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Atossa Personalized Medicine Slides

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January 18-19, 2011 presentation

January 18-19, 2011 presentation

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  • $322 per Patient Weighted AverageCosts are under $20 per slide
  • Breast cancer prevention
  • As MASCT System biomarker tests expand the availability of additional NAF would be usefulAdministration of oxytocin 5 to 10 minutes before MASCT collection provides up to a 10-fold increase in NAFUS Patent 5,798,226, exclusively licensed to Atossa, covers the use of oxytocin for NAF collectionAdditional clinical trials and FDA approval will be required for Oxy-MASCT commercialization
  • Transcript

    • 1. Mobile Android Apps
    • 2. The Next Generation in Women’s Health Solutions
      Advancing Women’s Breast Health
    • 3. Patented, FDA-Cleared
      Breast Cancer Risk Assessment Test
      Inexpensive, Cost Effective, Painless, Safe Adjunct to Mammography
      Potential to Significantly Reduce Breast Cancer
      “The Pap Test for Breast Cancer”
      3
    • 4. Atossa Genetics
      Two-Pronged Medical Solution
      Collect
      NAF
      Diagnose
      NAF
      Cytology & Biomarker
      Services
      MASCT System Product
      4
    • 5. Atossa Genetics
      Two-Pronged Business Model
      Product and Service Revenue
      $13 Billion Annual US Market
      Near-Term Launch in 2011
      Experienced Management
      5
    • 6. The Breast Cancer Problem
      1 In 8 Lifetime Cancer Risk
      519,000 New Cases per Year
      Literally One Death/Minute
      $3.8 Billion Financial Burden
      6
    • 7. Breast Cancer
      Doesn’t Happen Overnight
      Takes > 8 Years to Develop
      Identifying Pre-Cancerous Changes Empowers Patients & Physicians
      Obtaining Samples Has Not Been Practical- Until Now
      Despite Shortcomings, 38.9 MM Women in U.S. Have Annual Mammograms
      7
    • 8. Pap Test
      for Breast Cancer
      Both Cervical and Breast Cancer Develop Over About a Decade
      The Cervix Undergoes Similar Pre-Cancerous Changes
      PAP Test has lowered Cervical Cancer by 74%
      PAP Test is Most Successful Screening Test in Medical History
      8
    • 9. Atossa
      Products & Services
      SERVICES:
      Slides Prepared and Interpreted in Atossa Laboratory; Report Prepared: Medicare: $322 per Patient
      PRODUCTS:
      Mammary Aspirate Specimen Cytology Test or (MASCT)
      Reusable device for collecting Nipple Aspirate Fluid (NAF), which contains cells
      Pump: $200
      Patient kit: $50
      9
    • 10. Patient Flow and Procedures
      Painless,
      10 minute Test -
      No radiation
      MAMMOGRAPHY OR
      CLINIC
      PATIENT WAITING
      FOR TEST
      Cytology report
      START
      MASCT SYSTEM
      COLLECTS SAMPLE
      ATOSSA LABORATORY
      PREPARES SLIDES
      SAMPLES ARE SHIPPED
      FOR ANALYSIS
      10
    • 11. Atossa Services:Patented Cytology and IHC
      Patient List Prices are Two-to Over Three-Times Medicare Reimbursement Rates
      80% Normal
      INITIAL ROUTINE STAINING
      20% Hyperplasia
      Reflex IHC
      11
    • 12. Clinical Utility:Over 200 papers and 20,000 Women
      NIPPLE ASPIRATE FLUID CYTOLOGY AND THE GAIL MODEL FOR BREAST CANCER RISK ASSESSMENT IN A SCREENING POPULATION
      Jeffrey A. Tice,1 Rei Miike,2 Kelly Adduci,3 Nicholas L. Petrakis,2 Eileen King,2 and Margaret R. Wrensch2
      1 Division of General Internal Medicine, Department of Medicine, 2Department of Epidemiology and Biostatistics, and
      3 Cancer Center, University of California, San Francisco, San Francisco, California
      BREAST CANCER RISK IN WOMEN WITH ABNORMAL CYTOLOGY IN NIPPLE ASPIRATES OF BREAST FLUID
      M. R. Wrensch, N. L. Petrakis,R. Miike, E. B. King, J. Neuhaus, M. M. Lee (Department of Epidemiology and Biostatistics, School of Medicine), K. Chew (Cancer Center), University of California, San Francisco; M. Rhys, School of Nursing, University of California, Los Angeles
