Category Archives: FluoroPharma Medical Inc. FPMI

FluoroPharma Medical, Inc. (FPMI) Targets #1 Most Wanted

June 29, 2012

In 1950, the FBI formally announced their Ten Most Wanted list to the world, in an attempt to promote the identification and capture of the most notorious fugitives. If there were a ten most wanted health list, coronary artery disease (CAD), still the world’s #1 killer, would be at the top. Several million people die every year from CAD. In the U.S., it is responsible for approximately one third of all deaths. It’s little wonder that the health industry is gunning for CAD in a big way.

However, in spite of huge investments in drugs to fight the disease, it is becoming clear that drugs cannot cure coronary artery disease. Although progress has been made in reducing LDL (sometimes called the “bad” cholesterol, a risk factor for CAD), the fact remains that up to 35% of heart attack patients do not have high blood cholesterol levels, even though most of them have atherosclerosis (hardening of the arteries). In addition, attempts to use drugs to raise the level of HDL (“good” cholesterol) have proven unsuccessful.

The best weapon to use against CAD remains early diagnosis and diagnostic follow-up, using sophisticated technologies such as positron emission tomography (PET) scanning, the best technology for detecting the subtle biological processes associated with CAD and other diseases. And this is exactly the market targeted by FluoroPharma Medical, developers of advanced tracer chemicals needed to make PET effective. FluoroPharma’s two lead products are CardioPET, used for the assessment of myocardial metabolism, and BFPET, used for the assessment of blood flow in CAD patients. They are also developing VasoPET, to be used for the detection of vulnerable plaque in CAD patients.

Studies have shown PET imaging to be cost-effective for CAD management. It can result in a 50% reduction in the use of coronary arteriography and CABG, a 30% reduction in CAD management costs, and excellent short-term patient outcomes, compared with conventional SPECT imaging.

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FluoroPharma Medical, Inc. (FPMI) Offers Major Market Advantages

June 22, 2012

For developing businesses, one of the keys to potential growth is to present products that have unique benefits not found elsewhere, providing a decided advantage in the marketplace. In the rapidly expanding field of molecular imaging, FluoroPharma Medical differentiates itself by developing unique imaging agents used in PET (Positron Emission Tomography). The company is developing radiopharmaceuticals that allow the early detection of disease, such as heart disease, long before traditional symptoms appear. The products that FluoroPharma is developing have distinct advantages in their ability to highlight critical processes that point to developing cardiovascular disease, sometimes called coronary artery disease (CAD), the country’s number one killer, at its earliest stages.

FluoroPharma has three products under development for addressing CAD. Two are currently clinical-stage molecular imaging pharmaceutical product candidates: CardioPET for the assessment of myocardial metabolism, and BFPET for the assessment of blood flow for CAD. They also have VasoPET for the detection of vulnerable plaque in CAD patients which is currently in preclinical development with human clinical trials expected in 2013. All of these products have technical advantages, and increase the potential value of FluoroPharma in the marketplace.

In a recent coverage initiation report by Life Tech Capital, it was noted that the molecular imaging space has been active for mergers and acquisitions, such as Eli Lilly’s acquisition of Avid Radiopharmaceuticals Amyvid™ [18F ] florbetapir for Alzheimer’s PET imaging in 2010 for $300M in cash and up to an additional $500M for milestones. Life Tech went on to say that they believe FluoroPhama’s cardiac PET imaging portfolio could make them an attractive M&A or partnering candidate as early as Phase II completion should they show strong clinical results.

BFPET advantages:

– Rapid extraction of BFPET from the blood
– Stable heart uptake of BFPET over time
– High target to background ratios
– Convenient imaging window within 30 minutes of injection

CardioPET, if approved, is also expected to have several advantages for cardiac viability assessment, and would represent the first imaging agent available in the United States for patients that cannot undergo stress-testing with acute and chronic Coronary Artery Disease.

VasoPET is unique in its approach to the non-invasive detection of vulnerable plaque, which is a significant unmet need and a large unaddressed market opportunity with billions of medical costs currently being expended on heart attack and stroke victims.

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FluoroPharma Medical, Inc. (FPMI) Appoints Thijs Spoor to Chairman of the Board

June 15, 2012

FluoroPharma Medical, a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today after the closing bell announced that it has appointed Thijs Spoor to the position of Chairman of the Board. Mr. Spoor will also continue to hold the positions of President and CEO as he assumes the role formerly held by Dr. David Elmaleh.

Mr. Spoor was appointed President and CEO of FluoroPharma Inc. on September 15, 2010. Prior to joining the company, he was the CFO of Sunstone BioSciences. He also worked as a consultant at Oliver Wyman, primarily engaging with pharmaceutical and medical device companies. Additionally, Mr. Spoor has been an equity research analyst at J.P. Morgan and Credit Suisse, covering the Biotechnology and Medical Device industries. Mr. Spoor also worked with Amersham / GE Healthcare where he oversaw the nuclear cardiology portfolio and most recently as the Director of New Product Opportunities leading the PET strategic plan.

Mr. Spoor holds a Nuclear Pharmacy degree from the University of Toronto as well as an M.B.A. from Columbia University with concentrations in finance and accounting.

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FluoroPharma Medical, Inc. (FPMI) Board of Directors Provide Invaluable Experience and Direction

June 11, 2012

It’s hard to imagine a successful company without a board of directors that is insightful, responsible, and comfortable with any technologies involved in the company’s products or operations. A board is, after all, generally responsible for formulating and establishing broad company objectives, thereby setting the general direction of the company.

In the case of FluoroPharma Medical, a Boston-based developer of proprietary medical diagnostic imaging products for use with positron emission tomography (PET) scanning systems, the emphasis is on the technology side of the equation, reflected strongly in the company’s small but critical board of directors made up of the company’s key officers.

