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4661-4680 of 10899
http://www.ocbcresearch.com/pdf_reports/company/Biosensors-090529-OIR.pdf
OrSee Busy (say this in cantonese) said fair price is 74 cents ! Simple maths (74 - 57) x (big lots) = (shxt loads of money to be made) ....dont care anymore about these fundamentalist...share extremist and number analysts about these speed eluding stens and clinical trials and Funny Drug Administers etc... blink and you will regret that u missed this boat.... Who is selling? Hands up? Please sell it to me.... They need only small amount of money as far as I know, even the ah-long downstairs at the food court can sort out their cash flow need.
perspicacious (clap clap clap)
dcang84 ( Date: 29-May-2009 16:31) Posted:
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It would do this counter alot of good if the company could find a snappy resolution to the debt issue. It could be a drag on the stk.
ah yes. at least they are not bleeding red ink like they did a couple of years ago.XiaoMaGe888 ( Date: 29-May-2009 19:14) Posted:
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Fair value is about 80cents rather than 90cents for up to Q2 2009 after reading the Q4 results, will support this level. We think Mid term Long term both good, if you want short term I suggest go try s-chip and penny shares. No need to talk down this share so that you can accumulate. There is enough for you if you accumulate now.
Cheers!!!!!!must have confident ,BIG now is profitable company.
TuaPekGong9413 ( Date: 29-May-2009 15:17) Posted:
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Expected... coming down.
But for long term, is ok.
To the person who sold his shares @0.585.Hats off!!! You are damn f**king fast.
It wouldn't surprise me if it moves up but I think u ought to read the presentation slides @ their website.In so many words they are screaming 'MONEY NO ENUFF' assuming they fulfilled and achieved the set targets,margins, etc.
I think most investors are concerned with the size of capital required which would ultimately affect the options under consideration-refinancing, share placement, rights issue, etc. i dun think it will be a small amount (it will be more than just working capital).
Put it simply, this stock is for the VERY long term investor.
TuaPekGong9413 ( Date: 29-May-2009 15:08) Posted:
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Confessions of a deluded bengster68.Pls spin another tale for old time sake.
bengster68 ( Date: 29-May-2009 12:47) Posted:
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have faith in this counter. rem...this counter is a very slow counter. it reacts very slow to news. it shall rise soon...60cents
imagine, if BIG had cheong after their announcement, ppl will say becos company made profit. now the stock nvr cheong, ppl say becos lately cheong too much or loyalty issues. its just like if today got heavy rain, ppl will say becos many days nvr rain liao. but when it doesnt rain, ppl will say becos now its the hot period.......sigh......
I think you short a lot.
Old news but since no one posted, I just want to clarify some of my earlier strong but wrong opinions. I now feel no M&A chances liao. I doubt MDT will be interested in BIG since their Endeavor Resolute DES trials are doing well. There was market rumour circulating that Terumo may be paying another US$40m to further reduce their NOBORI CE markets royalty. Now the royalty from Terumo is US$1.8m this quarter, that means NOBORI is not exactly selling very well in CE. Why would Terumo want to pay US$40m cash now to further reduce royalty of something that is not selling well? Maybe in Japan market yes, but in CE markets again? I doubt Terumo will do it. After further analysis, I feel that USA market is out of reach for BIG due to FDA problems and Wright patent. Ask yourself: How come no news about FDA IDE? The catalysts for this company are China JWMS and future royalty from NOBORI Japan market. I think BIG may do a rights issue to settle their US$45m debt expiring Nov 09. Just my humble opinion.
CORDIS – Nevo™ Sirolimus-eluting Coronary Stent Yields Superior Results to Taxus® Liberte® Stent in Pivotal Clinical Trial
New Approach to Coronary Stenting Shows Superior Results in Key Six-Month Safety and Efficacy Endpoints
Barcelona, Spain – May 19, 2009 – At six months, the NEVO™ Sirolimus-eluting Coronary Stent, incorporating RES Technology™, was superior to the Taxus® Liberte® Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results released today. In addition, no reports of stent thrombosis were reported in patients treated with NEVO™ through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
“We are extremely pleased with the results from this trial and believe NEVO™ has the potential to return Cordis to global leadership in the drug-eluting stent market,” said Seth Fischer, Company Group Chairman and Worldwide Franchise Chairman, Cordis Corporation.
