TRIREME MEDICAL LINES UP ASIAN STRATEGY WITH NEW BOARD MEMBERS

 

TriReme Medical Lines Up Asian Strategy With Key Appointment of New Board Members

 

PLEASANTON, Calif., May 9, 2011 /PRNewswire-AsiaNet/ --

 

TriReme Medical, Inc. (TriReme), a leading developer of innovative catheters and stents for the treatment of complex vascular disease, announced today the appointment of Mr. Supratim Bose and Mr. Michael Kleine to their Board of Directors.

 

Mr. Bose, Founder and CEO of Bose Consulting Group, is based in Singapore and was until recently Company Group Chairman at Johnson & Johnson with responsibilities for all of the Medical Devices & Diagnostics franchises across the Asia-Pacific Region. Mr. Bose was also a member of the Worldwide Group Operating Committee at Johnson & Johnson Medical Devices & Diagnostics Group.

 

Mr. Kleine was previously President and CEO of Biosensors International (SGX), a medical device company listed on the Singapore Stock Exchange. He brings vast experience in medical devices having held CEO and President positions at Microvention, Thermo Cardiosystems, Sorin Biomedical and Bird Medical.

 

" TriReme is developing an exciting range of innovative and differentiated devices and I am excited to help lead their Asian centered strategy," commented Mr. Bose. Mr. Kleine added, " TriReme has created a truly global vision and its expansion is supported by a strong pipeline of unique products."

 

" Supratim and Mike's enormous experience with the Asian markets provide an extended dimension to both our Board and management teams. TriReme is honored to have the endorsement of both industry veterans who support and share our global vision of medtech growth and development in Asia," said Eitan Konstantino, PhD, President and Chief Executive Officer of TriReme.

 

About TriReme Medical, Inc.

 

Based in Pleasanton, California, TriReme Medical, Inc. is a privately held medical device company dedicated to the development, manufacturing, and commercialization of next generation percutaneous devices for the treatment of complex coronary and peripheral arterial disease. The Company's novel balloon and stent therapies are specifically designed for large, unmet clinical needs.

 

AccessClosure signs distribution agreement to enter into UK, Switzerland and France   

 

India Infoline News Service / 12:15 , May 17, 2011 

 

The extravascular Mynx device, designed for patient comfort while providing hemostasis without sutures or implants, will be sold as part of Biosensors' interventional cardiology product range.

 

  AccessClosure, Inc., the market segment leader in extravascular closure devices, announced today an exclusive agreement with Biosensors International for the distribution of the Mynx(TM) Vascular Closure Device throughout the United Kingdom, Switzerland and France. The extravascular Mynx device, designed for patient comfort while providing hemostasis without sutures or implants, will be sold as part of Biosensors' interventional cardiology product range.

 

" These European countries represent a meaningful market opportunity for us, and we are pleased to be able to partner with Biosensors' established sales force for the distribution of Mynx," said Gregory D. Casciaro, President and CEO of AccessClosure. " Distribution in international markets is a key component of AccessClosure's growth strategy, and provides an excellent complement to our direct sales presence in the United States."

 

    Biosensors will join AccessClosure's existing and growing global network of distributors. Biosensors is now the fifth largest drug-eluting stent (DES) supplier globally, marketing its BioMatrix(TM) family of DES systems which offer the unique combination of Biolimus A9(TM), an anti-restenotic drug developed by Biosensors exclusively for use with DES, and an abluminally-coated biodegradable polymer. Biosensors has a well established direct presence in the UK, Switzerland and France, and will provide AccessClosure with broad and rapid access to those markets.

 

" We are pleased to offer the Mynx device as part of our interventional cardiology product range" said Jeffrey B. Jump, CEO of Biosensors. " The Mynx device, paired with our portfolio of drug-eluting and bare-metal stents, allows us to offer a more complete solution to our customers. The Mynx has had great success in the United States and other international markets, and we anticipate similar success in these European countries."

 

The Mynx Vascular Closure Device utilizes a conformable, water-soluble polyethylene glycol (PEG) sealant to immediately seal the femoral artery. Dissolving within 30 days, Mynx leaves nothing behind but a healed artery. The extravascular device is designed for increased patient comfort and clinical versatility. The Mynx, which received its first FDA approval in May 2007, has been used in over 800,000 procedures to date

 

 

Plans For Largest Ever Drug-Eluting Stent

Paris, France, 18 May 2011 –

The trial will enroll more than 10,000 patients from an " all-comers" population eligible for PCI, allocated to receive either BioMatrix Flex™ (Biosensors’ Biolimus A9™-eluting stent system with abluminal biodegradable polymer), or the market-leading DES system with a durable polymer. Recruitment into the study, involving over 100 sites around the globe, is due to start in early 2012, with data being collected for up to two years following stent implantation.

The protocol of the study is currently under development, and is likely to involve a " 2x2 factorial" design, with the second randomization being to either a short or long duration of anti-platelet therapy. The primary endpoint will be a true clinical evaluation, assessing patient safety. Global LEADERS will be independently designed, implemented and analyzed by the study investigators, who in addition to Prof. Serruys (Erasmus Medical Center, Rotterdam, Netherlands) will include Co-Principal Investigator Professor Stephan Windecker (University Hospital, Bern, Switzerland). The study will also have regional Principal Investigators in Europe, South America and Asia. Dr. Marco Valgimigli (University of Ferrara, Italy) will act as Principal Investigator for the anti-platelet therapy portion of the study.

