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I think Sheff had a call into the company to try to figure out what day they were presenting, but I don't believe he heard back. It's sometime between the 6th and the 9th, so Thursday through the weekend. Hopefully we'll get a PR before weeks' end next week.
Anybody know when they are announcing results next week?
Thanks Smurf, I'd love to see $1 plus from news, but I'd be happy with mid 80's. GLTY.
Right now I am going with yahoo estimate ($1.20). Give or take $1. Correct that this will be a swing trade for me. As always once it's UP it must cool down that is when I jump back in again.
Smurf, is this just a trade for you into the data release? What's your target price with good news? Hard for me to judge how the stock will react given the low volume of this stock, I hope the market notices the news.
Just picked up 22,000 shares of FPMI today. Looking forward to data next week. I think we'll get a nice lift from this if we can gather some attention to this bad boy.
Wait for me folks of FPMI.. will be joining soon..
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=96457277
Id day the target price is up there on a long term scale if it involves up listing and all, I'm thinking it can be estimated from market size of the industry, os, potential earnings, etc. I don't plan on holding for years on end though. Prolly flip and buy back on dips, rinse repeat.
Hard to say. I'd guess if results are compelling the market will take notice. We should get some nice volume and might move to the $1-1.20 range if the market likes the results.
All IMO,
Murocman
What is everyone thinking for a price target if positive results are presented at the conference the 2nd weekend of February?
volume .....what volumr this hardly trades....
why the volume is so low here....what abt Lantheus imaging market leader already ahead of them..
why the volume is so low here....what abt Lantheus imaging market leader already ahead of them..
why the volume is so low here....i mean nothing zero..
why the volume is so low here....i mean nothing zero..
Nice post who are the competitors, number of outstanding shares , when will they start generating revenue? seems long way to go...
Very impressive presentation at the biotech showcase today. What is the boards consensus?
Their financials look terrible timber
FPMI – Disease Detection at a Molecular Level
FluoroPharma Medical is focused on discovering and developing patented Positron Emission Tomography (PET) imaging products designed to improve patient management by evaluating cardiac disease at the cellular and molecular levels. The company is currently advancing four different PET imaging agents, which differ from imaging tools such as MRI, CT, and Ultrasound in that they candetect and asses pathology before serious signs of disease are evident.
The company’s CardioPET, for the detection of coronary artery disease, uses a radio-labeled analog to the natural fatty acids utilized as an energy source by the heart, allowing for the visualization of the anatomic location and state of the muscle to detect problems in advance of symptoms that would lead to a stress test. This agent is slated to enter phase IIb clinical trials by year end.
BFPET is also for the detection of coronary artery disease. BFPETis designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential, two of the most important physiological indicators contributing to adequate blood supply to the heart. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.Phase II clinical trial results are expected by year end.
FluoroPharma’s third agent for coronary artery diseases is VasoPET. This imaging agent allows clinicians the ability to visualize potential areas that may cause embolisms and thrombosis. VasoPET is designed for patients that have already had a heart attack or stroke with the risk of a potentially fatal recurrence. The agent is on track for phase Ib clinical trial by year end.
Lastly, the company’s AZPET imaging agent addresses Alzheimer’s disease by attaching to the amyloid deposits (plaque) in the brain and makes them visible on a PET scan, thus allowing the early detection of the disease.
FluoroPharma Targets Two of the Biggest Medical Markets
FluoroPharma is developing breakthrough molecular imaging agents for use with positron emission tomography (PET) designed to fulfill critical unmet medical needs. These new agents give clinicians crucial tools for the detection and assessment of pathology before clinical manifestation of diseases. Without the proper imaging agents, even the most advanced PET technology is essentially blind. However, the proper agents, formulated to integrate with and thus reveal subtle biological processes associated with a specific disease, can provide an unmatched window to the inner workings of the human body. The primary disease areas targeted by FluoroPharma are cardiovascular disease (CAD) and Alzheimer’s disease, two of the biggest global medical markets around.
According to the Centers for Disease Control and Prevention, approximately a quarter of all deaths that occur in the U.S. are directly linked to cardiovascular disease, taking some 600,000 people each year. It’s the leading cause of death for both men and women. In addition, coronary heart disease costs the U.S. over $100 billion annually. And yet it is reported that only 27% of people polled were aware of all the major symptoms of a heart attack and knew to call 911. It’s not surprising that almost half of sudden cardiac deaths occur outside the hospital.
That’s why FluoroPharma’s tracer agents are so important and could make such a big difference. Specifically, the company has developed three different products for detecting conditions that can lead to heart attack, conditions that may not present any symptoms. BFPET is designed to reveal cardiovascular blood flow in combination with stress testing. CardioPET is designed to detect regions of fatty acid uptake for the diagnosis of CAD in patients unable to undergo stress testing. And VasoPET detects inflamed plaques, which are the plaques most likely to rupture and cause a heart attack or sudden death.
FluoroPharma is also developing AZPET, designed to help image amyloid deposits, valuable in the early detection of Alzheimer’s disease and for researchers. According to the Alzheimer’s Association, more than 5 million Americans are already living with the disease, a number that is expected to grow dramatically as the population ages. Alzheimer’s costs the nation over $200 billion, a number that could grow to $1.2 trillion by 2050 if something isn’t done.
For more information, visit www.FluoroPharma.com
FPMI Targets Piece of $7 Billion Market Growing to $15 Billion
FluoroPharma, a developer of imaging drugs that underpin important diagnostic capabilities of positron emission tomography (PET), targets a fast-growing market. This market is currently over $7 billion in size and is expected to top $15 billion in 2015.
One of the elements driving this growth is the increasing demand for personalized medicine, something that requires a clear and accurate view of key biological processes occurring deep within the body. Other market drivers include an aging population and the growing demand for cost-effective imaging technologies in the Asia-Pacific market. Cardiology and neurology remain two of the industry’s strongest growth opportunities. In the case of FluoroPharma, the current focus is on cardiovascular (CV) disease and Alzheimer’s disease, with imaging drug products that allow PET scans to display in exquisite detail processes that can lead to such diseases.
