| Latest Forum Topics / Biosensors |
 Post Reply
|
|
Is Biosensors a good buy?
|
|||
|
bengster68
Master |
24-May-2008 16:10
|
||
|
x 0
x 0 Alert Admin |
JNJ will do their NEVO DES (Conor Sirolimus) clinical trials progressively. Finish the first one, results good, start the second one. Any prudent DES company will plan clinical trial sequence this way also. This is to reduce the risk VS cost involved in case the stent undergoing clinical trial is a failure. After one trial is completed with promising results, the second trial will then be initated. The whole process will take about 5 years of burning cash with eventual target of FDA approval. Normally, companies will start with the CE approval first (small patient enrollment and no need to do costly massive RCT). If the clinical results for CE approval is good, then they will proceed ahead for the more massive scale clinical trial for FDA approval (will burn a lot more cash). I think for 388 patients, JNJ will spend less than US$10m cash only. The industry average cost to conduct a 9 month trial per patient is approx US$20,000 per patient. This US$20,000 cost per patient involve doctor consultation, hospital bills, cost of DES and cost of delivery system, periodic following up for end-point measurements, etc. Patient enrollment will take a few months, plus standard 9 months duration of end-point measurement plus 3 months to tabulate data. So, the results of the first NEVO DES clinical trial most likely will be out somewhere end 2009 (maybe in TCT2009). This will give JNJ a "wild card" to call a bluff on during takeover negotiations after BIG's LEADERS results which will be ready in a few months time. Even if NEVO doesn't work by end 2009, maybe JNJ would have already bought BIG by end 2008 / early 2009. US$10m cash burning for clinical trial is really "peanuts" to JNJ. JNJ will definitely use NEVO DES as a smoke screen to cover up their internal desperateness to make another DES acquisition. | ||
| Useful To Me Not Useful To Me | |||
|
genester
Member |
24-May-2008 15:59
|
||
|
x 0
x 0 Alert Admin |
JNJ using biodegradable polymer - does it infringe on BIG's IP rights?
|
||
| Useful To Me Not Useful To Me | |||
|
|
|||
|
bengster68
Master |
24-May-2008 15:02
|
||
|
x 0
x 0 Alert Admin |
Xtent's share price super jialat also. Cash and cash equivalent is US$47m, market cap is US$85m. Looks dirt cheap to me considering what they have achieved in clinical trials. They can achieve such clinical results because they chose BIG as their licensing partner. BiolimusA9 and PLA biodegradable polymer is the currently the best DES technology available. Not an inducement to buy Xtent. I think Xtent should be getting their CE very soon also. FDA may give them shorter approval time because there is a very pressing market need for good long lesion DES. I think their FDA progress also kena stuck because of BIG's BiolimusA9 master drug file not approved yet. If Biomatrix get their IDE, Xtent should be getting their IDE soon. I think Singapore analysts won't bother about this Xtent info. | ||
| Useful To Me Not Useful To Me | |||
|
allright
Senior |
24-May-2008 14:01
|
||
|
x 0
x 0 Alert Admin |
Hey!!This is GOOD NEWS!!! Er...anyone know any analyst?? Copy this to them although they should be doing the homework themselves..never mind..we do the work for them . Bengster...you are great!!! | ||
| Useful To Me Not Useful To Me | |||
|
bengster68
Master |
24-May-2008 11:51
|
||
|
x 0
x 0 Alert Admin |
CUSTOM III: Registry data bolsters enthusiasm for the stent that can be customized to longer lesion lengths May 22, 2008 Shelley Wood Barcelona, Spain - The latest data on the adjustable-up-to-60-mm-length Custom NX drug-eluting stent (DES) build on the preliminary studies of the device, suggesting that in situ customization of stent length is safe and associated with low rates of clinical events and acceptable late loss at six months. Experts who spoke with heartwire called the device a "truly next-generation" device that could fill an urgently unmet need—long lesions. In new data presented during the EuroPCR 2008 meeting, investigators showed that, despite being used in some of the longest lesions ever treated in clinical trials, the Custom NX stent is associated with single-digit major adverse cardiac event (MACE) rates—something unheard-of in other long-lesion DES trials. Ironically, it is the unique strengths of the device in long lesions that pose problems for its manufacturers and regulators: there is no appropriate comparator for the pivotal large randomized trials. As previously reported by heartwire, the Custom