MONTCLAIR, NJ--(Marketwired -
July 29, 2013) - FluoroPharma Medical, Inc. (OTCQB: 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, announced today the release of a company overview as
presented by FluoroPharma's President, CEO and Chairman of the
Board, Thijs Spoor.
Mr. Spoor began the communication by stating, "This 'State of
the Union' serves to provide shareholders with a perspective on
FluoroPharma, its evolution and future potential. Let me begin with
the fundamentals. We have a clear focused plan for value creation
-- short term, low risk pathway, an experienced management team and
world-class advisors.
Our pipeline is moving forward and we have further strengthened
and expanded our global patent position. We believe that imaging
agents like our BFPET and CardioPET, will provide Cardiologists
around the world with faster, more accurate diagnostic tools with
increased sensitivity for the detection and assessment of acute and
chronic coronary artery disease (CAD). CAD affects millions of
patients worldwide and cardiovascular diseases remain a leading
cause of death and disability in the world.
On the capital markets side, we have expanded our presence and
outreach in the investment community, and are making progress in
raising our visibility with other key groups; including the medical
community and industry media. I am pleased and proud to share
with you that we are making significant strides in this
area. This week, FluoroPharma was prominently featured in the
prestigious Diagnostic &
Interventional Cardiology Magazine in an article by the editor
on advances in cardiac nuclear imaging. The article 'PET vs. SPECT,
Will PET Dominate over the Next Decade?' clearly positions our
company as an emerging leader as it addressed the advancements in
new radiotracers and technology related to both modalities.
Diagnostic & Interventional Cardiology Magazine is a
publication of choice in our industry as it helps keep readers up
to date on latest devices and technologies related to the
catheterization laboratory, cardiac imaging, diagnostic testing and
electrophysiology. In addition to new product releases, the
magazine also reviews new technologies with clinician end-users,
discusses trends, and offers product comparison charts. The
full article can be found on our website or by following the URL
http://www.dicardiology.com/article/pet-vs-spect-%E2%80%94-will-pet-dominate-over-next-decade."
Mr. Spoor continues, "One of our top priorities is to assess
potential strategic relationships that will accelerate our progress
and add shareholder value. As with all companies in this stage of
development, we certainly have our challenges and although there
are no assurances in any business, I am extremely excited and
confident about our future. Creating and developing the assets that
we currently have has taken time, dedication, tremendous effort and
a 'determination to succeed' attitude." Mr. Spoor noted key
milestones that occurred in the first half of this year to increase
shareholder value:
1. To heighten awareness and expand FluoroPharma's investor
base, Mr. Spoor presented business and portfolio updates at key
conferences such as Biotech Showcase 2013, OneMedForum 2013 and
more recently, Taglich Brothers 10th Annual Small Cap Equity
Conference on May 7th.
2. In January 2013, it was announced that Phase II Clinical
trials will be conducted at Massachusetts General Hospital for
BFPET, the company's imaging agent under evaluation for measuring
cardiovascular blood flow. Mr. Spoor notes, "We are very pleased
that our Phase II trials for BFPET will be developed at such a
prestigious institution as the Massachusetts General Hospital. This
news followed previous announcements of our Phase II trials in
Brussels on CardioPET, another of our novel diagnostic agents for
the detection and assessment of acute and chronic forms of coronary
disease. I am pleased to announce that this trial has now started
and we are looking forward to seeing interim results in the near
future. Massachusetts General Hospital has been instrumental in our
Phase I studies and we are excited that this relationship will
continue."
3. In February, we announced that FluoroPharma received initial
data from their Phase II Study on CardioPET. The study was designed
to assess myocardial perfusion and fatty acid uptake in coronary
artery disease (CAD) patients. According to Mr. Spoor, "The images
show high resolution in the heart and clear image quality,
bolstering our confidence in CardioPET. Prof. Roland Hustinx,
one of the investigators in the trial and head of nuclear medicine
at the University Hospital in Liege, further indicated that the
images obtained from CardioPET agree with previous clinical
findings. This marked a significant milestone for FluoroPharma and
CardioPET, one of the products in our pipeline."
4. In March, it was announced that FluoroPharma received a
patent covering a platform series of metabolic markers for PET and
SPECT imaging. The compounds' specific use is for metabolic
activity deficiencies in organs such as heart and liver as well as
for tumor tissue activity. Mr. Spoor commented, "This enhances
FluoroPharma's IP position and strengthens our 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.
This addition to our patent portfolio allows us to continue our
path towards enabling personalized medicine through precision
diagnostics. We believe that allowing clinicians to observe and
evaluate changes in the metabolic state of specific tissues and
organs, may open up new areas of awareness of the clinical
implications of altered tumor metabolism in diseases such as
prostate cancer as well as other conditions associated with lipid
metabolism in patients with metabolic disorders."
5. In April, Mr. Spoor announced that Dr. Joseph A. Pierro would
be joining the FluoroPharma Board of Directors. "Dr. Pierro brings
a wealth of expertise to FluoroPharma at an important time in the
company's evolution. His career in health care and his work in
imaging spans two decades. Dr. Pierro, a physician, has worked in
the Pharmaceutical industry in global clinical research development
and with the FDA across multiple therapeutic areas. Dr. Pierro is
currently the Chief Medical Officer for North America at Biomedical
Systems, where he is responsible for leading the Scientific Affairs
groups, providing medical and regulatory guidance.
