails to act properly.

Disclosure: I am long SLTM. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.

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Monday, 9 September 2013

Globus Medical: A Look At Catalysts That Will Drive Shareholder Returns

Executive summary

It is a fact that Globus Medical (GMED) maintains strong positive cash flows and yet it does not pay dividends. Rather than putting investors off, this should encourage them to find out more about this company that has successfully grown its revenues from quarter to quarter while maintaining almost flat company expenses. This article will show that it takes more than paying dividends to make any company worth your investment as Globus has a lot of catalysts that will drive shareholder returns in the future.

Getting to know Globus Medical

Globus is a company that operates in the Medical Devices industry with its focus on design, development and commercialization of various products geared toward helping spine disorder patients in their recovery journey. It was established in 2003 with headquarters in Audubon, Pennsylvania.

The company's products come in handy during thoracolumbar, interbody fusion, sacral and cervical procedures. It has been helpful in improving the rate of successful treatments of patients diagnosed with deformative, traumatic and degenerative conditions, including tumors.

Product offerings

The products offered by the company falls under two segments: Innovative Fusion and Disruptive Technologies segments. While the former services a broad range of spinal fusion surgical procedure needs, the latter offers services that improve the already existing procedures for such surgical procedures.

Now, with the Disruptive Technologies products, the company's management has proven its expertise when it comes to identifying a prospective market, even with its attendant risks. This is based on the fact that with these products meaning a shift in the known spine disorder treatments, physicians and patients are sure to go for it due to its attendant benefits but it was not going to happen with the flash of an eye. However, knowing that the technology improves surgical results, attracts minimal costs and limits patient's recovery period and hospital stay, the company's management expects increased demands for the applications in the nearest future.

Catalysts to drive growth

Revenue growth: In the last few quarters, Globus has continued to grow its revenue. Revenue for fourth quarter of fiscal 2012 came in at $100.5 million and increased to $105.0 million in first quarter of fiscal 2013 and $107.0 million in the second quarter of 2013.

Almost flat SG&A expenses: It is a common sight to see most companies' expenses increase as revenue increases. This is not the case with Globus as its company expenses remained almost flat even with the increase in revenue.

Flat cost of revenue: In the first quarter of fiscal 2013, the company reported $23.49 million as total cost of revenue and $23.50 million for second quarter of fiscal 2013. This shows that bringing in revenue is not expensive for the company.

Improving gross profit: With the company maintaining flat company expenses and cost of revenue, the gross profit will continue to improve.

Strong balance sheet: I know of several companies that pay dividends and yet have negative cash flow. Globus has a strong balance sheet with no debt in the last two fiscal periods. As at fiscal year 2012 ended December 31, 2012, the company had more approximately $212 million in cash.

Significant growth in the disruptive technology segment: The Innovative Fusion segment makes up a good percentage of the company's revenue at approximately 62%. The tide is beginning to turn as the fiscal year 2012 recorded a 38% increase in demand for products in the DT segment while the IF segment recorded 6%. This confirms management's expectations of increase in demand for DI products.

Proposed expansion: The company currently derives most of its revenue from its U.S. customers with only 8.3% coming from international markets. The company's management has set plans in motion to further expand its footprint in the international scene in order to fuel revenue and income growth in the coming quarters.

Several new products in the pipeline: With the 32% growth recorded in the DT impacted by increase in product offerings, the company is fueling this growth further with new products that are in different stages of development.

Statement Of Operations (In $ Millions)

Selling/General/Admin. Expenses, Total

Apart from the aforementioned, there are other areas the company needs to work on in order to further enhance the company's growth. Although it has other products in the pipeline, if it fails to develop products that are different from what is already obtainable in the market, in terms of design and functions, it might not make much difference. With slightly different and more functional products, the company will be able to capture a fair share of the market it operates in.

Also, if Globus develops and launches better products than its competitors, it will go a long way to drive the pricing of the products upwards as the demand grows more than supplies. With this, the company will be able to grow both its top line and bottom line.

Competition

Globus operates in a highly competitive industry with a handful of small and large corporations in play. The big players include Zimmer Holdings (ZMH), Medtronic (MDT), a division of Johnson & Johnson (JNJ) and Stryker (SYK). Its comparable peer in terms of market capitalization and area of specialization is NuVasive Inc. (NUVA). NuVasive has consistently strung three quarters together in terms of top line growth, only missing on the bottom line in the second quarter of fiscal 2013. With its expansion into the international market, the company is steadily working its way toward outgrowing the market it operates in.

It is not the best of times for Johnson & Johnson as the case of its recalled defective artificial hips continue to be in the news. Just recently, the large corporation is expected to spend over $3 billion as settlement for claims concerning its metal-on-metal hip implants, with each individual getting over $300,000 as claims.

On the other hand, Medtronic has given the indication that it does not want to miss out on the benefits accruing from the projected growth in the health-services industry. With the company's acquisition of Cardiocom, provider of monitoring services designed for patients with chronic diseases, Medtronic's expansion into the health-services industry will help it connect directly with its target audience. With the ever increasing number of aged individuals in the U.S., the company's investors are in for higher returns from this new business model.

Headwinds

Listed below are some of factors that could hurt Globus Medical's profitability. They are:

Reliance on third-party salesLimited customersContinued increase in price competitionUncertainty of gaining reimbursements from Centers for Medicare & Medicaid Services.Inability to gain clearance or approval of any of its pipeline products.Prolonged timeline of gaining approval for newly developed products.

Added bonus

For companies that sell products instead of services, delving into international waters usually means more expenses. However, with the currently decreasing cost per volume shipping costs, Globus will experience reasonable reduction in the cost of shipping its products for international sales. This decrease in shipping costs is necessitated by fierce competition among shipping companies which resulted in supplies being higher than demand and we all know what that means.

Conclusion

With Globus management opting to invest its free cash flows into research and development instead of paying dividends, investors can be sure of higher returns in the long term when management decides to pay dividends. With the planned expansion that is sure to result in continually growing revenues, earnings and profit margin, I believe the company will end up paying significant dividends against the minuscule amount paid by some companies in the name of dividends.

With the company known to increase its gross margins proportionally with sales, even as expenses and cost of revenue remain almost flat, there is no need reiterating the fact that Globus makes a good buy in long-term value. This is especially if you consider that you won't be paying for these massive catalysts you will enjoy in the near future.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Rockwell Medical Inc: SFP's Market Potential

Introduction

On September 4th, Rockwell Medical (RMTI) reported CRUISE-2 results which were practically identical to CRUISE-1 results, opening the door for an NDA submission within 6 months.

