According to a reputed Japanese healthcare journal Nikkan Yakugyo (4 March 20-11), the committee overseeing the approval of devices in Japan has cleared a major regulatory hurdle on March 2nd. This, we believe, will likely pave the way for formal approval of Nobori in Japan. Nobori is a drug eluting stent, produced and marketed by Terumo but with a licensing revenue-sharing arrangement from Biosensors. We believe this is potentially positive re-rating news for Bionsensors.

Nobori - one step closer to approval in Japan

Note also that Kyoto University will be conducting a 3,200 patient trial for the Nobori stent, measuring against Abbott’s market-leading Xience V (http://clinicaltrials.gov/ct2/show/NCT01303640). The trial is expected to start enrolment in May this year. This trial could provide a boost to Nobori’s market share at least initially, and could be a game-changer if results are positive in Nobori's favour.

We continue to remain positive on Biosensors given the imminent approval of the Nobori stent and see upside risk to our earnings estimates and PT. "

For info. Not a call to buy/sell.

Key takeaways from ASEAN Corp Day

On the placement of new shares to Atlantis and Ever Union, Biosensors believes that the corporate action will broaden the institutional base of investors, strengthening the group’s balance sheet. The share placement was also executed with the understanding from its strategic investor Hony Capital, which will see itself diluted from ~24% to ~21%. The group’s net cash is now ~US$190m, which positions it well for acquisitive growth.

Biosensors is optimistic about its China business and believes that its JV JWMS is likely the number 2 name by market share. In addition, the group will be completing the construction of a new manufacturing plant in Weihai, Shangdong in the next few months. The new facility will enhance capacity and improve productivity for JWMS in China.

On ASP pressures, Biosensors mentioned that, apart from the normal pricing reduction seen every year, there is no news of additional significant one-off cuts by the government. In fact, the decline will likely be gradual given that the tendering process has decentralized to the provincial level. The group is keenly awaiting the approval of BioMatrix in China, where they have submitted two applications -- approval for the stent itself, and the Biolimus drug.

Meanwhile, the group continues to perform well in the EU but concedes that the strong growth seen over the past few quarters may start to decelerate as it becomes more challenging to increase BioMatrix's market share from mid-teens to over 20%. However, it is expecting stronger growth to come from markets in Asia (eg. India, Vietnam, Taiwan). Additionally, BioFreedom may contribute to the revenue growth momentum upon its CE mark approval by FY12 (Mar-end).

The group cannot say when Terumo will receive approval as this is subject to the Japanese authorities. However, it is not a question of if, but when. "

For info. Not a call to buy/sell.

NewswireToday - /newswire/ - Beijing, China, 03/01/2011 - ResearchInChina, the vertical portal for Chinese business intelligence, announces the release of a new report - China Interventional Cardiovascular Device Industry Report, 2010.

In recent years, the prevalence rate of cardiovascular disease has increased year by year. According to the data issued by Ministry of Health of the People’s Republic of China, there were 20 million patients with coronary artery disease in China 2008, and the number rises at the annual growth of more than 1 million. The growth spurt of the patients suffering from heart disease has stimulated the fast growing demand for interventional cardiology operations and coronary stents.

In China, the number of PCI operation cases rose from 25,000 in 2002 to 242,000 in 2009 the coronary stent implantation amount increased from 40,000 sets in 2002 to 387,000 in 2009. In 2009, Chinese market size of interventional cardiovascular device (by terminal sales revenue of hospitals) reached RMB8.16 billion, up 30% from a year earlier.

Interventional cardiovascular device includes coronary stent and surgical support equipment. In 2009, Chinese coronary stent market valued RMB5.71 billion and the market size of surgical support equipment (including balloon catheter, catheter, and guide wire) hit RMB2.46 billion. The ratio of the two markets was about 7:3.

Before 2004, foreign companies dominated Chinese coronary stent market. Because of incessantly exploring core technologies and accumulating experience, Chinese enterprises enjoy the rising market shares yearly and even more than foreign counterparts by virtue of advantages in price and channel. By the amount of implantation, domestic enterprises swept about 77.7% market shares in 2009, while foreign peers took approximately 22.3% by the terminal sales revenue of hospitals, domestic enterprises held around 66.8% market shares in 2009, while foreign ones occupied 33.2% or so.

In 2009, MicroPort Scientific, Lepu Medical and JW Medical ranked the top three in terms of the market share of coronary stent by the terminal sales revenue of hospitals, MicroPort Scientific, Lepu Medical and JW Medical took the market share of 25.1%, 20.5% and 18.5% respectively. Remarkably, MicroPort and Lepu are with the diversified product lines of interventional cardiovascular device, and both of them focus on coronary stent and also pay attention to angiography catheter, guidewire, sheath introducer kit, etc, with the objective of ultimately covering the entire field of interventional cardiovascular devices. In addition, MicroPort and Lepu are making more efforts in the R& D of interventional cardiovascular devices. MicroPort is now developing the third-generation drug-eluting stent “Firehawk”, while Lepu is developing a new generation of magnesium alloy biodegradable stents.

However, in surgical supporting device market consisting of balloon catheter, catheter and guidewire, due to technical limitations, only less than 20% of products are made in China. The market is dominated by Cordis, J & J, Medtronic, Boston and other foreign brands. Yet, Chinese enterprises may simulate the development modes of those foreign companies. MicroPort, Lepu, Fisuntech, TemMed and other companies are enhancing R& D and production of surgical supporting instruments. In the future, the competition in the market of interventional cardiovascular supporting devices will intensify.

The report is based on social, economic and policy environments, the overall operation, market competition and development trends of Chinese interventional cardiovascular device industry. It not only studies such market segments as coronary stents, balloon catheters, catheters, guidewires, assistive devices and others in China, but also analyzes the operation and development of 12 major interventional cardiovascular device manufacturers including J & J Cordis, Medtronic, Boston Scientific, Abbott Guidant, B. Braun, MicroPort, Lepu, JW, Yinyi, OrbusNeich, Fisuntech, SCW Medical.