One in three adults have some form of CV disease, and PET molecular imaging offers superior image quality, but there are no widely adopted PET drug agents in cardiology. FluoroPharma has three products directly addressing the CV market:
• BFPET – For measuring cardiovascular blood flow, in combination with stress testing in patients with presumptive chronic cardiovascular disease, BFPET has the potential to become the new “standard” and replace SPECT (Single-Photon Emission Computed Tomography) in institutions with PET capability.
• CardioPET – For detecting regions of fatty acid uptake, CardioPET is for the diagnosis of acute and chronic CAD in patients that cannot undergo stress testing.
• VasoPET – For detecting inflamed plaques, which are plaques most likely to rupture and cause a heart attack or sudden death.
FluoroPharma is also developing AZPET, an amyloid deposit imaging agent for the early detection of Alzheimer’s disease.
For more information, visit www.FluoroPharma.com
The Case for FluoroPharma Medical, Inc. (FPMI)
FluoroPharma Medical is a New Jersey based developer of advanced imaging pharmaceuticals for use with positron emission tomography (PET). The company provides unique radiopharmaceutical imaging agents, unavailable from other sources, that allow PET technology to detect critical bioprocesses in the human body, designed to give doctors and researchers the tools to successfully track various manifestations of cardiovascular disease, Alzheimer’s disease, and certain types of cancer. Since these diseases are considered the most deadly and costly being addressed on a global basis, the market potential for supporting products is immense and growing.
FluoroPharma has two lead products, BFPET for imaging cardiovascular blood flow, and CardioPET for detecting fatty acid uptake, both of which are Phase-II ready with short study timelines, and both directed to very large markets. The company also has a pipeline of first-in-class imaging products: VasoPET for imaging inflammation and atherosclerotic plaque that will permit detection of dangerous plaque before symptoms occur, and AZPET for brain imaging to diagnose Alzheimer’s disease. It is also developing products for cancer detection. All of these products address significant unmet needs in billion dollar markets.
The company’s protected technology is compatible with current clinical practice, with reliable reimbursement in place, and is part of a clear and focused plan for short-term low-risk value creation. FluoroPharma is led by experienced management and world-class advisors.
Zacks Small Cap Research describes FPMI’s development momentum as accelerating in 2013, going on to point out that current PET tracers suffer from high cost, safety issues, and availability shortages, which encourages demand for FPMI’s novel radiopharmaceuticals. It also praises the company’s management for doing a commendable job with minimizing cash burn while making progress on product development. LifeTech Capital calls FluoroPharma’s pipeline of cardiac PET imaging agent candidates “game-changers” in the molecular diagnostics space, and points to the advantages of PET versus other types of imaging.
For more information, see the company website at www.FluoroPharma.com
Thank you. I will be looking this one over. A LOT To read and digest for sure. It would do many NEW Prospective traders here some good to actually read!!!!
We are working on the fact sheet.
Here is the latest company presentation: http://fpmi.missionir.com/presentation/
FluoroPharma Medical, Inc. (FPMI) Investment THESIS
Mission: "To become the leader in early detection of coronary artery and alzheimer diseases by developing breakthrough molecular imaging agents for positron emission tomography (PET)."
FluoroPharma Medical, Inc. is a biopharmaceutical company focused on discovering and developing patented Positron Emission Tomography (PET) imaging products to improve patient management by evaluating cardiac disease at the cellular and molecular levels. The company is currently advancing four different imaging agents to fulfill multiple critical unmet medical needs while providing clinicians important tools for detecting and assessing pathology before critical manifestations of disease.
According to GAI, the market for molecular imaging agents currently exceeds $1.7 billion annually and promises rapid growth for the foreseeable future. With one in three patients dying because of heart disease, FluoroPharma's cardiovascular program addresses the largest segment of the nuclear medicine market. In fact, every three seconds a U.S. patient is injected with a drug FluoroPharma’s products target, providing considerable opportunity for rapid growth and profitability.
Unlike traditional imaging modalities – MRI, CT, and Ultrasound – that reveal the anatomical abnormalities and cause for disease, PET provides insight into physiology and can detect disease non-invasively before anatomical manifestation is identified by offering visualization of biological processes at the molecular and cellular level. Featuring higher resolution scans with only a third of the radiation dose, as well as higher levels of reimbursement, PET has become the preferred imaging technology for a variety of diseases and disorders.
FluoroPharma's comprehensive technology platform promises to help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment and better patient outcomes. To date, the company has been issued patents related to its portfolio of imaging compounds in the United States, Europe, China, Japan, Canada, Australia, Finland, Portugal, Ireland, and Mexico. With a solid and experienced management team in place and the necessary resources to advance clinical development, FluoroPharma is well positioned to capitalize on its superior imaging technology.
Key Investment Highlights for $FPMI
Clinical Trials Confirmed Technologies are Safe and are Now Establishing their Efficacy
Intellectual Property in Place to Protect Proprietary Innovations Around the World
Cash On Hand to Advance Business Strategy
Technology Targets Multiple, Multimillion Dollar Healthcare Markets with Strong / Unmet Medical Needs
You see the CHANNEL we have been stuck in here phil? http://stockcharts.com/h-sc/ui?s=FPMI&p=D&b=5&g=0&id=p22092664587
Literally just Trading SIDEWAYS but with IMPRESSIVE VOLUME - Something has got to give imo. Even a run back to the $.95-$1 would be very nice to see. Next week I hope.......
http://stockcharts.com/h-sc/ui?s=FPMI&p=D&b=5&g=0&id=p22092664587
You think we break out here and back to $1 ? I see you have not played this in a while. I think NOW is the time to get back in or Add. Any $FPMI inuput would be nice. CHeck out the updated info in ibox
Around $20,000 in volume today eh. then again.....$FPMI has been having VERY SOLID Liquidity for most of 2013 from what I see.