Treating anemia in CKD patients requires the use of ESAs and supplemental iron. The first step is to increase the number of red blood cells in the body which is done by injecting ESAs. However, this process falters when the patient becomes iron-deficient, and so supplemental iron is provided to maintain hemoglobin levels. An additional benefit of supplemental iron is that it leads to a reduction in the needed dosing of ESAs.

IV Iron Therapy vs ESAs

There has been an ongoing debate in the dialysis industry about whether or not more IV iron therapy is preferred to a higher ESA dosing. A solution is only determinable with a long-term, large-scale, randomized trial where 1 arm is permitted IV iron, and the other isn't. Such a trial would be very costly due to the size and duration, unethical due to the restriction against IV iron use in the ESA-only arm, and produce confounding results. Regardless, what ESA or IV iron producer is going to finance this study if they aren't sure they would come out on top? What non-producer has the financial ability to execute such a grand trial?

The market cannot determine the right answer, which means that the choice between higher ESA dosing and more IV iron therapy will continue to be left to the judgment of dialysis providers. If a patient is susceptible to more risks, or in need of the additional benefits, of either ESAs or IV iron, then providers will act accordingly.

Consider this: When a provider is dealing with an issue in a patient, who hasn't taken IV iron before, what might be the more responsible solution? Introduce an entirely new drug along with its own associated risks, or simply increase the dosing of the already applied ESAs? Probably the latter, and the low use of IV iron therapy in the CKD demographic seems to support this reality.

For the most part, IV iron is used as a weapon of last resort, which is greatly hindering the market potential of current IV iron therapies. Recently, such drugs, along with ESAs, have been under-fire by the FDA due to increasing safety concerns.

The Solution for Dialysis Centers

Is there a drug that can perform the functions of supplemental iron without the safety concerns of current IV iron therapies, while still reducing ESA dosing? Yes, it's called SFP, and it has showcased superb clinical results this year.

The chemical properties of SFP make it safer than current IV iron therapies, while still retaining the functions of supplemental iron. Here is an excellent video that compares SFP with current IV iron therapies. The video goes into detail with regards to the advantages of SFP over current IV iron therapies. From recent clinical results, we know that continuous use of SFP does not lead to tissue iron overload or cause TSAT levels to exceed normal ranges. In addition, SFP has been shown to maintain or slow down the reduction in group ferritin levels, and maintain CHr levels. These endpoints have been crucial in distinguishing SFP's superiority over current IV iron therapies. The trials have confirmed SFP's ability to be continuously applied in the targeted demographic without concerning doctors with whether or not patients are being overloaded with iron. Using current IV iron therapies can lead to tissue iron overload, and to dangerous increases in TSAT and ferritin levels... They simply cannot be continuously applied.

With the results of the PRIME study, combined with the results for the primary endpoints of the CRUISE studies, SFP has proven that it will significantly reduce ESA dosages by 37.1%, while maintaining hemoglobin levels. Doing the PRIME study was quite a shrewd tactical move by management which will allow them to better negotiate with dialysis providers.

In conclusion, SFP is providing the benefits of supplemental iron without the risks that come with current IV iron therapies. SFP's convincing efficacy and safety data will encourage dialysis providers to use SFP across the board, since it's a low-risk method of consistently reducing their own operational costs.

Market potential for SFP

Rockwell Medical will be paid an approximate percentage of the savings associated with the reduction in ESA costs for dialysis centers. Since SFP can be applied continuously and consistently for any anemic CKD patient, the pricing scheme will be quite simple. Current IV iron therapies cannot operate in this stream-lined fashion due to their inconsistent application and risks associated with continuous use. As a result, using the market size of the current IV iron therapies does not provide an appropriate base for which we can estimate potential SFP sales. A better method would be to determine the percentage of expected savings dialysis providers will achieve if they use SFP.

Approximately 436k chronic kidney disease patients in the US are being treated for anemia with ESAs that cost around $8.5k/yr. This places the domestic market size of the ESA market for anemia at about $3.7B. Since SFP can reduce dosing by 37.1%, Rockwell Medical could save dialysis providers $1.37B each year in ESA costs. If we assume they share the savings 50/50 with the dialysis center, then that leaves SFP with potential domestic sales of $690M per year. Currently, Rockwell Medical has an established working relationship with DaVita (DVA) which owns a third of domestic dialysis centers. As a result of this partnership, Rockwell Medical already has access to potential sales of $227M/yr.

Miscellanious

Earlier this year, Rockwell Medical's stock price was negatively impacted from a depleting cash supply and dwindling profits from their base products. They have since raised money with dilutive and non-dilutive financing, and, in addition, the base revenues have bounced from their lows and look to be returning to previous highs.

After the successful CRUISE-1 results, short interest more than doubled, and, given post-CRUISE-2 price action, it's likely to only keep increasing. The shorts have done their best to keep price down despite the fair value being far higher. Clearly the shorts are expecting an imminent financing, but the company is not going to do a poorly-priced financing in the near-term.

The cash balance at the end of the 13Q2 was $42M, with a net loss of $11.9M/qt. At this rate they would deplete their cash reserves before the second half of 2014. However, during the second quarter both CRUISE trials were on-going. Management has guided that R&D expenses will drop as the clinical programs wrap up during the 13Q3-Q4 period. This will extend the life expectancy of the current cash supply to well into the second half of 2014, and perhaps to 14Q4. By then Calcitriol and increasing base product profits should start reducing the quarterly net loss to the point that the cash supply shouldn't dry up before Rockwell Medical starts operating at a net profit. This doesn't mean financing won't happen, only that if it does it will not be at a meaningful discount because Rockwell Medical will be raising from a position of strength, unlike earlier this year. If the company feels that they can get a fairly priced financing in the near-future, they may be motivated towards canceling their Hercule's debt which burdens the company with interest expenses. Financing or not, shorts are not going to be saved by a repeat March 2013 financing.

Finally, institutional ownership doubled during the second quarter of 2013, which suggests smart money believes Rockwell Medical will become a profitable enterprise in the near future with the launch of SFP and Calcitriol.

