Latest Forum Topics / Biosensors |
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Is Biosensors a good buy?
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bengster68
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15-Jun-2008 23:25
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Why did Conor invent the multiple reservoir holes method that concentrate the drug only on the 15% of the stent surface? JNJ claim that their NEVO DES has 85% less polymer contact than conventional DES (meaning that their drug reservoir only covers 15% of the vessel wall). What about the other 85% wounded vessel wall that are not in direct contact of the drug and in contact with just the stent's metal strut? Costar platform seems like a 15% DES, 85% BMS. Rojak them together, the effects are worst than BMS itself as what we saw on their GENESIS RCT using primecolimus drug? The more i think about it, the more i feel this Costar and NEVO bullsh.it just simply will not work. | ||||||||||||||||
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investor
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15-Jun-2008 23:14
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Biolimus is put on the abluminal surface of the stent and therefore it is directed ONLY onto the vessel wall where the scarring takes place, and also as it is also more fat-seeking than Sirolimus, it gets absorbs into the vessel wall where it is needed, rather than into the blood stream. These are probably the reasons why it does not go into the bloodstream as much as Sirolimus. The fact that Biolimus is 52 times less ! in the blood stream than Sirolimus, augurs well for the safety of the bio-matrix DES as compared to the cypher stent. |
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bengster68
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15-Jun-2008 23:09
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I think you got it right PAE! BiolimusA9 drug has fat seeking properties and the plaques that clog up arteries are actually fat deposits. BiolimusA9 drug targets its drug function locally by seeking the fatty deposits. The fatty deposits are at the clogged vessel wall and will be wounded by the balloon expanded scaffold metal strut. So BiolimusA9 drug acts locally on the wounds and not systematically in pheripheral blood in circulation. By virtue of this fat seeking property of BiolimusA9, just a little BiolimusA9 drug will have significant localised effects but very little systematic effects to the entire body system. This is truly revolutionary. BIG is indeed the real grandmaster of DES technology. Some analysts said that BiolimusA9 has the potential to be used in other forms of medical use. The reason behind this is because of BiolimusA9's unique fat seeking property to localise its drug effects without effecting the entire body system.
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PensionAlterEgo
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15-Jun-2008 22:31
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Thanks bengster and investor for the analysis and hints on possible Nobori Japan trial start dates and results release dates. The Maximum blood concentration of Biolimus A9 should be the concentration of the drug in the blood. The ideal stenting procedure should have less drug in the peripheral blood (the circulation); act locally and not systemically. I think if the drug goes to different parts of the body, there will be some other problems.. See http://www.biosensorsintl.com/sections/press/041210_stealth_aha_results.pdf, slide 9 and 23. |
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bengster68
Master |
15-Jun-2008 18:52
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The Cypher results in NOBORI CORE are generally close to what we see for other Cypher trials (except the late-loss is very good in NOBORI CORE RCT- normally between 0.16 to 0.18mm). Because the NOBORI CORE patient enrollment number is very small, the data collected may not fully represent the actual real world performance but its enough to give us a rough guide on how the larger scale RCTs against Cypher will be like in NOBORI JAPAN (to be used for Japan FDA approval) and LEADERS. One bad egg patient can skew the whole statistics (like what we see for one of the NOBORI patient with subacute stent thrombosis problem after 10 days. When the enrollment numbers are too small, its a bit of a "luck" element involved. A few more jialat case patients implanting your DES can pull down your results. From the small scale NOBORI CORE RCT, I think there is already evidence that NOBORI (a.k.a Biomatrix) showing some form of superiority against Cypher. Im not sure what that "maximum blood concentration" measurement is for but if Terumo highlighted this area that BiolimusA9 is 52 times less than Sirolimus, then it must be something