• David Elmaleh, PhD (Chairman, Director, Chief Scientific Advisor) is the Scientific Founder of FluoroPharma, an Associate Professor of Harvard Medical School, and Director of Contrast Media Chemistry at the Massachusetts General Hospital. Dr. Elmaleh is the inventor of three drugs currently in use or in late stage clinical trials, and has done extensive research on imaging compounds. He is a co-author of over 120 publications, as well as an inventor of more than 40 issued and pending patents. He is also the Scientific Founder of Biostream, now Molecular Insight Pharmaceuticals, and other start-ups.

• Thiis Spoor, MBA (Director, CEO, and President) was previously the CFO for Sunstone BioSciences. He holds a degree in Nuclear Pharmacy, and has an MBA from Columbia with concentrations in Finance and Accounting. He’s been a guest lecturer at Columbia Business School, Kings College in London, and the University of Newcastle in Australia. He has extensive experience in helping pharmaceutical and medical device companies evaluate their global revenue potential, given the complex interplay of regulatory approvals and other factors. He has also performed equity research analysis for JP Morgan and Credit Suisse, covering the Biotechnology and Medical Device industries.

• Bovan Goumnerov, MD (COO & VP Clinical Trials) has held executive level positions in healthcare and biomedical research. He was President of VasoStent, Inc., and Managing Director of CardioVas, Inc., both medical device start-ups in cardiac imaging and therapy. He’s done research in surgery and molecular biology at the Massachusetts General Hospital and The Shriners Burn Hospital for Children in Boston, where he held academic appointments with Harvard Medical School. He is co-author of many scientific publications.

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FluoroPharma Medical, Inc. (FPMI): A Key Player Against Heart Disease

June 1, 2012

FluoroPharma, a developer of advanced tracing chemicals used with positron emission tomography (PET) to help detect heart disease and other problems, recently received a positive report from Life Tech Capital Institutional Research. The points emphasized on top of the report tell much of the story:

• Three “Shots-on-Goal” in Cardiac PET Imaging
• Cardiac Disease is #1 Killer in U.S. and the World
• Growing M&A Interest in Molecular Imaging Space

The report went on to detail how FluoroPharma is in a good position to meet growing critical needs in healthcare, including their financial position. The primary focus of the report was on FluoroPharma’s work with PET tracer chemicals for identifying heart disease, although the company is also now investigating tracers for the early identification of Alzheimer’s disease.

Cardiac disease is the world’s leading killer, according to the World Health Organization, taking the lives of millions every year, with the exact number varying depending upon what is included in the definition. In developed countries, like the U.S., it takes the highest percentage of lives, with almost a third of all deaths attributable to it.

Although there are continued efforts to address smoking, diet, and exercise, one of the biggest factors in countering the disease is early detection, which is where FluoroPharma comes in. The company’s proprietary chemicals allow PET scanners to immediately spot areas of biological activity, at the cellular or even molecular level, that suggest developing cardiovascular disease, long before any symptoms appear. Their tracer chemicals (the “Three Shots on Goal”), BFPET, CardioPET, and VasoPET, are non-invasive imaging agents, allowing doctors and researchers to see the human body, and the heart process, as never before. Early detection will not only save lives, but huge amounts of money in the treatment of heart disease.

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FluoroPharma Medical, Inc. (FPMI) Product Commercialization Plans

May 24, 2012

FluoroPharma, a developer of specialized molecular imaging pharmaceuticals used with positron emission tomography (PET) to help detect heart disease and other problems, has stated that it intends to develop its products through the completion of phase II and/or phase III studies, at which point it will seek to partner with organizations that may facilitate the further development and distribution of its products.

Phase I clinical trials have already been completed on the company’s two lead products, CardioPET and BFPET, with pre-clinical trials completed for VasoPET, all related to cardiovascular disease (CAD) detection. The company’s AZPET product for detecting amyloid deposits in the brain for Alzheimer’s disease evaluation is currently in the development stage. Over 12 million patients in the U.S. alone have some degree of acute or chronic CAD, and millions of patients undergo molecular imaging studies every year, often to detect and evaluate such heart disease.

Assuming CardioPET and BFPET are approved, their competition will be the current standard of care, and companies that are engaged in the development and commercialization of novel cardiac perfusion agents. However, FluoroPharma says it does not see competition coming from specific competitors for CardioPET and to some degree for BFPET. FluoroPharma’s technologies will be competing mainly on an indication-by-indication basis with the existing or coming standards of care.

FluoroPharma believes current experimental imaging agents are limited by their short half-lives (generally less than ½ hour), requiring faster image collection and/or an on-site cyclotron or generator to provide an additional supply. For this reason, they believe that these agents represent little or no potential competition to FluoroPharma products. In contrast, the imaging agent used in FluoroPharma products has a 110-minute half-life, and is more amenable to regional production and distribution to off-site nuclear medicine centers.

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The Technology Behind FluoroPharma Medical, Inc. (FPMI)

May 17, 2012

FluoroPharma Medical, Massachusetts-based developer of advanced imaging pharmaceuticals for use with positron emission tomography (PET), intends to become the leader in the early detection of coronary artery and alzheimer diseases, two of the most high-profile diseases in the country. Through the use of unique FluoroPharma chemical agents, PET technology will help clinicians detect and assess subtle indications of pathology long before the appearance of traditional symptoms. Early detection has long been established as a major factor in the success of disease intervention, and is also a critical tool in associated research.

The technology behind such early detection is represented by FluoroPharma’s principal products:

• CardioPET – This imaging agent exploits the dietary needs of the heart as it relates to glucose and fatty acids. By introducing a chemical group which alters the breakdown of fatty acids (the hearts main food source), clinicians can track their distribution into the heart muscle and assess health and viability.