Company Valuation

Assumptions

Current base revenue will peak at $60M with 20% profit marginsCalcitriol is approved this quarter (very unlikely it isn't), leading to $25M in peak sales (<7% market capture) with 55% profit marginsSFP revenue operating at a 90% profit marginInitial revenue growth for SFP is dramatic given the pre-existing network with DaVitaAssuming initial Calcitriol sales underperform, no more than 5M additional shares will be added in second half of 2014.Overlap in marketing and commercialization costs between the 3 distinct revenue streamsDrastic reduction in R&D expenses due to ended CRUISE 1 & 2 trials.Rockwell Medical does not expand SFP outside of DaVita's domestic dialysis market (Quite unreasonable, especially considering Keryx (KERX) is trading as if it will tap into the entire market with their phosphate binder)

Price Targets

Near-term target: $11 (Calcitriol approval)6 month target: $15 (NDA submission and safety trial results)12 month target $20 (Initial Calcitriol sales and SFP approval)24 month target: $25

The day after CRUISE-2 results, Summer Street raised their price target from $20 to $25. It seems clear to us that they did not limit their projections by assuming Rockwell Medical does not expand outside of DaVita's market. Thus, our price targets should be considered conservative.

Note: Most of this article, including this price target section, was written while the stock was still trading at $6.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in RMTI over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Wednesday, 4 September 2013

Rockwell Medical: Expecting Good Cruise II Data In September

In this article I intend to present a favorable reason to be invested in Rockwell Medical (RMTI) stock.

Some RMTI History:

Rockwell Medical is biopharmaceutical company developing a pipeline of drug therapies targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. As one of the few major suppliers in the U.S., Rockwell's products are sold in the two largest dialysis centers, DaVita (DVA) and Fresenius (FMS), and used to improve the quality of life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Currently, Rockwell has three manufacturing and distribution facilities located in the U.S. Its operating infrastructure allows for a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP, upon FDA market approval. Rockwell's lead drug candidate is called Soluble Ferric Pyrophosphate (SFP) and is in late-stage clinical development for the treatment of iron deficiency in dialysis patients.

Soluble Ferric Pyrophosphate (SFP)
During regular dialysis treatments, SFP delivers iron to the bone marrow of a dialysis patient in a non-invasive, physiologic manner via dialysate. To date, in completed clinical trials, SFP has demonstrated that it can safely deliver sufficient iron to the bone marrow following treatment. Also, SFP is nearing results of its Phase 3 clinical studies (CRUISE-1 and CRUISE-2) and is expected to address an estimated $600M U.S. market.

Calcitriol Vitamin D Injection
Rockwell is also preparing to launch its FDA approved generic drug called Calcitriol, a treatment for secondary hyperparathyroidism (a parathyroid disorder) in dialysis patients. Shown to significantly reduce elevated parathyroid hormone levels, Calcitriol's active Vitamin D injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. As soon as Rockwell receives FDA manufacturing approval, it will be able to supply an estimated $350M U.S. market.

Rockwell's Key Benefits
Rockwell's exclusive renal drug therapy pipeline supports disease management initiatives to:

1) Improve the quality of life and care of dialysis patients in a growing market

2) Deliver safe and effective therapy

3) Decreases drug administration costs

4) Improves patient convenience

News For July 2013:
Rob Chioini, Founder, Chairman and CEO of Rockwell Medical, stated, "We are thrilled with the successful results of this CRUISE-1 efficacy study. In addition to demonstrating statistical significance and meeting the primary efficacy endpoint, the data show that in place of IV iron, SFP is a safe and effective iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores. These successful results, coupled with the recent positive PRIME study data demonstrating SFP's ability to significantly reduce ESA use, support our belief that SFP will set a new paradigm in iron therapy treatment for hemodialysis patients. We believe SFP is positioned to become the new standard of care in iron therapy. We anticipate confirmatory and successful results from the CRUISE-2 trial, which is nearing completion."

Some Financials - Second Quarter Results

Sales increased 7.1% up to $13 million compared to $12.1 million in Q2 last year.Multi-year contract with DaVita calls for increased business.CitraPure sales climbed significantly - increasing 61% over the last quarter.CitraPure is an innovative concentrate product that contains no acetate, the buffering agent used in a traditional concentrate product.CitraPure completely removes acetate and replaces it with citrate.CitraPure improves patient outcomes and actually makes patients feel better.CitraPure lowers a provider's cost of treatment.Gross profit for the quarter was $1.7 million consistent with last year.Research and development costs were $10.2 million.Net loss for the quarter was $11.9 million and consistent with last year, $2.5 million loss in Q1.Net loss is a result of the clinical development work for SFP.Company guidance: Sales and profits are expected to move higher looking forward, and investors should expect the R&D burn rate to continue to decrease upon completing its clinical development.Cash on hand: Rockwell had $41 million in cash at the end of the quarterShares outstanding: Company has about 39.9 million shares outstanding.

Source: here

Clinical Data Review
Now let's review the clinical data. Rockwell has completed two phase III studies CRUISE -1 and CRUISE -2. On July 1, 2013, Rockwell released positive clinical data from the pivotal CRUISE -1 study of SFP its iron delivery drug for iron replacement in hemodialysis patients.

The CRUISE -1 study achieved primary endpoints and statistical significance with a p-value of 0.011. SFP also met key secondary endpoints including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin and an increasing serum iron pre-to-post treatment without an increase in ferritin.

SFP data also demonstrated excellent safety endpoints. With respect to adverse events (AE's) or serious adverse events, there were no differences in frequency or severity between the SFP and placebo group. Overall, the AE's reported were successful and were reported as consistent with those that would be expected in the chronic hemodialysis population.

CRUISE -1 delivered extraordinary phase III efficacy and safety data. Given that the data was so successful the company feels confident that it will be able to obtain similar results from the CRUISE -2 study and gain FDA market approval for SFP too.

NOTE: CRUISE -2 has just finalized its patient dosing. The clinical team is now locking the data and the company anticipates reporting top-line results sometime in September.

The intent of Rockwell as I understand it is to package these two trials with other SFP clinical data and then submit the new drug application (NDA) to the FDA. This would take a few months to complete the process.

Cost Reduction Goals
The CRUISE -1 and expected CRUISE -2 results combined with the recent positive PRIME study data demonstrate that SFP can effectively deliver iron and maintain hemoglobin without increasing iron stores. Rockwell has suggested that its lead drug candidate Soluble Ferric Pyrophosphate (SFP) could reduce ESA use by a significant 35% which would be considerable.

ESA sales are costing taxpayers billions each year. Epogen, Procrit and Aranesp have ranked among the top selling drugs in the U.S., generating more than $8 billion a year for two companies, Amgen (AMGN) and Johnson & Johnson (JNJ). Amgen alone has one of the most lucrative monopolies of all time, yielding the biotechnology company over $40 billion in sales over the past 20 years.

