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NAVISCAN ANNOUNCES EUROPEAN LAUNCH OF POSITRON EMISSION
MAMMOGRAPHY
European Launch Marked By Presentations of Significant New Clinical Data
Demonstrating the Value of PEM in Improving Treatment Decisions for Breast Cancer
VIENNA, AUSTRIA – March 2, 2011 – 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 www.naviscan.com
Contact Information
Guillaume Bailliard
Executive VP, Marketing
Naviscan, Inc.
Tel: +1.858.332.0941