www.biomoda.com
609 Broadway NE
Albuquerque, NM 87102
Tel:505-821-0875
Fax:866-519-6156
Email: verrityg@biomoda.com
Biomoda is a cancer diagnostics company focused on the development of an inexpensive, simple, highly accurate in-vitro test for the early detection of lung cancer.
Biomoda trades under the symbol BMOD (OTC Bulletin Board) and files regular reports with the U.S. Securities and Exchange Commission (SEC), available HERE. Administrative offices and current research and development operations and laboratory functions, including a microscopy lab, assay development and formulation lab, are located at 609 Broadway NE, Albuquerque, New Mexico.
Biomoda is seeking U.S. Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process.
Future product and market extensions will focus on the diagnosis, screening and monitoring of other cancers. Assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development, as well as circulating tumor cell (CTC) technologies. The commercial viability of an inexpensive, highly accurate diagnostic test is a strong market-driven opportunity.
We believe the Biomoda technology represents a significant market opportunity by addressing a global health crisis. Pending FDA approval of the initial assay for detection of early-stage lung cancer, Biomoda expects its products will find rapid and broad acceptance in the marketplace by offering high sensitivity and accuracy at the cellular level, simple noninvasive use and very affordable cost.
Technology
The CyPath® assay is based upon Biomoda’s patent estate centered on molecular marker technology originally developed at Los Alamos National Labs. TCPP (5,10,15, 20-Tetrakis (Carboxyphenyl) Porphine), a synthetically manufactured porphyrin, is the active ingredient and the basis of CyPath®. The CyPath labeling solution binds to cancerous and pre-cancerous cells in tissue samples and causes them to fluoresce red under ultraviolet light. In internal validation testing, the CyPath® assay showed near 100% accuracy and 100% specificity with no false positives or false negatives.
The ongoing Phase II clinical trial is the first large-scale study of Biomoda’s CyPath® investigational-use-only (not yet FDA-approved) diagnostic. Biomoda recruited at-risk military veterans for the clinical trial, and results are expected in the first quarter of 2010. Funded by the New Mexico State Legislature from the state’s tobacco settlement funds, the veterans screening program is administered by the New Mexico Department of Veterans Services (NMDVS) and the New Mexico Institute of Mining and Technology (NM Tech).
Study volunteers undergo CT scans which are read by independent radiologists and provide deep-lung sputum samples to be screened for cancer with Pap stain analysis performed by independent cytopathologists. The sputum samples are also analyzed in the Biomoda lab with the CyPath® labeling solution. Under the study protocol reviewed by the FDA, those results are compared to the CT scans and Pap analyses. (Until it has received FDA approval, the CyPath® assay may not be used for diagnostic purposes.)
Pivotal Phase III clinical trials are expected to begin in 2010 at multiple locations throughout the United States. Phase III studies will follow the International Early Lung Cancer Action Program (I-ELCAP) enrollment and screening protocol, and all sites will be I-ELCAP approved. Upon completion of the Phase III trials, results and the associated statistical work will be submitted to the FDA for Pre-Market Approval (PMA) as a Class III medical device.
Management Team:
John J. Cousins, President, Chief Executive Officer and Director, has 25 years of management experience. He also serves as Biomoda’s Chief Financial Officer and has 10 years experience as a public company CFO. Mr. Cousins began his career as an electronics engineer, and he has worked for the ABC Television Network and Ampex. He has also been an entrepreneur and owned and operated his own businesses. Mr. Cousins holds undergraduate degrees from the Massachusetts Institute of Technology and Boston University. He earned an MBA from the Wharton School of Business at the University of Pennsylvania.
Constance Dorian, Vice President of Technical Operations, earned a B.S. in Biology from San Diego State University. She has 20 years experience in the design and development of In Vitro diagnostic assays, clinical studies, quality control, quality assurance, product support programs, product improvement programs, cost reduction programs, contract negotiations, inventory control, and production planning following FDA Guidelines.
Gordon Bennett, Fluorescence Microscopist, has a B.S. in physics as well as a J.D. from the University of New Mexico. His background is in photonics and electronics. Previously, he served as an adjunct faculty member at the College of Santa Fe and has held the Chair in Photonics and Biophotonics at Central New Mexico Community College in Albuquerque, New Mexico. He is currently a member of the Optical Society of America and the New Mexico State Bar.
Angela Dayile, Research Associate, holds science degrees from the University of New Mexico. Her expertise is in the coordination, conduction, and analysis of environmental and clinical research. She is currently working towards an M.S. in Health Education.
Tim Zannes, General Counsel, is a partner in the Zannes Firm. He previously ran a private investigation firm in New Mexico after leaving a position with the Albuquerque City Attorney’s Office. He worked for the firm of Lambros and Lambros in Cleveland, Ohio. Mr. Zannes attended the University of North Carolina and the University of New Mexico where he earned his JD degree.
Verrity Gershin, Director of Administration, has 11 years of experience in accounting, corporate filings and corporate administrative support. Ms. Gershin assisted with Biomoda’s initial public offering and provides assistance on compliance with federal securities law. Ms. Gershin holds a bachelors degree from the University of New Mexico.
Directors:
John J. Cousins, President, Chief Executive Officer and Director, has 25 years of management experience. He also serves as Biomoda’s Chief Financial Officer and has 10 years experience as a public company CFO. Mr. Cousins began his career as an electronics engineer, and he has worked for the ABC Television Network and Ampex. He has also been an entrepreneur and owned and operated his own businesses. Mr. Cousins holds undergraduate degrees from the Massachusetts Institute of Technology and Boston University. He earned an MBA from the Wharton School of Business at the University of Pennsylvania.
