Biosensors   

Is Biosensors a good buy?

Macquarie is listing a new warrant over Biosensors this morning.

Call BiosensoMBLeCW110202 (L9ZW) exercise price $1.20.*

 

1.03 is proving to be a strong resistance....

 

 

Novel Polymer-Free Drug-Coated Stent Demonstrates Comparable Safety and Efficacy to Conventional Drug-Eluting Stent with Durable Polymer at 12 Months

Washington DC, USA, 25 September 2010 –

BioFreedom represents the latest development in Biosensors stent technology, featuring a micro-structured abluminal surface which permits the controlled release of Biolimus A9™ without the use of a polymer. Two versions of the stent were studied in this trial – one with a drug dosage of 15.6 μg/ per mm of stent length (standard dose) and the other with a drug dosage of 7.8 μg/ per mm of stent length (low dose).

In this second cohort of the FIM trial, 107 patients were equally randomized to each of three treatment groups: BioFreedom standard dose (SD); BioFreedom low dose (LD); or Taxus Liberté. Median in-stent late lumen loss in patients receiving BioFreedom SD was 0.17 mm and in those receiving BioFreedom LD 0.22 mm, compared with a median in-stent late lumen loss of 0.35 mm in the Taxus Liberté group. BioFreedom SD demonstrated equivalent efficacy, measured by late lumen loss, compared with Taxus Liberté (P = 0.001), with a trend towards superiority (P = 0.11).

Both BioFreedom SD and BioFreedom LD demonstrated sustained safety up to 12 months, including absence of stent thrombosis.

"The results from this study are very significant as they demonstrate for the first time that a polymer free drug-coated stent is as safe and effective as a conventional drug-eluting stent with a durable polymer coating over a twelve-month period", commented Professor Grube. "I am excited about the concept of a polymer-free stent, as the rapid drug clearance and absence of a polymer drug carrier could promote more rapid vessel healing and ultimately reduce the need for longer term dual anti-platelet therapy. However, additional clinical data is required to confirm these initial encouraging results."

"These latest results confirm that we continue to lead the industry in stent innovation, first in terms of biodegradable polymer technology and now polymer-free technology", added Jeffrey B. Jump, President & CEO of Biosensors. "We are now in the process of planning larger studies with longer-term follow-up to further investigate this exciting development".

BioFreedom FIM is a prospective, multi-centre study involving 182 patients with symptomatic ischemic heart disease. It consists of a first cohort of 75 patients, with a secondary endpoint of in-stent late lumen loss at 4 months, and a second cohort of 107 patients, with a primary endpoint of in-stent late lumen loss at 12 months. In each cohort patients were randomized into three groups: those treated with BioFreedom SD; those treated with BioFreedom LD; and those treated with Taxus Liberté. Results from the first cohort, showing equivalence between BioFreedom and Taxus Liberté, were presented at TCT in 2009. The clinical status of the patients in the trial is being reported annually for five years from the date of stent implant.Biosensors International Group, Ltd ("Biosensors", "Company", BIG:SP) today announced 12-month results from the First-In-Man ("FIM") trial of BioFreedom™, a novel polymer-free drug-coated stent ("DCS") which showed a similar reduction in in-stent late lumen loss to Boston Scientific’s Taxus® Liberté® drug-eluting stent (DES), with no evidence of stent thrombosis. These results were presented by the Principal Investigator, Professor Eberhard Grube, International Heart Center Essen, Germany, as part of the First Report Investigations III session at the 22nd annual Transcatheter Cardiovascular Therapeutics ("TCT") scientific symposium, sponsored by the Cardiovascular Research Foundation.

 

 

 WASHINGTON, D.C.--BioFreedom, a polymer-free drug-eluting stent (DES) from Biosensors International, showed a strong safety profile, compared with the Taxus paclitaxel-eluting stent (Boston Scientific), whcih contains a durable polymer, based on the one-year results of the first-in-man BioFreedom presented as a late-breaking trial at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference.

The BioFreedom features a micro-structured abluminal surface, which allows the release of Biolimus A9 without the use of a polymer. There were two versions of the stent used in the trial--the BioFreedom low dose and the BioFreedom standard dose.

