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ActiViews Announces SFDA Clearance for CT-Guide™ Needle Guidance System in China

5/22/2012 7:53:35 AM

WAKEFIELD, Mass.--(BUSINESS WIRE)-- ActiViews, Inc, a company pioneering the development of simple, accurate, and cost-effective surgical navigation solutions, announced today that China’s State Food and Drug Administration (SFDA) has granted clearance to market CT-Guide™ navigation for minimal invasive interventions.

CT-Guide™ navigation is designed to assist physicians during CT-guided interventional diagnostic and therapeutic procedures such as percutaneous biopsies, ablations, and marker placements in the lung and liver. CT-Guide™ navigation shows physicians the real-time location of their interventional instruments and the trajectory to target on the CT images like a GPS guides a car using stored roadmaps.

“Following our two year process, the ActiViews team and I are extremely pleased that the Chinese SFDA recognizes the value of CT-Guide™ navigation,” commented Yuval Zuk, CEO of ActiViews. “We are also delighted to be able to deliver our unique and simple technology into China, as this will enable us to expand our geographical presence into one of the world’s fastest growing medical device areas.”

The People’s Republic of China has more than 5,000 interventionists at clinical centers around the country that could benefit by having access to a soft tissue navigation system utilizing the ActiViews unique core technology. In 2009, the Chinese government committed to develop the country’s healthcare system over a three-year period. The plan is to create a solid platform for universal healthcare access for all by 2020. This reform led to a significant growth for the medical device market, which is growing at a pace of 20-24 percent per year with the 2014 estimate to reach $40-50 billion.

“This registration clearance is a significant accomplishment for ActiViews and supports our global clinical strategy to penetrate markets that are accepting of novel minimal invasive technologies,” said Christopher von Jako, President of ActiViews, Inc.. “It connects us more closely to Chinese physicians wanting to utilize clinically relevant devices that strive to improve their patients’ health and wellness. We are excited to begin working with Chinese healthcare professionals later this year.”

About ActiViews:

ActiViews is a privately held high-tech medical device company that develops, manufactures, and markets novel surgical navigation solutions. The company’s mission is to become the leading provider of simple, accurate, and affordable navigation solutions in order to enhance physician confidence in performing minimally invasive thoracic and abdominal surgical oncology procedures. The U.S. Patent and Trademark Office has approved the core technology platform patent with other ancillary patents currently pending. CT-Guide™ navigation is the first and only commercially available system for CT-guided interventions in soft tissue applications for the U.S., Europe, and China. Only in China, CT-Guide™ navigation is branded as ActiSight™ navigation. ActiViews, Inc. is located in the metro-Boston area with Research and Development facilities in Haifa, Israel. For further information visit the website at ActiViews, Navigate with Confidence™.

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ActiViews, Inc.

Christopher von Jako, 617-909-3909

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