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Yes, BioMatrix is not fully absorbable. The scaffold (wire frame) is left behind after the polymer and drug is expended. However, it is still among the leaders of all commercially available stents in terms of trial results.
Fully absorbable stents like the Abbott BVS are in very early stage trials and their results shouldn't worry BioMatrix much. As pointed out, the trial numbers (N) and overall results are not very significant.
If I am not wrong, BioFreedom is also not fully absorbable. It coats BioLimus A9 directly onto a steel scaffold (without the use of a polymer). It has some early trial results but will an N of 182 at 1 year be enough for the CE mark? Note that it is still currently enrolling for a N=300 trial (according to their website). Some countries will require an N of thousands. However, its preliminary results does look very good. Only time will tell.
It seems that the current market leader is the Xience stent. They should go head to head against this with any new BioFreedom trial.
DES (Drug Eluting Stents) basically has 3 components, the stent, the polymer and the drug.
Biosensor's DES has a biodegradable (or bioabsorbable) polymer, BUT its stent is metallic and it IS NOT a biodegradable or bioabsorbable stent.
Both Abbot and Reva have a DES (both of which are in clinical trials and not yet approved for sale), which have a biodegradable or bioabsorbable stent. Commercially, Biosensors is the only company that has a DES for sale, where the polymer is biodegradable. They are pursuing a polymer-free DES, call biofreedom, and the CLINICAL RESULTS ( 1 yr) has ALREADY been announced. In fact, Biosensors has already submitted it to the EU authorites for CE mark approval.
To emphasize - doctors want a DES that can enable them to reduce the dual anti platelet therapy, and that means no polymer and no drug as soon as possible. Biosensors current biomatrix fulfill this requirement partially, as the polymer biodegrades, but it takes 6-9 mths.
The Abbot and Reva DES ( both are still in clinical trials) which have biodegradable stent is good in theory, but the polymer used in Abbot's stent will linger in the body for upto 2 yrs, and therefore has the potential to cause stent thrombosis - and that is why the dual anti platelet therapy is needed for quite a long period, whereas the Reva's DES has no such problem, but its clinical results wee not very good - probably worst than a bare metal stent (if my memory serves me right.)
So, Biosensor's Biofreedom looks like the right product, at the right time, if they can get it commercialised.
A personal opinion Not a call to buy/sell.
The terms "biodegradable" and "bioabsorbable" are used interchangably. It simply means the polymer degrades into carbon dioxide and water which is then absorbed into the blood. If you go back to the Wikipedia article and read it carefully to the end, you will see:
( http://en.wikipedia.org/wiki/Drug-eluting_stent )
Examples approved outside the US :
BioMatrix (Biosensors Int) S stent platform, bioabsorbable PLA coating with Biolimus A9 drug
see also: http://spo.escardio.org/eslides/view.aspx?eevtid=40&fp=999 slide 19
and this: http://www.healthgrabber.com/sessions/select-grube.pdf slide 22 amd 25
To understand why Biosensors claims that BioMatrix is one of the best stent in the world (if not "the best" stent in the world), read through both sets of presentation slides.
The new BioFreedom stent is polymer-less and this promises to be even better. However trial results have yet to be published and approval is not yet obtained.
As for the stent from the competitor company refered to in the TCTMD article; they have not got approvals for commercial sale, unlike BioMatrix.
Article taken from TCTMD.com - Looks like Dr. Renu Virmani does not think much of bioabsorbable stents.
By Caitlin E. Cox
Friday, December 03, 2010
The second generation of a new everolimus-eluting bioabsorbable stent shows improved results on optical coherence tomographic (OCT) imaging compared with its previous incarnation, with less late shrinkage and neointimal growth at 6 months, according to an analysis of the ABSORB trial published online December 1, 2010, ahead of print in the European Heart Journal.
For ABSORB, Patrick W. Serruys, MD, PhD, of the Erasmus Medical Center (Rotterdam, The Netherlands), and colleagues followed 2 cohorts of patients with single de novo coronary artery lesions who underwent PCI with the BVS (Bioabsorbable eVerolimus-eluting Stent; Abbott Vascular, Santa Clara, CA). The stent has a backbone of poly-L-lactic acid that provides support and a coating of poly-DL-lactic acid that contains and controls the release of everolimus. All components of the BVS, except for 2 radio-opaque markers, are expected to fully absorb into the human body within 2 years.