Principal investigator Eberhard Grube, MD, from the International Heart Center Essen in Germany, said that he and the BioFreedom investigators hypothesized that a polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings.

The researchers speculated that with this new stent design the potential advantages could be:

• Avoiding long-term late adverse effects that might be attributable to the polymer;
• Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts; and
• Possible shorter need of dual-antiplatelet therapy.

The trial enrolled 182 patients. The first cohort of 75 participants were randomized to the BioFreedom standard dose of 15.6 µg/mm (25 patients), the BioFreedom low dose of 7.8 µg/mm (26 patients) or the Taxus Liberté (24 patients) for a four-month angiographic follow-up. The second cohort of 107 participants were randomized to the BioFreedom standard dose of 15.6 µg/mm (35 patients), the BioFreedom low dose of 7.8 µg/mm (36 patients) or the Taxus Liberté (36 patients) for a 12-month angiographic follow-up. The angiographic follow-up rate in both cohorts was 92 percent.

The primary endpoint was in-stent late lumen loss at 12 months in the second cohort. (The non-inferiority margin was 0.24 mm.) The secondary endpoint was in-stent late lumen loss at four months in the second cohort, the results of which were reported at the 2009 TCT conference. Another secondary endpoint was the 12-month major adverse cardiac event (MACE) rate—which included death, MI emergent bypass or target lesion revascularization—in both cohorts.

Dual-antiplatelet therapy was recommended for a minimum of six months.

The in-stent late lumen loss of the second cohort met “our non-inferior criteria,” Grube noted.  For the primary endpoint, the rates were 1.7 in the BioFreedom standard dose arm, 0.22 in the BioFreedom low dose arm and 0.35 in the Taxus arm. Therefore, the BioFreedom standard dose, compared with the Taxus stent met the statistically significance of non-inferiority, with a trend toward superiority.

For the secondary endpoint of the one-year MACE for both cohorts, the rates were 6.1 percent in the BioFreedom standard dose arm, 11.6 percent in the BioFreedom low dose arm and 5.5 percent in the Taxus arm.

“Both BioFreedom standard dose and BioFreedom low dose demonstrated sustained safety up to 12 months, including an absence of stent thrombosis,” Grube reported. “The BioFreedom polymer-free drug-coated stent demonstrated comparable efficacy in inhibiting neointimal hyperplasia (as assessed by independent QCA analysis) compared with the paclitaxel-eluting stent at 12 months."

Grube acknowledged that the BioFreedom would be "intriguing" to compare to the market-dominant Xience V everolimus-eluting stent. At the time this trial began, Taxus was the most commonly used and considered superior among the first-generation stents. 

However, he added that larger trials with longer term follow-up are warranted to confirm these encouraging results.

 

Any news on BioFreedom?

 

ShiFu...whahha...finally u appear in this ...
so did u load any of this share..?

Need ur wise words....ohmmmmm.....
...

iPunter      ( Date: 25-Sep-2010 11:18) Posted: If they know, they would have 'mau' on it...    rather than tell you.. hehe..

 

Senior: Thoughtful analysis - One that Nomura will probably mimic during their re-rating.  What has not been accounted for and perhaps at this time has little value, is the proprietary superior technology possessed by BIG.  Articles and analyses indicate that China Market does not place a premium value on slightly superior patient outcome like Japan & US market do.  BUT based on  recent Microport trading action, mkt does value execution and revenue.  BIG seems to have "gotten it together" growing sales and profits.  BIG's profit growth should accelerate with closing of US office and the income tax expense associated with US presense.  My personal opinion is that Microport perhaps somewhat overvalued and BIG somewhat undervalued.  Are invetors going to arb these two counters until values close??

 

My apologies, the net profit for Biosensors in Q1 2011 (end Jun 2010) should be US$9.9m (excluding one-time write-offs) and not S$9.9m.

That is the net profit is approx S$13 m.