A copy of the full $FPMI research report can be downloaded here >> FluoroPharma Medical Report - http://scr.zacks.com/files/doc_coverage/Med-Tech%20-%20Brian%20Marckx/FPMI/April%202%202013_FPMI_Marckx_v001_q314va.pdf
CHeck out the recent News that $FPMI has been releasing:
FluoroPharma Medical's CEO and Chairman, Thijs Spoor, to Present at Taglich Brothers 10th Annual Small Cap Equity Conference on May 7thMarketwired(Tue, Apr 30)
FluoroPharma Medical To Present At Taglich Brothers 10th Annual Small Cap Equity ConferenceGlobeNewswire(Thu, Apr 18)
ARM Holdings' Biotech Twin: FluoroPharmaat Seeking Alpha(Wed, Apr 17)
FLUOROPHARMA MEDICAL, INC. Files SEC form 8-K, Entry into a Material Definitive Agreement, Change in Directors or PriEDGAR Online(Mon, Apr 15)
FluoroPharma Announces Appointment of Dr. Joseph A. Pierro to the Board of DirectorsMarketwired(Mon, Apr 15)
Weekly Stock Watch, Week Of 8 April 2013at Seeking Alpha(Mon, Apr 8)
FLUOROPHARMA MEDICAL, INC. FinancialsEDGAR Online Financials(Wed, Apr 3)
Development Momentum Accelerating in 2013Zacks Small Cap Research(Wed, Apr 3)
FLUOROPHARMA MEDICAL, INC. Files SEC form 10-K, Annual ReportEDGAR Online(Thu, Mar 28)
Stock Watch Wednesday, 27 March 2013at Seeking Alpha(Wed, Mar 27)
FluoroPharma Receives Patent on Metabolic Markers for PET and SPECT ImagingMarketwired(Fri, Mar 22)
Stock Watch Wednesday, 20 March 2013at Seeking Alpha(Wed, Mar 20)
FLUOROPHARMA MEDICAL, INC. Files SEC form 8-K, Regulation FD Disclosure, Other Events, Financial Statements and ExhibEDGAR Online(Wed, Mar 6)
Weekly Stock Watch, Week Of March 4at Seeking Alpha(Mon, Mar 4)
FPMI: CardioPET Excellent Image Quality from Phase IIZacks(Thu, Feb 28)
Is $FPMI one of your pages TOP Picks for the week/month poemstone? Price and VOLUME has really picked up eh? I hope that the accumulation continues and we reallllyyyyy surge! News would be great.
you must be confused. $FPMI is Much better than the vast majority of nonsense they alert.
Investor Materials you Need to read up on. $FPMI has a 25m OS and 20M float as I recall. Maybe you prefer the $.0005 type play.......that is not this.
FluoroPharma IR Kit
http://fpmi.missionir.com/ir
FluoroPharma Fact Sheet
http://fpmi.missionir.com/factsheet
FluoroPharma Presentation
http://fpmi.missionir.com/presentation
Positron Emission Tomography (PET) Wiki
http://en.wikipedia.org/wiki/Positron_emission_tomography
Do you have a FACT SHEET or Executive Presentation for $FPMI similar to what your other clients have?
Keep the information coming my as please. $FPMI requires a bit of reading and intelligence to keep fresh on it.
Thanks. I will review thisone. I have dabbled in $FPMI before and now is the time to return to it I believe.
FPMI Supports Growing Movement for Personalized Medicine
One of the buzzword terms in modern medicine today is “personalized medicine”. Instead of simply matching a drug or treatment to an over-arching disease based on a one-size-fits-all philosophy, as has been done in the past, the move now is to customize treatments, based on a much more detailed understanding of the patient, an understanding made possible by new technologies.
The bottom line is that not all patients are alike, and a given disease can take on remarkably different characteristics depending upon the person affected, potentially requiring significantly different drugs and other treatments. It’s a simple concept, but putting it into practice involves some of the most advanced medical technology available. Patients can seem identical, but can have subtle genetic or other variations that need to be considered for optimum treatment. Sophisticated genetic tests can reveal cell or molecular level factors that can affect medical decisions, but there are also other ways to identify what’s going on in the human body at the deepest levels.
FluoroPharma Medical is a developer of advanced tracer chemicals needed to make positron emission tomography (PET) an effective analytic tool. PET scans depend upon having the proper tracer chemicals to integrate with and highlight the internal process to be evaluated. Tracer chemicals are the key to unlocking PET’s remarkable potential.
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.
For more information, visit www.FluoroPharma.com
FPMI is "One to Watch"
FluoroPharma Medical, Inc. is a biopharmaceutical company focused on discovering and developing patented Positron Emission Tomography (PET) imaging products to improve patient management by evaluating cardiac disease at the cellular and molecular levels. The company is currently advancing four different imaging agents to fulfill multiple critical unmet medical needs while providing clinicians important tools for detecting and assessing pathology before critical manifestations of disease.
According to GAI, the market for molecular imaging agents currently exceeds $1.7 billion annually and promises rapid growth for the foreseeable future. With one in three patients dying because of heart disease, FluoroPharma's cardiovascular program addresses the largest segment of the nuclear medicine market. In fact, every three seconds a U.S. patient is injected with a drug FluoroPharma’s products target, providing considerable opportunity for rapid growth and profitability.
Unlike traditional imaging modalities – MRI, CT, and Ultrasound – that reveal the anatomical abnormalities and cause for disease, PET provides insight into physiology and can detect disease non-invasively before anatomical manifestation is identified by offering visualization of biological processes at the molecular and cellular level. Featuring higher resolution scans with only a third of the radiation dose, as well as higher levels of reimbursement, PET has become the preferred imaging technology for a variety of diseases and disorders.
FluoroPharma's comprehensive technology platform promises to help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment and better patient outcomes. To date, the company has been issued patents related to its portfolio of imaging compounds in the United States, Europe, China, Japan, Canada, Australia, Finland, Portugal, Ireland, and Mexico. With a solid and experienced management team in place and the necessary resources to advance clinical development, FluoroPharma is well positioned to capitalize on its superior imaging technology.