NX stent's chief distinguishing characteristics are its length and customizability: the stent is composed of multiple, interdigitated cobalt chromium segments, each 6 mm in length, such that the length of stent can be custom-sized during a procedure, up to a maximum length of 60 mm, while being more flexible in tortuous vessels. It was also designed such that two lesions up to 60 mm in total can be treated within the same procedure, without retracting the delivery catheter and introducing a second stent. The drug used on the stent is Biolimus A9, a rapamycin derivative, applied only to the surfaces of the stent that contact the vessel wall; the polymer is bioerodable; and the delivery system includes a resizable balloon, allowing the operator to use a smaller balloon length for postdilatation, rather than reintroducing a separate balloon. Six-month results from the CUSTOM II presented at last year's EuroPCR meeting suggested that the device was associated with a MACE rate of approximately 9%. Stent length sized as needed Dr Bernard De Bruyne (OLV Hospital, Aalst, Belgium) presented results from the CUSTOM III registry during the late-breaking clinical-trials session at EuroPCR. He explained to heartwire that the device developer—Xtent—went with a registry study for the third trial in the development program because the company had made significant changes to the handle on the delivery catheter that is used to control stent length and to detach the desired length of the stent. Like the CUSTOM II trial, CUSTOM III was in four European countries—Germany, France, Belgium, and the Netherlands—at a total of 13 centers. Presenting the six-month results for CUSTOM III, de Bruyne reported that the device was associated with an overall MACE rate of 7.8% for the 90 patients included in the registry. These patients either had long lesions, in whom the six-month MACE rate was 5.1%, or received two stent segments during the procedure, delivered sequentially, with a MACE rate of 12.9%. Angiographic results indicated a low rate of in-stent binary restenosis (4.4%) and low in-stent late loss (0.17 mm). According to de Bruyne, there was only one case of stent thrombosis in the study, and this occurred within the first 30 days and in a non-Custom NX DES that was also implanted during the procedure. In an interview with heartwire, de Bruyne noted that in two-year follow-up from the CUSTOM I trial there have been no cases of late stent thrombosis with the Custom NX stent, although only 30 patients participated in this first-in-human study. But at least in theory, a lower rate of stent thrombosis is plausible for this stent: it uses a bioerodable polymer, it avoids the need for multiple overlapping stents, and it can be customized according to lesion length, protecting patients from inappropriately long stents. "Stent length is a factor in both restenosis and stent thrombosis," de Bruyne points out. "It's recognized more and more that it is important to stent exactly to the right length, matching the right length of stent to the length of the lesion. It is not good practice to overstent." Long stent length a chief asset Should the Custom NX stent prove itself in larger, randomized trials, de Bruyne believes long lesions will be the real niche for this device. "I would say long lesions are currently treated inappropriately, and suboptimally, with most stents, because we need to use several stents one after another, with multiple overlap, and this is typically what Xstent Custom NX avoids. 'Niche' is really not the right word because it is really a large number of patients in whom we are lacking any sort of device. This is where the device brings something new, something additional, something that we did not have before. He believes the device's ability to treat consecutive lesions in patients with multilesion disease will offer a new option for some patients but is not its chief appeal. "In these patients, we can use up to 60 mm of stents cut in several pieces if we want, but in my personal opinion, this will be a second-choice indication. I think regular stents will still be used in a large number of cases." Commenting on the study for heartwire, Dr William Wijns (OLV Hospital Aalst), who chaired the late-breaking session, also highlighted the benefits of a long stent. "I really think that the unmet medical need is the very long, diffuse lesions," he said. Currently available DES have maximum stent lengths in the low-30-mm range. "As soon as you need to go beyond that, you need to overlap stents, and there are multiple issues associated with overlapping. The difficulty