ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities
* Reuters is not responsible for the content in this press release.
ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate
Abnormalities
MINNEAPOLIS, Oct. 8 /PRNewswire-FirstCall/ -- ProUroCare Medical, Inc. (OTC
Bulletin Board: PUMD and PUMDU) today announced the completion of a National
Institute of Health and National Cancer Institute-supported clinical study.
The study's purpose was to evaluate the ability of the company's ProUroScan
imaging system to visualize and document abnormalities in the prostate
detected or monitored by the digital rectal exam (DRE). The results of the
clinical study will be submitted to the U.S. Food and Drug Administration
(FDA) in support of a 510(k) application in the near future after third party
validation of the data.
In an earlier clinical study conducted by Artann Laboratories and Dr. Robert
Weiss at the Robert Wood Johnson Medical Center, and published in the
peer-reviewed journal Urology, 168 patients were assessed using the ProUroScan
system to demonstrate the technology's ability to provide an objective and
reproducible image or map of the prostate. In an ensuing meeting with the FDA,
a modified clinical study was discussed which would involve imaging at least
40 patients using an enhanced version of the ProUroScan imaging system.
This study, which closed on September 25 with support from Artann
Laboratories, ultimately included 57 patients recruited at the following
medical centers:
-- University of Minnesota Veterans Affairs Medical Center, Minneapolis,
Minn.;
-- Robert Wood Johnson Medical School Division of Urology, New Brunswick,
N.J.;
-- AccuMed Research Associates, Garden City, N.Y;
-- Urological Associates of Lancaster, Lancaster, Pa.; and
-- Mayo Clinic, Rochester, Minn.
"While still preliminary, we're very encouraged by the results of our clinical
study and believe they compare favorably to the March 2008 study published in
Urology," said Rick Carlson, CEO of ProUroCare Medical. "The key value of this
technology is the ability of the system to generate a real-time image of the
prostate that physicians can use to visualize and document abnormalities in
the prostate in patients identified as potentially having prostate
abnormalities on digital rectal examination."
More details on the study's purpose, population, criteria and investigators is
available at:
http://www.clinicaltrials.gov/ct2/show/NCT00822952?term=Prostate+Mechanical+Imaging&rank=1
The ProUroScan imaging system is designed to complement the DRE, and to
provide patients with potential prostate abnormalities the ability to have
their prostates imaged in real time with records electronically stored for
later comparison.
About ProUroCare Medical, Inc.
ProUroCare Medical, Inc. is a publicly traded company engaged in the business
of creating innovative medical imaging products. The company's current focus
is the ProUroScan prostate imaging system, which is now in clinical trials for
the mapping of prostate abnormalities detected by DRE. Based in Minneapolis,
Minn., ProUroCare is traded on the OTCBB market.
Safe Harbor Statement
This news release contains certain "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements are typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar expressions.
These forward-looking statements are not guarantees of ProUroCare's future
performance and involve a number of risks and uncertainties that may cause
actual results to differ materially from the results discussed in these
statements. Factors that might cause ProUroCare's results to differ materially
from those expressed or implied by such forward-looking statements include,
but are not limited to, the ability of ProUroCare to find adequate financing
to complete the development of its products; the high level of secured and
unsecured debt incurred by ProUroCare; the dependence by ProUroCare on third
parties for the development and manufacture of its products; and other risks
and uncertainties detailed from time to time in ProUroCare's filings with the
Securities and Exchange Commission including its most recently filed Form 10-K
and Form 10-Q. ProUroCare undertakes no duty to update any of these
forward-looking statements.
SOURCE ProUroCare Medical, Inc.
Rick Carlson, Chief Executive Officer of ProUroCare Medical, Inc.,
+1-952-476-9093, rcarlson@prourocare.com; or Jeff Elliott of Halliburton
Investor Relations, +1-972-458-8000, jelliott@halliburtonir.com
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.



Follow Reuters