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PLC’s Growth Initiative: Renal Guard May 7, 2007. Forward-Looking Statements. This presentation includes forward-looking statements that include risks and uncertainties. In the opinion of PLC, such statements are believed to be reasonable, but there can be no assurances that such
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Forward-Looking Statements This presentation includes forward-looking statements that include risks and uncertainties. In the opinion of PLC, such statements are believed to be reasonable, but there can be no assurances that such expectations will prove to be correct. For a discussion of factors that could affect the outcome, please refer to the Company’s filings with the Securities and Exchange Commission. LA 00241
Renal Guard Growth Initiative We have developed a novel technology, with intellectual property filed, that addresses an unmet clinicalneedin a large and growing patient population that can be easily adopted into medical practice. Renal GuardTM Addresses more than 1 million patients in a $500 million market LA 00241
Renal Guard™ Growth Initiative Our technology is The market is the prevention of Contrast Induced Nephropathy It’s the right opportunity at the right time. LA 00241
PLC’s Growth Strategy • PLC growth strategy focused on: • Expanding our product portfolio • Increasing our core competencies • Growing our revenues • Building out from our core business to launch a new business opportunity • Moving forward through a methodical evaluation of the market and PLC’s key strengths • But where to start? LA 00241
Finding the Right Opportunity:in the Cath Lab • Rapid growth in interventional and image-guided medical procedures pointed to the cath lab • More than 7 million interventional cardiology and radiology procedures performed annually worldwide LA 00241
Evaluate the Opportunity Key Factors for Success • Unmet clinical need • Large patient population • Novel technology • Easily adopted medical practice • Strong intellectual property • Excellent revenue potential LA 00241
Unmet Clinical Need: Contrast Induced Nephropathy • X-ray angiography uses contrast agent to capture images of the heart • These contrast agents can be toxic to the kidney • This can lead to a life-threatening condition called contrast-induced nephropathy (C-I-N) • There is no satisfactory method of preventing C-I-N in the market today LA 00241
The C-I-N Market Contrast-induced nephropathy could affect an estimated 1 million patients a year (and that number will continue to grow) representing a potential market of almost $500 million. The incidence rises with these all-too-common conditions: Source: JACC 2004, Health Advances’ interviews. LA 00241
serum creatinine Predicting CIN Risk CIN risk increases as patient’s serum creatinine levels increase. LA 00241
The Consequences of C-I-N Hospitalization, Morbidity, and Mortality C-I-N can lead to: • Prolonged hospital, • Increased ICU stays, • Need for dialysis, and • Ultimately increased mortality LA 00241
Addressing C-I-N • Researchers have searched for an answer to C-I-N • Contrast companies and drug companies have pursued solutions for preventing C-I-N • Despite these efforts, C-I-N rates are still considered high. LA 00241
Addressing C-I-N Hydration • Overnight hydration is currently the most efficacious form of C-I-N prevention. • patient admitted for 12 hours of hydration pre-procedure and 12 hours post-procedure • logistically cumbersome • Bolus hydration used in lieu of overnight hydration, • a risk of volume overload • commonly performed at a rate significantly lower than that shown to provide protection due to the fear of overhydration and pulmonary edema LA 00241
Promising Direction PRINCE Study discussed inducing a high urine flow rate may provide a benefit against contrast-induced nephropathy • Urine flow rates above 150 ml per hour showed modest reduction in rates of acute renal failure • Not optimal because the hydration protocol was a fixed amount and not matched to each individual’s response LA 00241
Promising Direction • Further analysis of the PRINCE data has led us to believe that a significant reduction in the rate of C-I-N can be achieved with higher urine outputs if matched hydration can be performed in a precise, safe, and real-time manner. LA 00241
Proof of Concept Study - Animal • Renal Guard therapy group - - no C-I-N • Control group consistently bumped over C-I-N threshold • Study conclusion: High urine output with matched replacement to maintain intravascular volume eliminated the incidence of C-I-N Hours Post Contrast Exposure LA 00241
Proof of Concept Study - Human • Tested Concept (not device): High urine flow with matched fluid replacement to prevent C-I-N • 10 patients enrolled in the study • 9 patients - - remained at or below baseline creatinine • 1 patient - - 25% increase in creatinine over baseline. • “Isn’t there a device that does this?” LA 00241
Renal Guard™ The PLC Solution • Renal Guard combines a high-speed fluid pump and a urine collection system • Generates high urine output while balancing patient’s fluid input/output • Accomplished by a continued intravenous infusion of a matched volume of saline US: Not available for sale in the United States. OUS: Exclusively for Clinical Investigations. To be used by qualified investigators only. LA 00241
Renal Guard™ Renal Guard therapy is designed to: • Provide the benefits of hydration in an automatic system • Prevent contrast agents from clogging in the kidney • Limit toxin exposure in the kidneys US: Not available for sale in the United States. OUS: Exclusively for Clinical Investigations. To be used by qualified investigators only. LA 00241
Renal Guard™ Renal Guard™ Path to Success • Scientific Advisory Board • Intellectual Property • Program Timeline LA 00241
Scientific Board of Advisors • Dr. Jeff Brinker - - Johns Hopkins University • Specialty: Interventional Cardiologist/C-I-N Prevention • Dr. Peter McCullough - - William Beaumont Medical Center • Specialty: Cardiologist/C-I-N Prevention • Dr. Fred Resnic - - Brigham and Womens Hospital • Specialty: Interventional Cardiologist/Cardiology Informatics • Dr. Michael Rudnick - - Penn Presbyterian Medical Center • Specialty: Nephrology/C-I-N Prevention • Dr. Richard Solomon - -University of Vermont • Specialty: Nephrology/C-I-N Prevention LA 00241
Our Patent Wall Patents have been filed within the renal protection field covering: • Methods • Hardware • Software • Disposables LA 00241
Next Steps on the Path • Manufacturing/Engineering • Building devices and disposables • U.S. Clinical Plan • Pilot trial initiated in Q4 2006 - - 40 patients • Pivotal trial to be initiated in 2007 • Regulatory • CE Mark • Discussions with the FDA - - Probable PMA path • Sales/Marketing • International – indirect distribution strategy • Domestic – PLC sales team LA 00241
Expected Timeline International Distributor Plan Limited Launch CE Mark 2007 US Pivotal Trial FDA Review Commercial Launch Pilot Trial • 2008 2009 2010 LA 00241
7 million cath procedures per year Renal Guard™ Market Size Excellent Revenue Potential 1 million patients to be protected Worldwide Potential Market Size $500 million (at $500 per procedure pricing) LA 00241
Key PLC Attributes Contributing to the success • Resources necessary to prove efficacy of science • Strong balance sheet • $10 million in cash (As of 3/31/07) • No debt • New U.S. TMR Distributor -- Novadaq • TMR business providing ongoing cash flow • PLC senior management team • Cath lab experience LA 00241
Renal Guard™ Key Points • More than 7 million cath procedures performed worldwide annually • Contrast media is used in each cath procedure • Contrast is toxic to the kidneys • Renal GuardTM expected to protect kidneys during cath procedures • Novel technology with filed intellectual property • Clinical Trial under way LA 00241
Renal Guard™ the Right Opportunity at the Right Time LA 00241