RING!!RING!!RING!!!
Last call for BIG!!!!!!!!!!!!!!
Bro..... is BIG time ok......not big tmie......

jackjames ( Date: 01-Sep-2008 08:13) Posted:
|
Biosensors poised for the big time
It'll present results of landmark clinical trial today in Munich on stent comparison
DESPITE a relatively quiet past, Biosensors International Group is poised to make a splash in the market.
Founded in 1990 as a developer and marketer of critical care catheter systems, they have since diversified into the interventional cardiology industry with their proprietary coronary stent, as well as the drug- eluting stent market with their flagship BioMatrix product line.
Its most recent milestone is its landmark LEADERS clinical trial, which compares the safety and efficacy of BioMatrix against Cypher, the stent system of long-established industry leader Johnson & Johnson.
The results of the trial will be presented today during a key session of the European Society of Cardiology (ESC) meeting in Munich.
'Based upon previous clinical trials and existing clinical data, we have great confidence in our unique system,' said Mike Kleine, president and chief executive officer of Biosensors.
'We hope that the results of the LEADERS trial will continue to support BioMatrix's excellent track record and provide a solid clinical foundation for the future,' he added.
Biosensors has held its own against larger players in the field, with its Biolimus A9 drug-eluting stent technology demonstrating clinical superiority over Boston Scientific's TAXUS Liberte drug-eluting stent in a previous trial.
Their success was clear in the company's strong first-quarter financial results, which showed a revenue growth of 303 per cent year-on-year, and a net profit rise of 107 per cent to US$16.5 million, largely due to the sale of BioMatrix stents.
'Biosensors has found itself in a wonderful position,' said Mr Kleine. 'We are attracting very strong management talent to align with a very strong product.'
Looking ahead, the company has strong aspirations. It has hired over 22 top sales and marketing people in Europe, to form a sturdy infrastructure as its clinical data is released. It has also consolidated its overseas and local manufacturing sites from four facilities in Singapore, the US and the Netherlands, into one facility here, in order to improve organisational efficiency. New research and development goals are being pursued, such as the development of a polymer- free stent.
'Many have asked me about profitability, but you can't be penny wise and pound foolish when you're about to launch a major product,' said Mr Kleine. 'Our goals are ambitious, and the only way (to achieve them) is by investing in the right people and materials. Shareholders should be looking to see that this company fulfil its potential.'
The company is similarly ambitious on a long-term scale, with plans to maintain a strong presence in Asia and achieve a 10 per cent market share in the US$1.6 billion European drug-eluting stent industry.
'In three years, we aim to be a US$250 million company,' said Mr Kleine. 'And there's nobody in the organisation who doesn't think that's possible.'
Hi Bengster,
The article appeared on Sat. ST, Part D, page D11.
The company is called Amaranth Medical, valued at 20 million US. Of this 10 million is investment from US-based venture capital. The founder ia a NTU lecturer : Prof.Freddy Boey, 52.
Pls. check yesterday's ST section D and give your comment, thks.
01 Sep 2008 11:00-12:30 Hot Line II Munich - Zone A4 12:12pm LEADERS - Limus Eluted from A Durable versus Erodable stent coating (Randomized Comparison of a biolimus-A9 eluting stent with a sirolimus-eluting stent for percutaneous coronary intervention.
Dear Bio Supporters,
Could anyone advice the exact time for Bio's presentation during the ESC congress 2008. I managed to find the scientific program but can't really tell the actual schedule. please find attached link for the ECS table. http://spo.escardio.org/search.aspx?eevtid=24
Regards, 
investor ( Date: 31-Aug-2008 14:51) Posted:
|
I think that the key issue for the Leaders Trial is that FINALLY, there is a BIG ENOUGH TRIAL for Biosensors to show that their bio-matrix does not pose any problems for patients, in terms of safety and efficacy.
The bio-matrix does not have to be 'superior' clinically to the Cypher stent for it to make an impact - It is OK as long as the results are similar.
I think the more important aspect of this trial is that it will probably involve stent overlapping for some sub-sets of patients due to the longer lesions, and if you look at stent overlapped in Renu Virmani slides, the Bio-matrix comes out the clear winner - Which should translate to better clinical outcome down the road.
Hopefully, the design of this study will focus on some of the subsets like overlapping stents, diabetes, etc, in order to demonstrate the efficacy and safety of the Bio-matrix.
FOr discussion.
ironside ( Date: 31-Aug-2008 07:00) Posted:
|
I believe BiolimusA9 does have certain advantages over Sirolimus esp the unique fat seeking properties of BiolimusA9 drug to target directly at the fatty plaque causing vessel clogging. The PLA Biodegradable Polymer that Biomatrix uses should be a more superior polymer technology than Cypher's very old durable polymer technology. Among all the durable polymer technology being used by all the major 4 players, i believe Cypher and Taxus probably has the worst durable polymer technology because they are the older version of durable polymer.
Look out for Binary Restentosis, TLR, MACE and late stent thrombosis percentage rates. These are the key areas to determine which is the better stent. Endothelial recovery rate using OCT scan will not be available yet until TCT2008. Better keep out fingers crossed at this moment but i do have a feeling Biomatrix should be able to show some form of superiority against Cypher. The percentages cannot kelong but the calculation of statistical difference "P Value" can be manipulated though. Recently, BSX was accused by experts for manipulating the statistical difference for their Taxus Liberte statistics ("p" value) to show non-inferiority of which if another interpretation method is used, Taxus Liberte would have shown statistical "P value" inferiority.
altius ( Date: 31-Aug-2008 11:42) Posted:
|
A word of caution about the upcoming Leaders Trial results. I believe that it may be difficult for Biomatrix to show any sort of statistical superiority over the Cypher in stent in the initial 9 month follow-up. Both stents use a 'limus drug and so both will have a low degree of late loss. The thinner struts of the Biomatrix stent may help reduce the number of periprocedural MI's which should lower it's 9 month MACE rate. I think that the real advantage of the Biomatrix stent will be revealed in the longer term follow-ups where the novel way the drug coating is applied and the PLA polymer will help to increase the rate of endothelialization and thus help reduce late stent thrombosis.
Bengster,
In the same ST yesterday, there was a report about a NTU lecturer and his Stent company. His company also produces DES. Care to comment on this company ?
There was an article about cardiology on Straits Times (Home Section) on Saturday. Biosensors was mentioned in the ST article for upcoming ESC conference which will bring more international recognition to Biosensors. The article also mentioned about Biosensors will be releasing the LEADERS clinical results at ESC2008 which will be comparing Biomatrix and Cypher (the current best selling DES).
I think BIG will chiong on Monday!!!
Recent OCBC research
http://www.ocbcresearch.com/Article.aspx?type=research&id=20080813093943_63393
Make
what a nice word.....DESPERATE .............he should use F^*& DESPERATE....... sit tight tight......and watch for more action....
Look like BIG team is moving in the right direction....... hope this east wind come at the right time....
with a good results........ BIG is nicely doll up for some suitors now......