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Can advise how you know that Biomatrix DES may be approval early January 2011?
Tks
If 1.18 fails to hold, it could correct to 1.16 or even 1.12 before Christmas. This provide anothe opportnuty to load up before it rebounce up after christmas/new year in anticipation of Japan's approval of Biomatrix DES in early January 2011.
I also believe BIG could easily breach $2.00 and will keep some of my position for the long ride. The new team that HONY has encouraged seem to be very capable. I am especially impressed by the new investor relations person who seems to have a great deal of contacts and experience. Remember - perceptions drive value and stock price.
I am half believing that Biosensors could go into the $2 and above kind of range, but have sold off nearly everything.
I agree that it doesn't matter which trial the CE mark for BioMatrix is based on as long as it is there. However, those who believe that the N=200 trial for BioFreedom is good enough for a CE mark will be in for disappointment and a longer wait.
Don't believe me - go check with those who know. Many such researchers in Biopolis.
My whole point is: patience, be prepared to wait 3 to 5 years. The returns will more than what many people imagine. There is no guarantee - the management can still mess up - but the returns will me much more than the risk.
Hi, Just for fun, you are right. At that time, the CE mark was delayed for a long time, and BIG had to supplement data (namely from Nobori ) to convince the CE Auth, in order for approval to be granted. And that is why , both BIG and Terumo got approval at the same time.
For info.
Hi investor, thanks for pointing out that Biosensors used the Stealth clinical trial results instead of Leaders for Biomatrix's CE mark. However, if i remember correctly, Biosensors also used Terumo's Nobori trial results in it's CE mark application.
The biomatrix product used in the stealth clinical trial of 120 patients IS DIFFERENT from the biomatrix product used in the Leaders trial. In fact, the leaders trial product is offically called the biomatrix flex.
There is another CE mark obtained for the Biomatrix flex, I think sometime in Jan 2010 (cannot remember the exact date).
So, Biosensors is in fact marketing both the original biomatrix and the biomatrix flex right now..
THe difference between both products are :
THe old biomatrix consists of a stent ( called the S-stent), with a primer (very thin coating) call parylene-C on it, before the polymer and drug is laid on it.
The new biomatrix flex has a new stent (make more flexible) and it does not have parylene-C on it.
It doe not matter actually, whether the CE mark is due to the stealth clinical trial or the Leaders trial, (It is upto each individual to believe what they want to believe) as long as Biosensors has the CE mark and are marketing it.
For info.
I did not notice this before but it is on the Biosensors website:
http://www.biosensors.com/intl/sites/default/files/pdf/LEADERS%20Trial_12%20months%20Data.pdf
Note when the LEADERS trial started - late 2006 !!
I do not believe that BioMatrix obtained the CE mark based on a N=120 phase 2 trial. There are exceptions but this is generally almost impossible for a new product.
Also, when trial results are announced at world class conferences the paper has to be submitted for review months before the conference - which means the LEADERS results are already available (at very least in raw form) in early 2008.
If N=120 is enough, why doesn't BioFreedom get its CE Mark by now? BioFreedom's trial is past the 18 months point for N=200. Why did the management say they are conducting discussions with regulatory bodies to develop a protocol to develop a multinational trial like LEADERS for BioFreedom?
investor ( Date: 08-Dec-2010 12:22) Posted:
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I know that the patients in the leaders trial is not 120, but 1707. (How can I not know, having followed Biosensors from 2005 until now)
Biosensors obtained the CE mark on 18th Jan 2008 , based on the 120 patient Stealth clinical trial. Similarly, Terumo obtained the CE mark also on 18th Jan 2008, based on the Nobori I trial, which comprises of a total of 363 patients (phase 1 and 2 combined).
The Leaders trial first results for 9-mths data was presented during EuroPCR 2008 on 1st Sep 2008 - It is NOT THE BASIS for the CE mark. - But it contributed significantly to a growing acceptance of the Biomatrix.
For info
For those who missed the "live" webcast of the most recent results announcement, here is the link to the recorded video:
http://www-waa-akam.thomson-webcast.net/cn/dispatching/?event_id=23053e5c851694b2f469724c96fef6c8&portal_id=ef313dc423a2de17d12353153514e25b
Appropriate media player need to be installed on your PC.
