plc’s growth initiative: renal guard may 7, 2007
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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.
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
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™
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?
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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
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
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
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.
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
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
This presentation is the property of PLC Medical Systems, Inc. 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.
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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
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
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.
This presentation is the property of PLC Medical Systems, Inc. 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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
• 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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
• 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™
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™
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™
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
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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
• 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
This presentation is the property of PLC Medical Systems, Inc. LA 00241
International
Expected Timeline
Distributor Plan CE Mark Limited Launch
2007
2007 2008 2009 2010
Pilot Trial Pivotal TrialFDA
ReviewCommercial Launch
US
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
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
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™
This presentation is the property of PLC Medical Systems, Inc. LA 00241
the
Right Opportunity at the Right Time
Renal Guard™
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