SFP has demonstrated that it is able to deliver both significant clinical and economic benefit to patients. Beyond the clinical data the additional key component is the company's claim that it could reduce dialysis treatment costs by $700MM. This is a significant savings and one solution to Medicare's cost reduction agenda.

Institutional Holders

25.5% and increasingNumber of Holders: 75New Positions: 21Decreased Positions: 10

(click to enlarge)

Source: here

In Summary
Within the next few months, Rockwell expects that the great majority of its customers will be purchasing CitraPure, where sales have climbed significantly by increasing 61% over the last quarter. I also expect Calcitriol to enable Rockwell to increase sales and profit margins considerably while strengthening its existing business. Rockwell's data also supports my strong belief that Soluble Ferric Pyrophosphate (SFP) will set a new standard and significantly raise the bar in the current IV iron therapy market for dialysis patients.

Additional growth and leverage will come online with its planned offering of SFP once it becomes FDA approved. Given the realization that the CRUISE -1 data was so successful I'm very confident that it will be able to obtain similar results from the CRUISE -2 study and gain FDA market approval for SFP too. The FDA may even accelerate the approval process under the FDA Fast Track Development Program due to its effectiveness and favorable cost savings benefits.

The PRIME study demonstrated that regular administration of SFP-iron via dialysate reduced the usage of erythropoietin stimulating agents (ESAs) during hemodialysis by 37.1% while maintaining iron balance and maximizing iron delivery. Also, remember that there was favorable data included in the DRIVE plus DRIVE-II studies, which shows that patients in the ferric gluconate group required significantly less epoetin usage.

So, in reviewing all of the pertinent data and research on the company, I along with the company's enthusiasm for success, believe that we could achieve a significant run-up into and subsequently following the release of favorable data. This is not usual either. With the anticipation of positive CRUISE -1 data that was released on July 11, 2013, RMTI stock moved from about $3.40 to over $5.90 following the announcement, or a 73.50% move.

It's quite possible that shareholders could see a move from the mid-$5s up to the mid-$6 level and then a pop to between $11 - $12 (70% - 100%) upon and shortly after approval just like we experienced with the CRUISE -1 data release. If the data are not successful you can expect a significant hair cut in the stock. It would be entirely up to your discretion to hold though, and/or following the data. Also, let's not discount that Rockwell's recent guidance suggested that sales and profits are expected to move higher looking forward.

Note: When trading in the biotech arena, holding into clinical data is Highly Speculative and I rarely like to hold through this type of circumstance, however in this particular case I'm very confident in my decision to hold up to 80% or more of my current long position moving into the September data. I'm that confident, just like I was going into a positive outcome with VIVUS (VVUS) last year. You can read my comments here on February 21, 2012 and again on July 18, 2012.

Disclosure: I am long RMTI. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

Additional disclosure: I also trade VVUS stock and may add to my RMTI within the next 72 hours.


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Monday, 2 September 2013

Globus Medical: A Look At Catalysts That Will Drive Shareholder Returns

Executive summary

It is a fact that Globus Medical (GMED) maintains strong positive cash flows and yet it does not pay dividends. Rather than putting investors off, this should encourage them to find out more about this company that has successfully grown its revenues from quarter to quarter while maintaining almost flat company expenses. This article will show that it takes more than paying dividends to make any company worth your investment as Globus has a lot of catalysts that will drive shareholder returns in the future.

Getting to know Globus Medical

Globus is a company that operates in the Medical Devices industry with its focus on design, development and commercialization of various products geared toward helping spine disorder patients in their recovery journey. It was established in 2003 with headquarters in Audubon, Pennsylvania.

The company's products come in handy during thoracolumbar, interbody fusion, sacral and cervical procedures. It has been helpful in improving the rate of successful treatments of patients diagnosed with deformative, traumatic and degenerative conditions, including tumors.

Product offerings

The products offered by the company falls under two segments: Innovative Fusion and Disruptive Technologies segments. While the former services a broad range of spinal fusion surgical procedure needs, the latter offers services that improve the already existing procedures for such surgical procedures.

Now, with the Disruptive Technologies products, the company's management has proven its expertise when it comes to identifying a prospective market, even with its attendant risks. This is based on the fact that with these products meaning a shift in the known spine disorder treatments, physicians and patients are sure to go for it due to its attendant benefits but it was not going to happen with the flash of an eye. However, knowing that the technology improves surgical results, attracts minimal costs and limits patient's recovery period and hospital stay, the company's management expects increased demands for the applications in the nearest future.

Catalysts to drive growth

Revenue growth: In the last few quarters, Globus has continued to grow its revenue. Revenue for fourth quarter of fiscal 2012 came in at $100.5 million and increased to $105.0 million in first quarter of fiscal 2013 and $107.0 million in the second quarter of 2013.

Almost flat SG&A expenses: It is a common sight to see most companies' expenses increase as revenue increases. This is not the case with Globus as its company expenses remained almost flat even with the increase in revenue.

Flat cost of revenue: In the first quarter of fiscal 2013, the company reported $23.49 million as total cost of revenue and $23.50 million for second quarter of fiscal 2013. This shows that bringing in revenue is not expensive for the company.

Improving gross profit: With the company maintaining flat company expenses and cost of revenue, the gross profit will continue to improve.

Strong balance sheet: I know of several companies that pay dividends and yet have negative cash flow. Globus has a strong balance sheet with no debt in the last two fiscal periods. As at fiscal year 2012 ended December 31, 2012, the company had more approximately $212 million in cash.

Significant growth in the disruptive technology segment: The Innovative Fusion segment makes up a good percentage of the company's revenue at approximately 62%. The tide is beginning to turn as the fiscal year 2012 recorded a 38% increase in demand for products in the DT segment while the IF segment recorded 6%. This confirms management's expectations of increase in demand for DI products.

Proposed expansion: The company currently derives most of its revenue from its U.S. customers with only 8.3% coming from international markets. The company's management has set plans in motion to further expand its footprint in the international scene in order to fuel revenue and income growth in the coming quarters.

Several new products in the pipeline: With the 32% growth recorded in the DT impacted by increase in product offerings, the company is fueling this growth further with new products that are in different stages of development.