NEVO™ is the first drug-eluting stent utilizing RES Technology™, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The NEVO™ Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64 percent in the NEVO™ arm as compared to the Taxus® Liberte® arm (0.13 mm compared to 0.36 mm, p<0.001). In-stent late lumen loss, which is tissue growth within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events, also known as MACE.
In addition, NEVO™ also showed superior angiographic results to the Taxus® Liberte® Stent in reducing restenosis, a reblockage in a stent, at six months. Angiographic restenosis was reduced 86 percent (1.1 percent in the NEVO™ arm compared to 8.0 percent in the Taxus® Liberte® arm, p<0.002).
NEVO™ also reduced the incidence of MACE (major adverse coronary events) by more than 40 percent compared to the Taxus® Liberte® Stent (4.1 percent vs. 7.0 percent respectively; p=0.226). MACE events occurring between hospital discharge and six months were reduced 67 percent from 4.8 percent with the Taxus® Liberte® Stent to 1.6 percent with NEVO™ (p=0.08).
NEVO RES I was not designed to show differences in clinical outcomes, however, patients treated with NEVO™ had numerically lower rates of events with respect to target lesion revascularization (1.6 percent for NEVO™ vs. 3.2 percent for the Taxus® Liberte® Stent; p=0.33) and the composite of death or heart attack (2.6 percent vs. 4. 3 percent respectively; p=0.26) compared to patients receiving the Taxus® Liberte® Stent.
Stent thrombosis can be a significant clinical issue with coronary stents and frequently results in heart attacks or death. Based on the ARC (Academic Research Consortium) definitions of stent thrombosis, which have been adopted by the interventional cardiology community, there were no reports of stent thrombosis in the 202 patients receiving NEVO™ while there were two reports of stent thrombosis in the 192 patients receiving the Taxus® Liberte® Stent, both of whom were on dual anti-platelet therapy at the time.
“In this trial, NEVO™ was superior to Taxus® Liberte® in a number of key safety and efficacy measures, including the primary end-point of late lumen loss,” said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France and one of three primary investigators of the NEVO RES I trial. “We also saw an emerging safety profile with NEVO™ that adds to our enthusiasm about the potential of this drug-eluting stent for patients with coronary artery disease.”
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation noted, “Not only did NEVO™ significantly outperform Taxus® Liberte® in important measures but these results also indicate that the potential for a strong safety profile supporting the opportunity for patient-specific tailoring of the drugs traditionally needed to prevent thrombosis is quite promising.”
Dr. Rogers continued, “Based on these results, the potential for a strong safety profile with NEVO™ is quite promising. NEVO™ is designed to improve patient outcomes by providing a unique vascular safety profile, the proven efficacy of Sirolimus and excellent deliverability.”
Results in Diabetic Patients in NEVO RES I
It is widely known that patients with diabetes tend to present with more complex coronary lesions and are more challenging to treat. In the NEVO RES 1 study, a similar magnitude of benefit of the NEVO™ Sirolimus-eluting Coronary Stent over the Taxus® Liberte® Stent was seen in patients with diabetes as in patients without diabetes.
In a pre-specified subset analysis of the 65 patients with diabetes completing six-month follow up to date, there was a 60 percent reduction in in-stent late lumen loss with NEVO™ versus the Taxus® Liberte® Stent (0.17 mm compared to 0.42 mm, p<0.03). The magnitude of the differences seen in favor of NEVO™ was similar to the 65 percent reduction seen in 277 non-diabetic patients (0.12 mm, compared to 0.34 mm in the Taxus® Liberte® arm, p<0.001).
NEVO RES I Study Overview
The NEVO RES I study is a randomized, multi-center comparison of the NEVO™ Sirolimus-eluting Coronary Stent to the Taxus® Liberte® Stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound (IVUS) at six months.
The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
The NEVO™ Sirolimus-eluting Coronary Stent is an investigational device. It is not yet approved or available for sale in any market.