David Lambros, Director, was the elected law director of Brook Park, Ohio, and presently serves as the law director of the Village of Valley View and the Village of Kelley’s Island, Ohio. As law director, Mr. Lambros serves as chief legal counsel to cities negotiating with corporations and businesses, and is an expert in municipal law. Mr. Lambros has practiced law for more than 25 years and served on various boards, including Commerce Exchange Bank and Southwest General Hospital. Mr. Lambros presently is a director on the Systems Board at Southwest General Hospital, a multi-million dollar company.
Lewis White, Director, is Chief Executive Officer and Director of New Energies Nebraska, LLC, a subsidiary of Standard Alcohol Company. Previously, Mr. White was CEO of Los Hojas Corporation and owned a successful childcare business for 20 years. He has also been a real estate investor, principal of a food services business catering to niche markets and an employee of the State of Nebraska. Mr. White earned a business administration degree from the University of Nebraska at Omaha. He is a major shareholder in Biomoda.
Maria Zannes, Director and Corporate Secretary, brings more than 30 years of experience in the environmental and energy industries where she worked in multiple capacities, including federal lobbyist and company president. Formerly president of a national waste-to-energy trade group in Washington, D.C., Ms. Zannes currently consults for private clients in the medical and environmental industries. Ms. Zannes was a legislative aide and press secretary to U.S. Rep. Charles Wilson (D-Texas) after leaving her home state of New Mexico where she began her career as a journalist. Ms. Zannes is licensed to practice law in Washington State and New Mexico.
Medical Advisors:
Thomas Bauer, MD, is Chief of Thoracic Surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Newark, Delaware, and Principal Investigator of the Biomoda Phase II clinical trial currently underway. He is also a clinical assistant professor of surgery at Jefferson Medical College and adjunct assistant professor of biological sciences at the University of Delaware. He has lead several lung and esophageal cancer studies and heads up Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP). Dr. Bauer has authored dozens of peer- and nonpeer-reviewed publications and abstracts and serves on many committees and programs.
Dan Merrick, MD, is known for his work in anatomic and clinical pathology, and molecular genetic pathology. He has published several papers on lung cancer and is an expert on sputum cytology. Dr. Merrick graduated from the University of Washington Medical School.
Tim Kennedy, MD, is associated with the University of Colorado and specializes in internal medicine, pulmonology and cytopathology. He is an expert in sputum cytology. Dr. Kennedy has authored many peer-reviewed publications, belongs to dozens of professional societies and serves on many committees. He has held faculty positions at the University of Arizona and University of Colorado Health Sciences Center.
Ramesh Gopal, MD, is a board-certified radiation oncologist serving as Medical Director of radiation treatment at the M.D. Anderson Cancer Center satellite at the Presbyterian Kaseman Hospital in Albuquerque, New Mexico.
Lara Patriquin, MD, is a Principal Investigator for Biomoda’s Phase II clinical trial. Dr. Patriquin is a radiologist at Radiology Associates and Presbyterian Hospital in Albuquerque, New Mexico.
Steve Groshong, MD, PhD, is a pathologist at the National Jewish Hospital in Denver and Assistant Professor at the University of Colorado, Denver.
Clinical Advisors:
Richard Phillips MSPH, PhD is a Principal Consultant in Medical Device development at Quintiles Consulting. He had four years of employment at FDA’s Office of Device Evaluation, serving as a first-line scientific reviewer in the Chemistry and Toxicology Branch, Division of Clinical Laboratory Devices, and then as Chief, Anesthesiology and Defibrillator Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices. Before joining FDA, Dr. Phillips worked for three in vitro diagnostic device companies, serving each company in the capacity of Director of Clinical Research/Clinical Affairs. Dr. Phillips is a Diplomate of the American Board of Forensic Toxicology, and the author of numerous papers in clinical chemistry, analytical and forensic toxicology, and in vitro diagnostic devices. He is a member of the American Association for Clinical Chemistry, Association of Clinical Scientists, Clinical Ligand Assay Society, Society of Forensic Toxicologists, and the American Academy of Forensic Sciences. Dr. Phillips earned his BS in Biology and Chemistry from Marian University, Indianapolis, IN, his MSPH from Univ. of North Carolina, Chapel Hill, NC, and his Ph.D. from Indiana University, Bloomington, IN.
Richard Holcomb PhD is an Associate Senior Consultant with Quintiles. Dr. Holcomb works with clients in the medical device, pharmaceutical, biologic, and biotechnology industries to develop and implement preclinical and clinical development plans, with special emphasis in medical devices regulated by the Food and Drug Administration (FDA). Dr. Holcomb has a B.S. in Mathematics from Michigan Technological University, an M.S. and a Ph.D. in Biometry from the University of Minnesota.
Tom Zimmerman, CRO Project Advisor with Alquest, Inc., has 25 years experience in clinical laboratory operations and management. He is an expert in laboratory logistics, data management, point-of-care issues, quality assurance and validation. Mr. Zimmerman has worked for Nichols Institute Reference Laboratories, SmithKline Beecham Clinical Laboratories, Focus Diagnostics, Medtox Laboratories, ViroMed Laboratories, and Mayo Medical Laboratories/Clinical Trial Services where he was senior analyst programmer and more recently Operations Administrator for Core Laboratory Services. Tom earned his BA from St Cloud State University in Minnesota
Patents:
Outstanding Shares as of November 16, 2009: 76,923,012
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Phoenix Arizona 85014
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