Global LEADERS aims to build on the concept of the landmark LEADERS study, which was the first head-to-head randomized trial between two limus DES in an " all-comers" patient population using clinical outcomes as its endpoint. LEADERS results suggested that a DES with biodegradable polymer could be safer in the long term than a DES with durable polymer – especially in high-risk patient populations – under conditions which resemble those of routine clinical practice.

" I am delighted to be involved with this logical development of the original LEADERS study" , commented Prof. Serruys. " By continuing the concept of a head-to-head study against a widely-used drug-eluting stent with durable polymer using a true clinical endpoint, and involving nearly six times as many patients, we anticipate that the study will be sufficiently powered to produce meaningful results on the benefits of a drug-eluting stent with biodegradable polymer in a broad range of pre-defined patient subgroups."

" Global LEADERS should provide us with further valuable information, in that it will evaluate the risks and benefits associated with a short versus a long duration course of anti-platelet therapy following DES implantation in a large number of patients" , added Prof. Windecker.

" We are delighted to once again have the opportunity to be involved in a truly ground-breaking study, which represents another first for Biosensors in the field of drug-eluting stent research" concluded Biosensors Co-CEO Jeffrey B. Jump. " LEADERS changed the mind-set of how DES trials were perceived, and established a new benchmark for their design. Now Global LEADERS will raise the bar again for DES trial design in a wider population" .

The BioMatrix Flex stent system offers the unique combination of Biolimus A9™ (BA9™), an anti-restenotic drug developed and patented by Biosensors exclusively for use with drug-eluting stents, combined with a biodegradable poly-lactic acid (PLA) polymer abluminally coated onto an advanced, highly flexible stent platform designed for enhanced deliverability. BA9 has the highest lipophilic profile of the common limus drugs, enabling rapid absorption by the tissue and minimizing systemic exposure. The PLA polymer fully degrades into carbon dioxide and water over a six to nine month period as it releases BA9. Plans for Global LEADERS (" LEADERS II" ), the largest ever randomized clinical trial involving a head-to-head comparison between two drug-eluting stents (DES), were announced yesterday during the opening session of EuroPCR by Co-Principal Investigator Professor Patrick W. Serruys.

###

For further information, please contact:

Mr. Wong Teck Yenn

Director, Investor Relations, Biosensors International Group

Tel: (65) 6213 5708

Email: ty.wong@biosensors.com

Randomized Clinical Trial Announced at EuroPCR

Terumo launches its drug-eluting stent, " Nobori," in Japan

It should be obvious to everyone by now, whether you are a trader, shortist, or a long term investor, the upward trend in Biosensors is probably quite puzzling, and perhaps, there are reasons for it, reasons that  are   not yet fully appreciated by the investors at large.

 

I shall try to speculate on these 'reasons', and I hope that everyone should do due diligence before jumping into the stock, as I may very well be completely wrong.

 

First, let me quote from this week's Edge magazine, in an interview with Yang Liu, who is overseeing Alantis China, one of the funds who bought 8.18 % or approx 108 m shares in Biosensors.

 

In Alantis's portfolio, ' One company likely to benefit from Beijing's increased spending on healthcare is Shandong Weigao, China's largest medical device maker. It has a joint venture with Medtronics and Yang Liu contends that it will deliver DOUBLE the growth of Chinese GDP over the next 2-3 yrs'

 

As we know by now, Shandong Weigao and Biosensors both owned 50 % of JWMS each.

 

The BIG reason, in the bullishness of Biosensors share price, I think is the tremendous potential in China's healthcare sector, of which I believe Biosensors will play a big part, after some re-structuring of the ownership of JWMS between Weigao and Biosensors, as well as the approval of the bio-matrix in China.

 

Also, on 8th April, Nomura released a 18 page report on the DES landscape and I quote " Global med-tech giants believe the worst is over in 2010 in terms of regulatory ASP pressure, and are BULLISH on the volume growth potential in the relatively UNDER-PENETRATED markets - eg, CHINA, INDIA and BRAZIL. " Unquote

 

I quote again, excerpts from this report "

 

“Our market share is atrociously low, but yet we have high brand recognition. So what I smell is huge opportunity and in order to capture that opportunity, we have to have partnerships and we have to get a lot of feet on the street” – J. Raymond Elliot, CEO of

 

Boston Scientific remarked on the opportunities in China/India (BSX 4Q10 Earnings call, 2 Feb 2011).

 

In the analyst days held by Johnson & Johnson (JNJ) and Medtronic Inc (MDT) this year, both med-tech giants shared similar views on the growing importance of emerging markets to the medical device industry. In the past, MDT used to view the world as the US and OUS (outside of the US), assuming that OUS was one big market, but its business is now more aligned towards developed markets and emerging markets. The four BRIC countries (Brazil, Russia, India and China) have been singled

 

out as key markets where the governments are increasing healthcare spending, in stark contrast to budgetary constraints in developed markets. " Unquote

 

So. I think, the key reasons, are the strong growth in the mkts of China and India, in which, big players like Boston Scientific, Medtronics, J & J are already noticing, and in which Biosensors is already well positioned, in the not too distant future, via its 50 % owned JWMS and its own approvals.

 

Again, not a call to buy/sell.