– Agent: Muscle State Imaging Agent
– Type: Fatty Acid (Labeled with Fluorine 18)
– Condition: Coronary Artery Disease
– Status: Phase 1 clinical trials completed

• BFPET – By recognizing the electrical charge of the myocardial cell walls, this imaging agent allows a view into the blood flow of the heart, and identifies tissue with perfusion as well as mitochondrial integrity of the cells – a strong indicator for cell viability.

– Agent: Blood Flow Imaging Agent
– Type: Positively Charged Molecule (Labeled with Fluorine 18)
– Condition: Coronary Artery Disease
– Status: Phase 1 clinical trials completed

• VasoPET – By targeting active molecule receptors associated with inflammatory conditions, this imaging agent allows visualization of areas in the blood vessels that may potentially initiate thrombosis and embolism.

– Agent: Vulnerable plaque Imaging Agent
– Type: Receptor Connecting Molecule (Labeled with Fluorine 18)
– Condition: Coronary Artery Disease
– Status: Pre-Clinical studies completed

• AZPET – This imaging agent specifically seeks out and attaches to amyloid deposits in the brain. This allows a PET scan to reveal the areas where amyloid plaque has deposited, helping in the early detection of Alzheimer’s disease.

– Agent: Amyloid Deposit Imaging Agent
– Type: Molecule that targets that bind Amyloid Protein (Labeled with Fluorine 18)
– Condition: Alzheimer’s Disease
– Status: Development Stage

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General Market Opportunity for FluoroPharma Medical, Inc. (FPMI)

May 8, 2012

FluoroPharma Medical is a developer of unique, targeted molecular imaging pharmaceuticals used with positron emission tomography (PET). Although the company is focused primarily on the detection of cardiovascular disease (CAD) related processes, the company has other imaging agents in the pipeline. The company’s market opportunity is based largely upon their lead products:

• CardioPET detects regions of metabolic insufficiency, for cardiac viability assessment.
• BFPET measures cardiovascular blood flow, and is designed for myocardial perfusion imaging.
• VasoPET detects vulnerable coronary artery plaque, an especially dangerous form of plaque.

The size of the FluoroPharma market can be viewed as directly related to the number of molecular imaging studies anticipated to be performed using PET imaging, together with the size of the overall cardiovascular disease market. In the U.S. each year, millions of patients undergo molecular imaging studies, many of which are performed to detect and evaluate ischemic heart disease and myocardial infarction in patients with acute and chronic forms of CAD. These studies have been shown to be valuable in predicting long-term outcomes and for helping assess patient risk. Over 12 million patients in the U.S. alone have some degree of acute or chronic CAD.

Although the total U.S. market opportunity for molecular imaging agents is over $1.3 billion and is projected to grow at approximately 5% annually, the Nuclear Cardiology sub-segment of this market is growing at a much faster rate, roughly 20%, and now accounts for approximately $700 million in annual revenues. FluoroPharma estimates the potential market opportunity, five years following the approval of its first product, at between $500 million and $700 million annually.

CardioPET and BFPET are already up for approval, and FluoroPharma sees little if any competition coming from specific competitors for the two. What competition there is should be on a case-by-case basis. FluoroPharma anticipates eventually partnering with organizations that can help with further development and distribution.

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The FluoroPharma Medical, Inc. (FPMI) Business Strategy

May 2, 2012

FluoroPharma Medical intends to lead in the discovery, development, and commercialization of innovative and targeted molecular imaging pharmaceuticals that improve disease detection, management, and overall patient care. The company’s focus has been chemical tracer agents that are used in conjunction with positron emission tomography (PET), allowing PET scans to detect various biological processes occurring deep within the body. Such detection is valuable for identifying potential early stage disease, as well as being a tool for researchers.

Specific steps the company is taking or planning to take include the following:

• Seek regulatory approval in the U.S. and other countries for the company’s primary product candidates, BFPET, CardioPET, and VasoPET, all designed for use with PET scanning related to cardiovascular disease and processes. This involves phase II trials in the U.S. and Europe, followed by a multi-center phase III trial for registration purposes.
• Develop in-house specialty sales and marketing teams to market the above products in the U.S., and enter into licensing agreements with established PET companies for the production and distribution of products, also developing strategic collaborations for non-U.S. markets if promising.
• Expand the indications for which the products may be used, into non-acute settings for the diagnosis of coronary disease.
• Advance the development of preclinical product candidates into oncology, cardiology, neurology, and other areas of unmet medical need.
• Expand product pipeline through the use of proprietary platform technologies, acquisitions, and strategic licensing arrangements.

FluoroPharma’s management team has extensive experience in regulatory and clinical development of molecular imaging products, which will be utilized to increase the probability of product approval. PET diagnostic products can take significantly less time to evaluate for approval than typical therapeutic agents, due to the relatively short time required for performing molecular imaging studies.

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FluoroPharma Medical, Inc. (FPMI) Addresses Heart Disease with Unmatched Proprietary Products

April 25, 2012

In the marketplace, the principal strength of FluoroPharma Medical, developer of tracer agents for use with positron emission tomography (PET), is the uniqueness and effectiveness of their products. Their chemical agents, by highlighting certain biological processes in the body, allow PET technology to identify disease activity long before traditional symptoms appear. Their protected proprietary formulations offer clear advantages over competitor products, and, by focusing on the diagnosis of coronary artery disease (CAD), they address a major and largely unmet market need.

BFPET – FluoroPharma’s novel blood flow imaging agent is for use in conjunction with stress testing for the detection of ischemic and infarcted tissue within the heart muscle tissue of patients having suspected or proven chronic CAD. It enters the myocardial cells of the heart muscle in direct proportion to blood flow and membrane potential – the two most important physiological indicators of adequate blood supply to the heart. Specifically, the company believes that certain damaged heart tissue can be more reliably detected using BFPET. If approved, BFPET will represent the first molecular imaging blood flow agent commercialized for use in the cardiovascular segment of the PET imaging market.

