Singapore's Biosensors launches sales of BMX-J stent in key Japan market

Biosensors International Group announced this week it has started sales of its BMX-J drug-eluting stent (DES) system in Japan, which it says is the third-largest single-country market in the world, after the United States and China, for such devices.

The company, in a press release, said it sees strong growth potential in Japan where the stent's technology, which incorporates a biodegradable polymer coating together with an immunosuppressive drug, is well accepted by cardiologists.

BMX-J incorporates the biodegradable polymer and the company's proprietary drug, Biolimus A9, which inhibits restenosis, or renarrowing of the arteries, following stent implantation. The company first announced the Japan regulatory approval of BMX-J in August this year.

The company said the BMX-J will provide an alternative to the DES currently available to interventional cardiologists in Japan and said it was expanding its distribution channels to increase coverage and ramp up sales.

Last month, Abbott Laboratories ($ABT) said a "positive" one-year clinical result in Japan comparing its dissolvable Absorb heart stent to Xience represents a milestone for the product, which is currently an investigational device in the country, as well as in the U.S., and is not yet approved for commercial use.

For Abbott in Asia, the trial potentially extends its device reach in the region's top reimbursement market as it works with Johnson & Johnson ($JNJ), GE Healthcare ($GE) and Boston Scientific ($BSX) in the Asia Pacific Medical Technology Association, a group launched in April to focus on regional regulatory and commercial industry issues.

Biosensors, which is headquartered in Singapore, has operations worldwide.

Earlier this year, the company said it was leveraging Chinese buyout funds to seek foreign acquisitions to build its business in chronic diseases.

In June, Biosensors said full-year revenues for the quarter ended March 31 fell 7% to $75.9 million on lower licensing revenues and foreign exchange impacts. In May, the company completed enrollment for its CREDIT II stent trial.

Japan and China are two of the biggest markets in Asia for medical devices.

According to the latest official figures from Japan's Ministry of Health, Labor and Welfare Annual Pharmaceutical Production Statistics, the Japanese market for medical devices and materials in 2012 was approximately $32.5 billion, up 8.7% from 2011 in yen terms. Japan's total imports of U.S. medical devices were approximately $7.4 billion in 2012, the latest year for which figures were available.

Of interest last month, China Daily published a lengthy op-ed article by Dwight Clark, medical director of US-Sino HeartCare, which argues that stent implants are too widely used and often unnecessary in China and elsewhere.

- here's the release