 ALso, since the number of shares for Microport is 1.404 billion vs Biosensors number of shares at approx 1 billion, the earnings per share for Microport is approx 1.07 cents Sing, vs 1.3 cents Sing for Biosensors for their respective qtrs  (using net profit divided by number of shares).

That is, Biosensors actually earns more than Microport, in terms of earning per share.

Again, these numbers are crunch using approximations and they may or may not be subject to errors. Info about Microport is gotten from their prospectus.

For info - Not a call to buy/sell.

 

Some interesting facts about the Microport IPO.

The IPO price at HK$6.10 represents a mkt cap of HK$8.56 Billion or aprox S$1.5 Billion, using an exchange rate of 0.175.

At closing price of HK$8.29, mkt cap = HK$11.6 Billion = S$2.0 Billion approx.

Number of shares in issue is approx 1.404 Billion, and earnings (net Profit) for Q1 2010 (end Mar 2010) is 80 million RMB, based on revenue of 176 million RMB.

That is net profit in Sing $ is $15 million (taking ex rate of 0.19).

Comparing against JW Medical, JW net profit is approx 70 million RMB for Q2 2010 (data taken from Shangdong Weigao Q2 results - profit of 34.9 million RMB x 2)

That is, Microport's net profit of 80m RMB (Q1 2010)  is quite close to JW profit of  70m RMB (however it is Q2 2010), and better than Biosensor's net profit of S$9.9m (excluding one-time writeoffs).

However, Microport's mkt cap of S$ 2.0 billion is twice that of Biosensors, which at closing price of 1.01 is approx S$1 billion.

It remains to be seen, whether in the next few weeks, the share price of Microport can be maintain at this level, which would imply that Microport is overvalued or Biosensor's share price is undervalued.

OR the mkt has more confidence that Microport's fundamentals are stronger than Biosensors.

Some general facts and figures - Not a call to buy/sell.

 

If they know, they would have 'mau' on it...

   rather than tell you.. hehe..

 

today price strength is not strong...may i know ...it's peak?
so just adjusting only?

 

Thanks bro limkt009,

If BIG good,I good lah!!!

 

CHEERS.

limkt009      ( Date: 24-Sep-2010 16:32) Posted: little horse bro, long time no hear from you, how have you been?

 

little horse bro, long time no hear from you, how have you been?

 

MICO 8.30HKD and Dow Future 4.22pm +40 points

BIG should Lai Liao!!!!!!!!!!!!!

 

 

Took profit today. Similarly, will buy back later

 

 

Take profits all news in liao,...buy bk cheaper later

 

All the news baked in already, just waiting for the next catalyst.....

gbleng      ( Date: 23-Sep-2010 17:07) Posted: hmmmm... still waiting.... gbleng      ( Date: 22-Sep-2010 11:28) Posted: will it break it or not?

 

DJ MARKET TALK:Biosensors +1.0% On MicroPort Debut,Stent Findings (2010/09/24 10:19AM)‏

 

0219 GMT [Dow Jones] Biosensors (B20.SG) +1.0% at S$1.03, extending 6.3% rise since start of this week, supported by HK listing of MicroPort Scientific (0853.HK), maker of equipment used in keyhole surgery, which started trading today. Recent interest also underpinned by several positive announcements by Biosensors since last week, including findings affirming efficiency of its stent systems. "While the positive data is not a surprise to us given that two-year data has already proven its safety and efficacy, we believe it is re-affirmative and should drive incremental market share gains," says Nomura, which has Buy call with S$1.20 target. Tips stent-maker''s upcoming BioFreedom stent as next catalyst for shares; "a potentially positive data set (on BioFreedom) will underpin Biosensors'' long-term competitiveness and may open doors to the U.S. drug-eluting stent market." Orderbook quotes tip minimal upside beyond new 52-week high of S$1.05 set in early trade. (frankie.ho@dowjones.com)

 

OMG....0853.HK ( Mircoport ) is now hk$7.73...u guys can check it out via www.yahoo.com.hk (finance)

a bit time lag...too bad i run out of $$$...otherwise i will buy that too...

 

MICRO 7.85 HKD, DAY HIGH ....