CardioPET – A unique molecular imaging agent, CardioPET is designed to assess myocardial metabolism for the detection of ischemic and infarcted tissue, including for patients unable to undergo stress testing, as well as for cardiac viability assessment to predict functional improvement for revascularization patients. CardioPET would represent the first imaging agent available in the U.S. for use in patients with acute and chronic CAD that cannot undergo stress-testing, and could have other operational advantages as well.

VasoPET – Designed to detect vulnerable coronary artery plaque in patients with CAD, VasoPET addresses a significant unmet clinical objective. If approved, it would represent the first PET cardiac product to reliably image inflamed plaque and therefore may differentiate between vulnerable and stable coronary artery plaque. The rupture of such plaques and the subsequent formation of thrombi are currently recognized as the primary mechanisms of heart attacks and strokes.

FluoroPharma intends to be a leader in the discovery, development, and commercialization of innovative and targeted molecular imaging pharmaceuticals that improve disease detection.

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FluoroPharma Medical (FPMI) In Summary

April 19, 2012

FluoroPharma Medical, a developer of imaging agents for use with positron emission tomography (PET) scanning, helps to make visible subtle biological processes occurring deep within the body. From its founding in 2003, with technology licensed from Massachusetts General Hospital, the company has been steadily developing important imaging drugs for diagnostic testing, including much needed PET tracers for use in the diagnosis of cardiac disease at the cellular and molecular level. Below are some of the key facts relating to FluoroPharma.

Lead Products:

• BFPET – Myocardial perfusion imaging
• CardioPET – Cardiac viability assessment
• VasoPET – Inflamed atherosclerotic plaque imaging

Clinical Benefits:

• Current methods do not assess myocardial health
• Higher diagnostic accuracy
• Alternative to invasive procedures

FluoroPharma Advantage:

• Proprietary products that support new technologies for personalized medicine
• Two Phase II ready products with short study timelines, both directed to very large markets
• Robust pipeline of first-in-class imaging products
• Technology compatible with current clinical practice, with reliable reimbursement in place
• Clear and focused plan of value creation
• Experienced management and world-class advisors
• Intellectual property in place to protect proprietary innovations around the world

Growing Market:

• Global market for imaging agents expected to exceed $15 billion by 2015
• Increasing demand for personalized medicine
• Growing volume of diagnostic exams and associated equipment sales
• Aging population expanding commercialization potential
• Global spread of new technologies, with Asia-Pacific and other high growth markets
• Drive for cost effective analysis to avoid unnecessary or inappropriate operations

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FluoroPharma Medical, Inc. (FPMI) Takes On the CAD Stress Test

April 13, 2012

FluoroPharma, a developer of imaging agents used in association with positron emission tomography (PET) scanning, was founded in 2003 by Dr. David Elmaleh, currently the company’s Chief Scientific Officer, who has gathered around him some of the most knowledgeable people in the radiopharmaceutical and medical technology industries. Together they are developing a protected portfolio of PET tracer agents, including their lead products, CardioPET, BFPET, and VasoPET, designed for use in evaluating different processes associated with coronary artery disease (CAD), the country’s #1 killer. Nearly one-third of all Americans are believed to have some form of cardiovascular disease.

People with CAD typically have plaque accumulations on their coronary artery walls. As a result, their heart cells can end up getting a reduced supply of oxygen, which can eventually cause increasing chest pain and ultimately a heart attack. CAD is a progressive disease, and can lead to sudden death, with little or no warning. That’s where cardiac imaging comes in. Using PET technology, with the specially designed tracer chemicals from FluoroPharma, doctors can detect regions of metabolic insufficiency and measure cardiovascular blood flow and inflamed plaque, giving them a vital lead in identifying heart disease before the first symptoms even appear.

Traditionally, for low to moderate risk patients, an exercise stress test was used to measure heart function, determining the heart’s ability to respond to external stress. The patient is attached to an EKG monitor, while undergoing various levels of activity on a treadmill or stationary bicycle. However, such tests are known for their relatively low accuracy and poor reliability in evaluating the patient’s risk of heart attack. And stress tests have no way of detecting what are called vulnerable plaques, which are plaques more likely to cause an attack. But someday soon the traditional stress test could go the way of the dinosaur. VasoPET in particular is being designed to identify such vulnerable plaques, providing a much earlier and more accurate CAD picture than any stress test. Together with the other FluoroPharma cardio related products, doctors will at last be able to gain a clear view of heart disease at its earliest stages, potentially saving lives and countering the huge social and economic costs associated with CAD.

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FluoroPharma Medical, Inc. (FPMI) Joins Major Players in PET Market

April 10, 2012

The use of PET scans (positron emission tomography) for identifying and evaluating cancer is well-known. Most of the millions of PET procedures currently performed in the U.S. every year relate to cancer diagnosis. But developers are now hot on the trail of other applications for this one-of-a-kind technology that has the potential for letting doctors and researchers see even the most minute biological processes, events happening at the cellular and molecular level, to spot disease processes long before they manifest themselves in traditional ways.

Today researchers at FluoroPharma Medical, a developer of imaging agents used in conjunction with PET scanning, are fast developing agents that can be used to detect diseases of the heart and arteries, in addition to processes that have been linked to Alzheimer’s Disease. Coronary artery disease (CAD) and Alzheimer’s together represent huge potential markets for imaging agents. The need for such radioactive tracers is expected to reach $900 million within the next 5 years. The hope is to have multiple tracers for these diseases, each one with its own unique and beneficial qualities, providing a multiple set of tools for viewing the disease process.

The scope of such opportunities is now attracting some of the world’s biggest players. Eli Lilly and their subsidiary, Avid Radiopharmaceuticals, just announced FDA approval of Amyvid, a radioactive diagnostic agent for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline. Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer’s Disease, and is detected using PET scan images of the brain.

