ProUroCare Medical Inc. · OTC:PUMD
ProUroCare Medical — Corporate Update (September 2012)
19 slides from ProUroCare Medical's corporate update, Sep 18, 2012
Slide 1: Shareholder Update September 2012
Shareholder Update September 2012
Slide 2: Safe-Harbor Statement
Safe - Harbor Statement This presentation 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
Slide 3: ProUroCare Update - Contents
ProUroCare Update - Contents ProUroCare Market Opportunity FDA Clearance of ProUroScan TM System » Benefits of “ de novo” versus traditional 510(k) clearance » Expanded physician interest » Expanded investor interest Coming Milestones Through 2013 Strategic Partner Strategy Funding Requirements 3
Slide 4: ProUroCare Market Opportunity
ProUroCare Update ProUroCare Market Opportunity 4
Slide 5: Addressable market across the prostate disease life-cycle
Annual Primary Care Physician Visit Diagnostic Urology Visit Biopsy Urology Visit Surveillance Urology Visit ProUroCare elasticity measurement technology has the potential to address the entire life - cycle of prostate disease management – a $4 Billion+ addressable market in the U.S. alone . DRE
Slide 6: Strong Incentives to Find Alternative Tools for Identifying Prostate Disease
Strong Incentives to Find Alternative Tools for Identifying Prostate Disease ▪ More than $3 billion is estimated to be spent in the U.S. annually on PSA - related testing 1 ▪ USPSTF report questions value of PSA testing ▪ DRE and PSA testing combined is only 56% effective 2 ▪ Only 25% of 1 million b
Slide 7: FDA Clearance of ProUroScan System
ProUroCare Update FDA Clearance of ProUroScan System 7
Slide 8: ProUroScan Cleared by FDA
ProUroScan Cleared by FDA De novo clearance received from FDA on April 27, 2012 (510k No. K093579) Approved labeling claim: “To create an image and document abnormalities in the prostate following an abnormal DRE” Approval serves as a foundation for approval of future mechanical imaging techno
Slide 9: Benefits of De novo Clearance
Benefits of De novo Clearance ▪ Company can use its own device as a predicate in future 510(k) filings » 510(k) filings have more specific processing timelines » FDA now familiar with concept of mechanical elasticity imaging technology ▪ Specifications and special controls laid out in the de novo ap
Slide 10: Post FDA Approval Expanded Physician Interest
Post FDA Approval Expanded Physician Interest ▪ More than 30 major institutions have indicated a strong interest in placing a system in their facility ▪ Physicians have expressed interest in conducting a variety of post - marketing clinical studies, including use of ultrasound and MRI in combination
Slide 11: Post FDA Approval Increased Investor Interest
Post FDA Approval Increased Investor Interest ▪ FDA clearance has significantly changed investor’s perspective of the company and our technology ▪ New interest and participation from larger, more sophisticated investors ▪ In discussions with several institutional investors ▪ Exploring financing opti
Slide 12: Coming Milestones through 2013
ProUroCare Update Coming Milestones through 2013 12
Slide 13: Coming Milestones
Coming Milestones ▪ Submit draft cleaning & disinfection protocol to FDA ▪ Secure financing to support planned programs ▪ Establish strategic partner agreement(s) ▪ Begin placing 4 - 5 training systems with key opinion leader physicians ▪ Complete modifications to existing single use probe to meet F
Slide 14: Coming Milestones (continued)
Coming Milestones (continued) ▪ B egin rollout of Gen 1 commercial systems to 10 - 12 key opinion leader physicians upon receipt of FDA approval of multi - use probe ▪ Begin post - marketing studies with key opinion leader physicians ▪ Develop information systems platform to expand data management c
Slide 15: Added Operational Expertise
Added Operational Expertise ▪ Stan Myrum contracted to lead product and technology development. Experience and expertise includes: » Former Medtronic VP Quality & Operations » Operations and manufacturing of medical devices » Due diligence assessments » Sensor function and manufacturing ▪ Larry Getl
Slide 16: Strategic Partner Strategy
ProUroCare Update Strategic Partner Strategy 16
Slide 17: Narrowing Strategic Partner Focus
Narrowing Strategic Partner Focus ▪ Exploring collaboration and strategic partnerships with companies in the market segments shown below ▪ Developing relationships with likely strategic targets with assistance of Cherry Tree & Associates ▪ Increased interest following FDA approval, and company worki
Slide 18: Funding Requirements
ProUroCare Update Funding Requirements 18
Slide 19: Funding Requirements
Funding Requirements ▪ Ability to hit milestones is dependent upon receipt of adequate funding ▪ Management projects a need for $4.5 to $5.0 million through mid - 2013 to achieve operating goals ▪ In addition, we are working to fund or refinance $1.1 million of debt and licensing payments in 2012 ▪
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