Statement Of Operations (In $ Millions)

Selling/General/Admin. Expenses, Total

Apart from the aforementioned, there are other areas the company needs to work on in order to further enhance the company's growth. Although it has other products in the pipeline, if it fails to develop products that are different from what is already obtainable in the market, in terms of design and functions, it might not make much difference. With slightly different and more functional products, the company will be able to capture a fair share of the market it operates in.

Also, if Globus develops and launches better products than its competitors, it will go a long way to drive the pricing of the products upwards as the demand grows more than supplies. With this, the company will be able to grow both its top line and bottom line.

Competition

Globus operates in a highly competitive industry with a handful of small and large corporations in play. The big players include Zimmer Holdings (ZMH), Medtronic (MDT), a division of Johnson & Johnson (JNJ) and Stryker (SYK). Its comparable peer in terms of market capitalization and area of specialization is NuVasive Inc. (NUVA). NuVasive has consistently strung three quarters together in terms of top line growth, only missing on the bottom line in the second quarter of fiscal 2013. With its expansion into the international market, the company is steadily working its way toward outgrowing the market it operates in.

It is not the best of times for Johnson & Johnson as the case of its recalled defective artificial hips continue to be in the news. Just recently, the large corporation is expected to spend over $3 billion as settlement for claims concerning its metal-on-metal hip implants, with each individual getting over $300,000 as claims.

On the other hand, Medtronic has given the indication that it does not want to miss out on the benefits accruing from the projected growth in the health-services industry. With the company's acquisition of Cardiocom, provider of monitoring services designed for patients with chronic diseases, Medtronic's expansion into the health-services industry will help it connect directly with its target audience. With the ever increasing number of aged individuals in the U.S., the company's investors are in for higher returns from this new business model.

Headwinds

Listed below are some of factors that could hurt Globus Medical's profitability. They are:

Reliance on third-party salesLimited customersContinued increase in price competitionUncertainty of gaining reimbursements from Centers for Medicare & Medicaid Services.Inability to gain clearance or approval of any of its pipeline products.Prolonged timeline of gaining approval for newly developed products.

Added bonus

For companies that sell products instead of services, delving into international waters usually means more expenses. However, with the currently decreasing cost per volume shipping costs, Globus will experience reasonable reduction in the cost of shipping its products for international sales. This decrease in shipping costs is necessitated by fierce competition among shipping companies which resulted in supplies being higher than demand and we all know what that means.

Conclusion

With Globus management opting to invest its free cash flows into research and development instead of paying dividends, investors can be sure of higher returns in the long term when management decides to pay dividends. With the planned expansion that is sure to result in continually growing revenues, earnings and profit margin, I believe the company will end up paying significant dividends against the minuscule amount paid by some companies in the name of dividends.

With the company known to increase its gross margins proportionally with sales, even as expenses and cost of revenue remain almost flat, there is no need reiterating the fact that Globus makes a good buy in long-term value. This is especially if you consider that you won't be paying for these massive catalysts you will enjoy in the near future.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Tuesday, 20 August 2013

Have your say: industry wide survey for 'Pre-filled syringes and medical devices' launched

Main Category: Medical Devices / Diagnostics
Also Included In: Conferences
Article Date: 19 Aug 2013 - 8:00 PDT Current ratings for:
Have your say: industry wide survey for 'Pre-filled syringes and medical devices' launched
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SMi Group announces the launch of Industry Wide Survey for Pre-Filled Syringes and Medical Devices and invites industry professionals to take part in it. The survey launched with the purpose of preparing for the 6th Annual Pre-Filled Syringes Conference taking place in London on the 27th-28th of January 2014.

The survey consists of 10 questions and will take less than 5 minutes to complete. All respondents will get a copy of the results and 10% discount to participate in the conference. Closing date for the survey is October, 4, 2013. To take part please go to http://www.surveymonkey.com/s/M8F9RVM

Who should participate in the survey:

Chief Executives, Chief Scientific Officers, Vice Presidents, Heads, Directors, Managers, and Principal Scientists in the following areas:

Pre-Filled Syringes and Medical DevicesChemistryDrug Delivery SystemsDrug Device SafetyDrug Product Process DevelopmentFormulation and Aseptic Filling TechnologiesInspection ManagementNovel Drug Delivery SystemsPareneteralsPharmaceutical SciencesQuality AssuranceSafe Medication Practice and other sector-related professionals.

For more information about the survey contact Julia Rotar via jrotar@smi-online.co.uk, +44 (0) 20 7827 6088.

To take part in the Survey go to http://www.surveymonkey.com/s/M8F9RVM.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our medical devices / diagnostics section for the latest news on this subject.

About SMi Group

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries.

We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries.

For more information, please visit http://www.smi-online.co.uk

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MLA

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Monday, 19 August 2013

Factors influencing medical decisions for a cognitively impaired family member

Main Category: Public Health
Also Included In: Alzheimer's / Dementia
Article Date: 19 Aug 2013 - 1:00 PDT Current ratings for:
Factors influencing medical decisions for a cognitively impaired family member
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Decision-making by a surrogate for a family member who is unable to make medical decisions is more complicated than decision-making by patients themselves, according to a study from the Regenstrief Institute, Indiana University Center for Aging Research and the Charles Warren Fairbanks Center for Medical Ethics of Indiana University Health.

The researchers found that family decision-makers considered the cognitively impaired patient's wishes and interests. But they also took into account their own needs and preferences.

Factors influencing surrogate decision-makers included:

Respect for the patient's input. The patient's prior wishes. Consideration of the patient's best interests. The surrogate's own wishes as a guide. The surrogate's religious and spiritual beliefs. The surrogate's own interests. Family consensus.

"Family members often say that they wish they knew more about their loved one's views on medical care," said Regenstrief Institute investigator Alexia Torke, M.D., associate professor of medicine at the IU School of Medicine and an IU Center for Aging Research scientist. "And whether or not surrogates know what the patient would have wanted had they been able to make the decision for themselves, we learned that family members may feel compelled to substitute what they themselves want, or to paraphrase the Golden Rule: do to others as you would have them do to you.

"Surrogates also consider the feelings and beliefs of other family members," said Dr. Torke, senior author of the study. "The individuals who are making decisions for those who cannot are the survivors - they take into account the fact that they have to live with other family members as and after they make surrogate decisions."

"Making Decisions for Hospitalized Older Adults: Ethical Factors Considered by Family Surrogates" is published in the Summer 2013 issue of the Journal of Clinical Ethics.

