SHENZHEN, China, June 13 /Xinhua-PRNewswire/ -- Mindray Medical International Limited (NYSE: MR) ("Mindray"), a leading developer, manufacturer and marketer of medical devices worldwide, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (the "FDA") for its AS3000 next generation anesthesia delivery system (the "AS3000") developed by Datascope Patient Monitoring, a Mindray company ("DPM").
"We're optimistic about the addition of this powerful anesthesia workstation to our growing portfolio of FDA approved medical devices and comprehensive suite of product offerings," said Mr. David Gibson, DPM's president. "The AS3000 enables us to expand our base of physiologic monitoring throughout the peri-operative environment, increase our market share in the anesthesia delivery systems market and further strengthen our leading position in ambulatory surgery centers and community hospitals."
The AS3000 delivers precision anesthesia and ventilation assistance with an intuitive design developed to bring a higher level of ergonomics to the operating room. The AS3000 is designed specifically to penetrate the anesthesia delivery systems market within the U.S., which is a market that the company estimates will generate approximately US$250 million in 2008. The system provides enhanced inhalation anesthesia and ventilation support capabilities for a variety of anesthesia cases and critical care settings, including hospitals, health clinics, outpatient and ambulatory surgery centers, specialty and surgical hospitals. The new system can be easily integrated with existing DPM monitors including the recently launched Spectrum OR and Gas Module III and will notably expand market coverage of the DPM Anesthesia product line.
"The high quality, competitively priced AS3000 is a testimony of our commitment to leverage a global R&D platform in order to tailor products by functionality and price and move up the value chain," said Mr. Xu Hang, Mindray's chairman and co-chief executive officer. "We're encouraged by this approval, the combined efforts of our world-class China-based and DPM engineering teams and the future potential of this complementary fit of assets."
Mindray noted that this FDA clearance is part of the company's strategic focus to gain market share within the peri-operative markets which has been strengthened by the acquisition of Artema Medical and the recent release of the Spectrum OR anesthesia monitor.
Mindray has to date received FDA 510(k) clearance for a total of 16 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems; DPM has to date received FDA 510(k) clearance for a total of 9 products.
About Mindray Medical International Limited
Mindray is a leading developer, manufacturer and marketer of medical devices 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 globally headquartered in Shenzhen, China, with U.S. headquarters in Mahwah, New Jersey. Mindray also has sales and service offices internationally in Amsterdam, Istanbul, London, Mexico City, Moscow, Mumbai, Sao Paulo, Seattle, Toronto and Vancouver. For more information, please visit http://www.mindray.com .
About Datascope Patient Monitoring
DPM develops, manufactures and markets proprietary patient monitoring products and medical devices for clinical healthcare markets in cardiology, radiology, anesthesiology, emergency medicine and critical care. The company's products are sold throughout the world through direct sales representatives and independent distributors.
Acquired by Mindray in May 2008, DPM is headquartered in Mahwah, New Jersey. For more information, please visit DPM's website at http://www.datascopemonitors.us.
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. All information and forward-looking statements provided in this press release are as of June 12, 2008, and Mindray undertakes no duty to update such information or forward-looking statements, except as required under applicable law.