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Naviscan, Inc. Receives Shonin Approval for High-Resolution Breast Pet


7/31/2012 8:28:37 AM

Tokyo, Japan – July 31, 2012 –Naviscan, the global leader in organ-specific molecular imaging, announced today that it received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to market its high-resolution PET scanner in Japan. The breast application of the scanner is Positron Emission Mammography or PEM. As the incidence of breast cancer in Japan is projected to rise by 24% in the next 7 years, PEM is a welcome addition by Japanese physicians allowing them to see lesions as small as 1.6mm. Since PEM is also not affected by breast density, the metabolic imaging scanner will be particularly helpful given the high percentage of Japanese women with dense breasts. PEM has been used for over two years at Yuai Clinic in Yokohama, helping physicians treat breast cancer.

“We are delighted to obtain market approval from the Japanese PMDA, thus enabling a greater number of local patients to benefit from PEM imaging,” stated Fabien Reyjal, President of SCETI K.K., Naviscan’s Japanese distributor. “The most advanced Molecular Breast Imaging device on the market, PEM, will provide Japanese breast physicians and imaging specialists with tremendous possibilities to diagnose breast cancer. We look forward to expanding PEM in Japan, an innovative and much needed technology.’’

PEM imaging shows the location as well as the metabolic phase of a lesion. This information is critical in determining whether a lesion is malignant and influences the course of treatment by distinguishing between benign and malignant lesions, what physicians term “specificity.” Recent prospective multicenter studies have demonstrated that PEM has similar sensitivity and higher specificity than breast MRI. 60 scanners have been installed at hospitals, imaging centers and cancer institutes on four continents. The scanner is the only FDA-cleared, CE-marked, and now Shonin-approved, 3D Molecular Breast Imaging (MBI) device on the market.

About Naviscan, Inc.

Naviscan, founded in 1995, develops and markets compact, high-resolution PET scanners intended to provide organ- specific molecular imaging and guide radiological and surgical procedures. The Naviscan PET scanner is currently installed and available in breast and imaging centers throughout the world with global distribution in 34 countries. The Company is headquartered in San Diego, California and is the first to obtain FDA clearance and CE Mark for a high- resolution PET scanner designed to image small body parts and for breast biopsy image guidance.

Contact Information

Guillaume Bailliard

Executive Vice President

Naviscan, Inc.

Tel: +1.858.332.0941

gbailliard@naviscan.com



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