FluoroPharma’s own amyloid deposit imaging agent is a molecule that targets and binds with amyloid protein, and is labeled with Fluorine 18 to make it show up in PET scanning. Such diagnostic tools offer a greatly improved level of diagnosis for Alzheimer’s. Currently, approximately one in five patients clinically diagnosed with probable Alzheimer’s Disease end up having no Alzheimer’s pathology at autopsy.

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FluoroPharma Medical, Inc. (FPMI) Takes Aim at the Heart

April 9, 2012

FluoroPharma Medical, based in Boston, is a developer of imaging agents for use with positron emission tomography (PET). PET is a nuclear medicine imaging technology able to make visible very subtle events occurring deep within the body, uncovering otherwise hidden disease processes prior to the manifestation of more easily identifiable pathologies.

PET offers physicians and researchers insights into body dynamics that no other imaging options can, but it won’t work without tracer chemicals that can be linked to and highlight the reactions being investigated, and many current tracers are simply inadequate for what is needed. FluoroPharma, founded by Dr. David Elmaleh and led by a team with extensive radiopharmaceutical and medical technology experience, is researching new tracer chemicals to meet these needs.

Although there are millions of PET procedures performed in the U.S. annually, most are used in relation to cancer diagnosis. However, several factors have led to a shift in favor of using PET technology for the diagnosis of cardiac disease, which is a primary field of research for FluoroPharma. The company’s lead products, CardioPET and BFPET, are designed to improve patient diagnosis and management by evaluating various forms of cardiac disease at the cellular and molecular level. Molecular imaging is of significant value to patients with acute and chronic forms of coronary artery disease (CAD), providing benefit in the initial evaluation of patients with suspected but unproven CAD, and in those patients in whom a diagnosis of CAD has been established and information on prognosis or risk is required.

The market for novel cardiac PET tracing agents is expected to grow by at least 14% annually over the next five years, to approximately $900 million. It’s largely a wide-open market, other than one currently marketed branded cardiac PET tracer (which suffers from certain issues). FluoroPharma is focused on capitalizing on this fast growing market.

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March Was Another Important Month for FluoroPharma Medical, Inc. (FPMI)

April 2, 2012

In March, when FluoroPharma Medical, a developer of unique imaging agents for use with positron emission tomography (PET), filed their 10-K for fiscal 2011, there were no surprises, leading Zack’s Investment Research to reaffirm its $2.00 price target and recommendation of “Outperform”. In that same month, FluoroPharma announced that they had signed a letter of intent with SGS Life Sciences to provide clinical research services for Phase II trials of FluoroPharma’s CardioPET imaging agent for determining cardiac viability. It’s an important step for the company, since CardioPET is expected to be one of FPMI’s first products to reach the marketplace, where it would offer a superior alternative to stress testing and represent a major market opportunity.

The three primary products for FluoroPharma are:

• CardioPET – For cardiac viability assessment (detecting regions of metabolic insufficiency)
• BFET – For myocardial perfusion imaging (measuring cardiovascular blood flow)
• VasoPET – For inflamed atherosclerotic plaque imaging (detecting inflamed plaque)

PET technology fills a critical gap in diagnostic imaging, allowing doctors and researchers to see important biochemical processes taking place at the cellular and molecular level, something that other imaging technologies simply cannot match. To do this requires chemical tracers that can integrate themselves into the process being monitored.

There are approximately 12 million PET imaging procedures carried out in the U.S. each year, but currently available PET tracers have significant drawbacks, including high cost, safety issues, and supply shortages. And most of these scans are for the diagnosis of cancer. As a result, there is a growing demand for new radiopharmaceuticals, including tracers for heart imaging such as those under development by FPMI. Basically, FluoroPharm’s drugs improve diagnostic accuracy over existing technologies, improving patient assessment. And it’s not just an American market. Although the U.S. has traditionally been the biggest imaging market, the primary destination today for new PET scanners is China, meaning an increased demand for new tracers.

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FluoroPharma Medical, Inc. (FPMI): Catching Alzheimer’s in the Act

March 27, 2012

Approximately 1 out of 8 older Americans has Alzheimer’s disease. It is the most common form of dementia, and the sixth leading cause of death in the U.S. In spite of extensive research and public attention, the disease still has no known cure or even an effective treatment, although there are drugs designed to counteract some of the symptoms. The total social cost of Alzheimer’s disease is difficult to determine, but 5.4 million Americans currently live with the disease, and the annual cost of directly related care is estimated to be approximately $200 billion, a figure that is expected to climb dramatically with the aging population.

One of the problems in working with Alzheimer’s is the fact that it involves subtle chemical processes deep within the brain. Beta-amyloid plaques, abnormal proteins that are associated with the disease, have traditionally required brain biopsy to detect with assurance. An easier, less invasive method for detecting such changes related to Alzheimer’s would prove of tremendous value, not only to researchers who could better track and analyze the disease processes, but also to patients and their families who could take the medical and other steps necessary to deal with it. It could also help avoid unnecessary treatment and care by differentiating Alzheimer’s from other diseases.

One of the greatest potentials for successfully identifying Alzheimer’s disease in its earliest stages rests with positron emission tomography (PET), a nuclear medicine imaging technology able to make visible hidden chemical processes within the body. FluoroPharma Medical, a developer of advanced medical diagnostic imaging tracer chemicals for use with PET, is currently working on an imaging agent, called AZPET, which seeks out and attaches to amyloid deposits in the brain, making them visible on a PET scan, allowing early detection of Alzheimer’s. It’s just one of the important tracer chemical products that FluoroPharma is currently developing. The company’s goal is to become the leader in the early detection of coronary artery and Alzheimer’s disease.

