A Medical Device Daily

Mindray Medical International (Shenzen, China) has reported updates on new product launches and its product pipeline for domestic and international markets.

Xu Hang, co-CEO and chairman, said, “It is our goal to release seven to nine high-quality, competitively-priced products every year, which we achieved in 2007.”

In November, the company released the BS-120, a low-throughput biochemistry analyzer targeted at replacing semi-automatic, bio-chemistry analyzers. Mindray ssaid that the analyzer is positioned for hospitals and clinics in rural China as well as small hospitals and labs in international markets. It said that the BS-120 also can serve as a backup machine for large hospitals and labs.

The BS-120 has received CE-mark and State Food and Drug Administration approval and is available in both domestic and international markets.

In December, the company released the M5, a portable diagnostic ultrasound system for international markets. The M5 will target traditional markets such as radiology and ob/gyn as well as point-of-care testing centers such as emergency and operating rooms, intensive care units and general practice offices.

Mindray said the M5 is expected to be launched in the domestic market upon SFDA approval in 1Q08.

Other products released during ‘07 include the Beneview T5 patient monitoring device, PM-60 pulse oximeter, BS-400 biochemistry analyzer, MR-96A enzyme-linked analyzer and MW-12A microplate washer.

The PM-7000, a multi-parameter patient monitoring device, received U.S. FDA 510(k) clearance in 4Q07.

In order to gain market share in the high-end market segment, Mindray said it plans to release its BC-5300 and BC-5380 compact five-part hematology analyzers, targeted for mid- to high-end hospitals in China and medium-end labs in international markets. The two models are expected to receive SFDA approval by the end of this month and the CE mark during the first quarter.

The company said it expects the DC-3 color ultrasound diagnostic imaging system to be launched in China and international markets upon receiving CE-mark and SFDA clearance in the first quarter. The DC-3 is designed to have wide applications in abdominal, ob/gyn, endovaginal, cardiac, small parts and pediatric markets.

Mindray also expects its EX55 and EX65 compact anesthesia machines to receive CE-mark and SFDA approval during the 1Q08.

The company said it will apply for FDA 510(k) clearance for its Beneview T5, T6, T8, PM-60, BS-200 chemistry analyzers and both its M5 and DC-3 diagnostic ultrasound systems. To date, it has received FDA clearance for a total of 11 products.

KCI seeks growth in Asia Pacific region

Kinetic Concepts (KCI; San Antonio), a global provider of advanced wound care technology and therapeutic services, reported the appointment of Patrick Loh as president-Asia Pacific and member of the KCI executive committee.

In this new position, Loh will be responsible for developing and implementing the company’s growth strategies for its V.A.C. (Vacuum Assisted Closure)Therapy and therapeutic surfaces businesses throughout the region. He will be located in Shanghai.

Loh joins KCI from Thermo Fisher Scientific (Waltham, Massachusetts), where he was VP-Asia Pacific. Prior to that, he was general manager-Greater China for Fisher Scientific (Seabrook, New Hampshire) .

Loh began his career at B. Braun Medical, a German healthcare company with products in both the hospital and home patient care market, where he spent nearly 11 years that included numerous posts in international markets.

“The Asia Pacific region offers substantial growth opportunity for KCI,” said KCI President and CEO Catherine Burzik. “Patrick has significant experience in managing operations throughout the Asia Pacific region and will be a strong addition to our leadership team. His knowledge of the healthcare, medical and life sciences industries will be invaluable as we work to expand the availability of our innovative wound care and surfaces therapies throughout this region of the world.”

KCI’s products incorporate its V.A.C. technology, which the company says can reduce the cost of treating serious wounds.

Genizon raises Series E C$31 million

Genizon BioSciences (Montreal) reported the closing of its Series E financing in the amount of C$31 million. The lead investor is BTF (Haarlem, the Netherlands), a venture capital fund focused on late-stage biotech companies. Several other existing investors also participated.

The company’s funding since its founding in 1999 now totals over $130 million.

“Genizon’s outstanding DNA resources and a platform that is applicable to many stages of drug development make a compelling investment case,” said Jan Mellegers, CEO of BTF. “The company has impressed us with its ability to not only discover many genes in each disease, but also to assemble these into GeneMaps that lead to new drug targets and biomarkers.”

Using its platform, Genizon has discovered comprehensive maps of genes and biomarkers – labeled GeneMaps — involved in schizophrenia, attention deficit hyperactivity disorder, endometriosis, longevity, psoriasis and Crohn’s disease, and is currently completing studies in rheumatoid arthritis and Alzheimer’s disease.

The company said the new investment will be used partly to finance additional genome-wide association studies in the four major diseases associated with metabolic syndrome: obesity, Type 2 diabetes, dyslipidemia and hypertension. These studies will be accompanied by evaluations of links between metabolic syndrome, coronary heart disease and Alzheimer’s disease, and with genes discovered by Genizon in longevity that appear to protect against these diseases.

Canadian firm eyes domicile in U.S.

Current Technology (Vancouver, British Columbia) said the company is seeking shareholder approval to move the domicile of the corporation from Canada to the U.S. A special meeting of shareholders will be held in Vancouver on Feb. 29, open to shareholders of record Jan. 24.

“The vast majority of our shareholders live in the U.S.,” said CEO Robert Kramer. “More importantly, completion of our anticipated 51% purchase of Texas-based Celevoke will concentrate our business activities there. The U.S. has the largest capital market in the world, and we believe shareholders will benefit from our participation in that dynamic market as a domestic rather than foreign corporation.”

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