we have in knowing how much overlap you have in vivo is absolutely not trivial, and the overlap region is a high-risk zone: this has been proven over and over again and the FDA is very much concerned about this." Wijns points out that the interdigitated feature of the Custom NX stent means that the different 6-mm modules of the deployed stent are placed next to each other but not physically connected, so there is no actual junction between segments. "That's a fundamental difference from all the other devices, because all of them, even the corrugated-ring design, have some sort of bridge from one element to the other. Here there is no bridge; it means there is enormous flexibility and a lot of adaptability to all the curves—in a 60-mm stent, it is as if you are implanting 6 mm of stent, times 10." He acknowledged that there are some concerns that this design has raised about migration between the sequential segments or that there might be gaps where restenosis could develop—so far, this has not been an issue in the three CUSTOM trials to date, and the gap appears, if anything, smaller than the gaps between stent struts. Citing other data also presented during EuroPCR by Dr Eberhard Grube (Helios Heart Center, Siegburg, Germany), Wijns pointed out that the CUSTOM trial program—particularly CUSTOM II, where mean lesion length was 31 mm—has included the longest lesions ever studied in DES trials, and some of the smallest reference vessel diameters, yet the MACE rate even for long lesions has been strikingly low. Grube showed a graph plotting MACE rates and lesion length for all the early DES trials showing that event rates run in a straight line from RAVEL—lowest MACE and shortest lesion length—to TAXUS V—longest lesions and highest MACE, around 20%. Yet the CUSTOM results, added to the graph, have very long lesion lengths yet single-digit MACE. "That's why I'm saying this is a different animal," Wijns explained. Hurdles ahead for randomized trials The next step for the Custom NX stent is a larger randomized trial comparing the Custom NX with a market-approved DES in patients with long lesions and/or multivessel disease. Ironically, de Bruyne points out, a trial assessing the stent for multivessel disease "would not be so difficult to organize." By contrast, he continued, "In long lesions, theoretically, it may be difficult to obtain ethical approval, not because of the Custom NX stent, but because we already know that treating patients with approved DES, where we need to overlap several stents, is not totally appropriate. So, paradoxically, there is an intrinsic recognition that the Custom NX stent might be better in these long lesions." Wijns agreed. "This will pose all sorts of problems for the FDA, because what is the comparator? How do you do a randomized trial with something that cannot be compared with something else? I have seen the results at six months of the cases done at our hospital—you simply do not recognize the vessel." He continued: "I don't want to sound too enthusiastic about this—I did not do the cases myself, so I'm not really involved—but I do really think it is something new, it's not just another stent on the list. You will not find many people who share the enthusiasm for this device, because it hasn't been in many hands so far. But I think people just don't know about it yet." | ||
| Useful To Me Not Useful To Me | |||
|
|
|||
|
bengster68
Master |
24-May-2008 11:46
|
||
|
x 0
x 0 Alert Admin |
I feel large MNCs like JNJ has got a lot of cash to burn to do all sorts of clinical trials. They will have to continue with that hopeless Costar platform stent because: 1. JNJ said it was the multiple novel reservoir holes that attracted JNJ to buy Conor. JNJ cannot U-turn on their earlier stand. So they have to continue all sorts of clinical trials to answer to their shareholders and to safe face for Costar's non-performance in earlier clinical trials using Paclitaxel drug and Primecolimus drug. JNJ has no problem burning US$100m cash (over a period of 5 years with low initial burning until FDA RCT trial starts) for all these Conor Sirolimus DES clinical trials. Its very small change to them. I feel even if JNJ think there is 50% chance this new NEVO DES cannot work, they just have to proceed ahead. Cannot U-turn back. I spoke to a DES engineering expert before about Conor's disasterous clinical trial results and he said most the the DES engineers feel that Costar's multiple novel reservoir holes is the root of the problem of Costar DES platform. The drug is stored in the reservoir holes and the diffusion to spread evenly to the