of importance. I suspect blood concentration level will trigger blood-clots leading to stent thrombosis. Maybe this blood concentration level thing is to show people that using NOBORI has much lesser chance of getting blood clots. I suspect Terumo got their Japan IDE somewhere in Apr 2007. This is because BIG received a US$5m milestone from Terumo in May 2007 (as per BIG's announcement) and such milestone payment normally comes in about one month after a certain huge milestone has been achieved (like Japan IDE). Japanese are very secretive by nature and they tend to keep things more on silent mode like a "silent ninja". NOBORI JAPAN RCT involves only 335 patients and if Terumo wants to enroll quickly (by having more enrollment trial centres but cost of conducting the clinical trial will be more expensive as compared to just a few trial centres), 335 patients can be enrollmented and implanted all within 2 months. But 335 patients only is not really an expensive clinical trial and Terumo has the cash to burn. If they want to finish enrollement in 2 months, it is absolutely no problem to Terumo as they can burn a couple of millions more but do the RCTs faster with more enrollment centres. BIG's LEADERS trial involves 1700 patients and enrollment was completed within 6 months, the fastest in the history of DES clinical trials. Fast enrollment also means patients are confident in your in-trial product and there are many volunteers easily available. However, i seriously think Terumo would have finished their last enrollment for NOBORI JAPAN by end Sept 2007. Add 9 months duration and that will end June 2008. Give Terumo another 3 months for all kinds of data tabulation, statistics anlaysis, results analysis, preparation of presentation, etc. By end Sept 2008 NOBORI JAPAN should be ready for full presentation. Also, Terumo has a track record of making important NOBORI clinical trial presentations at TCT conferences. TCT2006 we saw NOBORI 1 phase 1, TCT2007 we saw NOBORI 1 phase 2. I think TCT2008 in mid-October we should see Terumo presenting the full 9 months of NOBORI JAPAN. Cardiovascular device companies just love to showcase their clinical trial results in large scale conferences like EUROPCR and TCT. TCT is the largest Cardio event globally and it is always the best time to make presentation for maximum media impact and gain admiration from all the top Cardio experts present at the conference. I hope this TCT2008 BIG and Terumo can give JNJ 2 big slaps on both JNJ's cheeks via stunningly good LEADERS and NOBORI JAPAN results. That will be it for all JNJ's "track record bullsh.it". MDT's Endeavor DES didn't do well in ENDEAVOR III RCT against Cypher couple of years back. Let BIG and gang finish up the job of proving Cypher is obsolete. |
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investor
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15-Jun-2008 17:35
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In Terumo's Q208 results (calendar end sept 2007), they mentioned that clinical trials have started in Japan and in the ESC 2007 magazine called CLINICA dated 21st Sept 2007, there was a report quoting Terumo as saying that 'they are currently enrolling patients for the Japan Nobori' clinical trial. Assuming enrollment is complete by end Dec 2007, we might have the 6-mths data in TCT2008 ? (Oct 2008) |
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PensionAlterEgo
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15-Jun-2008 11:04
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Bengster, not sure if you have an idea of the ongoing NOBORI Japan trial. Do you know when it started and when the results are out. Please see the following slides at..http://www.europcronline.com/diapos/EuroPCR2008/4594-20080515_1304_Room02_Danzi_Gian-Battista/Danzi-20080515-1304-Room02.pdf I was trying to get a gut feeling of how the LEADERS trial outcome will look like since Biomatrix will be pitted against Cypher. So I noticed that Nobori CORE had already done a comparison with Cypher... but with very low sample numbers (107). In Nobori Japan trial, stent will also be compared with Cypher but with a slighthy larger sample size of 335. Would be good if you could comment on the Cypher numbers in the slides .. on whether they tally or are somewhat close to numbers seen in Cypher related trials. |
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bengster68
Master |
14-Jun-2008 22:54
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Below are the results of Conor's GENISIS trial. The trial results are justy getting bad to worse. Even worse than COSTARII RCT. This multiple reservoir stent platform is just "Ho Kuah Bo Ho Chiak". Even if you put in Sirolimus, it will still not work. When will JNJ ever wake up that they kena conned by Frank Litvack on all these reservoir holes bull.shit???