His background in imaging, his vast expertise in many
therapeutic areas including cardiovascular, and his experience at
the FDA, brings invaluable knowledge to FluoroPharma. This is a
pivotal time for FluoroPharma as Phase II data for the company's
two lead compounds are expected in 2013," Mr. Spoor concluded.
6. In June, the company announced that a review of currently
acquired imaging data from the Phase II Study for CardioPET further
supported the initial findings announced in February. According to
Mr. Spoor, "The images continue to be impressive, providing high
resolution in the heart and clear image quality for early and late
scans. Dr. Manuel D. Cerqueira, Chairman, Department of Nuclear
Medicine at the Cleveland Clinic found the images thus far obtained
from CardioPET indicate excellent image quality and that the
immediate acquisition of images will be very efficient for patient
work flow."
A Macro Perspective "In
summary, as clinician confidence in the diagnostic power of PET
continues to increase, we are more confident than ever that PET
will be the 'go to' modality for molecular imaging. It will do so
by enabling personalized medicine through precision diagnostics,
delivered cost-effectively in a manner with less radiation to
patients reflecting an increasing pressure from professional
societies, by leverage hardware advances already being
commercialized, and by taking advantage of the extra throughput
capacity present in the U.S. installed base of PET/CT
scanners."
It is believed that a pending isotope shortage in 2016 for the
SPECT cardiac imaging drug will increase the cost of SPECT cardiac
imaging and there may even be times when the procedure is not even
available due to disruptions in supply. With pressure to lower
costs in the healthcare system, this will result in a stronger
health economic argument.
"It makes sense when performing medical imaging procedures to go
with the modality that delivers the best image quality at the
lowest dose, one that renders reproducible results regardless of
the skill of the practitioner and is not vulnerable to supply-chain
disruptions. The case is that much stronger, when this modality
gains access to specialized radiopharmaceuticals that promise
cost-effective and clinically significant testing that will expand
the capability of routine healthcare practitioners in neurology,
oncology and cardiology," Spoor said.
A Company Perspective "From
a company perspective," Mr. Spoor adds, "our pipeline continues to
be on track. CardioPET images are strong in 'at-rest' patients and
based on the rate of patient enrollment, we are encouraged with the
data from our ongoing CardioPET trial and look forward to obtaining
interim results this summer. Our intention is to present CardioPET
interim findings at a major medical conference later this
year. BFPET is on track to initiate Phase II by year-end.
I have recently attended the Annual Meeting for the Society of
Nuclear Medicine and Molecular Imaging, where images and basic
science papers from our products were presented in scientific
sessions. It is encouraging that the basic science presented
advances our knowledge of the fundamentals of how our compounds
interact with the disease process. I am more confident that
FluoroPharma's pipeline of innovative products is in alignment with
the Society's direction of developing novel imaging strategies,
applicable to the era of molecular and personalized medicine,"
noted Mr. Spoor.
"We continue to develop VasoPET, our novel molecular imaging
agent for the detection of vulnerable coronary artery plaque in
patients with Coronary Artery Disease. The vulnerable (unstable)
atherosclerotic plaque is recognized to be the primary culprit for
the occurrence of myocardial and cerebral infarctions. VasoPET has
completed preclinical testing and preparation for an
investigational new drug (IND) application is underway.
And although our immediate focus is on cardiology, our portfolio
also includes early stage diagnostics for the early detection of
Alzheimer's disease. AZPET agents include an approach for directly
imaging beta-amyloid plaque and the compensatory receptor systems
in the elderly. Alzheimer's disease patients may benefit from new
treatments that have the potential to slow down disease progression
and impact the healthcare costs associated with Alzheimer's
disease. Imaging and follow up with drugs like AZPET could allow
these patients to receive the proper treatment earlier.
Our Technology is compatible with current clinical practice,
with reliable reimbursement in place.
We have a clear, focused plan for value creation -- short term,
low risk pathway, an experienced management team and world-class
advisors.
We have intellectual property in place to protect proprietary
innovations around the world.
Our products address significant unmet needs in billion dollar
markets.
There is strong M&A interest in Molecular Imaging Space.
The future for diagnostic imaging procedures with higher
sensitivity and specificity is promising as they provide early and
more accurate information to enable more effective treatment and
follow-up of its efficacy. Early treatment means saving the patient
from long and expensive hospital stays, which results in less time
away from family and work.
Our future is defined by the potential of the market, and that
too is strong. A high growth market provides burgeoning
opportunities and we believe we will be well positioned to seize
those opportunities.
As personalized medicine evolves, patients will see medical
diagnostic products matched closely to therapeutics, such that they
are more likely to be prescribed the exact treatment for their
condition. This will improve chances for cure and reduce
unnecessary costs and side effects.
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.
And as we look forward to advances in science and medicine,
FluoroPharma's goal is to enable personalized medicine through
precision diagnostics. Enabling the physician to prescribe the
right medicine, for the right person, at the right time, for the
right outcome, is only possible with the right diagnostics," Mr.
Spoor concluded.
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 artery 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 brain tissue affected by 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
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: 917-592-9260Investor
Relations:Richard MoyerCameron Associates, Inc.
Richard@cameronassoc.comPhone: 212-554-5466
FluoroPharma Medical (CE) (USOTC:FPMI)
Historical Stock Chart
From Dec 2024 to Jan 2025
FluoroPharma Medical (CE) (USOTC:FPMI)
Historical Stock Chart
From Jan 2024 to Jan 2025