About the NEVO™ Sirolimus-eluting Coronary Stent
Barcelona, Spain – May 19, 2009 – At six months, the NEVO™ Sirolimus-eluting Coronary Stent, incorporating RES Technology™, was superior to the Taxus® Liberte® Stent in reducing tissue growth within the stent that can potentially lead to repeat procedures, in new clinical study results released today. In addition, no reports of stent thrombosis were reported in patients treated with NEVO™ through six months.
The results of the NEVO RES I study comparing these two drug-eluting stents were presented during Late Breaking Clinical Trials at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.
“We are extremely pleased with the results from this trial and believe NEVO™ has the potential to return Cordis to global leadership in the drug-eluting stent market,” said Seth Fischer, Company Group Chairman and Worldwide Franchise Chairman, Cordis Corporation.
NEVO™ is the first drug-eluting stent utilizing RES Technology™, which incorporates hundreds of small reservoirs, each acting as a depot into which drug-polymer compositions are loaded. This unique design allows drug delivery from a stent with a surface that is 75 percent bare metal upon insertion and which becomes purely bare metal following drug delivery and polymer bioresorption in approximately three months based on in vivo data. By contrast, currently marketed drug-eluting stents have 100 percent of their surfaces coated with drug and polymer and the polymer is never fully bioabsorbed.
The NEVO™ Sirolimus-eluting Coronary Stent had significantly lower in-stent late lumen loss, the primary endpoint of this prospective, randomized clinical trial. Specifically, late lumen loss was reduced by 64 percent in the NEVO™ arm as compared to the Taxus® Liberte® arm (0.13 mm compared to 0.36 mm, p<0.001). In-stent late lumen loss, which is tissue growth within a stent, reduces the diameter of the lumen thus restricting blood flow through the stent and can potentially lead to major adverse coronary events, also known as MACE.
In addition, NEVO™ also showed superior angiographic results to the Taxus® Liberte® Stent in reducing restenosis, a reblockage in a stent, at six months. Angiographic restenosis was reduced 86 percent (1.1 percent in the NEVO™ arm compared to 8.0 percent in the Taxus® Liberte® arm, p<0.002).
NEVO™ also reduced the incidence of MACE (major adverse coronary events) by more than 40 percent compared to the Taxus® Liberte® Stent (4.1 percent vs. 7.0 percent respectively; p=0.226). MACE events occurring between hospital discharge and six months were reduced 67 percent from 4.8 percent with the Taxus® Liberte® Stent to 1.6 percent with NEVO™ (p=0.08).
NEVO RES I was not designed to show differences in clinical outcomes, however, patients treated with NEVO™ had numerically lower rates of events with respect to target lesion revascularization (1.6 percent for NEVO™ vs. 3.2 percent for the Taxus® Liberte® Stent; p=0.33) and the composite of death or heart attack (2.6 percent vs. 4. 3 percent respectively; p=0.26) compared to patients receiving the Taxus® Liberte® Stent.
Stent thrombosis can be a significant clinical issue with coronary stents and frequently results in heart attacks or death. Based on the ARC (Academic Research Consortium) definitions of stent thrombosis, which have been adopted by the interventional cardiology community, there were no reports of stent thrombosis in the 202 patients receiving NEVO™ while there were two reports of stent thrombosis in the 192 patients receiving the Taxus® Liberte® Stent, both of whom were on dual anti-platelet therapy at the time.
“In this trial, NEVO™ was superior to Taxus® Liberte® in a number of key safety and efficacy measures, including the primary end-point of late lumen loss,” said Christian Spaulding, M.D., F.A.C.C., Professor of Cardiology, Assistance Publique-Paris Decartes University Hospitals, Paris, France and one of three primary investigators of the NEVO RES I trial. “We also saw an emerging safety profile with NEVO™ that adds to our enthusiasm about the potential of this drug-eluting stent for patients with coronary artery disease.”
Campbell Rogers, M.D., Chief Scientific Officer and Global Head, Research and Development, Cordis Corporation noted, “Not only did NEVO™ significantly outperform Taxus® Liberte® in important measures but these results also indicate that the potential for a strong safety profile supporting the opportunity for patient-specific tailoring of the drugs traditionally needed to prevent thrombosis is quite promising.”