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bengster68
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14-Jun-2008 22:47
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PensionAlterEgo
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14-Jun-2008 14:30
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interesting read about conor's past.. Although Cordis took some beating with 7 key people... it appears that the people in Conor's are still intact. This Frank guy is still the CEO. Roger Campbell, the CTO is still championing the Nevo Stent. So JNJ must be still betting on Costar in the near future.. Too bad there is not much data on this RES-ELUTION trial or data. Would be interesting to see how it performs.. ![]() Actually from the presentation slides at http://www.europcronline.com/diapos/EuroPCR2008/4568-20080515_1254_Room01_Rogers_Campbell/Rogers-20080515-1254-Room01.pdf slide 20, I am not so convinced (although I am not a biomed person) by their reservoir design and choice of alternating the drug realease in two opposite directions. I shall not say why..(in case my comments gets adopted ![]() |
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bengster68
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14-Jun-2008 12:23
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A bit of Conor's history and duno why Rick Anderson even bother to buy over Conor. OCTOBER 31, 2005 Crashing The Stent Party Conor Medsystems is trying to take on Goliaths J&J and Boston Scientific Conor Medsystems Inc. (CONR ) is developing a new breed of stent that may have the power to swipe large swaths of business from rivals such as Johnson & Johnson (JNJ ) and Boston Scientific Corp. (BSX ) But the company's chief executive officer, Dr. Frank Litvack, has a controversial past, and there are thorny questions about potential conflicts of interest and litigation that could torpedo its fortunes. Stents, especially the ones that are coated with drugs to prevent blockage by scar tissue, are one of the most lucrative areas of medicine. The market for such "drug-eluting" devices is expected to reach $5.1 billion by the end of this year, up from $3.9 billion in 2004, according to CIBC World Markets Corp. J&J and Boston Scientific are the two gladiators in this field, but many physicians are keeping a close eye on Conor's product as well. Although the stent's rate of restenosis, or recurrence of arterial blockages, has been about the same as existing devices, some doctors say Conor's is easier to implant and may prove safer and more effective. On Oct. 21, the Menlo Park (Calif.) company will release new data from clinical trials at a top cardiovascular meeting in Washington. "If it came out in the U.S. right now, the market would swing," says Dr. Dean Kereiakes, a professor of clinical medicine at Ohio State University who is serving as a co-principal investigator for Conor's U.S. clinical trial. Yet Conor's technology is difficult to assess, in part because some doctors helping to evaluate the devices have received stock options from the company. Among the 14 doctors who sit on Conor's scientific advisory board and are participating in clinical trials of its stent, three received consulting fees and five have received options, according to documents obtained by BusinessWeek. Such relationships are a growing source of concern in the medical-device industry, drawing increasing scrutiny from regulators and medical ethicists. Still, Wall Street is smitten with Conor's potential. Last December the company went public at $13 a share, then soared to $23 for a market cap of nearly $800 million. Conor has virtually no revenue and is not expected to make a profit until 2008, but CIBC analyst John P. Calcagnini, who has a $26 price target on the stock, believes Conor can take 11% of the market by 2009. TREADING CAREFULLY Before that happens, though, Conor must navigate a minefield. Its powerful rivals vastly outspend the startup on research and development. Its stent has not yet been approved in any market. And this February, Conor was sued for patent infringement in Europe by Vancouver (B.C.)