Key Investment Highlights
• Clinical Trials Confirmed Technologies are Safe and are Now Establishing their Efficacy
• Intellectual Property in Place to Protect Proprietary Innovations Around the World
• Cash On Hand to Advance Business Strategy
• Technology Targets Multiple, Multimillion Dollar Healthcare Markets with Strong / Unmet Medical Needs
FluoroPharma Powerpoint Presentation
http://content.stockpr.com/fluoropharma/media/d1569342f8a53f7ba4117c6bb4cbb83d.pdf
Radioactive Growth In Nuclear Medicine: An Overview
http://seekingalpha.com/article/1230721-radioactive-growth-in-nuclear-medicine-an-overview
By Daniel Lauchheimer
Radioactive Growth In Nuclear Medicine: An Overview
Feb 27 2013, 15:46 | 18 comments | includes: CAH, COV, FPMI.OB, GE, NAVB
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
In a previous article I spoke about the medical device industry. In that article, I spoke about one branch of medical devices -- cardiac and orthopedic implants, but that only tells part of the story. Aside from the large implantable device industry, a large part of the segment includes imaging technology. GE (GE) and Siemens (SI) both form the core of this segment -- dominating all areas of imaging -- X-Ray, CT, MRI, PET scans, etc. However, aside from this part of the imaging world, we must also focus on the agents that scanners use to highlight anatomical and metabolic functions of the human body. One branch of these types of agents, use drugs laced with radioactive isotopes that collect metabolic data from the body, appropriately called radiopharmaceuticals. Many of the major pharmaceutical companies including Bayer (BAYRY) and Eli Lilly (LLY) have divisions dedicated to this field, with other players including GE, Covidien (COV), DraxImage (JUBILANT.NSE) Lantheus, Bracco, and Cardinal Health (CAH) having more extensive operations in this area. I will focus my comments in this article to the subfield of nuclear cardiology, which uses the aforementioned imaging agents to study patient cardiac functions. In this article I will examine, in some detail, the work these major players do in this area, and also examine some of the smaller players, and see how they fit into the larger picture.
Nuclear Medicine: A Background
Before we take a deep dive into the business elements, a brief background of nuclear medicine is in order.
In order for doctors to understanding a patient's condition they need to take a look inside their body to check out any problems. Doctors can do this by performing exploratory surgery, which due to its invasive and dangerous nature we obviously try to avoid. Doctors also can use X-Ray or CAT Scan, which sends photon beams into the patient, and form a chemical reaction with X-Ray film that creates an X-Ray image. An MRI machine works much differently, it uses a magnet to send radio waves into your body, which collect information, and then gets sent back to an antenna that collects and processes the images. Doctors can enhance these images by using contrast agents to highlight certain portions of the body.
These agents can take on many forms. From the simple iodine contrast, to as we will now see the more exotic radiopharmaceutical agent. As we mentioned above, radiopharmaceuticals are drugs laced with radioactive isotopes. These agents emit energy in the form of photons, which can then get read by special scanners called SPECT and PET scanners. Tc99m sestamibi, Tc99m tetrofosmin, and Thallium 201 Chloride are the most common agents used in nuclear medicine (and more specifically nuclear cardiology), and fluorodeoxyglucose or FDG is the most common agent used in PET scans. The main difference between SPECT or PET scans lies in how much information gets collected by the scanner. SPECT scanners collect a single photon and process that image (the 'S' in SPECT stands for single), whereas PET scanners collect two photons and process the information generated by both photons. Clearly, a PET scan because it collects more information will produce a higher quality image.
In 2000, the medical world experienced a breakthrough when scientists combined the PET scanner with a CT scanner, which allowed doctors to examine both the metabolic and anatomical functions of the body in one image. This greatly increased the visibility and clarity with which doctors could make decisions about patient health. This breakthrough moment sparked an increased interest in this area, with an increase in the amount of radiopharmaceuticals brought to market that could fully take advantage of this new technology. In the next section I will move to examine these developments, and the companies involved in these changes.
Molecular Imaging Agents: Current Trends
As mentioned, no major drug maker manufacturers PDG for PET scanning, but three major companies make radiopharmaceutical products for SPECT scanning. Covidien makes a Thalium 201 Chloride product, which has steadily lost market share to more powerful Tc99m products manufactured by Lantheus and GE. Additionally, Cardinal Health has a large business for the distribution and production of nuclear pharma products. However, despite the heavy involvement these companies have in the SPECT space, most of them have not developed a competing product in the PET space.
Lantheus marks the departure from this trend. Privately held Lantheus, which nonetheless files 10-Q's and 10-K's with the SEC, currently has a late stage PDG product, which seeks to improve on the current quality of care by improving image quality produced by the PET scan.
Another company making a major move in this space is FluoroPharma (FPMI.OB). FPMI currently has three drugs in various stages of clinical trials. The following table gives its four products at their respective stages of development:
Drug - Stage of Development
BFPET - Phase 2
CardioPet - Phase 2
VasoPet - Early Stage
AZPet - Early Stage
Since VasoPET and AZPET have not fully developed I will focus my comments on the two later stage drugs -- BFPET and CardioPET. FPMI plans to use both of these drugs for use in the field of nuclear cardiology. BFPET, in addition to beginning its phase II trial, has already received patent rights in Australia, and had two positive testings in China. BFPET began its Phase II trial in January 2013 and expects the trial to last 6 months. CardioPET has also began Phase II trials, which it commenced in March 2012.
BFPET and CardioPET, like the Lantheus drug, both provide a breakthrough in diagnostic ability by dramatically improving the image quality generated by the PET scan. Additionally, because of this higher image quality, doctors can offer patients a more personalized medical experience, which will increase the accuracy of the course of treatment. These factors will allow doctors to get better patient outcomes than the previous standard of care -- PDG.
BFPET when used in conjunction with stress tests, can help doctors distinguish between merely damaged (ischemic) and dead (infarcted) coronary arteries. The image quality produced by BFPET has so far been proven far superior to PDG.
CardioPET offers an even bigger breakthrough. As mentioned, in the case of BFPET, and with most nuclear imaging agents, patients must go through a stress test in order for the marker to work. However, many patients cannot undergo a stress test due to health concerns. Enter CardioPET, which allows patients who cannot undergo stress tests to have the benefit of high quality nuclear imaging. Whereas in the case of BFPET, Lantheus plans on offering a competing product, in the case of CardioPET, no other company has plans to bring a drug to market in the near future.
Importantly, we should note, these imaging agents do not require the same type of time to develop as their therapeutic brethren (p.3 in link). In the case of therapeutic pharmaceutical trials, patients must go through the course of treatment, which can take a lot of time, and must have long term follow ups to assess efficacy and safety. Radiopharmaceuticals on the other hand, have a short course of treatment, and follow up occurs immediately. This has the effect of cutting down dramatically the amount of time it takes to approve the drugs in half -- from 10 years to 5 years.
After learning about the scientific trends in the radiopharmaceutical market, let us now turn our attention to specific market trends.
