(BW)(UT-SORENSON-MEDICAL)Sorenson Medical获得了中国国家食品药品监督管理局批准，在全中国范围内提供其用于止痛ambIT PCA移动输液泵
美国商业新闻2006年2月6日美国盐湖城消息——
南亚医药有限公司(South Asia Pharmamedic Ltd.)是中国最大的制药/医疗设备分销商，其成为了Sorenson Medical在中国市场中的主要分销合作伙伴
Sorenson Medical是率先推出用于止痛之用的便携式移动输液泵的供应商，今天宣布其将会进军中国的医疗设备市场，其率先推出的ambIT? PCA移动式输液泵已经得到了中国国家食品药品监督管理局(FDA)的批准。公司还宣布它已经选择了位于香港的南亚医药有限公司(Pharmamedic)作为其在中华人民共和国(PRC)与香港特别行政区的分销合作伙伴。
Sorenson Medical的ambIT PCA输液泵是一款轻便的便携式输液设备，使得病人们在接受痛苦的治疗过程中能像正常人一样生活，同时能减少麻醉药所带来的副作用与成瘾性。像是ambIT这样的止痛式输液泵同时还使得病人在接受外科手术后能够自由移动，在室里保持舒适姿势，避免住院期间被感染的风险以及缩短住院时间。ambIT输液泵的尺寸只当于电视遥控器，可以放置在腰间皮带内，使用两节AA电池就能够运行。
Sorenson Medical首席运营官LeVoy Haight说道：“我们非常高兴能够与多家中国政府机构进行合作，尤其是中国国家食品药品监督管理局，其已经批准我们的输液泵系列产品进入中国市场。我们相信我们的产品性能强大而且携带方便，能够为提高中国保健质量做出积极的贡献。”
AmbIT PCA移动输液泵要最终符合中国标准还需要完成以下几部分重要工作：设备需要通过由独立的中国试验室完成的安全测试，其中包括对提交的与输液泵性能历史有关的安全数据进行评估。除此之外，Sorenson Medical的设计与制造体系必须要能符合严格的ISO 13485国际医疗设备质量体系要求与美国食品与药物管理局的质量体系规定。这些评估均由中国政府机构完成，我们在设备或者系统功能方面没有任何保留。
Sorenson Medical选择了南亚集团控股公司(South Asia Group Holding Co.)旗下的子公司南亚医药有限公司作为ambIT PCA的中国区主要分销商，目的是快速有效的打入中国市场。南亚医药有限公司拥有大中国区最广泛的药品与医疗设备分销网络。
南亚医药有限公司首席执行官Michael Wong说道：“能被Sorenson Medical选中担任其先进的医疗设备的中国市场主要分销合作伙伴，我们感到非常荣幸。我们相信我们的分销能力的覆盖深度与广度，能够帮助ambIT PCA迅速成为市场中这一门类产品的领先设备。”
Haight补充说道：“南亚医药有限公司拥有丰富的经验，对于市场充满了了解，而我们则想要将这款能够拯救人类生命的经过市场考验的技术打入进包括大城市在内的全中国的保健体系当中，这完全是天作之合。”
南亚医药有限公司通过为多家企业代理销售肾病产品、心脏病产品、眼科产品以及医用一次性产品——以及药品——已经在中国市场取得了卓越成功。南亚医药有限公司分销网络目前能够覆盖遍布中国四大直辖市以及17个省内的60多个城市里的500多家医院。通过与二级城市里的大型批发商建立密切的合作关系，南亚医药有限公司还能够将产品销售到那些一般企业难以进入的小城市与乡镇地区。
关于Sorenson Medical
Sorenson Medical ( www.sorensonmedical.com )专门设计与生产用于精确给药的易用的袖珍式电子移动输液泵。AmbIT系列输液泵产品在术后止痛、提供化疗与IV anti-invectives以及其他连续性与间歇性门诊治疗方面提供了新选择。Sorenson Medical已经在美国食品药物管理局进行了注册，并且通过了ISO 13485:2003和ISO 13485:1996质量体系认证（加拿大医疗设备修订版）。Sorenson Medical的产品均通过了CE认证（符合欧洲标准），能够在欧盟与欧洲经济共同体地区进行销售。
关于南亚医药有限公司(South Asia Pharmamedic Ltd.)