-based Angiotech Pharmaceuticals (ANPI ) and Boston Scientific. Angiotech licenses a drug called paclitaxel to Boston Scientific that inhibits the growth of scar tissue. Conor uses the same drug in its clinical trials, but claims the way it incorporates and releases the drug is novel and doesn't infringe on its rivals' patents. Boston has not yet sued Conor in the U.S., but if Conor tries to crack the U.S. market, Boston is expected to do so. "We haven't even looked into other potential infringements on the catheter side," says Boston's chief technology officer, Fred A. Colen. If Conor were to lose the patent lawsuit, it would be forced to start a new stent trial with another drug, which would delay commercialization by several years. Even if Conor's device receives government approval, there's no proof that its stent offers a clinical advantage. "There are a lot of potential advantages," says Dr. Jeffrey A. Brinker, a professor at the Johns Hopkins University School of Medicine. But how likely are they to be realized? "I don't know," Brinker says. No one is claiming that doctors enlisted by Conor are intentionally skewing the data because of their stock options. Moreover, there is no Food & Drug Administration rule barring doctors who participate in clinical trials from obtaining compensation from a company whose devices they are evaluating. But many universities, medical organizations, and scientific conferences now require that doctors disclose these relationships. According to the disclosure documents, five of the doctors who have received stock options are top cardiologists at Columbia University and Stanford University Medical Centers and the Scripps Clinic. The doctors named couldn't immediately be reached for comments. Columbia, Stanford, and Scripps say that their doctors who are affiliated with Conor have not violated any rules, and Conor also says that it has done nothing improper. Company execs say they paid doctors for their expertise with options since, as a small startup, Conor had little cash. It's difficult to specify the value of compensation that each doctor receives because Conor does not release that data. In their disclosures made to medical conferences, doctors must reveal the type of compensation they receive, such as stock ownership, but not its value. In its financial filings, Conor said it granted options to purchase 1,137,750 shares of its stock -- valued at $26 million -- to "consultants and other non-employee service providers." However, Conor says not all of those consultants are doctors. Some are contract workers, such as engineers. Dr. Kereiakes of Ohio State receives airfare and several thousand dollars from Conor to attend meetings. But he sees no conflict, he says, because he is taking a hefty pay cut to devote time to Conor. Conor says it forbids lead investigators from receiving options, but Kereiakes and his co-investigator would not take them anyway because they say it would harm their credibility. "I would not embarrass myself and give a presentation when I have a million dollars in stock from a company," he says. "There's nobody in the world that would say that's not a conflict of interest." Dr. Litvack's professional background has also attracted attention. Having served as co-director of the Cardiovascular Intervention Center at Los Angeles' Cedars-Sinai Medical Center from 1986 to 2000, he was recruited by Conor co-founder and Chief Technology Officer John F. Shanley to serve as CEO in the fall of 2001. But his track record as an entrepreneur is uneven. Litvack has helped run three companies, one of which was Advanced Interventional Systems Inc. The company developed laser technology to clear up artery blockages, but it lost a patent infringement lawsuit in 1992 and never gained much traction with doctors. In 1994 it was acquired by its chief rival, Spectranetics Corp. (SPNC ), for just $12 million -- a thin sliver of the $150 million market cap it reached after going public in 1991. Is Frank Litvack headed for a debacle like the one that burned investors more than a decade ago? CIBC's Calcagnini scoffs at the idea. "That's old news," he says."People are trying to detract from the idea that Conor has a novel design." At least two physicians with no financial ties to Conor give its device high marks. Today's leading drug-eluting stents were designed as bare metal tubes, and the companies later added drug coatings. By contrast, Conor designed its stent from the ground up to deliver drugs to surrounding tissues. The idea comes from Conor's Shanley, who used computer-guided manufacturing techniques to create hundreds of little wells for drugs on the stent's lattice. SLIPPERY SUCCESS Some cardiologists say Conor may succeed because its stent, which is thinner and less sticky than existing drug-coated stents, is more easily maneuvered through a clogged artery. "If everything else was me-too, just that one feature would take the whole market," says Dr. Mitchell Krucoff, a professor of medicine and cardiology at Duke University Medical Center who is the co-principal investigator of Conor's U.S. clinical trial. Krucoff says he has received less than $10,000 in consulting fees from Conor. If current clinical trials go well, European regulators could approve Conor's stent by yearend -- and the FDA could follow by late 2007. Still, even with approval, Conor must battle Boston Scientific, J&J, and others. Boston Scientific is spending more than $200 million a year on R&D for new stents and delivery systems -- four times what Conor has spent during its entire six-year existence. For Litvack, the key to beating the competition is more innovation, both in devices and drugs. Conor is now developing a stent that uses anti-clotting compounds acquired from Novartis. "We believe the job of a good medical company is to make your products obsolete," he says. (*** Yeah right, now your product is obsolete before they can be commercialised! This Frank Latvick guy is just a con man) |