Molecular Imaging: Market Trends
When evaluating the market for nuclear cardiac PET scanning we need to evaluate three items, in this order:
1. The number of people affected with cardiac disease
2. Those who have cardiac disease that undergo a "nuclear scan"
3. The amount of those scans done by PET imaging
The answers, as you can find in FPMI's Corporate Presentation run as follows. Page numbers correspond to the pages in the corporate presentation.
1. One in three adults have some form of cardiac disease (p.12)
2. Out of that huge population, 15.5mm undergo undergo nuclear scans (p.10)
3. 2.6mm out of that 15.5mm undergo cardiac PET scans (p.10)
The numbers presented above come from 2009, the most recent available data. In the two years preceding 2009 cardiac PET scanning grew at CAGR of 17% compared to 6% for the nuclear imaging field in general. Considering this growth in nuclear imaging in general, and PET scanning specifically, estimates project the market for radiopharmaceuticals to increase from $7bn to $15bn by 2015. (p.8)
Drilling this down a bit further, considering the numbers presented above come from 2009, and presumably the numbers have grown since then, and further the market should double between 2011 and 2015, I think we can estimate by 2015 an eligible market of close to 6mm.
FPMI's two drugs -- BFPET and CardioPET -- both should have strong market positions. BFPET is the only drug known under development addressing its market, and CardioPET is one of two drugs under development. Assuming a 75% adoption for BFPET and a 25%, and lastly assuming a roughly even split of patients between the two drugs, FPMI should have 3mm patients using its drugs.
FPMI estimates it can charge $600 per dose of its medicine, which works out to $1.8bn in revenue from its two drugs.
Granted, I am probably painting a bit of a rosy picture of FPMI's market opportunity, but even considering these admittedly rough numbers, we can get a strong sense of FPMI's market opportunity.
Moving Forward
FPMI will not have any revenue until 2015, but will have some major regulatory milestones it will hit over the next few years that will catalyze the stock to rise or fall. Aside from these regulatory milestones, FPMI could prove an attractive takeout target for some major companies.
As mentioned, GE, as part of its GE Healthcare Unit has a major presence in the imaging space. In 2000, as interest in PET scanning increased due to the CT/PET invention, GE's radiopharmaceutical operation began to pick up steam. A major part of its effort in this area came when GE bought Amersham, a nuclear medicine company, for $14bn. We see from this large transaction the importance GE places on its nuclear medicine operation both from the device and pharmaceutical perspective, and how it might have the inclination to execute other transactions going forward.
However, we do not need to limit the list of potential acquirers to obvious players like GE, Bracco, or DraxImage. N one of the super major pharmaceutical companies, aside from LLY and Bayer have nuclear medicine units, and considering the positive growth trends, they might want to get involved in this growing segment.
Navidea: An Instructive History
Until now I have focused my comments on the scientific and economic background needed in order to understand the field of nuclear cardiology, I have not spent much time looking at other nuclear medicine development companies. As far as I can tell Navidea BioPharmaceuticals (NAVB) is the only other publicly traded development stage company trafficking in nuclear medicine. NAVB has three radiopharmaceuticals under development: Lymphoseek for lymphoma detection, AZD4694 for Alzheimer's disease detection, and RIGScan for tumor detection during surgery. All three of these drugs have had significant regulatory bumps over the years, most recently culminating with a rejection of NAVB's NDA for lymphoseek, despite the company's rosy projections in its most recent 10-K. Even with this history of shaky developments, and its most recent blow, NAVB has a $330mm market cap. FPMI, which admittedly has longer to go on the regulatory trail, but also has not had NAVB's hiccups, has a seemingly low market cap of $20mm.
FPMI's drugs also address a much larger patient population. As mentioned above, one out of every three adults have "heart problems", and a full 22mm of those get undergo nuclear imaging. NAVB's drug, on the other hand, only addresses a total population of 1.7mm new cases a year in the USA. Meaning, NAVB has much smaller potential market because not all 1.7mm of those patients will receive NAVB's nuclear imaging.
Considering these two factors -- more solid footing on the regulatory path, and a larger addressable market, I think we can confidently say that FPMI has strong short and long term possibilities.
FluoroPharma Medical Announces Initial Data From Phase II Study for CardioPET(TM) (FCPHA)
Images Show High Resolution in the Heart and Provides Extremely Clear Image Quality, Bolstering Confidence in CardioPET
MONTCLAIR, NJ -- (MARKETWIRE) -- 02/28/13 -- FluoroPharma Medical, Inc. (OTCBB: FPMI), 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 released images from the Phase II clinical trial for CardioPET™ (FCPHA) 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, which is designed to be used as a cardiac imaging agent and may be a more specific alternative to currently available diagnostic tests. Management believes its pharmacokinetic characteristics could be especially valuable in patients who are unable to exercise.
The Phase II trial is an open label study designed to assess the safety and diagnostic performance of CardioPET as compared with myocardial perfusion imaging and angiography, the current gold standard. Trial sites are located in Belgium and results continue to be expected over the next six months.
According to Prof. Roland Hustinx, one of the investigators in the trial and head of nuclear medicine at the University Hospital in Liege, "The images obtained from CardioPET are high quality and agree with previous clinical findings."
Thijs Spoor, Chairman and CEO of FluoroPharma Medical, commented, "Today's announcement marks a significant milestone for FluoroPharma and CardioPET, one of the extraordinary products in our pipeline. It is clear that novel diagnostic imaging agents are urgently needed and we are focused on driving forward the development of our pipeline to provide healthcare professionals around the world with new products that expand and improve their diagnostic capabilities and contribute to earlier, more accurate diagnosis and treatment of disease -- even before symptoms appear. We are very excited about the images coming from the CardioPET trial. Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and accounts for a significant and increasing percentage of deaths," Mr. Spoor added.
About FluoroPharma Medical
FluoroPharma is a biopharmaceutical company engaged in the discovery and development of proprietary PET imaging products to evaluate cardiac disease at the cellular and molecular levels. The Company has licensed technology from the Massachusetts General Hospital in Boston.
The Company's goal is to enable personalized medicine through precision diagnostics that will help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment, management and better patient outcomes.