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FluoroPharma Medical, Inc. (FPMI) Expands Global Patent Position with Patent Rights for BFPET in Australia

March 19, 2012

Today, shortly after the opening bell, FluoroPharma Medical announced that BFPET, its imaging agent for measuring cardiovascular blood flow, has been granted patent rights in Australia. BFPET is a novel cardiovascular blood flow imaging agent that, when used in conjunction with stress-testing, identifies patients with suspected and proven coronary artery disease (CAD). The patent expiration date is 2025.

Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and, according to the World Health Organization, cardiovascular diseases are the leading causes of death and disability in the world. The demand for faster, more accurate diagnostic tools continuously drives the development of non-invasive techniques with increased sensitivity and accuracy for the detection and assessment of acute and chronic CAD.

“Phase I clinical trial for BFPET indicates that the compound has an acceptable dosimetry and safety profile and provides high resolution images of the heart,” commented Dr. David Elmaleh, FluoroPharma’s Chairman of the Board of Directors and inventor of the technology. “Since BFPET has the potential to be a more sensitive marker than the currently available blood flow agents, we believe that BFPET will have strong advantages over currently marketed products in the detection of acute and chronic ischemia.”

“The future for diagnostic imaging procedures with higher specificity is extremely promising as they provide early and more accurate information to enable more effective treatment and follow-up of its efficacy,” added Thijs Spoor, FluoroPharma’s President and Chief Executive Officer. “We look at this as an evolution to more effective and efficient care. Early treatment means saving the patient from long and expensive hospital stays, which results in less time away from family and work.”

In November of last year, FluoroPharma announced that it had been granted patent rights in China for BFPET and another imaging agent, AZPET, for imaging of Alzheimer’s disease. In addition to Australia and China, patents related to FluoroPharma’s portfolio of imaging compounds have been issued in the United States, Europe, Japan, Canada, Finland, Portugal, Ireland, and Mexico.

Today’s announcement enhances FluoroPharma’s position in the Pacific Rim and strengthens its growing patent estate, further validating the importance and value of FluoroPharma’s technology in important growth markets where diagnostic imaging is playing an increasingly significant role in the early detection of disease. FluoroPharma’s imaging products will give clinicians the ability to detect and assess pathology before clinical manifestation of diseases.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) And The Heart

March 13, 2012

Cardiovascular disease (CVD), also referred to as coronary artery disease (CAD), has been on top of the world’s illness list for a long time, and yet it’s still surprising to consider that fully one-third of all American’s are believed to have some form of the disease. CVD/CAD are general terms used to describe certain disorders that can affect your heart as well as your body’s blood vessels. Such problems are the primary cause of death in the U.S., claiming one million lives annually.

The disease usually involves plaque accumulations on the walls of the coronary arteries, which can ultimately constrict the flow of blood and oxygen to the heart to such a degree that the heart muscles are unable to properly function. The result can be fatal, with little or no advanced warning. Cardiac imaging is used to diagnose the disease and to determine the presence and severity of ischemic heart disease and the related risk of suffering a heart attack. It is also used to help determine the most appropriate course of treatment.

For some patients, facing lower risks, an exercise stress test may be used to evaluate heart function. However, the test is often inaccurate and poor as a predictor of heart attack. For patients facing higher risks, or for those unable to safely go through a stress test, doctors can use some form of imaging, such as MRI. If even this is unable to clearly identify the problem, doctors can perform a coronary angiogram, involving a contrasting agent and X-rays to identify blockages.

FluoroPharma Medical is building a portfolio of chemical tracer products, with a focus on heart disease. These tracers are used in conjunction with positron emission tomography (PET) and help make visible the minute cellular processes associated with the disease. They do this by being specially formulated to become part of the process, allowing doctors and researchers to detect possibly dangerous conditions that other forms of detection miss.

FluoroPharma has three tracer products directly related to the heart and related diseases. CardioPET, BFPET, and VasoPET are all designed to overcome the weaknesses of other diagnostic methods. For example, PET technology itself has been shown to reduce the number of coronary angiography and revascularization procedures by over 50% and reduce overall costs by 30%.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) and the Growing Need for Tracers

March 8, 2012

Medical researchers are today coming up with new understandings of the molecular processes that cause disease to a degree never before possible. Alzheimer’s, cancer, and heart disease, among many others, are now being studied at the cellular and molecular level, unlocking the microscopic reactions that ultimately lead to pathology.

These discoveries represent a boon to researchers, but pose something of a conundrum to doctors and drug researchers who desperately want to take advantage of the new-found knowledge. If you’re a doctor, for example, what way do you have of knowing if these critical but hidden processes are taking place in a patient’s cells? Is your only option to wait until the patient gets sick, developing clearly recognizable symptoms? By then, it may be too late to effectively treat the disease. If you’re a drug researcher, are there more exact ways of tracking a drug’s reaction than simply seeing if patients get better?

Positron emission tomography (PET) is by far the most effective way of seeing the subtle chemical reactions going on inside the body. The technology detects rays given off by a positron-emitting radionuclide (tracer). But the tracer must be able to somehow integrate itself into the process being evaluated, and it must do it in such a way that the signals can be interpreted to provide the answers sought.

FluoroPharma Medical is developing the much needed tracer chemicals that do exactly that. The company currently offers three tracer products for the identification of processes related to cardiovascular disease, one of the biggest disease markets in the world. In addition, it is in the process of developing an imaging agent that attaches to the amyloid deposits (plaque) in the brain, making them visible on a PET scan, thus allowing the early detection of Alzheimer’s disease.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) First in Class Diagnostic Agent Advanced to Phase II Study

March 1, 2012

FluoroPharma Medical, a biopharmaceutical company engaged in the development of breakthrough diagnostic imaging products that utilize positron emission tomography (PET) technology to detect and assess pathology before clinical manifestation of diseases, just announced that the company has recruited SGS Life Science Services as the contract research organization (CRO) for their Phase II study of CardioPET to assess myocardial perfusion and fatty acid uptake in coronary artery disease (CAD) patients.