Investor,
The LEADERS trial had a N of 1707, not 120. N=120 probably refers to an earlier trial (Stealth 1, 2005?). They even conducted another trial Becon 1 with N= 292 before LEADERS. LEADERS obtained 1 year results probably atound early 2008 and CE mark was awarded in mid-2008.
For medical devices and drugs, N of low hundreds will not be taken seriously for new devices and entities. Usual norm will be numbers of low thousands. N of a few hundreds are usually Phase 2 trials which has to be conducted to demonstrate safety before the main trial can take place.
Hi, Just for Fun - Thanks for the update.
Actually, the 182 patients trial is not that small. The Bio-matrix was approved based on a 120 patient clinical trial.
I was under the impression that the trial that they want to conduct similar to the Leaders trial was meant for the US mkt. Let me go in and listen again, tonight,
Just-for-fun is right. The main clinical trial for BioFreedom has not yet taken place. They are merely preparing for these trials. In their webcast presentation for the recent financial quarter, it was very clear that the main BioFreedom trial is still being planned. This was said in reply to the OCBC analyst. This webcast also gave a lot of hints regarding the future prospects of Biosensors. However, in the bio-technology sector, don't expect to see results in weeks or months. Sometimes it takes 10 years or more.
An extreme example I know about is TauRx. It has a drug to slow down or halt the progress of Alzheimer's disease. The discovery/invention was in the mid-1980s. The company was started probably about 8 years ago. And they have not yet completed (as far as I know) their main clinical trials. 25 years - can you wait this lomg?
But this is an extreme example. In BioFreedom's case, they expect to start the main trial early next year. (Look out for a jump in their R&D expenses for clues when this is started.) The results will take 2 to 3 years to finalize and approval (subject to a spectrum of conditions) will then be forthcoming. I will be quite happy to see approval for Biofreedom in 2013.
Meanwhile, BioMatrix should continue to be one of the best stent in the market. In the webcast, the management said that they are seeing increasing market share in all markets they have approvals in. Some of these are at the 15% level and increasing. I estimate that 30% or more can be achieved if marketed well. Adding the licence fees from Terumo, revenues can reach US$500 mil and more when approvals from the major markets are obtained. And remember that the gross margins are in the 70% range. However, this will take a few years more - patience needed.
The Devax acquisition is also very interesting. Devax is the only DES that is targeted at bifurcation cases. According to the company, bifurcation happens in 15% to 20% of all cases requiring stent implants. They have recently obtained their CE mark and have been put on an accelerated path for approval by the US FDA. Devax's monopoly status in (say) 15% of a marketof US$5 bil annually is very interesting. Again, patience is recommended - this won't happen next quarter.
Declaration of interest: (very very) long in this stock.
Hi investor, if you listen to the webcast on the 2Q/1H Results Briefing, CEO mentioned that biosensors is meeting up with the regulatory authority and investigators to determine the protocols and primary end points (Q&A portion...at abt 25mins) for a clinical trial similar to LEADERS. Also the BioFreedom's First-In-Man trial (N=182) is too small to get CE mark.
Agreed is a good counter. I just sold mine today. Cheers.
In reply to Just-for-fun, on 14th Oct 2010, during the audio conference given by Yoh Chiu Lu, regarding the sale of his shares, Nomura's Lim Jit Soon asked Jeff Jump, whether the First-in Man data from the Bio freedom trial can be used for CE mark authority.
Jeff's reply was ' definitely' and that they are infact meeting the EU authorities regarding this issue - I take it to mean that Biosensors has or will be submitting the clinical trials for CE mark.
You may want to listen to the audio conference yourself (somewhere around 19 mins onwards).
On a separate note, Biosensors seem to be trending upwards, but in a very slow and measured manner, even in a quiet mkt like this - Amazing.
4 important events to watch out for, in the coming qtrs, which should be positive for Biosensors.
1) Approval to mkt in Japan
2) Approval to mkt in China (Maybe Hony's presence will help)
3) Launch of Devax bifurcated DES in Europe
4) Last but not least, CE Mark for Bio Freedom (may take a while)
AS usual not a call to buy/sell.
For info.
$1.23 now
can anyone share what does biomatrix do and what is impact of the new product ?
tbt001 ( Date: 06-Dec-2010 13:37) Posted:
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