iCAD Initiates Clinical Study of Its Virtual Colonoscopy CAD in Partnership with...

iCAD Initiates Clinical Study of Its Virtual Colonoscopy CAD in Partnership
with ACR Image Metrix

NASHUA, N.H., June 19 /PRNewswire-FirstCall/ -- iCAD, Inc. (Nasdaq: ICAD),
an industry-leading provider of Computer-Aided Detection (CAD) solutions for
the early identification of cancer, today announced it has initiated a
clinical study for Colon CAD, its virtual colonoscopy CAD product, in
partnership with ACR Image Metrix, a subsidiary of the American College of
Radiology (ACR). iCAD and ACR Image Metrix, having completed the development
portion of the study, are collaborating on study execution including a multi-
reader, multi-case (MRMC) clinical study designed to assess the impact of
Colon CAD on the accuracy of interpreting CT Colonography exams also known as
virtual colonoscopies. The study will also assess the sensitivity of Colon CAD
for detecting polyps and will measure the impact of iCAD's CT Colon CAD
product on interpretation and workflow.
Virtual colonoscopy offers patients a less invasive option to conventional
colonic polyp detection techniques. Reviewing these images can be tedious and
challenging because of the amount of information captured in a CT exam. iCAD's
colon CAD product uses sophisticated image processing analysis technology to
identify polyps in images with the potential for streamlining the reading
process and improving accuracy, productivity and workflow. The study, which
will be managed and executed by ACR Image Metrix, will include up to 20
radiologists, is expected to take about six months to complete and will
include the analysis of several hundred cases tested with virtual colonoscopy
featuring Colon CAD.
"Moving to this clinical study, which should enable iCAD to submit the
necessary data to the FDA, is an exciting step bringing the Company closer to
taking our Colon CAD product to market," said Ken Ferry, President and Chief
Executive Officer of iCAD. "Working with ACR Image Metrix, a group with a high
level of expertise in this area, will be of great value in helping us prove
the tremendous benefits we believe our Colon CAD product can provide both in
polyp detection and workflow enhancement. We believe our Colon CAD product has
tremendous market opportunity and will be a great addition to our established
CAD product lines for breast cancer detection."
Although 140,000 people in the U.S. will be diagnosed with colon cancer
this year, it is one of the most preventable cancers when early polyps are
detected and removed. More than 82 million Americans are over 50 years of age,
thus making them eligible for colorectal cancer screening; however,
diagnostics are significantly underutilized, due at least in part to the
invasive nature of current screening procedures such as colonoscopy. Results
from recent trials including the National CTC Trial conducted by the ACR
Imaging Network (ACRIN) that demonstrated the effectiveness of virtual
colonoscopy as a screening procedure, coupled with recent initiatives to
establish Medicare reimbursement for the procedure, may increase the viability
of virtual colonoscopy for colorectal cancer screening and are likely to drive
increased utilization of the procedure.
"CT Colonography will not only provide a new and necessary option for
cancer detection, but has the potential to increase screening rates
nationwide," said Abraham Dachman, M.D., Professor of Radiology, University of
Chicago Medical Center and Principal Investigator of the Colon CAD study.
"While we expect the benefits in polyp detection will be significant, we are
also exploring how enhanced workflow features can add to the benefit CAD
provides to CT Colonography."
About ACR Image Metrix
ACR Image Metrix is a subsidiary of the American College of Radiology
(ACR), the premier professional society serving more than 32,000 radiologists
committed to ensuring that imaging is safe, effective, and accessible to all
patients. ACR Image Metrix is based on the successes of ACRIN(R), the
NCI-funded clinical trials cooperative group established in 1999 to assess
emerging imaging technologies. ACRIN(R)'s clinical trials have involved as few
as 65 to more than 50,000 subjects and have handled over 50 million images.
The ACRIN(R) portfolio includes such high-profile studies as the Digital
Mammographic Imaging Screening Trial (DMIST) and the National Lung Cancer
Screening Trial (NLST).
About iCAD, Inc.
iCAD, Inc. (Nasdaq: ICAD) is an industry-leading provider of Computer-
Aided Detection (CAD) solutions that enable healthcare professionals to better
serve patients by identifying pathologies and pinpointing cancer earlier. iCAD
offers a comprehensive range of high-performance, upgradeable CAD systems for
the high, mid and low volume mammography markets. iCAD is entrusted with the
task of early cancer detection by over 2,000 women's healthcare centers
worldwide. For more information, call +1 877 iCADnow or visit
www.icadmed.com.For iCAD, contact Darlene Deptula-Hicks, EVP and CFO at
603-882-5200 x7944 or
via email at ddeptula@icadmed.com
For iCAD Investor Relations, contact Anne Marie Fields of Lippert/Heilshorn &
Associates at 212-838-3777 x6604 or via email at afields@lhai.com
For iCAD Public Relations, contact Jill Testagrossa of Schwartz Communications
at 781-684-0770 or via email at icad@schwartz-pr.com
"Safe Harbor" Statement under the Private Securities Litigation Reform Act
of 1995:
Certain statements contained in this News Release constitute "forward-
looking statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements involve a number of known
and unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company to be materially different
from any future results, performance or achievements expressed or implied by
such forward-looking statements. Such factors include, but are not limited to,
the risks of uncertainty of patent protection, the impact of supply and
manufacturing constraints or difficulties, product market acceptance, possible
technological obsolescence, increased competition, customer concentration and
other risks detailed in the Company's filings with the Securities and Exchange
Commission. The words "believe", "demonstrate", "intend", "expect",
"estimate", "anticipate", "likely", and similar expressions identify forward-
looking statements. Readers are cautioned not to place undue reliance on those
forward-looking statements, which speak only as of the date the statement was
made. The Company is under no obligation to provide any updates to any
information contained in this release.
SOURCE iCAD, Inc.

Darlene Deptula-Hicks, EVP and CFO of iCAD, Inc., +1-603-882-5200 x7944,
ddeptula@icadmed.com, or Investor Relations, Anne Marie Fields of
Lippert/Heilshorn & Associates, +1-212-838-3777 x6604, afields@lhai.com, or
Public Relations, Jill Testagrossa of Schwartz Communications,
+1-781-684-0770, icad@schwartz-pr.com, both for iCAD, Inc.