About ProUroCare Medical

ProUroCare is engaged in the business of developing innovative products for the detection and characterization of prostate disease. Our initial product is a “prostate mechanical imaging” device called the ProUroScan System. The ProUroScan is an imaging system that is designed to produce an elasticity image of the prostate as an adjunctive aid in visualizing and documenting abnormalities of the prostate that have been detected by a digital rectal examination (“DRE”). As an adjunct to DRE, the ProUroScan system will be used following an abnormal DRE to generate real-time images of the prostate that can be stored electronically.

As a development partner with Artann Laboratories, ProUroCare has provided marketing, manufacturing, clinical, patent and financial support to advance the ProUroScan system to a point where it now under review by the FDA and is being readied for commercialized in the urology market. In total, more than $23 million has been directed to the development of this innovative product and technology.

Since our inception, our goal has been to establish the ProUroScan System as the standard of care in the process of detecting and monitoring prostate disease, and to leverage our mechanical imaging technology and intellectual property to create new products both within and outside the field of urology. The key business strategies by which we intend to achieve these objectives include:

Obtain Regulatory Clearance for the ProUroScan Prostate Imaging System. We are actively pursuing FDA clearance under a de novo application for a labeling claim to support use of the ProUroScan System to create an image to aid physicians in documenting abnormalities in the prostate following a suspicious DRE.

Commercialize Our Products in Collaboration with a Corporate Distribution Partner. As an effective way to accelerate worldwide sales and marketing support for the ProUroScan System, we are working to establish a relationship with a large medical device, diagnostic or drug company. Having a partner will enable us to penetrate markets more quickly and obtain additional financial support in the form of licensing fees, equity investments and "in kind assistance."

Expand and Protect Our Intellectual Property Position. We believe that our issued and licensed patents, patent applications and technology will provide a strong position from which the company can successfully market the current ProUroScan System and develop new products within the prostate disease market. We will also work to expand coverage for this technology in other market segments and for additional new technologies that may be developed with our business partners. We intend to implement a global patent because of the significant market opportunities that exist for our products outside the United States.

Drive Market Adoption and Establish Prostate Mechanical Imaging as a Standard of Care for Detecting Abnormalities in the Prostate. Our clinical development strategy is to collaborate with leading physicians and scientific experts involved with prostate disease. We have established a high level of awareness and strong working relationships with leading physicians and believe that their involvement will allow us to create overall market awareness and scientific validity for the ProUroScan System.

Drive revenue through the sale of ProUroScan images direct to end user customers. We expect our primary revenue stream will consist of fees charged per procedure rather than from sales of equipment. There is a high incentive for patients to seek additional information so they can make an informed and reasonable decision for themselves and their family. We believe that patients will be willing to pay for the ProUroScan System procedure out of their personal funds in sufficient numbers to support the launch of our product in advance of receiving a favorable coverage decision. Over time, we will document the value of the ProUroScan imaging procedure and pursue government and other third-party reimbursement coverage.

Leverage our Imaging Technology for Additional Clinical Applications and Indications. We intend to continue to conduct research and development through Artann and other development partners that will enable us to expand our current applications and indications for use. Specifically, we plan to study and develop enhanced versions of the system that may be able to monitor changes in prostate tissue over time, guide prostate biopsies, do prostate disease screening and assess changes in prostate size following drug treatment for ("BPH"). We believe that the underlying technology also has potential applications in other organ systems in addition to the prostate.

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