FluoroPharma's initial focus is the development of breakthrough positron emission tomography (PET) imaging agents and is advancing two products in clinical trials for assessment of acute and chronic forms of coronary disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image Alzheimer's disease and agents that could potentially be used for imaging specific cancers.
In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, Ireland and Mexico.
For more information on the Company, please visit: www.fluoropharma.com
About CardioPET
CardioPET is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body. FFAs are the major source of energy for healthy myocardium, where they are transported into the mitochondria and are then metabolized via beta-oxidation. CardioPET has completed Phase I studies where it was well tolerated and did not induce any adverse events or clinically significant deviations in laboratory values. The total radiation exposure was minimal and well within safety limits.
About Coronary Artery Disease (CAD)
Coronary Artery Disease (CAD) is a leading cause of death and disability globally. The World Health Organization (WHO) estimated that more than 17 million people have died from heart attack, angina pectoris (chest pain) or both. It is also estimated that by 2030, this number will almost double.
Forward-Looking Statements
Except for historical information contained herein, the statements in this release are forward-looking. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding FluoroPharma's research and development activities and anticipated operating results. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in FluoroPharma's filings with the United States Securities and Exchange Commission. FluoroPharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
Media:
Carol Perlman
FluoroPharma Medical, Inc.
cperlman@fluoropharma.com
Phone: 917-592-9260
Investor Relations:
Richard Moyer
Cameron Associates, Inc.
Richard@cameronassoc.com
Phone: 212-554-5466
Released February 28, 2013
http://ir.stockpr.com/fluoropharma/company-news/detail/304/fluoropharma-medical-announces-initial-data-from-phase-ii-study-for-cardiopettm-fcpha
Financial Reporting/Disclosure
Reporting Status U.S. Reporting: SEC Filer
Audited Financials Audited
CIK 0001402785
Fiscal Year End 12/31
OTC Market Tier OTCQB
Profile Data
SIC - Industry Classification 2835 - Diagnostic substances
Business Status Development Stage Company a/o Mar 31, 2008
Incorporated In: NV, USA
Year of Inc. Not Available
Employees Not Available
Company Officers/Contacts
Johan Spoor President, CEO
Tamara Rhein CFO
Company Directors
Lawrence Atinsky
Peter S. Conti
Johan Spoor
Walter Witoshkin
Company Notes
Formerly=Commercial E-Waste Management, Inc. until 6-2011
Service Providers
Auditor/Accountant
Wolf & Company, P.C.
Boston, MA, 02110
United States
Legal Counsel
Sichenzia Ross Friedman Ference LLP
61 Broadway
New York, NY, 10006
United States
Investor Relations Firm
Cameron Associates
1370 Avenue of the Americas
New York, NY, 10019
United States
http://www.otcmarkets.com/stock/FPMI/company-info
FPMI Security Details
Share Structure
Market Value1 $18,584,611 a/o Mar 05, 2013
Shares Outstanding 24,135,858 a/o Dec 17, 2012
Float 9,543,270 a/o Dec 17, 2012
Authorized Shares 200,000,000 a/o Dec 17, 2012
Par Value 0.001
Shareholders
Shareholders of Record 132 a/o Mar 16, 2012
Short Selling Data
Short Interest 29,228 (5.04%)
Feb 15, 2013
Significant Failures to Deliver No
Transfer Agent(s)
VStock Transfer
http://www.otcmarkets.com/stock/FPMI/company-info
Initial Images Show Positive Results for BFPET in Patients With Coronary Artery Disease
FluoroPharma Medical, Inc. (FPMI), 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 announced that they have received high quality images in an investigator-sponsored clinical trial in China where patients with CAD were given BFPET, its imaging agent for measuring cardiovascular blood flow. This is most encouraging as the company is starting phase II trials.
Patients are being imaged at the PLA 301 hospital in Beijing where the images give a direct comparison between stress perfusion imaging using sestamibi and BFPET. According to Dr. Alan Fischman, former head of nuclear medicine at Massachusetts General Hospital and the principal investigator of the BFPET phase I trial, "initial results are impressive. Image quality obtained using PET is superb. BFPET shows clear diagnostic qualities as well as increased resolution, inherent in PET. The initial images look spectacular and we are confident that when all the patients are imaged, the data will further support clinical development of the agent." Approximately 20 patients are expected to be imaged with this investigator-initiated study concluding by the beginning of the 4th quarter of 2012.
"These images mark a milestone for BFPET and this exciting technology; bringing it a step closer to the world's medical community. We firmly believe, however, that the true beneficiaries of imaging agents like BFPET will be patients as it offers the potential for non-invasive diagnostic images with higher specificity. This will provide early and more accurate information to enable more effective patient management decisions," commented Thijs Spoor, FluoroPharma's President and Chief Executive Officer. "Today's announcement supports our earlier findings and increases our confidence that the images we observed in Phase I will be reproduced in Phase II. It also validates 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," he added.
About BFPET: Myocardial Perfusion Imaging FluoroPharma's BFPET is a novel imaging agent for myocardial perfusion imaging with the potential for measuring cardiovascular blood flow. BFPET, a Flourine-18 labeled tracer, has been designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential. These are two of the most important physiological indicators upon which adequate blood supply to the heart depends. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.
Ischemic and infarcted cells should take up less BFPET than healthy myocardial cells. The signal emitted by BFPET should be inversely proportional to the extent of myocardial injury. Therefore, FluoroPharma believes that ischemic heart tissue can be reliably detected by using BFPET
Late last year, FluoroPharma announced that it had been granted patent rights in China for BFPET and another imaging agent, AZPET which is still in the very early phase of discovery.
About Symptomatic coronary artery disease (CAD) 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. Cardiologists' 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
About FluoroPharma Medical FluoroPharma is a biopharmaceutical company engaged in the discovery and development of proprietary PET imaging products to evaluate cardiac disease at the cellular and molecular levels. The Company has licensed technology from the Massachusetts General Hospital in Boston.
The Company's goal is to enable personalized medicine through advanced imaging products that will help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment, management and better patient outcomes.
The Company's initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). FluoroPharma is advancing two products in clinical trials for assessment of acute and chronic forms of coronary disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image Alzheimer's disease and agents that could potentially be used for imaging specific cancers.
In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, Ireland and Mexico.
FPMI Targets #1 Most Wanted
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.