南亚医药有限公司(Pharmamedic)是南亚集团控股公司(South Asia Group Holding Co.)旗下的子公司，也是大中国地区领先的医疗产品分销商之一。南亚医药有限公司作为多家医疗企业的代理在中国人民共和国(PRC)、香港特别行政区以及台湾地区销售医用一次性产品、肾病产品、心脏病产品、眼科产品以及药品。公司的分销网络覆盖整个台湾地区以及遍及中国四大直辖市及17省内的60余个城市里的500多家医院。通过与二级城市里的大型批发商建立密切的合作关系，南亚医药有限公司能够将产品销售至其他企业难以进入的小城市与乡镇地区。
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联系方式：Sorenson Medical对外关系部 David Parkinson，801-287-9472 david@sorensoncompanies.com
(BW)(UT-SORENSON-MEDICAL) Sorenson Medical Receives Chinese FDA Approval to Provide Its ambIT PCA Ambulatory Infusion Pump for Pain Management throughout China
SALT LAKE CITY--(BUSINESS WIRE)--Feb. 6, 2006--
South Asia Pharmamedic Ltd., One of China’s Foremost Pharmaceutical/Medical Equipment Distributors, Selected as Key Distribution Partner for the Chinese Market
Sorenson Medical, a provider of pioneering portable ambulatory infusion pumps for pain management, today announced its expansion into the Chinese medical device market with the approval of the company’s pioneering ambIT(R) PCA ambulatory infusion pump by the Chinese State Food and Drug Administration (FDA). The company also announced that it has selected Hong Kong-based South Asia Pharmamedic Ltd. (Pharmamedic) as its distribution partner in the People’s Republic of China (PRC) and Hong Kong.
Sorenson Medical’s ambIT PCA pump is a lightweight, portable infusion device that enables patients to go about their normal lives as they receive pain treatment, while reducing the threat of side effects and addiction from narcotic drugs. Infusion pain pumps such as ambIT also allow patients to remain mobile after surgery and to recover comfortably at home, avoiding the risk of hospital-acquired infections and prolonged hospitalization. ambIT pumps are about the size of a TV remote, are housed in a belt pack and run on two AA batteries.
"We are extremely pleased with the cooperative effort among various Chinese State agencies, and especially the FDA, in granting approval of our infusion pump product line for the Chinese market," said LeVoy Haight, COO of Sorenson Medical. "We believe the performance and convenience of our products will make a positive contribution to the quality of health care throughout China."
Final approval of the ambIT PCA ambulatory infusion pump to the Chinese standard included several key components. The device was required to pass safety testing by an independent Chinese testing laboratory, including review of submitted safety data regarding the pump’s history of performance. In addition, Sorenson Medical’s design and manufacturing systems had to demonstrate compliance with the rigorous ISO 13485 International Quality System Requirements for Medical Devices and the U.S. Food & Drug Administration Quality System Regulations. These reviews were completed by the Chinese government agencies with no reservations regarding either the device or the systems’ capabilities.
Sorenson Medical chose Pharmamedic, a subsidiary of South Asia Group Holding Co., to act as the company’s primary distributor of the ambIT PCA throughout China in order to rapidly and effectively penetrate the Chinese market. Pharmamedic has one of the most comprehensive distribution networks within Greater China for pharmaceuticals and medical devices.
"We are honored to have been selected by Sorenson Medical as its key distribution partner for this leading-edge medical device in the Chinese market," said Michael Wong, CEO of South Asia Pharmamedic Ltd. "We believe our depth and breadth of distribution coverage will help to quickly establish the ambIT PCA as a category-leading device in
this market."
"We see a strong fit between Pharmamedic’s depth of experience and understanding of the market and our desire to bring this proven, life-saving technology to the Chinese health care system, not only in the major cities, but throughout the PRC," added Haight.
Pharmamedic has achieved outstanding success in China through sales of renal disease, cardiology, ophthalmic and hospital disposable products -- in addition to pharmaceutical products -- for a variety of companies. The Pharmamedic distribution network currently covers more than 500 hospitals in 60-plus cities across 17 provinces and four municipalities in the PRC. Through close relationships with large wholesalers in second-level cities, Pharmamedic is also able to resell to other small municipalities and townships in the PRC which are otherwise less accessible.
About Sorenson Medical
Sorenson Medical (www.sorensonmedical.com) specializes in the design and manufacture of compact, electronic ambulatory infusion pumps that are easy to use and deliver medication precisely. The ambIT line of infusion pumps offers physicians new options for managing post-operative pain, for delivering chemotherapy and IV anti-invectives, and for other continuous or intermittent therapies in
the outpatient setting. Sorenson Medical is FDA registered and the quality system is certified to ISO 13485: 2003 and ISO 13485:1996 with Canadian Medical Device Amendments. Sorenson Medical’s products are CE marked (European Conformity) for distribution in the European Union and European Economic Area.
About South Asia Pharmamedic Ltd.
South Asia Pharmamedic Ltd. (Pharmamedic), a subsidiary of South Asia Group Holding Co., is one of Greater China’s leading distributors of medical products. Pharmamedic markets on behalf of a variety of medical companies throughout the People’s Republic of China (PRC), Hong Kong and the Republic of China (ROC), selling hospital disposables, renal, cardiology, ophthalmic, and pharmaceutical products. The company’s distribution network currently includes the entire ROC, as well as more than 500 hospitals in 60-plus cities across 17 provinces and four municipalities in the PRC. Through close relationships with large wholesalers in second-level cities, Pharmamedic is able to resell to other small municipalities and townships that are otherwise inaccessible.
(C) 2006 Sorenson Medical. All products and brand names are trademarks or registered trademarks of their respective owners. All rights reserved.
CONTACT: Sorenson Medical Public Relations David Parkinson, 801-287-9472 david@sorensoncompanies.com