An estimated four out of 10 hospitalized adults lack decision-making capacity due to cognitive impairment. When patients are unable to make their own decisions, surrogates often are called upon. Dr. Torke notes that the need for surrogate decision-making is growing as life-sustaining medical technology becomes more available, the population ages, and the prevalence of diseases such as Alzheimer's and other forms of dementia increases.

In the study, the investigators interviewed 35 surrogates with a recent decision-making experience for a hospital patient age 65 or older. The group was almost evenly split between white and African-American surrogates. Eighty percent of the respondents were female; 60 percent were the daughters of the cognitively impaired patient.

"Because surrogates also imagine what they would want under the circumstances and consider their own needs and preferences as well as those of the patient for whom they are acting, standard ethical models of surrogate decision-making [in the academic literature] must account for these additional considerations," the paper noted. "Surrogates' desire for more information about patient preferences suggests a need for greater advance care planning."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our public health section for the latest news on this subject.

IU School of Medicine student Jenna Fritsch, B.S., is first author of the paper. Co-authors, in addition to Dr. Torke, are Sandra Petronio, Ph.D., of the Department of Communication Studies in the IU School of Liberal Arts at Indiana University-Purdue University Indianapolis; and Paul R. Helft, M.D., of the Department of Medicine at the IU School of Medicine and the IU Melvin and Bren Simon Cancer Center. Drs. Torke, Petronio and Helft are members of the Charles Warren Fairbanks Center for Medical Ethics at IU Health, of which Dr. Helft serves as the director.

Dr. Torke was supported by an award [K23AG031323] from the National Institute on Aging at the National Institutes of Health. Fritch was supported by the Medical Student Training in Aging Research program, administered by the American Federation for Aging Research and the National Institute on Aging. The content of the study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Indiana University

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Electronic medical records calculate health risk score, to prevent unplanned readmissions

Main Category: Public Health
Also Included In: IT / Internet / E-mail
Article Date: 19 Aug 2013 - 0:00 PDT Current ratings for:
Electronic medical records calculate health risk score, to prevent unplanned readmissions
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A health risk score calculated automatically using routine data from hospital electronic medical records (EMR) systems can identify patients at high risk of unplanned hospital readmission, reports a study in the September issue of Medical Care, published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

The score, called the Rothman Index, may provide a useful tool for lowering the rate of avoidable repeat hospitalizations, according to the report by Elizabeth Bradley, PhD, of Yale School of Public Health and colleagues. They write, "Clinicians can use the Rothman index to target hospital programs and supports to patients at highest risk of readmission."

Routine Data Identify Patients at High Risk of Readmission

The researchers evaluated the Rothman Index as a "practical tool" for assessing readmission risk. The Rothman Index software uses information from the hospital EMR system to provide a continuously updated score indicating the likelihood of death or readmission within 30 days.

The score is calculated automatically using routine data on each patient's vital signs, routine nursing assessments, skin condition, heart rhythms, and laboratory tests. Lower Rothman Index scores (from a maximum of 100) indicate a higher risk of readmission.

Dr Bradley and colleagues evaluated the ability of the Rothman Index to predict hospital readmission, based on data from more than 2,700 patients hospitalized during 2011. (During this time, doctors and nurses did not have access to the Rothman Index scores.) Sixteen percent of the patients had an unplanned readmission within 30 days after hospital discharge.

The Rothman Index was strongly associated with the risk of unplanned readmission. For patients in the highest-risk category - Rothman Index less than 70 - readmission risk was more than 1 in 5. By comparison, for those in the lowest-risk category - Rothman Index 80 or higher - the risk was about 1 in 10.

After adjustment for other factors, patients in the highest versus lowest risk category were more than two and a half times as likely to be readmitted within 30 days of discharge. The Rothman Index predicted readmission across diagnoses and medical specialties.

Rothman Index Could Help Efforts to Lower Repeat Hospitalizations

Unplanned hospital admissions are a major quality and cost issue in the US healthcare system. About 20 percent of Medicare patients are readmitted to the hospital within 30 days, at an estimated cost of $17 billion per year. Hospitals are looking for more effective ways of reducing readmissions - especially now that Medicare has begun reducing payments to hospitals with high readmission rates.

The Rothman index is especially valuable because it is calculated automatically from routine data, requiring no manual input from busy healthcare professionals. It was developed by brothers Michael and Steven Rothman in memory of their mother, who died unexpectedly four days after hospital discharge following heart surgery.

During their mother's illness, the Rothman brothers were surprised to learn that the hospital's EMR system did not generate summary patient health measures that might have alerted doctors to unrecognized complications that were present at discharge. While neither of the brothers had medical training, both were computer scientists with experience in applying complex analytical tools to massive electronic databases.

The new study suggests that the Rothman Index could help reduce rates of unplanned readmission, identifying a group of patients two to three times more likely to be readmitted. Implemented into daily care, the Rothman Index could provide "a practical way for clinicians to identify patients who might be at higher risk for unplanned readmission and intervene specifically for these patients to try to avert unplanned readmission," Dr Bradley and coauthors write.

"We know the Rothman Index is associated with readmissions, but we do not know if it can be used to improve decision making at the bedside in terms of when patients are discharged," commented Dr Bradley, who is professor of public health at the Yale School of Public Health and faculty director at the Yale Global Health Leadership Institute.

"We also don't know if physicians would benefit from using it as part of determining what kinds of added supports at home and in the community might be arranged at discharge," Dr Bradley added. "Answering these questions will determine if the Rothman Index can be used prospectively by clinicians to reduce readmissions and adverse events post-hospitalization."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Dr Bradley's coauthors were Olga Yakusheva, PhD, Leora I. Horwitz, MD, Heather Sipsma, PhD, and Jason Fletcher, PhD.

Wolters Kluwer Health

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Saturday, 17 August 2013

Consumer choices may be adversely affected by irrelevant information in medical testimonials

Main Category: Public Health
Also Included In: Psychology / Psychiatry
Article Date: 17 Aug 2013 - 0:00 PDT Current ratings for:
Consumer choices may be adversely affected by irrelevant information in medical testimonials
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Medical testimonials on the Internet and elsewhere present powerful personal stories and useful information, but they can also be dangerous to your health if distracting, irrelevant information leads to inappropriate treatment decisions, say researchers at the University of North Carolina at Chapel Hill.

"Distracted by Details: Narrative Influence Following Conflicting Stories" * was published in July in the journal Media Psychology. Authors were Joseph P. Simons, a 2013 Ph.D. graduate in social psychology, and Melanie C. Green, assistant professor of psychology, in UNC's College of Arts and Sciences.