FluoroPharma Medical, Inc. Offers Major Market Advantages @ Seeking Alpha
FluoroPharma Medical, Inc. (OTCQB: FPMI) engages in the discovery, development and commercialization of proprietary medical diagnostic imaging products. The company’s initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, amyloid plaque in Alzheimer’s disease and agents for detection of certain types of cancer.
At Seeking Alpha, contributor MissionIR writes that for a developing business to be considered valuable, it needs to "present products that have unique benefits not found elsewhere, providing a decided advantage in the marketplace." He argues that FluoroPharma is such a company, writing that "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."
He goes on to elaborate on the company's 3 main products - CardioPET for the assessment of myocardial metabolism, BFPET for the assessment of blood flow for CAD, and VasoPET for the detection of vulnerable plaque in CAD (currently in preclinical development) - as well as their unique advantages.
Read the full article at Seeking Alpha.
FPMI Offers Major Market Advantages
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.
For more information, see the company website at www.FluoroPharma.com
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FluoroPharma Medical, Inc. 8 Hillside Ave Suite 207 Montclair, NJ 07042 Phone: (973) 744-1565 www.FluroPharma.com Info@FluoroPharma.com | MissionIR 3645 Marketplace Blvd. Suite 130-280 Atlanta, GA 30344 Phone: (404) 941-8975 www.MissionIR.com Editor@MissionIR.com |
FluoroPharma Medical, Inc. (FPMI) is focused on discovering and developing patented Positron Emission Tomography (PET) imaging products to improve patient management by evaluating cardiac disease at the cellular and molecular levels. The market growth for this imaging technology presents tremendous opportunity for innovative developments that address unmet medical needs. FluoroPharma is currently advancing four different imaging agents to fulfill these critical needs while providing clinicians important tools for detecting and assessing pathology before critical manifestations of disease.
Unlike traditional imaging modalities (MRI, CT, and Ultrasound) that reveal the anatomical abnormalities and cause for disease, PET provides insight into physiology and can detect disease non-invasively before anatomical manifestation is identified by offering visualization of biological processes at the molecular and cellular level.
Featuring higher resolution scans with only a third of the radiation dose, as well as higher levels of reimbursement, PET has become the preferred imaging technology for a variety of diseases and disorders.
For more information, visit www.FluoroPharma.com
Presentation FPMI.MissionIR.com/Presentation
CardioPET (coronary artery disease) is on track to start Phase IIb clinical trials by year end. This muscle state imaging agent exploits the dietary needs of the heart as it relates to glucose and fatty acids. By introducing a radio-labeled analog to the natural fatty acids utilized as an energy source by the heart, the technology allows for the visualization of the anatomic location and state of the muscle to detect problems in advance of symptoms that would lead to a stress test.
FluoroPharma believes that within the third year of launch, CardioPET could be used in approximately 700k procedures, growing to 1+ million procedures in the following five years. This could equate to a potential revenue opportunity to FluoroPharma of approximately $400 million in the third year (2019/2020) and $600+ million in the fifth year (2021/2022) after launch.
BFPET (coronary artery disease) Phase II clinical trial results are expected by year end. BFPET, a Flourine-18 labeled tracer, has been designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential. These are two of the most important physiological indicators upon which adequate blood supply to the heart depends. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.
FluoroPharma estimates that BFPET could capture about 1% - 3% of the total market for MPI radiopharmaceuticals in the first full year after launch (possibly 2016/2017) and will account for about 20% - 30% of the market five years following launch (possibly 2021/2022). Contingent on the selling price that the Company is able to achieve, this could mean revenue from sales of BFPET as high as $50 million in the first full year after launch and $700 million five years after launch.
*CardioPET could be used in combination with FluoroPharma’s BFPET or other blood flow agents in performing Cardiac Viability Assessment (CVA)
VasoPET (coronary artery disease) is on track for Phase Ib clinical trial by year end. By targeting the active adenosine phosphate molecule receptors which are associated with inflammatory conditions this imaging agent allows us to visualize potential areas that may cause embolisms and thrombosis. VasoPET is designed for patients that have already had a heart attack or stroke with the risk of a potentially fatal recurrence.
FluoroPharma believes that VasoPET could be used in approximately 30k PET scans in the first full year of launch, growing to 450k and 700k scans in the third and fifth year (post-launch), respectively. Assuming a $600 cost per dose, this could result in revenue opportunity of $18 million in year one (2017/2018), $270 million in year three, and $420 million in year five (2022/2023).
AZPET (Alzheimer’s disease) is an imaging agent that attaches to the amyloid deposits (plaque) in the brain and makes them visible on a PET Scan, thus allowing the early detection of Alzheimer’s disease.
According to GAI, the market for molecular imaging agents currently exceeds $1.7 billion annually and promises rapid growth for the foreseeable future - the global market for molecular imaging agents is projected to exceed $15 billion by 2015. With one in three patients dying because of heart disease, FluoroPharma's cardiovascular program addresses the largest segment of the nuclear medicine market.
The World Health Organization estimates that 7.3 million deaths were directly attributable CAD during 2008 (12.8% of all global deaths), making CAD the leading cause of death worldwide. In the United States alone, cardiovascular disease is responsible for 32%, or 1 in every 3 deaths, of all deaths.
FluoroPharma's comprehensive technology platform aims to help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment and better patient outcomes.
To date, the company has been issued patents related to its portfolio of imaging compounds in the United States, Europe, China, Japan, Canada, Australia, Finland, Portugal, Ireland, and Mexico. FluoroPharma is backed by a highly experienced management team and the necessary resources to advance clinical development and capitalize on its superior imaging technology.
Novel Cardiac PET Tracing Agents Market Forecast to grow by at least 14% Annually to Approximately $900 million by 2017
FluoroPharma’s products utilize positron emission tomography (PET) technology, a molecular imaging platform that is growing rapidly due to its inherently superior sensitivity and specificity compared to other imaging options. The company’s PET imaging products improve patient management by evaluating cardiac disease at the cellular and molecular levels.
Molecular Imaging Market
Molecular imaging fulfills unmet needs in diagnosis and follow-up therapy by enabling visualization, characterization, and measurement of biological processes at the molecular and cellular level. Unlike more commonly known imaging modalities – MRI, CT, and Ultrasound– that provide insight into the anatomical manifestation of disease, molecular imaging techniques provide insight into physiology and can detect disease before anatomical manifestation is identified.
