Company Announces Update on Product Approval Pipeline
SHENZHEN, China, March 31 /Xinhua-PRNewswire/ -- Mindray Medical International Limited (NYSE: MR) today announced it has received 510(k) clearance from the United States Food and Drug Administration ("FDA") for its portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyzer. Mindray has to date received FDA 510(k) clearance for a total of 14 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems.
The company also announced it has received approval from the Chinese State Food and Drug Administration ("SFDA") for the M5 and its DC-3 color ultrasound imaging system and provided an update on its product approval pipeline.
"Our growing portfolio of FDA-approved medical devices reflects our commitment to achieving the highest standards in quality and performance and is part of our long-term strategy to compete in the most sophisticated markets in the world," said Mr. Xu Hang, Mindray’s chairman and co-chief executive officer. "Our unique, China-based model leverages world-class R&D that tailors products by functionality and pricing needs for more than 140 countries worldwide. With our established direct sales and service network in the United States and Europe expanded by our recent acquisition, I’m optimistic about our ability to deepen Mindray brand awareness and continue to gain market share."
Latest product launches and approvals
In the first quarter of 2008, Mindray’s portable M5 ultrasound imaging system received both FDA and SFDA approval and has been launched in both domestic and international markets. The M5 is the company’s first laptop-size ultrasound imaging device, weighing only six kilograms and combining brilliant color imaging with uncompromised 2D performance. Hand Carried Ultrasound ("HCU") is one of the fastest growing ultrasound segments in the United States and in international markets. The M5 is ideally suited for doctors’ offices, clinics and surgery centers that traditionally forego ultrasound imaging equipment due to space and applicable technology constraints.
The company’s BS-200 automatic bio-chemistry analyzer also received FDA clearance in the first quarter of 2008 and is available in domestic and international markets. The BS-200 is an automatic low-throughput bio-chemistry analyzer designed to replace semi-automatic bio-chemistry analyzers. It is targeted for hospitals and clinics in rural China as well as small hospitals and labs in international markets. It also serves as a backup machine for large hospitals and labs.
The DC-3 color ultrasound imaging system, designed to have wide applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets, received SFDA approval in the first quarter of 2008. The product is ideally suited for hospitals and clinics seeking to replace black and white ultrasound imaging systems.
New approval pipeline
During the fourth quarter of 2007, the company submitted applications for FDA approval for three of its BeneView series products, including the T5, T6 and T8 multi-parameter patient monitoring devices.
The company expects to receive SFDA approval for its EX55 and EX65 compact anesthesia machines in the second quarter of 2008.
About Mindray
Mindray Medical International Limited is a leading developer, manufacturer and marketer of medical devices in China with a significant and growing presence worldwide. Established in 1991, Mindray offers a broad range of products across three primary business segments: patient monitoring & life support products, in-vitro diagnostic products, and medical imaging systems. Mindray is headquartered in Shenzhen, China, and has 29 local sales and service offices in China, as well as sales and service offices in Amsterdam, Istanbul, London, Mexico City, Moscow, Mumbai, Sao Paulo, Seattle, Toronto and Vancouver. For more information, please visit http://www.mindray.com .
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about new product releases and regulatory approvals are forward-looking statements. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Forward-looking statements involve inherent risks and uncertainties. Information regarding these risks and uncertainties is included in our public documents filed with the Securities and Exchange Commission. For a discussion of some of the risks and important factors that could affect Mindray’s actual results and financial condition, see "Risk Factors" in Part I, Item 3D of Mindray’s Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and "Operating and Financial Review and Prospects" in Part I, Item 5 of Mindray’s Annual Report on Form 20-F for the fiscal year ended December 31, 2006. Mindray does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release is as of March 31, 2008, and Mindray undertakes no duty to update such information, except as required under applicable law.
For investor inquiries please contact:
In China:
Susan Du
Mindray Medical International Limited
Tel: +86-755-2658-2518
Email: Susan.Du@Mindray.com
Justin Knapp
Ogilvy Public Relations Worldwide, Beijing
Tel: +86-10-8520-6556
Email: Justin.Knapp@Ogilvy.com
In the United States:
Jeremy Bridgman
Ogilvy Public Relations Worldwide, New York
Tel: +1-212-880-5363