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bengster68
Master |
14-Jun-2008 12:07
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The following memorandum was sent to Conor Medsystems, Inc. and Cordis Corporation employees on December 8, 2006. To Cordis Corporation and Conor Medsystems, Inc. Associates: The cardiovascular market continues to be one of the fastest growing segments of the health care industry as populations in the United States and other countries continue to age. Upon the completion of the acquisition, which is subject to certain closing conditions, the relationship between Conor Medsystems, Inc. and Cordis Corporation would create a unique opportunity for two exceptional companies with strong technology capabilities and outstanding employees to build a stronger, more diverse cardiovascular franchise. The combination of talent from Conor Medsystems and Cordis businesses gives us the ability to advance the vision of defeating cardiovascular disease by delivering better medical options sooner to many millions of patients suffering from cardiovascular disease. To ensure our capacity to deliver these important new therapies, we have formed an Acceleration Steering Committee comprised of Frank Litvack, Chairman and Chief Executive Officer; Michael Boennighausen, Vice President and Chief Financial Officer; Jeff Shanley, Founder and Chief Technology Officer; and Azin Parhizgar, Vice President and Chief Operating Officer from Conor Medsystems, and Rick Anderson, Company Group Chairman, Johnson & Johnson; Todd Pope, President, Cordis Cardiology; Joe Prati, Vice President, Finance; Campbell Rogers, Chief Technology Officer; and Lisa Uthgenannt, Vice President, Human Resources from Cordis Corporation, a Johnson & Johnson company. The proposed acquisition of Conor Medsystems affirms Cordis’ focus on accelerated growth through expanded capabilities and investment in Conor Medsystems’ technologies. Through a multiyear strategy, we will build on the complementary expertise of both organizations. To achieve this goal, the Steering Committee has responsibility for establishing the acceleration objectives and guiding principles, organizing work teams from each company, monitoring the planning process, approving transition plans, and overseeing the transition implementation. This past week, the Steering Committee met and agreed on the mission and goals of our planned future together and the three phases of our integration strategy. • The first phase will accelerate and enhance the capabilities and programs of Conor Medsystems with support from Cordis and Johnson & Johnson • The second phase will create a drug delivery center of excellence in vascular technologies, including an Advanced R&D center that focuses on delivering therapeutics through medical devices. This is a critical component of Cordis’ West Coast Strategy to enhance research and development capabilities around innovative product concepts. • The third phase will explore possibilities in a broad range of clinical indications beyond cardiovascular categories. Our work will be guided by the following principles: • Protecting, maintaining, and investing in the Conor Medsystems technology platform • Retaining and enriching technical capabilities and talent of both organizations • Utilizing Cordis and Johnson & Johnson resources, lessons learned, and infrastructure • Respecting each others’ ideas, capabilities, and expertise Upon closure, our near-term efforts will focus on the following activities: • Supporting efforts to secure approvals for Conor products worldwide • Fully integrating Conor Medsystems products into the Cordis global sales and marketing strategy • Expanding the Cordis West Coast Innovation Strategy to include Conor Medsystems Within the coming weeks, Acceleration Leaders from each company will be named and these individuals will form their teams. The teams will develop detailed goals and a work plan for the successful implementation of the three-phase strategy. It is important for us all to remember that the implementation of the strategy would become effective only upon conclusion of the acquisition, projected for the first quarter of 2007.