Cohort A included 30 patients treated with BVS 1.0, while Cohort B tested the newer BVS 1.1 in 101 patients. The current analysis compares 12 lesions from each cohort that were imaged at baseline and 6-month follow-up with OCT.
Baseline clinical, angiographic, and OCT characteristics largely were similar between the 2 groups, with the exception of smoking, which was significantly higher in the 1.0-treated patients (33% vs. 0%; P = 0.03). By 6 months, late shrinkage—which occurs due to the scaffold’s loss of structural integrity in conjunction with fatigue and constrictive remodeling of the vessel following injury—was less severe in BVS 1.1-treated lesions than in those treated with the previous design. Neointimal area and thickness also were reduced with the newer model.
These changes translated into significantly smaller reductions in mean and minimal lumen areas from baseline to 6 months for the newer stent (table 1).
Table 1. Outcomes on OCT at 6 Months
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BVS 1.0 |
BVS 1.1 |
P Value
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Absolute Shrinkage, mm2
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0.98
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0.07
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0.01
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Relative Shrinkage
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13.0%
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1.0%
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0.01
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Neointimal Areaa
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23.6%
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12.3%
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< 0.01
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Neointimal Thickness, μm
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166.0
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76.4
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< 0.01
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Relative Difference in Mean Lumen Area from Baseline
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-35.1%
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-16.1%
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< 0.01
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Relative Difference in Minimal Lumen Area from Baseline
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-47.0%
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-20.7%
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< 0.01
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a In-scaffold area obstruction.
By 6 months, the strut appearance of BVS 1.0 on OCT had substantially changed from baseline, whereas 100% of BVS 1.1 struts maintained a black box appearance.
In addition, patients treated with the BVS 1.0 had significant angiographic late loss, with a decrease in minimum lumen diameter of 0.43 mm from baseline (P = 0.01). Those receiving BVS 1.1, meanwhile showed a non-significant 0.08-mm decrease. The difference in late loss between the 2 designs did not reach statistical significance by 6 months (P = 0.07).
Optimizing Design
According to Dr. Serruys and colleagues, the manufacturing process was modified between BVS 1.0 and 1.1 “to enhance the mechanical strength and mechanical durability of the struts. Moreover, the new design has in-phase zigzag hoops linked by bridges that allow for a more uniform strut distribution, reduce maximum circular unsupported surface area, and provide more uniform vessel wall support and drug transfer. The polymer mass, coating content, amount of drug, and the strut thickness remain the same.”
“The slower bioresorption process of the BVS 1.1, compared with the BVS 1.0, is the most plausible explanation for the near elimination of the late shrinkage and for the higher inhibition of the neointimal response,” they conclude, adding that further research will assess whether these differences are preserved.
But Does It Matter?
In a telephone interview with TCTMD, Renu Virmani, MD, of CVPath Institute (Gaithersburg, MD), expressed skepticism about the paper. “These measurements, are they leading to something? Do they tell us something? I don’t believe so,” she said. “I think that the improvement they’ve made [in design] is real, but I doubt very much whether we can glean anything from [this small number of patients] because they are too few.”
“You need a large study, you cannot do cherry picking,” Dr. Virmani stressed, adding that the degree of difference between the stents appears implausible and that the mechanism also needs better explanation. “If you had done a preclinical study and shown me that the flow rate and sheer forces are much better in one than the other, I would understand that more,” she said.
David E. Kandzari, MD, of Piedmont Heart Institute (Atlanta, GA), however, was more optimistic that the paper held useful information.
“Bare-metal stents came into existence in interventional cardiology because, while they don’t necessarily prevent neointimal hyperplasia more than just balloon angioplasty, [they] provide architectural scaffolding that would prevent elastic recoil. No matter how appealing a bioresorbable stent may be, if it cannot fulfill those initial requirements that we demanded back in the mid-90s, it still may not be effective,” he explained. Although it is unclear whether BVS 1.0 [stent’s] limitations arose from the design of the stent itself or properties of absorption, “the newer design of the stent seems to provide the essential requirement of preventing recoil but at the same time provides the opportunity for drug elution and eventual bioresorption.”