Cardiovascular Market
Symptomatic coronary artery disease (CAD) affects more than 13 million patients and accounts for more than 30% of all deaths. Cardiologists’ 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. Molecular imaging is currently used in more than 9 million myocardial perfusion imaging (MPI) procedures, the standard test for diagnosing CAD.
Additional Diagnostic Markets
Approximately 5.2 million people in the United States are living with Alzheimer’s and 10 million Baby Boomers will develop the disease in their lifetime. Currently, there is no single diagnostic test that proves a person has AD. FluoroPharma is developing new options for early detection and treatment of Alzheimer’s, to improve patient care and create new paths for Alzheimer’s disease management.
Prostate cancer is the most frequently diagnosed and second most lethal malignancy among men in the United States. FluoroPharma is developing new compounds to enable earlier and more accurate diagnosis of prostate cancer.
Following is a list of FluoroPharma’s patents and pending patents:
Cardiovascular and thrombus imaging agents, methods and kits
United States Patent 6,299,857
Elmaleh, et al.
Issued - October 9, 2001
Expires – December 27, 2016
Foreign patents granted: EP, JP, MX, FR, DE, CH, UK
Tumor imaging agents, methods and kits
United States Patent, 6,187,286
Elmaleh, et al.
Issued - February 13, 2001
Expires - December 27, 2016
Foreign patents granted: CA, MX, EP, AU
Imaging Agents for Early Detection and Monitoring of Cardiovascular Plaque
US Patent Pending No. 98 94 5939
Elmaleh, et al.
Utility (CIP): 09/530,818 #7060251
Granted - June 13, 2006
Expires - September 8, 2018
Utility: 11/286,930 #7,438,891
Issued - October 7, 2008
Expires - September 8, 2018
Foreign patents granted: AU DIV
Method for Monitoring Blood Flow and Metabolic Method for Uptake in Tissue with Radiolabeled Alkanoic Acid
Elmaleh et.al.
United States Patent No. 7,790,142 B2
Issued – September 7, 2010
Expires – February 3, 2025.
Foreign patents granted: EP, HK.
Catalytic Radiofluoronation
Elmaleh et. al.
United States Patent No. 7632485
Issued – December 15, 2009
Expires- February 24, 2025
Foreign patents granted: MX
Biotin Compounds for Targeting Tumors and Sites of Infection
Elmaleh et. al.
United States Patent No. 5716594
Issued – February 10, 1998
Expires – June 6, 2014
Foreign patents granted: JP, HK, EP, FR, DE, IE, UK
FluoroPharma has compiled a number of valuable online resources that pertains to the Company’s research. To read the latest industry news, learn about latest advances in molecular imaging diagnostics and therapy and understand emerging imaging technologies please click on any of the links below.
Radiology Links:
Cardiac Imaging Links:
Imaging Molecular Imaging Links:
Thijs Spoor Chairman of the Board, CEO & President
Thijs 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. He has been a guest lecturer at Columbia Business School, Kings College in London, and the University of Newcastle in Australia, and has presented at medical grand rounds and psychiatric grand rounds at various hospitals on the role of brain imaging.
Spoor previously held the title of CFO for Sunstone BioSciences. Prior to joining Sunstone BioSciences, he worked as a consultant at Oliver Wyman where he helped pharmaceutical and medical device companies evaluate their global revenue potential given the complex interplay of regulatory approvals, the reimbursement environment, as well as the impact of physician preference within constantly evolving standards of care. He further specialized on the implications of healthcare reform on new product approval and health insurance reform.
Spoor has also been an equity research analyst at J.P. Morgan and Credit Suisse where he covered the Biotechnology and Medical Device industries. Spoor worked in the pharmaceutical industry spending 10 years with Amersham / GE Healthcare where he worked in seven countries in a variety of roles including setting up GMP facilities meeting ISO 9001 standards, accountability for the entire nuclear cardiology portfolio, and most recently as the Director of New Product Opportunities leading the PET strategic plan.
Boyan Goumnerov, MD COO & Vice President Clinical Trials
Dr. Boyan Goumnerov has held executive positions in the healthcare and biomedical research fields, the most recent being his role as president of VasoStent Inc. and managing director of CardioVas Inc., start-up medical device companies targeting the field of intravascular cardiac imaging and therapy. His academic background includes research within the departments of Surgery and Molecular Biology at the Massachusetts General Hospital (MGH) and The Shriners Burn Hospital for Children, Boston, where he held academic appointments with Harvard Medical School. Dr. Goumnerov also did extensive work within the Department of Pathology/Neuropathology at Children's Hospital Boston, in developing image analysis protocols for evaluation of neuromuscular diseases before moving to MGH. He is co-author of numerous scientific publications. Dr. Goumnerov obtained his M.D. from the Medical University of Sofia, Bulgaria, and worked as a clinician prior to relocating to the United States.
Tamara Rhein CFO
Before joining FluoroPharma in 2011 as Controller, Tamara Rhein was the Controller of Manhattan Pharmaceuticals where she was responsible for maintaining the critical financial functions as well as performing a wide range of activities including financial statement preparation, footnote disclosures for SEC filings, stock option accounting, and quarterly and year-end audits. Prior to Manhattan, Rhein was employed with Vyteris, where her primary role was to manage the SEC accounting and reporting department. In addition to her financial responsibilities, Rhein worked with the CEO on the launch of a new product. In this capacity, she managed critical aspects of coordination, timing, and tracking of the initiative.
Rhein also previously served vice president of New Business at Credit Suisse First Boston, where she provided comprehensive research and analysis to guide senior management on certain projects and complex business transactions; and vice president of External Reporting at Donaldson, Lufkin & Jenrette, where she prepared and reviewed SEC filings for Donaldson, Lufkin & Jenrette as well as Donaldson, Lufkin & Jenrette direct. She was extensively involved in the Initial Public Offering of the Donaldson, Lufkin & Jenrette direct tracking stock issued in May 1999.
Rhein began her career as a senior auditor for Deloitte & Touche, where she planned and administered audit engagements for several large banks and insurance companies. She received a Bachelor of Science in Accounting from California State University, and is a Certified Public Accountant.
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