Company News

Cardiology Product Potential, Clinical Trial Progress and Capital Acquisition Success Drive the Company's Next Moves

MONTCLAIR, NJ -- (Marketwired) -- 10/23/15 -- 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 cardiovascular disease, announced today the release of a company overview as presented by FluoroPharma's Chairman & CEO, Thijs Spoor, and its President, Thomas Tulip, PhD.

Mr. Spoor began, "I'm very pleased to provide this 'State of the Union' update to our shareholders. The fundamentals for PET cardiac imaging remain strong, with the global isotope market expected to reach $4.5 billion in 2015. Recent reports project that the market could approach $7 billion by 2020, and the need for better diagnostic imaging tools for cardiologists remains unchanged. Cardiovascular procedures and operations increased 28% in the decade between 2000 and 2010, and the challenges and costs of managing cardiovascular disease continue to grow. Myocardial perfusion imaging is still the most frequently used nuclear medicine procedure in the U.S., while the use of PET technology continues to increase in the U.S., Europe and Asia. The recognition of PET's unique potential in imaging cardiovascular disease and uncertainty in the global supply chain for Molybdenum-based SPECT procedures beyond 2016 have increased the expectations for PET cardiac imaging."

He continued, "We're encouraged by the progress made to date with the completion of a CardioPET Phase II study, and are confident in the imminent start and rapid recruitment for the BFPET Phase II trial in the U.S. With recent success in the acquisition of investment capital, we are prepared to take the next important steps to enhance shareholder value."

Mr. Spoor provided a detailed review of key milestones achieved recently:

  1. Efforts to secure investment capital have been successful. Spoor stated, "The environment for small-cap companies has been challenging, but the PET story remains compelling to investors. The fundamental needs in cardiology patient management haven't changed, and the issues are global in nature. Ongoing partnering discussions have also been positive. Partnership discussions evolve more productively during the course of Phase II clinical trials, and we're encouraged by the increasing level of interest based on the images generated by CardioPET. We'll be in a unique position shortly to have Phase II images for two compounds simultaneously, and that should increase the interest even further."
  1. The company named as its new President, Dr. Thomas Tulip, a distinguished healthcare veteran with vast experience in pharmaceutical development across the health care continuum, from pre-clinical discovery to commercialization of diagnostics. Dr. Tulip held senior leadership positions at Navidea Biopharmaceuticals, Lantheus Medical Imaging (LMI), Bristol Myers Squibb (BMS) and DuPont Pharmaceuticals, and currently serves on the Board of Directors of the Medical Imaging Technology Association (MITA) and leads its PET Working Group in the Molecular Imaging Section. Dr. Tulip stated, "I am pleased to be joining FluoroPharma at this pivotal moment for the Company and the patients it seeks to benefit. Heart failure and diabetes, today's cardiovascular epidemic, are chronic, debilitating functional and metabolic disorders. The continued growth of more 'accountable' health care delivery models create increasing demand to find better ways to direct resource utilization. FluoroPharma is in a unique position to enable better care for heart failure patients by providing advanced options for cardiovascular healthcare providers, which satisfies the growing demands for more economical, accountable care."
  1. The CardioPET Phase II study was closed in December 2014 after meeting its recruitment target. The subject image data is being reviewed by an expert research partner and is being customized for systematic reading by qualified and experienced Nuclear Cardiology practitioners. The seminal presentation for CardioPET was delivered at the 2014 American College of Nuclear Medicine / SNMMI Mid-Winter meeting, presented by Dr. Fabian Demeure of UC Louvain, Belgium. It was the first of four scientific abstracts that were presented at international meetings during the year, including the SNMMI Annual Meeting, the American Society of Nuclear Cardiology, and the European Association of Nuclear Medicine. All presentations reported consistency in biodistribution, image quality and interpretability. Dr. Tulip commented, "The scientific presentations included initial results comparing performance of the agent to that of SPECT. A case study published in the Journal of Nuclear Cardiology suggested there were substantial differences in at least one subject. "We were very pleased with the acceptance of our clinical data for presentation at these prestigious meetings. All have confirmed our expectations of the product performance, and gave us new insight about potential unique applications, such as the assessment of coronary flow reserve, a metric of growing importance to the heart failure specialist," Dr. Tulip added. "The final reporting of this study will be a major step in confirming the hypothesis and moving forward to the next studies with greater confidence."
  1. The Phase II trial for BFPET is now open for patient recruitment at Massachusetts General Hospital in Boston. The company has partnered with an expert Contract Research Organization (CRO) for managing the imaging data in the BFPET Phase II study. "We have added another dimension of expertise in cardiac PET image processing and quantitation, important capabilities as we explore the best possible indications for BFPET," said Mr. Spoor. "All of the key components are in place to recruit the first subjects at Massachusetts General Hospital, and as an open-label study we expect to have patient images to review in the very near future," he 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 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.

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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.


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Source: FluoroPharma Medical, Inc.