A Medical Device Daily

Sysmex (Kobe, Japan) and bioMérieux (Marcy L’Etoile, France) said they have signed an agreement by which Sysmex will take a 34% equity stake in bioMérieux Japan.

The new company, called Sysmex bioMérieux Co. Ltd., will promote and commercialize the entire bioMérieux product line in Japan starting April 1. The joint venture will manage the regulatory filing and marketing activities of bioMérieux products in Japan.

Sales and customer service activities will be contracted out from the j-v to Sysmex, which is a world leader in clinical laboratory testing of blood, urine and other specimens, providing instruments and reagents for clinical laboratory testing as well as laboratory information systems as part of a comprehensive service and support system.

A major global player in in vitro diagnostics, bioMérieux has a leadership position in microbiology analysis, with a comprehensive offering of products for streamlined workflow and improved quality in microbiology testing.

Microbiology testing is commonly practiced to identify causative bacteria and to measure their susceptibility to certain antibiotics or drugs for the diagnosis and treatment of patients suspected of having infectious diseases.

Market volume for microbiology testing in Japan is estimated at about 30 billion Japanese yen per year and is the second-largest in size worldwide.

Sysmex and bioMérieux have been developing their global partnership since last July, when bioMérieux became a global partner to distribute Sysmex’s automated UF-1000i urine sediment analyzer to its extensive clinical microbiology customer base. This new venture reinforces the long-standing partnership between the two companies.

bioMérieux CEO Stéphane Bancel said, “We could not have found a better partner for this key market. bioMérieux Japan is No. 19 in the Japanese IVD market, while bioMérieux is No. 7 worldwide. We have been lacking scale in several critical functions [such as] commercial operations and customer service. By partnering with the No. 1 diagnostics company in the Japanese market, we will bring [our] products to a broader customer base.”

Calypte’s China j-v gets manufacturing license

Calypte Biomedical (Lake Oswego, Oregon), a maker of HIV diagnostic tests, said its Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., has received a permit to manufacture medical devices issued by the Beijing branch of the State Food and Drug and Administration (SFDA).

The manufacturing permit enables the facility to manufacture in vitro diagnostic tests for the domestic Chinese market once specific product approval is received. The permit is required before Beijing Marr can sell an approved product within China.

Calypte said Beijing Marr is awaiting approval from the SFDA to distribute and sell Calypte’s Aware HIV-1/2 OMT rapid diagnostic test within China.

Beijing Marr is a joint venture between Calypte and a Marr Group subsidiary, established to manufacture Calypte’s Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for both the Chinese and international markets.

Aware HIV-1/2 OMT is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes, with an accuracy comparable to that of U.S. FDA-approved, blood-based laboratory HIV EIA tests, according to the company.

Roger Gale, Calypte president/CEO, said, “Coming on the heels of the recent ISO 13485 certification of Beijing Marr’s manufacturing facility, this permit is another significant milestone that brings us much closer to our objective of manufacturing and marketing our rapid test product for the Chinese market.”

Beijing Marr CEO David Harris, said, “This permit is required because the State Food and Drug Administration moved regulatory oversight for HIV tests from the Drug Division to the Medical Device Division. Our team has been working diligently to obtain this permit to ensure that we will be permitted to manufacture our Aware HIV-1/2 OMT test once it has been approved for sale in China.”

Rapid growth seen in Chinese knee market

According to a report by the Millennium Research Group (Waltham, Massachusetts), sales of reconstructive knee implants will skyrocket in China, at an almost 25% compound annual growth rate from 2007 through 2012.

Strong economic growth, favorable demographics and an improving quality of life, particularly in the country’s urban areas, will drive this market throughout the next five years, according to the report, Chinese Markets for Large-Joint Reconstructive Implants 2008.

Millennium said the Chinese reconstructive knee implant market, currently pegged at nearly $100 million, will almost triple to reach just under $300 million by 2012.

“Because China’s strong economic growth has spurred the rise of a middle class, many now have the financial resources to improve their quality of life,” the company said. “Some of the country’s aging and osteoporotic citizens are doing so by spending on elective knee implant surgery. In order to accommodate this increasing demand, more surgeons are training to perform knee implant procedures.”

The Millennium group’s Global Markets for Large-Joint Reconstructive Implants report series covers India, the U.S., Japan, and Europe. Coverage of industry competitors includes Biomet, DePuy, Smith & Nephew, Stryker, Zimmer, local Chinese competitors and others.

Millennium Research Group, a Decision Resources company, is a leading provider of medical-tech market intelligence.

Medegen adds Mexican manufacturing unit

Medegen (Ontario, California), a provider of medical devices, components and manufacturing services to the healthcare industry, said it has expanded its manufacturing capabilities into Tijuana, Mexico. The company said the recently opened facility will enable it to meet a heightened demand for outsourced contract manufacturing.

Medegen cited forecasts of annual growth rates of 10% for the medical device market, with contract manufacturing expected to reach the $8 billion mark industry-wide by year end.

The new 42,000-square-foot facility will enhance contract manufacturing capabilities to the medical device and pharmaceutical industries, and also will handle Medegen’s finished goods assembly for its Maximus brand of IV therapy products.

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