Dr. Rogers continued, “Based on these results, the potential for a strong safety profile with NEVO™ is quite promising. NEVO™ is designed to improve patient outcomes by providing a unique vascular safety profile, the proven efficacy of Sirolimus and excellent deliverability.”
Results in Diabetic Patients in NEVO RES I
It is widely known that patients with diabetes tend to present with more complex coronary lesions and are more challenging to treat. In the NEVO RES 1 study, a similar magnitude of benefit of the NEVO™ Sirolimus-eluting Coronary Stent over the Taxus® Liberte® Stent was seen in patients with diabetes as in patients without diabetes.
In a pre-specified subset analysis of the 65 patients with diabetes completing six-month follow up to date, there was a 60 percent reduction in in-stent late lumen loss with NEVO™ versus the Taxus® Liberte® Stent (0.17 mm compared to 0.42 mm, p<0.03). The magnitude of the differences seen in favor of NEVO™ was similar to the 65 percent reduction seen in 277 non-diabetic patients (0.12 mm, compared to 0.34 mm in the Taxus® Liberte® arm, p<0.001).
NEVO RES I Study Overview
The NEVO RES I study is a randomized, multi-center comparison of the NEVO™ Sirolimus-eluting Coronary Stent to the Taxus® Liberte® Stent in de novo native coronary artery lesions. Key secondary endpoints include target lesion failure, target vessel failure, major adverse cardiac events (MACE), stent thrombosis, target lesion revascularization, target vessel revascularization, and angiographic in-stent and in-segment binary restenosis at six months. A subset of patients in each treatment arm was evaluated via intravascular ultrasound (IVUS) at six months.
The study involved 394 patients at 40 sites throughout Europe, South America, Australia and New Zealand. Patients received clinical follow-up at 30 days and six months and will be followed annually through five years.
Data from this trial will support a regulatory filing for a CE mark in countries outside the United States.
The NEVO™ Sirolimus-eluting Coronary Stent is an investigational device. It is not yet approved or available for sale in any market.
About the NEVO™ Sirolimus-eluting Coronary Stent
NEVO™ is made of cobalt chromium, which makes the stent flexible and conformable with thin struts to maximize vessel coverage. The biodegradable polymer used to contain and release Sirolimus facilitates rapid endothelialization and results of pre-clinical studies indicated no greater inflammation than seen with bare metal stents.
NEVO™ also contains the same drug, Sirolimus, as the CYPHERÒ Sirolimus-eluting Coronary Stent, which has now been used in more than three million people worldwide. Data supporting the safety and efficacy of Sirolimus in coronary applications is now available out to six years, and this body of clinical evidence is completely unmatched by any other anti-restenotic stent.
Upcoming Clinical Trials for NEVO™Sirolimus-eluting Coronary Stent
Cordis Corporation also announced today additional information of the study designs for upcoming clinical trials for NEVO™.
NEVO II will be a global, randomized, non-inferiority trial comparing NEVO™ to the Xience V™ Everolimus-eluting Coronary Stent. The study plans to enroll several thousand patients with coronary artery disease and will include expanded enrollment in multiple patient subgroup. The primary endpoint of the study is target lesion failure at 12-months. The study will be led by Patrick Serruys, M.D., Erasmus University, Rotterdam, The Netherlands; Stephen Windecker, M.D., University of Bern, Switzerland; and Manual Sabate, M.D., Hospital de Sant Pau, Barcelona, Spain. Results from this trial will provide long-term data in support of a Pre-market approval (PMA) application with the U.S. Food and Drug Administration (FDA).
NEVO III will be a non-randomized, single-arm trial evaluating clinical outcomes in approximately 1,200 patients throughout the U.S. and Canada. The primary endpoint will be TLF at 12-months. The study will be led by Dan Simon, M.D., Case Western Reserve University School of Medicine, Cleveland, OH; and David Kandzari, M.D., Scripps Clinic, San Diego, CA. NEVO™ will be compared to the CYPHER® Stent control arm of the CYPHER Stent/DAPT (dual anti-platelet therapy) trial (described below).
The CYPHER® Stent/DAPT trial will enroll approximately 2,000 patients and will compare clinical outcomes in a broad range of patients receiving DAPT for 12 months versus 30 months after receiving a CYPHER® Stent. This trial will contribute to the company’s involvement in a broader DAPT clinical program, required by the FDA, which involves all FDA-approved drug eluting stents.