entire vessel wall may not happen after the stent is expanded by the balloon catether (the wire mesh is pressing on vessel wall, pushing out the vessel wall). All other DESs uses evenly coated drug around the entire metal mesh, only Biomatrix coat BiolimusA9 on the "half-side" of metal mesh touching the vessel wall because drugs coated on the other half do not promote good ethodiXXXXX (healing growth over the wire mesh) 2. I believe JNJ has been eyeing for BIG for a long time and they know they made a very bad acquisition mistake buying Conor. These MNCs grow large by acquisitions. Look around the DES industry landscape, BIG is the best and only worthwhile takeover target left. The fact that they acquired Conor shows that JNJ still want to remain as a dominant player in DES industry and I believe they will not hesistate to perform another acquisition to get themself into this position. JNJ also know their safest and best hope to get back to their glorious DES leader days hinges on strategic acquisition. If their NEVO DES will not work again, no more show to act and Cordis is really finished. So they are using their NEVO DES as a fronting to appear that they are not so desperate to pay a high price for acquisition of BIG. Its like playing poker game: Never show your real emotion/ intention and keep your cards close your chest. To get CE Mark, 388 patients will cost JNJ less than US$10m cash burning for clinical trial. Spend this US$10m as a poker game to call a bluff against BIG to press down the price that BIG wants. If JNJ can successfully call the bluff and reduce US$300m in BIG's takeover price tag, then this US$10m "clinical trial burning" will be very worthwhile. That is why i feel BIG need to have at least US$250m cash in bank to show JNJ that we can remain independent and we have the financial ability to become global DES powerhouse all by ourself. We don't need to be bought over to grow big and we have the ability to canibalise your global market share. |
||
| Useful To Me Not Useful To Me | |||
|
investor
Senior |
23-May-2008 22:05
|
||
|
x 0
x 0 Alert Admin |
J & J seems to be very serious in the Conors Sirolimus Drug eluting stent platform, with a bio-degradable polymer. They have named the new DES as the Nevo DES, and it is their strategy to use this in their future DES technology. They will start a clinical trial towards applying for a 'CE Mark', using 388 patients, to be followed by a 1000 patient cinical trial for IDE submission in the US, and lastly a 1770 patient clinical trial for the US FDA approval. THe details can be seen in their webcast in the recently concluded EUROPCR conference. To view the webcast, go to the EUROPCRONLINE.COM, under the webcast section, and click the title 'Expanding Indications for drug eluting stents - What does the future holds' I believe this is the first time, that one of the DES giants, has publicly come out in strong support for bio-degradable polymer technology, by incorporating it in their next generation des technology. (Thereby vindicating Biosensors' pioneer approach in this area) For information only. |
||
| Useful To Me Not Useful To Me | |||
|
bengster68
Master |
23-May-2008 19:42
|
||
|
x 0
x 0 Alert Admin |
MDT got Endeavor (captured 20% USA market share within 3 months), Abbott has got Xience which i think will capture 30% of USA market share by end 2008. BSX has got Promus (a.k.a Xience) so at least BSX has got a life jacket, JNJ got only Cypher (the first DES in market) and that useless Costar which is forever failing clinical trials. I believe by end 2009 Xience (and Promus) will capture abt 60% of USA market share. JNJ's future in DES industry looks very bleak. Without newer and better DES weapon, JNJ's Cordis division is going to close shop sooner than we expect man. Its a very costly takeover mistake for JNJ to buy Conor. Not just about the US$1.4B cash gone down the drain but kena wipe and and erased off the DES industry. JNJ was the pioneer and leader in this industry. Very very costly takeover mistake. Freaking sad case man..........
|
||
| Useful To Me Not Useful To Me | |||
|
|
|||
|
allright
Senior |
23-May-2008 12:29
|
||
|
x 0
x 0 Alert Admin |
I think we be patient and wait for the results. Frankly, I think the new management are ok and will bring BIOSENSORS to a greater level. Have faith. Not asking to buy but just to be patient and have faith. We waited so long. Don't lose HEART(hahaha) | ||
| Useful To Me Not Useful To Me | |||
|
bengster68
Master |
23-May-2008 12:15
|
||
|
x 0
x 0 Alert Admin |
I think the BBs that bought earlier this week also lose money liao.......
