Presentation is loading. Please wait.

Presentation is loading. Please wait.

PLC’s Growth Initiative: Renal Guard May 7, 2007.

Similar presentations


Presentation on theme: "PLC’s Growth Initiative: Renal Guard May 7, 2007."— Presentation transcript:

1 PLC’s Growth Initiative: Renal Guard May 7, 2007

2 This presentation is the property of PLC Medical Systems, Inc. LA 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.

3 This presentation is the property of PLC Medical Systems, Inc. LA We have developed a novel technology, with intellectual property filed, that addresses an unmet clinical need in a large and growing patient population that can be easily adopted into medical practice. Renal Guard TM Addresses more than 1 million patients in a $500 million market Renal Guard Growth Initiative

4 This presentation is the property of PLC Medical Systems, Inc. LA Our technology is The market is the prevention of Contrast Induced Nephropathy It’s the right opportunity at the right time. Growth Initiative Renal Guard ™

5 This presentation is the property of PLC Medical Systems, Inc. LA 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?

6 This presentation is the property of PLC Medical Systems, Inc. LA 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

7 This presentation is the property of PLC Medical Systems, Inc. LA Key Factors for Success Unmet clinical need Large patient population Novel technology Easily adopted medical practice Strong intellectual property Excellent revenue potential Evaluate the Opportunity

8 This presentation is the property of PLC Medical Systems, Inc. LA 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

9 This presentation is the property of PLC Medical Systems, Inc. LA 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: Congestive Heart Failure Chronic Kidney Disease Age > 75 yrs Anemia Peripheral Vascular Disease Diabetes Mellitus Source: JACC 2004, Health Advances’ interviews.

10 This presentation is the property of PLC Medical Systems, Inc. LA Predicting CIN Risk CIN risk increases as patient’s serum creatinine levels increase. serum creatinine

11 This presentation is the property of PLC Medical Systems, Inc. LA The Consequences of C-I-N C-I-N can lead to: Prolonged hospital, Increased ICU stays, Need for dialysis, and Ultimately increased mortality Hospitalization, Morbidity, and Mortality

12 This presentation is the property of PLC Medical Systems, Inc. LA 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.

13 This presentation is the property of PLC Medical Systems, Inc. LA Addressing C-I-N 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 Hydration

14 This presentation is the property of PLC Medical Systems, Inc. LA 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

15 This presentation is the property of PLC Medical Systems, Inc. LA 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.

16 This presentation is the property of PLC Medical Systems, Inc. LA 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

17 This presentation is the property of PLC Medical Systems, Inc. LA 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 % increase in creatinine over baseline. “Isn’t there a device that does this?” Proof of Concept Study - Human

18 This presentation is the property of PLC Medical Systems, Inc. LA 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 The PLC Solution US: Not available for sale in the United States. OUS: Exclusively for Clinical Investigations. To be used by qualified investigators only. Renal Guard ™

19 This presentation is the property of PLC Medical Systems, Inc. LA 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. Renal Guard ™

20 This presentation is the property of PLC Medical Systems, Inc. LA Renal Guard™ Path to Success Scientific Advisory Board Intellectual Property Program Timeline Renal Guard ™

21 This presentation is the property of PLC Medical Systems, Inc. LA 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

22 This presentation is the property of PLC Medical Systems, Inc. LA Our Patent Wall Patents have been filed within the renal protection field covering: Methods Hardware Software Disposables

23 This presentation is the property of PLC Medical Systems, Inc. LA Manufacturing/Engineering Building devices and disposables U.S. Clinical Plan Pilot trial initiated in Q 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 Next Steps on the Path

24 This presentation is the property of PLC Medical Systems, Inc. LA International Expected Timeline Distributor Plan CE Mark Limited Launch Pilot Trial Pivotal Trial FDA Review Commercial Launch US

25 This presentation is the property of PLC Medical Systems, Inc. LA Excellent Revenue Potential Renal Guard ™ Market Size 1 million patients to be protected Worldwide Potential Market Size $500 million (at $500 per procedure pricing) 7 million cath procedures per year

26 This presentation is the property of PLC Medical Systems, Inc. LA 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 Key PLC Attributes

27 This presentation is the property of PLC Medical Systems, Inc. LA 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 Guard TM expected to protect kidneys during cath procedures Novel technology with filed intellectual property Clinical Trial under way Renal Guard ™

28 This presentation is the property of PLC Medical Systems, Inc. LA the Right Opportunity at the Right Time Renal Guard ™


Download ppt "PLC’s Growth Initiative: Renal Guard May 7, 2007."

Similar presentations


Ads by Google