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
- Clinical Trials Confirm Safety of Technologies – Are Now Establishing Efficacy
- Intellectual Property Positioned to Protect Proprietary Innovations
- Technology Targets Multiple, Multimillion Dollar Healthcare Markets
- Proprietary Products Support New Technologies for Personalized Medicine
- Robust Pipeline of First-in-Class Imaging Products
- Strong M&A Interest in Molecular Imaging Space
- Clear, Focused Growth Plan Aims for Low-risk, Short-term Value Creation
Fluropharma PET Imaging Agents
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.
Global Imaging Market
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.
Key Market Insights
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.
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
United States Patent No. 7,790,142 B2
Issued – September 7, 2010
Expires – February 3, 2025.
Foreign patents granted: EP, HK.
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.
Cardiac Imaging Links:
Imaging Molecular Imaging Links:
The Management Team
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.