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."
SOURCE ProUroCare Medical, Inc.