|
||
| Useful To Me Not Useful To Me | |||
|
bengster68
Master |
23-May-2008 12:13
|
||
|
x 0
x 0 Alert Admin |
Since Taxus is rated so lowly by the educated consumers reading cardio matters at crtonline, why is Taxus still the global best selling DES? That means the doctors are making the decision on which brand to use for his patient's implant. Patients just pay the doctors for consultation and could be generally ignorant about DES matters like clinical trial results. Why would doctors use the brand which most educated consumers rate it the lowest??? Something is definitely not right .......... $$
|
||
| Useful To Me Not Useful To Me | |||
|
investor
Senior |
23-May-2008 11:39
|
||
|
x 0
x 0 Alert Admin |
In an on-line poll in website 'crtonline.org' Which of the DES would you choose to use for your own family member? Cypher 7.38 % Taxus 2.82 % Endeavor 13.67 % XienceV/Promus 76.14 % It shows that the newer DES are getting much better reviews than the first generation DES. Also, Medtronics has just announced their quarterly results, and they managed to capture 20 % of the US mkt, in a short span of time, better than analysts' expectation. Again, it augurs well for the new generation DES. For info only - Not a call to buy/sell. | ||
| Useful To Me Not Useful To Me | |||
|
|
|||
|
XiaoMaGe888
Senior |
23-May-2008 11:21
|
||
|
x 0
x 0 Alert Admin |
BIG "XIAO AGAIN"  @##@$$$$$$$#####@@@@@@@@@$$$$$$$$$$$$
|
||
| Useful To Me Not Useful To Me | |||
|
AK_Francis
Supreme |
23-May-2008 01:45
Yells: "Happy go lucky, cheers." |
||
|
x 0
x 0 Alert Admin |
Yoh, we are brothers and sisters in the forum, no hard feeling, whatever it is. Free sparing, and learn fr each other leow. Today is a bad day but 2morow could be a better day loh. Cheers up folks. AK warmess regards. | ||
| Useful To Me Not Useful To Me | |||
|
cashiertan
Elite |
22-May-2008 23:32
|
||
|
x 0
x 1 Alert Admin |
ut wont give a damn abt the "info", no offence coz i am a technical trader not a FA or news trader. | ||
| Useful To Me Not Useful To Me | |||
|
cashiertan
Elite |
22-May-2008 23:25
|
||
|
x 0
x 0 Alert Admin |
but wont give a damn but the "info" no offence coz i am a technical trader not a FA or news trader. | ||
| Useful To Me Not Useful To Me | |||
|
cashiertan
Elite |
22-May-2008 23:25
|
||
|
x 0
x 0 Alert Admin |
no wonder big chiong recently out of the blues. seem like insider got the news liao.. | ||
| Useful To Me Not Useful To Me | |||
|
cashiertan
Elite |
22-May-2008 23:09
|
||
|
x 0
x 0 Alert Admin |
of coz now market is bad sentiments. even the local bbs also have to siam oneself and take lost sometimes.. | ||
| Useful To Me Not Useful To Me | |||
|
cashiertan
Elite |
22-May-2008 23:08
|
||
|
x 0
x 0 Alert Admin |
busy wif work recently and missed some of bios run up. yupz personally would have buy in at 76c few days back if i am monitoring.. it seem there is some dumping today but still there is much collected by BBs at their hand. will enter if bios break 77.5c. in fact based on basic TA and abit more risk taking, should have entered on 20/5 on opening. target potential is 86 or 89c |
||
| Useful To Me Not Useful To Me | |||
|
AK_Francis
Supreme |
22-May-2008 16:13
Yells: "Happy go lucky, cheers." |
||
|
x 0
x 0 Alert Admin |
Loon is the word leow. |
||
| Useful To Me Not Useful To Me | |||