CardioPET, one of FluoroPharma’s first in class PET imaging products, is a perfusion and fatty acid uptake indicator. The imaging agent allows assessment of acute and chronic coronary artery disease while patients are at rest. CardioPET may be an accurate alternative to standard treadmill stress-testing, which could be especially valuable in patients who are unable to exercise.

According to today’s press release, the phase II trial will be an open label trial designed to assess the safety and diagnostic performance of CardioPET as compared to stress echocardiography, myocardial perfusion imaging, and angiography. Two trial sites are planned in Belgium and results are expected in the second half of this year.

Thijs Spoor, President and Chief Executive Officer of FluoroPharma Medical, stated, “We are delighted to announce SGS Life Science Services as the CRO for this phase II trial; a significant milestone for FluoroPharma and our extraordinary pipeline of products. Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and accounts for a significant and increasing percentage of all deaths. It is clear that novel diagnostic imaging agents are urgently required and we are focused on driving forward the development of our pipeline to meet these needs.

“We are very excited to be initiating this Phase II study for CardioPET,” added David Elmaleh, Chief Scientific Officer of FluoroPharma Medical. “CardioPET’s differentiated and superior imaging profile could have a significant impact on the evaluation of CAD patients across the spectrum of disease severity. Because CardioPET can detect perfusion and fatty acid uptake insufficiency in the myocardium; CardioPET could potentially be an accurate alternative to stress-testing in patients with CAD.”

For more information, see the company website at

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The FluoroPharma Medical, Inc. (FPMI) Edge

February 27, 2012

The positive report just released by Zacks Small-Cap Research on FluoroPharma Medical, developer of advanced medical diagnostic imaging tracer products for use with positron emission tomography (PET), highlights the principal advantages of FluoroPharma in the healthcare market. Although healthcare itself is a steadily rising sea, with aging baby boomers continuing to feed the market, the distinctive advantages of FluoroPharma give the company a unique edge.

FluoroPharma is developing specialized tracer chemicals that are able to integrate themselves into subtle bodily processes, allowing sophisticated PET technology to detect biological events at the cellular and molecular level, long before the manifestation of disease symptoms. As such, PET technology represents an internal detection resolution unmatched by other diagnostic imaging approaches, and FluoroPharma’s focus on PET provides the company’s first key advantage in the healthcare marketplace.

In addition, FluoroPharma’s main radiopharmaceutical products target the extensive coronary artery disease (CAD) market. CAD remains a major global killer and is the subject of massive funding for the development of associated products. FluoroPharma has three tracer products directly related to CAD. CardioPET helps identify patients that will benefit from PCI or revascularization and guide intervention, and can evaluate CAD in patients that cannot go through stress tests. BFPET can be used for the detection of presumptive CAD in combination with stress testing, as well as for the improved detection of CAD related to multi-vessel disease. VasoPET can be used for evaluating patients experiencing Acute Coronary Syndrome or a risk of stroke, or for evaluating therapy following an acute cardiac event or stroke.

Yet another advantage for FluoroPharma is the unmatched capabilities of their particular tracers. Current CAD related PET tracers carry an unusually high cost, and have also experienced safety issues and availability shortages. As a result, there is a significant demand for new approaches, as offered by FluoroPharma.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) to Exploit Profitable Niche

February 21, 2012

FluoroPharma Medical, Inc. is a company seeking to develop breakthrough molecular imaging agents for the PET (positron emission tomography) type of 3D medical imaging of the human body to meet critical medical needs.

The company is not involved with the PET machinery, but instead provides the much-needed imaging agents necessary for PET imaging. These agents are designed to improve patient diagnoses and management by evaluating various forms of cardiac disease at the cellular and molecular level.

Each year in the U.S., millions of patients undergo molecular imaging studies to detect and evaluate various forms of coronary artery disease (CAD). These images are helpful to doctors who treat coronary artery disease and, in particular, help doctors diagnose patients with suspected CAD.

This is a very large market. In the United States, there are an estimated 12 million PET imaging procedures done per year. However, the vast majority of these scans are for the diagnosis of cancer. Doctors have traditionally opted for cheaper options such as MRI or CT scans with cardiac patients.

However, that is changing and there is large potential for FluoroPharma as PET scanning becomes more established in the cardiac sector. This market seems to be quickly shifting in favor of increased usage of PET scans for cardiac patients.

FluoroPharma expects to capitalize on this rapidly growing opportunity in this sector. It will do so through the introduction of its novel imaging agents into a market which is forecast to grow by at least 14% annually over the next five years to nearly a $1 billion market for cardiac patients alone.

The company’s focus at the moment is on four separate cardiac molecular imaging agents, two of which are in clinical stage development and are about to enter Phase II clinical trials. The third pharmaceutical candidate is in an early development stage with clinical testing likely to be several years away and the fourth is still in the discovery phase.

The two most-advanced candidates are: CardioPET, which allows assessment of coronary artery disease while patients are at rest; and BFPET, which is a novel cardiovascular blood flow imaging agent that concentrates in healthy myocardial cells and enables improved detection of CAD in cases of multi-vessel disease.

The third candidate is VasoPET, the only PET agent known to selectively target inflamed atheromatous plaque, making it easy for doctors to identify coronary artery plaque. The final candidate – AZPET – includes an approach for directly imaging plague and the compensatory receptor systems in the elderly to help track the progress of treatment of patients with Alzheimer’s disease.

The goal of the company’s cardiac products is to improve overall patient care in several ways. The products are expected to provide significantly greater diagnostic accuracy compared to current methods, thereby reducing the number of unnecessary diagnostic and therapeutic procedures.

The good news for FluoroPharma is that with the exception of one currently marketed branded cardiac PET tracer, which suffers from some well-known problems, the market for such tracers is basically wide open for the company.