"We grow up learning from stories and we often identify with the people or characters telling those stories," Green said. "So we are not used to stepping back and analyzing the information, especially in the context of complex medical conditions and treatment options." Green is a social psychologist whose research has focused on the power of narrative to change beliefs.

Green noted that consumers tend to give more credibility to testimonials coming from people with whom they have something in common, even though some kinds of similarities may be irrelevant for the decision at hand. For example, if someone loves classical music and reads an online or magazine testimonial about a cleaning product written by another classical-music lover, he or she is more likely to believe it is a good product, even if the classical-music connection has nothing to do with it.

Green and Simons hypothesized that this phenomenon would apply to medical treatment recommendations for a fictional "patient."

To test their hypothesis, researchers presented 111 subjects with general information about a fictional illness and two different drug treatments, including clear indicators for which treatment would be most medically appropriate. They then provided the subjects with two conflicting treatment testimonials and asked them to recommend the most appropriate treatment option for a "patient" with the same illness.

The testimonials included information directly relevant to the illness and appropriate treatment options, the study noted, while other information was irrelevant to the medical situation. The irrelevant information reflected shared interests between the people giving the testimonials and the "patient" for whom the subjects were making a treatment recommendation, such as a love of classical music or baseball.

"As predicted, distracting similarities led to less [medically] appropriate treatment recommendations," the researchers wrote. They noted that the study didn't allow for determining the role of personal relationships with the "patient."

"Personal stories can often provide valuable perspectives on medical conditions, as long as consumers recognize that irrelevant factors can distract them, resulting in decisions based on a 'gut feel' for the storyteller's credibility, rather than whether the data are accurate and applicable to a specific situation," Green added.

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Friday, 16 August 2013

Care may be improved for LGBT's by recording sexual orientation and gender identity in their medical records

Main Category: Psychology / Psychiatry
Also Included In: Primary Care / General Practice;  IT / Internet / E-mail
Article Date: 15 Aug 2013 - 1:00 PDT Current ratings for:
Care may be improved for LGBT's by recording sexual orientation and gender identity in their medical records
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Recording the sexual orientation and gender identity (SOGI) of individuals in their health records would greatly facilitate identifying the unique health needs and health disparities of LGBT individuals, leading to improved quality and outcomes of their health care. The advantages of reporting this information and the growing support for including it in electronic health records (EHRs) are described in an article in LGBT Health, a new peer-reviewed journal from Mary Ann Liebert, Inc., publishers, launching in fall 2013. The article is available free on the website.

Sean Cahill, PhD and Harvey J. Makadon, MD, The Fenway Institute (Boston, MA), emphasize the need for more data and research on LGBT health and health disparities, as noted in a 2011 Institute of Medicine report that recommended routine collection of SOGI information and its inclusion in EHRs. Ready access to this information could facilitate conversations between clinicians and patients about risk factors and targeted preventive measures. Cahill teaches public policy at New York University (New York, NY) and Makadon is Clinical Professor of Medicine at Harvard Medical School (Boston, MA).

In the article "Sexual Orientation and Gender Identity Data Collection in Clinical Settings and in Electronic Health Records: A Key to Ending LGBT Health Disparities" * the authors describe overwhelming support for routine collection of SOGI information among LGBT advocacy groups and HIV/AIDS organizations, as well as the support for SOGI data collection in the Healthy People 2020 initiative, and the Obama administration's Affordable Care Act.

"The Obama Administration has taken significant strides toward increasing LGBT data collection on health surveys," said Cahill. "Right now the federal government is considering whether to include SOGI as standard demographic questions in Stage 3 meaningful use guidelines, which set the standard for data collection in EHRs. We believe that including SOGI measures in these guidelines would dramatically increase our understanding of LGBT health disparities and our ability to address them."

"While there is no question about the benefits of collecting such data, some concern has been raised about the security of the EHR and potential misuses," says Editor-in-Chief, William Byne, MD, PhD, Icahn School of Medicine at Mount Sinai, New York, NY. "In addition to addressing how to best elicit the data, Cahill and Makadon also address such implementation concerns."

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Monday, 29 July 2013

Robots taking over to help medical research

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Robots taking over to help medical research
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It has been a long and stealthy takeover, but robots now dominate many leading bioscience laboratories, doing in just hours what once took days or weeks. Now the convergence of automation with nanotechnologies, biomedics and advanced algorithms promises to take robotization of medical research much further.

In May of this year, Ross King, professor of machine intelligence at the UK's University of Manchester, traveled east to talk to students at the University of Nottingham campus in Ningbo, China. His paper "Robot scientists: Automating biology and chemistry" was a vindication of theories he and colleagues first proposed almost a decade ago.

In a 2004 letter to the journal Nature, they asked whether it might be possible to automate the actual "discovery" process of observation, deduction and conclusion. This would use a physically implemented robotic system that applied techniques from artificial intelligence (AI) to carry out cycles of scientific experimentation.

In China, as he had earlier at Brunel University in London, Prof. King named the two "robot scientists" Adam and Eve, constructed at the University of Aberystwyth in Wales. These robots form hypotheses, select efficient experiments to discriminate between them, execute the experiments using laboratory automation equipment, and then analyze the results.

Both Adam and Eve have made actual discoveries.

Adam was developed to investigate the functional genomics of yeast (Saccharomyces cerevisiae) and the robot succeeded in autonomously identifying the genes that encode locally "orphan" enzymes in yeast.

Adam the robot Prof. Ross King at the controls for Adam the robot, Aberystwyth University

In biblical fashion, Adam was followed by Eve using similar techniques to create a machine tasked toward automation and integration of drug discovery: screening, hit conformation, and quantitative structure-activity relationship (QSAR) development. Eve uses novel synthetic biology screens that combine the advantages of computational, target-based, and cell-based assays.

Prof. Ross King says:

"Our focus has been on neglected tropical disease, and using Eve, we have discovered lead compounds for malaria, Chagas, African sleeping sickness and other conditions."

Analytical robots like Adam, Eve or the more advanced products now being developed at centers of excellence - such as at the Fraunhofer Institute for Factory Operation and Automation (IFF) in Magdeburg, Germany - are a far cry from the robotic systems that first entered the lab some three decades ago.

The history of a leading company in the field - Hamilton Robotics - demonstrates the progression:

From precision syringes in the 1940sThrough the first semi-automated diluter in 1970To the first fully automated workstation for sample preparation in 1980.