Moving Forward Amid Uncertainty
In terms of the future for bioabsorbable stents, Dr. Virmani said the main question is whether they are worth the expense. “If you can afford it, yes, [but] we will have to pay an enormous price. It’s not going to be cheap when it comes to market,” she commented. “Unless you show me longevity for the patient, I don’t see the point. [Is it worth it] just because the vessel looks less jailed? I’m not convinced by that.” She also questioned whether the observed reduction in neointimal growth would persist and expressed doubt that BVS, with a strut thickness of 150 μm, could be widely used.
Moreover, Dr. Virmani pointed out that just because the scaffold is absorbed does not mean the vessel returns to its original state.
Dr. Kandzari agreed that for bioabsorbable stents the “late impact on vessel remodeling and health are complete unknowns today.”
These factors may affect whether clinicians are willing to adopt the technology, he noted. “My impression is that if this stent were to be available on the worldwide market today, it would still have a definite appeal and have fairly large market share,” said Dr. Kandzari. “But in speaking with physicians about it, I’m struck by the variability of responses and enthusiasm. And I think it’s in part because of the advances that we’ve had in everolimus-eluting stents,” with their apparent durability and favorable outcomes.
Existing second-generation DES set a very high standard, Dr. Kandzari commented. Designing trials that can demonstrate superiority is challenging, he said, so “do you just market them on physician intuition alone and hope adoption will be driven by perception rather than on actual clinical proof?”
Like Dr. Virmani, Dr. Kandzari said that cost might be an obstacle. He also pointed out that the BVS does not solve all of the challenges inherent to a permanent platform, in that most TLR occurs during the first year, when the scaffold would not yet be fully absorbed.
Even so, he said, “If you asked clinicians in 2006—with the whole drug-eluting stent dilemma and concerns about stent safety—do we need a bioresorbable stent? I think the answer would have been a unanimous yes. I think if you ask clinicians today, given the intuitive appeal, the answer would still be yes.”
There is a difference between Bioabsorble stent and biodegradable polymer. Currently, only Abbot and Reva are pursuing the bioabsorbable stent, where the stent is made of PLA polymer (for Abbot) and the stent is made of Magnesium (in the case of Reva).
The clinical results for Reva were not very good (in my opinion) and that of Abbot was acceptable, but I believe the clinical trials were quite simple and Abbot needs to do a big trial (at least 1000-1500 patients) and with no holds barred (ie like the Biosensors' Leaders trial) in order to prove safety and efficacy.
I saw a video interview of Abbot's Chief technical officer and his comments about the trial leads me to believe that it can only be ready much later than people believe, maybe 2014-2015. (my opinion).
Currently Biosensors is not going down this path yet - their strategy is in the Bio-freedom DES, where there is no polymer.
The thinking is that - even with a successful bioabsorble stent, the patient has to be on dual anti-platelet therapy as the polymer used in Abbot's design (PLA) may stay in the body for upto 2 YEARS ! I also believe that even if there is such a DES in the mkt, it will only be confined to simple lesions. Can you imagine a physical scaffolding in your blood vessel that gradually erodes away, and if it is too long, will its erosion be uniform ?, will the PLA polymer cause stent thrombosis ? (since the whole stent is PLA polymer), etc.
Actually, what the doctors want, in my opinion, is the elimination of the dual anti-platelet therapy soonest possible , as these drugs often cause internal bleeding, which may result in death, and the bioabsorbable stent does not do this, and in fact may even prolong it.
That is the reason, why Biosensors is pursuing the bio-freedom DES instead, and this product will probably be quite successful (in my opinion), if it is proven to be efficacious and safe. Reason - no polymer, and therefore behaves like a bare metal stent, and therefore no need for prolong dual anti platelet therapy.
Above are personal conjectures, and may not be entirely accurate, since I am not a medical doctor or clinician. As usual, not a call to buy/sell.
"A recent report released by iData Research on the interventional cardiology market revealed that bioabsorbable stents are expected to enter the European market by 2013 and the U.S. thereafter."
BioMatrix is a bioabsorbable stent already selling in Europe and elsewhere (e.g. India, Taiwan, Korea). Approval is expected in Japan and China soon.