Collaborative teams will be providing more clarity to both organizations as we work together to further define our strategy to accelerate our growth. Together, we are certain that our combined organization will accomplish more together than either could have alone. We know we can count on your focus, collaboration, and commitment to our combined success. The first steps we take together will be critical toward our long term ability to achieve our goals and realize our potential to positively impact health care professionals, patients, and employees. We will communicate our progress frequently, but in the meantime, feel free to contact your respective Acceleration Steering Committee members with additional questions. Thank you for your enthusiasm and dedication to our shared goals. Sincerely,
*** Looks like all of the acquisition mission, goals and integration startegy set out previously cannot be met. Even the key people involved are mostly gone. Cordis only has a "Destined-To-Fail" NEVO DES smoke screen to cover a small patch of their crotch area with the rest of their naked body exposed ![]() |
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bengster68
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14-Jun-2008 11:52
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The management at Cordis seems to be loosing heart. The Johnson & Johnson (nyse: JNJ - news - people ) subsidiary has had a round of significant turnover amongst its upper management in recent months with the latest announcement coming Friday morning that Todd Pope, the group's worldwide president, would leave on July 11. Pope is said to be leaving to pursue opportunities outside the company and to spend time with his family. A replacement has not yet been named and Cordis said it was not speculating on when Pope's slot would be filled. Cordis makes medical devices that are used in cardiovascular procedures, particularly drug-eluting stents--small wire-mesh devices that hold the heart arteries open and are covered in therapeutic drugs. Pope is the seventh senior person to announce his departure, according to Wachovia (nyse: WB - news - people ) analyst Larry Biegelsen, who broke the news to clients Friday morning. Other major departures included the company's group chairman, Rick Anderson; chief medical officer, Dr. David Kandzari; vice president of sales, Mark Valentine; vice president of health economics, Brian Firth and his replacement, Liesl Cooper; and the vice president of clinical affairs, Denis Donohoe. According to Cordis spokesman Chris Allman, the group will continue to be run by current group chairman Seth Fischer, who took over for Anderson in January. He was previously at J&J. Allman added that Donohoe and Firth are both retiring and that Kandzari left to pursue his medical practice. Biegelsen said in his note that Cordis's products are not performing as well financailly as competitors and that this could be an opportunity for some of the group's competitors, specifically Medtronic (nyse: MDT - news - people ), Abbott Laboratories (nyse: ABT - news - people ), and Boston Scientific (nyse: BSX - news - people ), to make further strides. A recent study showed that Abbott's Xience V stent, when compared with Boston Scientific's Taxus stent, was clinically superior. Biegelsen forecasts that Abbott will have 47% of the market share by 2011. In recent years, the market has been controlled by J&J and Boston Scientific. **** Cordis is sinking man! It is not about declining DES market as MDT and ABT are both doing very well. The fate of Cordis now is the result of a very bad MNC acquisition mistake. So many heads rolled in Cordis because of buying over Conor (Rick Anderson is the chief culprit). They lost US$1.4B and also are also losing their market position fast. All depends on whether their HQ JNJ wants to continue on their stent business or close down Cordis. If they want to continue on, they have to buy up another stent developer to fend off Endeavor and Xience to regain back their top position. If they close down Cordis, it will look very bad for JNJ from number one DES player to zero. JNJ's group profitability will be affected, PE (20 times for such MNCs) will result in many multiple billions of market capital being wiped out. The market capital loss is 20 times the loss of income from closing down Cordis. Likewise, if Cordis is doing very well, the positive effect on JNJ's market cap is 20 times the earnings of Cordis. Buying over BIG is JNJ's one and only hope left if they are want to rescue Cordis and get back to their former number one position. There is no other way out for them. Only BIG has the top class DES technology to beat Endeavor and Xience. |
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PensionAlterEgo
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14-Jun-2008 11:16
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Looks like Rick Anderson was the main guy in charge of Cordis when JNJ took over Conor Medsystem. JNJ top management really serious about JNJ's stent market decline man... |
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PensionAlterEgo
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14-Jun-2008 10:25
