Naviscan Announces European Launch of Positron Emission Mammography
By Naviscan Inc., PRNETuesday, March 1, 2011
European Launch Marked By Presentations of Significant New Clinical Data Demonstrating the Value of PEM in Improving Treatment Decisions for Breast Cancer
VIENNA, 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
Guillaume Bailliard, Executive VP, Marketing of Naviscan, Inc., +1-858-332-0941
Tags: Austria, california, March 2, Naviscan Inc., vienna