For a quick insight on the significance of "bioabsorbable", see: http://en.wikipedia.org/wiki/Drug-eluting_stent
Survey Reveals Cardiologist Preference for Bioabsorbable Stents Will Fuel Interventional Cardiology Market by 2013
Increase in Angioplasty Procedures Fuels U.S. Drug-Eluting Stent Market to Almost $2.5 Billion
VANCOUVER, BRITISH COLUMBIA -- (MARKET WIRE) -- 11/29/10 -- According to a comprehensive global survey on stents, stent-grafts and vulnerable plaque by iData Research (www.idataresearch.net), the leading global authority in medical device and pharmaceutical market research, the majority of cardiologists in the U.S., Europe, China, India, Middle East and Africa would use a bioabsorbable stent for the treatment of coronary angioplasty. In contrast, the majority of cardiologist in Japan and Latin-America would not use a bioabsorbable stent.
A recent report released by iData Research on the interventional cardiology market revealed that bioabsorbable stents are expected to enter the European market by 2013 and the U.S. thereafter. The U.S. market is estimated to quickly reach almost $750 million with companies such as Abbott Laboratories (NYSE: ABT), Biosensors International, and REVA Medical emerging as leaders.
iData's survey details the preferences and usage patterns from hundreds of cardiologists worldwide for bioabsorbable, bifurcated and drug-eluting stents, stent-grafts and vulnerable plaque treatment.
"The survey provided dramatic differences between geographical regions in usage trends," says Dr. Kamran Zamanian, CEO of iData. "Cardiologists in the U.S. and Europe are more willing to use new technologies such as bifurcated and bioabsorbable stents, while Japanese and Latin American cardiologists are more resistant, citing the lack of long-term clinical data, early recoil and technical challenges as drawbacks to these technologies."
iData's accompanying market report states that the U.S. market for interventional cardiology is expected to reach almost $5 billion by 2017, with increasing drug-eluting stent sales and the emergence of bioabsorbable and bifurcated stents fueling market growth.
iData's global cardiologist survey series includes: "Stents, Stent-Grafts and Vulnerable Plaque Treatment" and "Deep-Vein Thrombosis Treatment and Screening". These surveys accompany iData's newest global 3-report series on the "Markets for Interventional Cardiology Devices".
For more information, register free on iData's website at: http://www.idataresearch.net/idata/registration.php (SOURCE:http://www.qmed.com/news/26755/survey-reveals-cardiologist-preference-bioabsorbable-stents-will-fuel-interventional-card)
(Note: Biosensors has both bioabsorbable polymer stents and the biodegradabke (Biofreedom) stent)
"In addition to their bioabsorbable polymer stent, Biosensors have developed a polymer-free system, termed BioFreedom™. This uses a 316L stainless steel stent with a novel surface modification, creating a microporous reservoir on the abluminal surface to control release of the antiproliferative agent Biolimus A9. While 90% of drug is released after only 50 h, due to the high lipophilicity of Biolimus A9 (~10x greater than that of sirolimus), there is still a significant concentration of the drug in tissue surrounding the stent at 28 days. By 90 days, this has reduced to a negligible level. A first-in-man randomized trial (n = 75 patients) comparing BioFreedom (standard dose or low dose) with TAXUS Liberté (in 1:1:1 ratio) reported the primary end point of in-stent late loss at 6 months to be significantly lower in both standard and low-dose BioFreedom stents (0.08 and 0.12 mm, respectively) compared with TAXUS Liberté (0.37 mm; <0.0001 and p < 0.002).[40] No stent thromboses were observed in any arms and MACE were not significantly different. (SOURCE:http://www.medscape.com/viewarticle/727850_3; Interv Cardiol. 2010;2(3):341-350. © 2010 Future Medicine Ltd.)
