Naviscan Announces European Launch of Positron Emission Mammography

VIENNA, March 2, 2011 /PRNewswire/ --

- European Launch Marked By Presentations of Significant New Clinical Data Demonstrating the Value of PEM in Improving Treatment Decisions for Breast Cancer

Naviscan, Inc., announces the European launch of the Naviscan Positron Emission Mammography (PEM) scanner at two prestigious radiology conferences in Vienna. On March 3rd, at the European Society of Breast Imaging (EUSOBI) Annual Scientific Meeting, a podium presentation will focus on recently published PEM (Positron Emission Mammography) data demonstrating PEM's ability to reduce unnecessary biopsies by providing superior specificity, the ability to differentiate between benign and malignant lesions. Simultaneously at the European Congress of Radiology (ECR) conference, March 3 - 7, a poster will be presented featuring new clinical data on the role of PEM for assessment of axillary lymph node (ALN) status in patients with breast cancer.

PEM scanners are high-resolution breast PET systems (also referred to as 3-D Molecular Breast Imagers or Tomographic MBI) that can show 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. PEM scanners, which are about the size of an ultrasound system, are manufactured by Naviscan, Inc. and have been commercially available since 2007.

The poster will highlight new clinical data from researchers at the University of Chicago on the role of PEM for assessment of axillary lymph node status in patients with breast cancer. Current morphology-based tools for ALN staging include clinical examination, axillary ultrasound and breast MRI, but none are accurate enough to replace the need for pathologic evaluation of the axillary nodes. In this prospective study, 20 newly diagnosed breast cancer patients underwent mammography, breast and axillary ultrasound, breast MRI and PEM. Suspicious lymph nodes were evaluated and final ALN status was determined via pathology.

The preliminary data show promising results for PEM in accurate lymph node assessment. PEM demonstrates 88% sensitivity with a negative predictive value of 91% in assessment of ALN status in patients with breast cancer. The data show improved lesion detectability and decrease in background activity.

"Our study provides additional compelling evidence that PEM can play an important role in axillary staging, perhaps with more sensitivity than ultrasound or MRI," stated Dr. Daniel Appelbaum, Associate Professor of Radiology from The University of Chicago Medical Center. "Furthermore, these findings, in conjunction with PEM's more extensively documented role in evaluating the breasts themselves as well as whole body PET's excellent whole body staging, paves the way for a complete breast cancer work-up-primary tumor, regional and distant metastases--with one FDG dose."

Naviscan plans to distribute its PEM scanner in Europe in Q2 2011.

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 PEM scanner is currently installed and available in breast and imaging centers throughout the U.S. and other parts of the world. The Company is headquartered in San Diego, California and is the first to obtain FDA-clearance for a high-resolution PET scanner designed to image small body parts and for breast biopsy image guidance. For more information, call +1-858-587-3641 or visit http://www.naviscan.com