Such workstations, which mechanically handle samples under full computer control, meet the core dictionary definition of a robot as "a machine capable of carrying out a complex series of actions automatically." Their actual mechanical or physical "work" component also satisfies Karel Capek's original "forced labor" definition in his 1920 play R.U.R.. This is the play that introduced the word "robot" to the world.

Liquid handling is one of the four core applications for robotics in the laboratory. The others are:

Microplate handling: using robots to move plates around a workcell, between stacks and other devices (liquid handlers, readers, incubators, and so on). Advanced microplate robots integrate with third-party instruments to create work cells that automate applications and protocols to almost any level of complexity.

Automated biological research systems: robots provide automated handling and reading for various aspects of biological and biochemical research, ranging from flow cytometers to specific molecular biology applications such as PCR preparation and purification, colony picking or cell culture development.

Drug discovery screening: the most recent mainstream robotics application allows researchers to run a wide range of cell-based, receptor-based and enzyme-based assays typically used in high throughput screening (HTS).

The laboratory advantages of using robotics seem obvious, starting with the ergonomic benefits of automating tasks that would be tedious, repetitive, injurious or even hazardous for a human.

A robot makes no distinction between the backbreaking low rack a few centimeters off the floor and the one up high, for which a human would need to stand on a chair. Robots can also safely handle toxins, biohazards or operate in sealed or climate-controlled areas that we would find unbearable.

Laboratories originally embraced robotics because it seemed to offer an escape from the "quantity or quality" dilemma - the constant need to trade off speed for accuracy.

By contrast, it seemed robots could perform infinitely repeated operations to a supreme degree of precision that never varied and was infinitely controllable.

However, in practice, and particularly with high throughput screening, some limitations began to emerge. These included:

Long design and implementation timeProtracted transfer from manual to automated methodsUnstable robotic operation, andLimited error recovery abilities.

Furthermore, the need to reduce steps in robotic processes tended to encourage the use of less accurate homogenous assays over the heterogenous ones that most companies would prefer.

Early 21st century adoption of Allegro and other technologies based on assembly-line techniques overcame many of these problems by passing microplates down a line to consecutive processing modules, each performing just one step of the assay. Speed could be multiplied into the process by making each step bigger, with the 96-well microplate giving way to 384 and now 1,536-well plates.

The new capability of robots to screen such enormous plates unsupervised paved the way for the quantitative high-throughput screening (qHTS) paradigm that can test each library compound at multiple concentrations.

Maximum efficiency and miniaturization gave qHTS the theoretical capacity to carry out cell-based and biochemical assays across libraries of more than 100,000 compounds, testing between 700,000 and 2 million sample wells within a few hours.

However, few companies actually need to screen that many compounds in-house each day, with the associated costs of consumables such as assay reagents, cell cultures, microplates, and pipet tips, as well as the cost of data handling and analysis time.

When you add in the investment overheads for associated infrastructure, robotics can seem like a rich kid's toy.

During the first decade of the 21st century, growing numbers of contract companies doing high-throughput screening (HTS) offered assay development and screening, data analysis, and other library support.

The use of such contract robotics labs became a lot more popular after they stopped demanding royalty payments on any discovery. Such labs trade on the ability to offer ultra-fast turnaround times, running 24/7 on high-capacity HTS robotic workstations.

Some pharma and biotech companies began to outsource primary screening, keeping the higher-value, more proprietary secondary screening in-house, to enable higher hit rates for their teams. However, even these approaches are becoming redundant with new technology.

Essentially, high-throughput screening is the shotgun approach to research - using robotics to throw many thousands of chemical compounds against a target pathogen to see if its cell growth accelerates, stops, or is eliminated. The capacity is awesome, but the costs are high and the unit-to-success ratio is low.

A more sophisticated robotics-enabled paradigm is high-content screening (HCS) - a "rifle" approach that applies molecular specificity based on fluorescence and takes advantage of more sophisticated reagent classes.

High-content screening has the ability to multiplex, along with image analysis coupled to data management, data mining, and data visualization. All these help researchers focus on biological and genomic information and make far more targeted decisions on which assays to run.

Latest technology takes this targeting still further. Hudson Robotics recently announced what it terms high-efficiency screening (HES) for small molecules and antibodies.

High-efficiency screening uses a proprietary algorithm to compile a shortlist of library samples that will be screened. This is then passed on to a robotic workstation where the molecules are cherry-picked and screened in the appropriate assay.

Any molecules found to be active are used to enhance the model and the process is repeated until the user has both a list of active molecules, as well as the final model that can be used to search additional compound collections and guide synthesis of optimized analogs.

In preliminary testing against known compound databases, Hudson says its high-efficiency screening consistently identified the majority of known inhibitors of ten different biological targets after screening under 10% of a library containing some 80,000 diverse molecules.

Three decades in from the first laboratory use of robotics, it seems clear that the technology is still in its infancy. Robots may seem pervasive in today's biomedical research, but they have a long way to evolve.

For one thing, robots cannot easily coexist with humans, needing to work in safely enclosed areas. The Fraunhofer Institute has been studying this aspect and developed LISA, a prototype mobile lab assistant with touch sensitive "skin" and heat sensors to stop her bumping into humans and vice versa.

Meet Lisa the robot Meet LISA. She's the one on the left...

But even LISA is likely to look as clunky as the Wright Flyer once biomedics, 3D printing and nanotechnologies really come into play. A glimpse of the possibilities is offered by the robotic inchworm pioneered by Columbia University.

Biobots like these, or the DNA spiders developed at New York University and the University of Michigan are little more than fascinating, if rather scary, toys at the moment. But they point to a future where robotics moves beyond the research lab into the operating room - or even down into the molecular realm.

Written by Nick Valentine


Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our medical devices / diagnostics section for the latest news on this subject.

"High-throughput screening: The hits and leads of drug discovery - an overview," Journal of Applied Pharmaceutical Science 01 (01); 2011: 02-10. Full text

"A robotic platform for quantitative high-throughput screening," Assay and Drug Development Technologies 2008 October; 6(5): 637–657. Full text

"A Personal Perspective on High-Content Screening (HCS)," J Biomol Screen August 2010 vol. 15 no. 7 720-725. Full text "Application of chemistry-based functional proteomics to screening for novel drug targets," Comb Chem High Throughput Screen 2010 Jun;13(5):414-21. Abstract/summary Please use one of the following formats to cite this article in your essay, paper or report:

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