About ProUroCare Medical

The ProUroScan System is an imaging system designed for use as an aid to the physician in visualizing and documenting abnormalities in the prostate that have been previously detected by a digital rectal exam for men (DRE). As an adjunct to DRE, the ProUroScan System will be used following an abnormal DRE to generate a real time image and map of the prostate and to store this information electronically.

The ProUroScan’s unique technology uses measurements of relative tissue elasticity as detected by mechanical sensors and interpreted by mathematical algorithms to create images, rather than using transrectal ultrasound or other alternatives. The technology is based on work originally performed in the late 1990’s by Artann Laboratories Inc. (“Artann”) a scientific technology company based in Trenton, New Jersey, that is focused on early-stage technology development. In 2002, we licensed the rights to this technology and since then have worked with Artann on its development. In April 2008, we acquired the patents, patent applications and other know how associated with this technology. In July 2008, the Company entered into new license and development and commercialization agreements with Artann relating to their existing technology and know-how and all future technology developed by Artann in our field of use.

The ProUroScan system is not currently marketed or sold and is not cleared for marketing by the U.S. Food and Drug Administration (FDA). A 510(k) application for market clearance of this technology in the U.S. is anticipated to be filed with the FDA in 2009. Our initial goal is to obtain a basic mapping and data maintenance claim from the FDA under a 510(k) application for the current generation system. Once FDA 510(k) clearance is obtained on our current generation ProUroScan System, we intend to have the systems manufactured by one or more contract manufacturers and market the system in cooperation with a medical device company that has an established presence in the urology market.

We believe there is a market need to be able to visualize and create an electronic record (map) that can show the relative size and position of abnormalities in the prostate gland. We believe that the ProUroScan System will offer a solution that meets these needs and one that will (assuming we apply for and obtain FDA approval or clearance for this indication) enable physicians to monitor and compare images of the prostate over time.

We believe that the ProUroScan System’s existing technology provides a platform on which to develop multiple future generation systems. In the future, once 510(k) clearance is obtained for a basic mapping and data maintenance claim, we intend to work with Artann to develop and introduce enhanced versions and additional indications. We plan to study, explore and develop an enhanced version of the system that may be able to monitor changes in prostate tissue over time, guide biopsy of the prostate gland and assess changes in prostate size following drug treatment for Benign Prostatic Hypertrophy (BPH). Future generation systems will require us to obtain regulatory approval or clearance for use of the ProUroScan system for additional prostate related indications and file additional submissions with the FDA if we are to obtain expanded labeling claims.

Our elasticity imaging technology is protected by seven U.S. patents, seven foreign patents, five foreign patent applications. In addition, Artann has filed four additional U.S. patent applications that are licensed to us under the Artann License Agreement.

Not available for Sale in the United States.
CAUTION – Investigational device. Limited by Federal law to investigational use.