Hope this will benfit any sentiments towards biosensors?Looks like M&A very active in the Pharmaceutical and medical shares. This was yesterday
DJ MARKET TALK:C&O Pharma May Rise On Sumitomo Stake Buy News (2010/12/01 08:55AM)
0055 GMT [Dow Jones] C&O Pharmaceutical (E92.SG) likely to rise on news Japan''s Sumitomo Corp. (8053.TO) acquires 29% strategic stake in China-based drug maker for S$96 million, or S$0.50 per share; will become 2nd largest shareholder of C&O. Company says Sumitomo''s strategic investment "signifies a vote of confidence in C&O''s integrated competencies and business prospects," will help expand business in China healthcare market, explore export markets in Southeast Asia. Sumitomo will nominate 3 executive directors to sit on C&O''s board. Entry of one of world''s largest integrated trading companies into C&O, which has track record in entire value chain in pharmaceutical industry, likely eyed as positive step for business growth, while if earnings growth remains strong, Sumitomo may consider raising stake, which could entail mandatory takeover offer (above 30% trigger). Shares end flat at S$0.485 yesterday; recent S$0.50 high may cap gains. (matthew.allen@dowjones.com)
More on Lenovo and Hony Capital, BIG`s largest shareholder and our future hope is very bright with them on board.
Hu Zhongbin Hony Capital Nov. 18 officially announced that the second phase of its RMB 10 at the end of 2010 Fund was established. The holding of funds by the association as a sponsor, the National Social Security Fund has once again become a key investor.
After June 2008 the first phase of the Hony 20 billion yuan RMB fund investment, the National Social Security Fund as a key investor once again invest in Hony two yuan fund, the investment amount to 30 billion yuan. As a result, Hony Capital to become the first consecutive two-time National Social Security Fund Investment Fund Management team.
Hony investment, said fund raising goal of 8 billion yuan original, but given the amount raised the first delivery is more than 7 billion yuan, now plans to raise the total size of funds has been adjusted to no more than 100 billion yuan, is expected before the end of May 2011 complete a full delivery.
Chairman of the National Social Security Fund Council, said Dai, "A Phase II National Social Security Fund the first private equity investment fund management company is yi, yi we have great confidence in, worked out really well."
Hony Capital Fund, the first phase of a total of 5.026 billion yuan RMB, investment has been completed, the investment involved in financial services, cultural media, consumer, construction and other industries related to several leading companies, is expected to create huge returns for investors. Yi yuan fund the second phase will continue to focus on M & A investment and growth investments, focusing on upgrading and urban China's consumption growth in the process of two major investment themes.
Hony Capital CEO John H. Zhao said, "is both over-subscribed investment fund to obtain people's trust and support of Hony Capital, also shows that PE in China have bright prospects. Hony as a major force in the industry, not only for their own investors to earn good return on investment, but hopes to play in promoting economic development in China should have a positive role. "
After the completion of fund raising, the total capital investment management Hony more than 30 billion yuan, total assets of over RMB one billion, China PE fund management industry's largest fund management companies.
Hony Capital was established in 2003, Lenovo Holdings Limited's equity investment and management business in a professional company.
Hony Capital manages two funds dollar and the yuan, by 2010, the total size of over 30 billion yuan of funds.
gbleng ( Date: 27-Nov-2010 11:10) Posted:
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Hony Capital is solid and has a lot of connection. good for BIG
24 Nov 2010
Hony Capital to Receive RMB 3 billion Investment from China's Social Security Fund
November 24, Chinese private-equity firm Hony Capital (Beijing) Co. Ltd. said it has launched its second RMB-denominated fund and will receive a RMB 3 billion investment from China’s National Social Security Fund (NSSF), Securities Times reported Wednesday.
The fund, which aims to raise up to RMB 10 billion, targets companies in the financial services, mass media and construction sectors.
Hony Capital launched its first RMB fund in June 2008 when it received a RMB 2 billion investment from the NSSF. The fund raised RMB 5.03 billion.
The latest contribution from the NSSF makes Hony Capital the first private equity firm to receive two rounds of investment from the pension fund, the report said.
The NSSF is currently China’s largest professional PE investment institution. It is allowed to allocate up to 10% of assets to private equity.
