ProUroCare Medical Completes Multiple Site Clinical Study For Imaging Prostate Abnormalities

Main Category: Prostate / Prostate Cancer
Also Included In: MRI / PET / Ultrasound;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 09 Oct 2009 - 3:00 PDT

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ProUroCare Medical, Inc. (OTC Bulletin Board: PUMD and PUMDU) 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."

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