“The NEVO RES I, NEVO II and NEVO III trials will provide us with comparative data for NEVO™ against Taxus® Liberte®, Xience® and even our own CYPHER Stent,” said Dr. Rogers. “These data will provide physicians and their patients with important information to assess optimal treatments for coronary artery disease.”
Typical BIG way. going down......down.... down.....
We are only small players. No BB will come to these forums...
For 2 to 3 days don't jump into the BB trap. Watch closely clearing the positions and make a good decision by yourself when to go in. GOOD LUCK...
I agree with you. The rise during the past few weeks most likely peaked with the release of the results. Don't foresee it to rise further unless unexpected good news.
Not a call to buy or sell. DYODD & HW.
lostbell ( Date: 29-May-2009 09:42) Posted:
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Very steady move in the morning. No big players in to this yet. Looks similar pattern like last quater result announcement. Will be moving between .52 to .57 for the next couple of weeks unless there is no new news / rumour.
Biosensors International Group: Ends FY09 strongly
By Kelly Chia
Fri, 29 May 2009, 09:04:36 SGT
Summary: Biosensors International Group
(Biosensors) ended the year with its 4Q09 revenue rising 87% YoY to US$22.4m
while gross profit soared 243% YoY to US$15.2m. On a full year basis, gross
profit grew 3.3x to US$89.5m. The impressive performance was primarily due to
sustained growth in sales of its higher-margin Drug Eluting Stents (DES).
Management continues to keep costs under a tight lid as that only rose 27% YoY
- paltry in view of sales growth. FY09 bottomline was in the red at US$1.1m
compared with losses of US$34.6m the previous year. Management also updated
that it is on the right technology track as its larger competitors have
recently revealed similar DES programs. The company has indicated that it will
be able to repay its US$45m convertible notes but will likely undertake some
financing to sustain its strong growth spurt. Our estimates have been refined.
We are mindful that this year included licensing revenue of US$40m is likely
exceptional in nature. Core product revenue growth will continue to increase at
a rate of about 40%. The net result will show FY10F registering flattish total
revenue but better margins will see a stronger bottomline. We are maintaining
our medtech discounted model with a raised fair value of S$0.74 (prev. S$0.71).
Maintain BUY.
Everyone is finally catching up. Recently, J&J (with its Nevo Stent)
and Boston Scientific (with its acquisition of Labcoat in Jan ‘09) revealed
forays into the biodegradable polymer DES arena. This authenticates the
technology leadership of Biosensors where it will be presenting its 2-year
follow-up LEADERS trial results. The J&J Nevo stent recently presented its findings
but has a narrower trial indication with a much smaller patient pool while
Labcoat is even farther back in the clinical trial process. As we know it,
Abbott and Medtronic are still in developmental stages.
Funding for expansion. Biosensors has projected that its FY10 cash flows
will be able to repay the US$45m convertible notes that are due in Nov 2009.
However, doing so would leave little cash in hand to continue on its growth
spurt. The company has indicated that it will explore some form of financing.
Options such as more licensing agreements with larger upfronts or strategic
equity investments by another corporate are possibilities. We think pure equity
issues are unlikely unless its price appreciates substantially prior to its
repayment.
Maintain BUY. Our estimates have been refined. We are mindful that this
year included licensing revenue of US$40m is likely exceptional in nature. Core
product revenue growth will continue to increase at a rate of about 40%. The
net result will show FY10F registering flattish total revenue but better
margins will see a stronger bottomline. We are maintaining our medtech
discounted model with a raised fair value of S$0.74 (prev. S$0.71). Maintain BUY.
As I mentioned yesterday, this is a typical tendency of BIG. "Going down after results".
With yesterday result announcement it will never touch .60. Need some additional news / rumour to move upwards.
Today morning not seen any big players playing this counter till now. Small investor & contra players, please don't jump into this counter for 2 days. 2 cents worths of experience from my side.
any pull back is a golden chance to buy ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,im strongly confident any action after result,,,,,,,,,,,,,,,,,,,,,,cheers