The size of the assets held by the NSSF exceeded RMB 800 billion at the end of September, and the total is expected to grow to over RMB 1.5 trillion in five years.
infancybird ( Date: 29-Nov-2010 11:29) Posted:
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OCBC RESEARCH
Biosensors International Group: Growth momentum expected to continue
Summary: Biosensors International Group (BIG) has shown that it has put its past losses behind it and looks set to continue its turnaround story moving forward. It has demonstrated its resilience by increasing its drug-eluting stent (DES) market share in addressable markets to close to 15%, which has exceeded its 10% target. Traditionally, BIG’s product revenues for 2H have been stronger and we do not expect FY11 to be any different. This would be driven largely by its BioMatrix DES, which engages cutting-edge technology. BIG has also highlighted that it will enlarge its product portfolio and we are sanguine about the increased capabilities that could possibly arise. Part of this has come from inorganic growth, with the acquisitions of CardioMind and Devax recently. Internally, BioFreedom represents BIG’s next generation DES and initial First-in-Man trial results have been positive. We continue to like BIG for its technological superiority to its peers and execution capabilities. Hence we reiterate our BUY rating and DCF-based fair value estimate of S$1.35. Key risks include the roll-out of disruptive innovative products by competitors; failure to gain license approval in key markets; and clinical trial results that turn out to be unsatisfactory.
Looking at the trend line, looks like it will test again 1.24 soon.
topdog22 ( Date: 28-Nov-2010 23:18) Posted:
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I concur with both investor & gbleng's comments about valustion BUT I think the KEY component of share price and thus valuation is Investor expectations and risk tolerance. Traders by definition have very limited risk tolerance and a short term perspective whereas strategic investors have a much greater tolerance and a longer perspective. SGX is not known for high valuations due to our pragmatic nature and limited risk tolerance. As investor ownership of BIG expands beyond our borders to China, Hong Kong, US etc the full value of the counter will be unlocked.
Valuation is more an art than science. If it were the latter the smart analysts wouldn't get the valuation of apple and google that far wrong just a few years ago. The only metric is what is the value (as opposed to valuation) of BIG to the potential buyer. With HONY now the major shareholder, I think BIG is now a "China play". With its links with the Chinese govt, and if they were ever interested in BIG then the only metric is the value of BIG to the potential owners...??? I'm just star gazing, and wondering when the stars will align?
Purely me fantasizing...not a call to buy/sell
It is critically important to look at the earnings of Biosensors going forward and try to gauge accurately its net profit for year ending mar 2011 and mar 2012 in order to determine whether its target price should be 1.20 (DBS Vickers estimate), or 1.30 (OCBC) or 1.50 (Nomura) or 2.50, etc.
Therefore, looking at every qtr's earnings, management's guidance, new catalysts (which will add to earnings growth) will help one to gauge the value of Biosensors, based on comparables such as mkt cap, PE ratio, that the mkt is currently attributing to its competitors, like Lepu, Microport.
Biosensors make US$21.1m in net profit (excluding exceptionals) and I think they should be able to meet Nomura's target of US$48m for the whole yr ending Mar 2011. (excluding exceptionals).
Based on this, Biosensors is trading at PE of 23 times, (end mar 2011), Microport trading at PE of 31 times, Lepu trading at PE of 57 times.(Data taken from Nomura's report dated 10th nov 2010)
It can be argued that Biosensors is actually more valuable than Microport or Lepu as it not only has the China mkt, but is also in Europe as well and WILL ALSO be in Japan.
Looking from this angle, then Biosensors at current price of 1.19 is undervalued as compared with Microport or Lepu.
If we take current PE ratios, for Biosensors to reach Microport's valuation, its price should be 1.60 (taking 31 div by 23 times 1.19) and for it to reach Lepu's valuation, its price should be 2.94 !
Again, these metrics of measurement are based on simple correlation, and may not be true, or too simpistic.
Currently, Nomura's valuation looks the most realistic at the moment (my view), until new catalysts (whether positive or negative) come into play.
Having said that, the current mgmt's views was quite positive going forward into the next 2 qtrs.
And we have to bear in mind that when Jeff Jump talks about the 'acceleration of growth in Terumo', and 'broad base gain in mkt share', he WAS REFERRING to the period after the TCT conference on 21st Sep 2010.
That is, if what he says comes true, the spurt in growth should be REFLECTED in this coming qtr.
At the end of the day, continue to scrutinise each qtr's results, in order to have a sense of where Biosensor's valuation should be ,and continue to compare its valuation against its competitors.
Also, monitoring the technical picture (whether deterioration in trends is a temporary correction or a start of a downtrend) is important, as it may signal smart investors (or insiders) is buying up the stock ot selling down the stock.
AS always, Not a call to buy/sell.