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

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

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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 - PowerPoint PPT Presentation

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

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

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

Page 2: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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.

Page 3: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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 GuardTM Addresses

more than 1 million patients in a $500 million market

Renal Guard Growth Initiative

Page 4: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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™

Page 5: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

Page 6: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

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

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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

Page 8: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

Page 9: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

Congestive Heart Failure

Chronic Kidney Disease

Age > 75 yrs

Anemia

Peripheral Vascular Disease

Diabetes Mellitus

Source: JACC 2004, Health Advances’ interviews.

Page 10: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

Predicting CIN Risk

CIN risk increases as patient’s

serum creatinine levels increase.

serum creatinine

Page 11: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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

Page 12: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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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.

Page 13: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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

Page 14: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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Promising Direction

PRINCE Study discussedinducing 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

Page 15: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

Page 16: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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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

Page 17: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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• 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?”

Proof of Concept Study - Human

Page 18: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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• 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™

Page 19: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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™

Page 20: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

Renal Guard™ Path to Success

• Scientific Advisory Board

• Intellectual Property

• Program Timeline

Renal Guard™

Page 21: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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

Page 22: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

Our Patent Wall

Patents have been

filed within the renal

protection field covering:

• Methods• Hardware• Software • Disposables

Page 23: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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• 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

Next Steps on the Path

Page 24: PLC’s Growth Initiative: Renal Guard  May 7, 2007

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International

Expected Timeline

Distributor Plan CE Mark Limited Launch

2007

2007 2008 2009 2010

Pilot Trial Pivotal TrialFDA

ReviewCommercial Launch

US

Page 25: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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

Page 26: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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

Page 27: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

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

Renal Guard™

Page 28: PLC’s Growth Initiative: Renal Guard  May 7, 2007

This presentation is the property of PLC Medical Systems, Inc. LA 00241

the

Right Opportunity at the Right Time

Renal Guard™