Being one of the main players in a soon-to-be billion dollar market makes FluoroPharma Medical a truly exciting long-term investment opportunity.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) Continues to Move New Products Forward

February 13, 2012

Turning a good idea into a money making product can be a formidably expensive project, especially when dealing with medical substances to be introduced to the human body. FluoroPharma, developer of medical diagnostic imaging agents for use with PET (positron emission tomography) scanning, is believed to be in a strong position to accomplish exactly that with its two primary imaging assets, CardioPET and BFPET. CardioPET is an imaging agent designed for cardiac viability assessment, detecting regions of metabolic insufficiency. BFPET is designed for myocardial perfusion imaging, measuring cardiovascular blood flow. The company is about to take both of these products through phase II testing, considered an important step for attracting partners.

FluoroPharma has made significant progress in the last couple of years, advancing its pipeline of products and solidifying its finances, primarily through a reverse merger with a shell company in May of 2011. The result has been an expanded investor base. The reverse merger also helped raise money to meet the terms of the company’s licensing agreement with Massachusetts General Hospital, the source of key technology. FluoroPharma announced in December that it had raised an additional $1 million from investors, for a 2011 total of over $7 million.

Cardiology is an especially promising market. Nuclear cardiologists are anxious for new tracers, and cardiology is one of the focal points for FluoroPharma agents. PET molecular imaging technology allows doctors and drug developers to create the highest resolution images of internal structures, plus, unlike most imaging, it can provide a real time view of molecular metabolism, revealing what’s really happening in the body down to the cellular level. Although PET technology is currently used mostly for cancer diagnosis and monitoring, FluoroPharma believes that there is a huge potential market for cardiovascular and neurological applications. Cardiovascular disease is still the number one killer, and agents that can help in related diagnosis and drug development could be the next hot ticket.

For more information, see the company website at

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FluoroPharma Medical, Inc. (FPMI) As a Takeover Target

February 3, 2012

For many emerging companies, the ideal exit is a big-money major-corporate buyout, giving principals and investors a whopping return. Unfortunately, it’s not the most common outcome. Getting the right mix of technology, application, market demand, management, and financing is definitely the exception, not the rule. But FluoroPharma Medical, based in Boston, may be the one company that’s on the right side of the equation.

FluoroPharma is a provider of medical diagnostic imaging agents used with positron emission tomography (PET). The advantage of PET, versus other types of diagnostic imaging, is its unique ability to assess molecular metabolism, allowing doctors to see not only the body, but exactly how it’s functioning at the cellular and molecular level. It also allows major drug developers to create highly targeted pharmaceuticals, one of the hottest fields in drug development. PET is a critical and unmatched technology, but it depends entirely upon having the right diagnostic imaging agents, chemicals that can be used with PET technology to highlight and track the most subtle bodily processes.

Today, there is a huge and largely unmet demand for such biomarker agents. With the right biomarkers, doors open to all sorts of personalized drug development, making companies with the right biomarker technologies extremely valuable. In December of 2010, when Eli Lilly acquired Avid Radiopharmaceuticals, and its Alzheimer’s related imaging agent technology, they paid $800 million, giving investors a very big Christmas gift. Perhaps more significantly, however, is the fact that Lilly was just one of several bidders.

In the case of FluoroPharma, there are already three important PET imaging agent products in the portfolio, all related to the huge cardiovascular market. CardioPET, BFPET, and VasoPET can be used for identifying subtle processes that can point to heart disease and stroke, still the biggest killers on the planet, and other agents are in the FluoroPharma pipeline.

For more information, see the company website at

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The Case for FluoroPharma Medical, Inc. (FPMI)

January 30, 2012

When FluoroPharma CEO, Thijs Spoor, recently gave a presentation summarizing the rising importance in medical diagnostics of PET technology, and the associated radiopharmaceuticals such as those developed by FluoroPharma, it brought into focus a major gap between the promise of PET and the current availability of chemical agents needed to make the promise a reality.

PET (Positron Emission Tomography) is a branch of nuclear medicine imaging that uses mildly radioactive tracer chemicals to highlight extremely subtle biological processes actively taking place at the cellular and even molecular level within the human body. As such, it represents functional scanning versus simply structural scanning. It doesn’t just show how the body looks, but what the body is doing at the most detailed level. The result is the highest contrast resolution available for internal imaging.

However, none of it works without the availability of suitable tracer chemicals which can insinuate themselves into otherwise imperceptible biological processes, making them visible to the advanced PET hardware and software. For a given targeted process, the market requires an appropriate and safe tracer chemical. Nuclear cardiologists, for example, are very anxious for new tracer agents that can be used to better identify and track processes related to heart disease. In particular, cardiology clinicians are looking for a vulnerable plaque imaging agent, a better profusion agent, and a viability agent, all of which are now part of the FluoroPharm portfolio:

• BFET – For myocardial perfusion imaging (measuring cardiovascular blood flow)
• CardioPET – For cardiac viability assessment (detecting regions of metabolic insufficiency)
• VasoPET – For inflamed atherosclerotic plaque imaging (detecting inflamed plaque)

These targeting agents can make a big difference in the treatment of heart disease, still the number one killer in the country. In the case of FluoroPharma’s VasoPET product, used for detecting inflamed plaque, which is the most unstable and dangerous type of plaque, early detection is critical, since the first symptom of such a problem is often sudden death.

Because there are still a very limited number of such tracer agents, the thousands of expensive PET scanners currently in hospitals around the country and the world are significantly under-utilized, creating a cost effectiveness issue that only more and better agents can address. In addition, the production of such agents by cyclotron operators requires a high level of fixed costs which, when spread over a handful of agents, increases the per unit cost of agents. So there is also a strong economic need for new agents to be developed.

For more information, see the company website at

Let us hear your thoughts: FluoroPharma Medical, Inc. Message Board


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