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October 3, 2012

Fluoropharma Medical (FPMI): Potential Breakthroughs in Heart Disease Diagnosis

Imagine that you’re at risk for a heart attack. How would you know?  A doctor may give you electrocardiograms (EKG), stress tests or angiograms, but these tests are can be inconclusive or late in diagnosing problems.  As a result, you could end up receiving a one-size-fits-all treatment that greatly increases the odds of potential future complications.

Unfortunately, this situation is very common around the world. Heart disease causes nearly 25% of deaths in the United States, according to the Centers for Disease Control, with some 785,000 first-time coronary attacks each year. These and other issues represent a significant problem for the medical community.

Innovative Technologies

Fluoropharma Medical Inc. (OTCBB: FPMI) has proprietary PET (positron emission tomography) imaging products to detect and evaluate diseases like these, at the earliest stages before clinical manifestation. This will enable more effective treatment, management and better patient outcomes. In particular, the company’s novel imaging agents for PET scans will advance personalized medicine in making the invisible… visible.

The company has three products based on this concept:

  • BFPET is a Phase II product designed to measure cardiovascular blood flow with the potential to become the new “standard” and replace SPECT in institutions with PET scanning capabilities. In Phase I trials, the technology showed excellent perfusion imaging properties with no adverse events in a 12 patient study.
  • CardioPET is a Phase II product designed to detect regions of fatty acid uptake in order to diagnose acute and chronic coronary artery disease (CAD) in patients that can’t undergo stress testing. In Phase I trials, the technology showed clinical findings that were consistent with MPI SPECT with substantially superior quality.
  • VasoPET is designed to detect inflamed plaques that are at risk for rupture and subsequent clinical consequences (such as heart attack or stroke). Early identification has the potential to save more than $30 billion in hospitalization cost, creating a large potential end market for this early stage product. VasoPET has completed preclinical testing and preparation for an investigational new drug (IND) application is underway.

Quantifying the Potential

There are approximately 12 million patients in the U.S. alone with suspected acute or chronic forms of coronary artery disease in need of molecular imaging studies, according to Fluoropharma’s 10-K filing with the SEC. Industry sources cited in the same report peg the industry at about $1.3 billion in size and growing at around 5% annually.

The Nuclear Cardiology sub-segment of this industry is growing at a significantly faster rate of approximately 20% – due to its higher efficacy than alternative methods – and accounts for about $700 million annually. As a result, the company estimates its potential market opportunity for its first product to be between $500 million and $700 million.

Assuming the company can capture just 10% of this market, this could equate to between $50 million and $70 million in annual revenues – growing at 20% per year – for its first product.

Great Investment Opportunity

Fluoropharma Medical’s proprietary technology is compatible with current clinical practice with reliable reimbursement in place. The company has established a clear, focused plan for value creation with a short-term, low-risk pathway to commercialization for investors.

With a market capitalization of just $22.5 million, the company trades at just a fraction of its potential valuation, if its technologies can successfully reach the market.

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