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Cordis Turnover Indicator of Stent Collapse 06.13.08, 7:15 PM ET - from Forbes Management problems at Cordis, one of the leading U.S. stent makers, is just further indication that the stent market is not in good health. The Johnson & Johnson (nyse: JNJ - news - people ) subsidiary has had a round of significant turnover amongst its upper management in recent months with the latest announcement coming Friday morning that Todd Pope, the Cordis group's worldwide president, would leave on July 11. Pope is said to be leaving to pursue opportunities outside the company and to spend time with his family. A replacement has not yet been named and Cordis said it was not speculating on when Pope's slot would be filled. Cordis makes medical devices that are used in cardiovascular procedures, particularly drug-eluting stents--small wire-mesh devices that hold the heart arteries open and are covered in therapeutic drugs. There have been signs the stent market is weakening. One of Cordis' major competitors, Boston Scientific, cut jobs at the end of last year, with the Street expecting 2,000 to 3,400 more cuts from its 28,000 employee total. Pope is the seventh senior person to announce his departure, according to Wachovia (nyse: WB - news - people ) analyst Larry Biegelsen, who broke the news to clients Friday morning. Other major departures included the company's group chairman, Rick Anderson; chief medical officer, Dr. David Kandzari; vice president of sales, Mark Valentine; vice president of health economics, Brian Firth and his replacement, Liesl Cooper; and the vice president of clinical affairs, Denis Donohoe. According to Cordis spokesman Chris Allman, the group will continue to be run by current group chairman Seth Fischer, who took over for Anderson in January. He was previously at J&J. Allman added that Donohoe and Firth are both retiring and that Kandzari left to pursue his medical practice. Biegelsen said in his note that Cordis's products are not performing as well financially as competitors and that this could be an opportunity for some of the group's competitors, specifically Medtronic (nyse: MDT - news - people ), Abbott Laboratories (nyse: ABT - news - people ), and Boston Scientific (nyse: BSX - news - people ), to make further strides. A recent study showed that Abbott's Xience V stent, when compared with Boston Scientific's Taxus stent, was clinically superior. Biegelsen forecasts that Abbott will have 47% of the market share by 2011. In recent years, the market has been controlled by J&J and Boston Scientific. A Danish study was published the Journal of the American Medical Association in January comparing the leading stent by Boston Scientific with that from Cordis. The study showed that it made little difference which stent was used and that they performed equally well. "This is the first large-scale study to address the problem this way," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City. "They excluded hardly anyone. And in a clinical practice that treats a broad spectrum of patients, it doesn't seem to matter much whether patients get the sirolimus-eluting stent or the paclitaxel-eluting stent." >> have to cheer for Mr. Seth Fischer to look for BIG..!!! |
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JustForFun
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13-Jun-2008 11:41
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XTENT Announces European Regulatory UpdateMENLO PARK, Calif., June 12, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- XTENT, Inc. (Nasdaq: XTNT) today announced a progress update regarding its application to the designated European Notified Body for CE Mark approval of its Custom NX(R) DES System. XTENT's European Notified Body confirmed that recently presented six-month follow up results from the CUSTOM III study will be incorporated by the Drug Agency, which reviews the drug formulation submission of XTENT's CE Mark application, into its current review cycle. XTENT's CE Mark application, which included two components, the XTENT design dossier and the drug formulation submission, was filed in December 2007. "Given the positive results of CUSTOM III, we are encouraged that the Drug Agency, which has already approved Biolimus A9(R) and PLA combinations on two other DES platforms, has accepted the additional data for review. This, we believe strengthens an already robust submission for our Custom NX System," said Gregory D. Casciaro, XTENT's President and CEO. The company anticipates a response from its European Notified Body regarding its CE Mark application this summer. |
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AK_Francis
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13-Jun-2008 00:17
![]() Yells: "Happy go lucky, cheers." |
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its not the same place the matter, its the travelling time. 10 over hrs, if got transit worst loh. hope next A380 will fly to Frankf or Brlin. | ||||||||||||||||
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cashiertan
Elite |
12-Jun-2008 23:33
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68 cents prove to be a support .. can buy near it but sell if broken | ||||||||||||||||
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bengster68
Master |
12-Jun-2008 22:27
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8th trip equals Huat Ah!!! (I arrange German sausage in a letter "8" formation and put another "8 formation" with 2 full mugs of beer side by side for you). Hope when you come back, you can see some kopi money from BIG and Fiberchem. ![]() |
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jackjames
Elite |
12-Jun-2008 22:14
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brother ben, that's my 8th trips to Germany , it is very boring to be at the same place every single trips, sianz.. so, I will skip one week of stock watching, when I am back, it better show me at least 76 cents, LOL.. let's see. |
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