      THE ROLE OF NIPPLE-ASPIRATE FLUID CYTOLOGY IN BREAST-CANCER RISK SCREENING
      Joel Bentz, M.D., Clinical Professor of Pathology, University of Utah, Salt Lake City, UT
      12
    • 13. Why Should a Women
      Have a MASCT Test?
      Predicts breast cancer up to 8 years in advance
      Mammography cannot detect pre-cancers
      Actionable information
      Increased screening frequency
      Preventive measures
      MASCT is simple, quick,
      convenient, painless, safe
      (no radiation), and cost effective
      13
    • 14. How Do You Use the Information?
      Step 1: Test NAF For Hyperplasia
      Step 2: If Present, Treat For 6 Months
      Step 3: Retest NAF For Treatment Success
      No Mammography
      Changes
      33 patients 6 mo therapy
      BASELINE:
      CYTOLOGY, ADH
      PSA BIOMARKER = 37.5
      FOLLOW-UP:
      CYTOLOGY, IMPROVED
      PSA BIOMARKER = 112
      Sauter et al. Breast. 16(5):489-94, 2007
      14
    • 15. MASCT Procedures & Revenue
      At $372 Per Patient, Total Available Market In
      the U.S. Exceeds $13 Billion Per Year
      MAMMOGRAPHY
      CLINIC
      Mammography Clinic Demographics
      8600 Centers in the U.S.
      Each Center Provides 4500 Mammograms per Year
      38.9 Million Mammograms per Year in the U.S.
      15
    • 16. All MASCT Steps Are Patented
      US Patent 6,887,210
      US Patent 6,889,073
      Mammography Clinic or office
      Patient waiting for test
      Cytology report
      US Patent 6,887,210
      US Patent 6,889,073
      US Patent 6,889,073
      MASCT System
      Collects NAF
      ATOSSA LABORATORY PREPARES SLIDES
      SAMPLES SHIPPED FOR ANALYSIS
      16
    • 17. Worldwide Patent Protection:14 Issued Patents with Additional Pending
      Canada
      Europe
      Japan
      United States
      HONG KONG
      Australia
      17
    • 18. Competition:Breast Cancer Screening
      Neomatrix is a privately held company with a device that collects fluid From the breast for screening
      250 machines placed
      Performed over 50,000 tests
      18
    • 19. MASCT Launch Calendar
      Q1 2011
      MANUFACTURING FOR FIELD TESTING DONE
      LABORATORY IDENTIFIED AND LEASED DONE
      Q2 2011
      FIELD TESTING BEGINS
      LABORATORY CLIA-REGISTRATION
      Q3 2011
      REGIONAL ROLL-OUT IN PACIFIC
      NORTHWEST
      Q3 2012
      NATIONAL ROLL-OUT
      19
    • 20. 2nd Generation Product:Oxy-MASCT System
      Additional NAF would be aid biomarker
      detection
      Atossa discovered oxytocin increases NAF 10X
      US Patent 5,798,226 covers oxytocin use for
      NAF collection
      Additional clinical trials & FDA approval needed
      20
    • 21. 2nd Generation Services:Molecular Biomarkers
      MicroRNA Patterns
      Next Gen Sequencing
      DNA Methylation
      Transcriptome
      Proteomics
      Glycosylation
    • 22. Management & Board of Directors
      Steven C. Quay, M.D., Ph.D., Chairman, CEO
      Christopher Benjamin, CFO
      Shu-Chih Chen, Ph.D., Chief Scientific Officer
      Mr. John Barnhart, Former Senior Walt Disney Executive
      Stephen Galli, M.D., Chairman, Pathology Dept.,
      Stanford Medical School
      Alexander Cross, Ph.D., Former CEO, Syntex Corporation
      22
    • 23. 5 FDA Approved Drugs and 1 Device Invented and Developed
      Steven C. Quay, M.D., Ph.D.
      23
    • 24. Pharmaceutical Business Experience:Patent, Development, Marketing
      Over $1.3 Billion In Negotiated Milestone
      Payments, Up-front Payments, And Other Consideration
      24
    • 25. Princess Atossa
      “IN 518 B.C., PRINCESS ATOSSA, WIFE OF DARIUS THE GREAT, BECAME THE FIRST WOMAN IN RECORDED HISTORY TO BE DIAGNOSED WITH BREAST CANCER. SHE WAS TREATED BY THE COURT PHYSICIAN, DEMOCEDES, BUT DIED SHORTLY THEREAFTER.
      “ATOSSA GENETICS IS DEDICATED TO HER AND THE MILLIONS OF WOMEN WHO HAVE SUFFERED FROM THIS DREADED DISEASE.”
      Steven C. Quay, M.D., Ph.D.
      Founder, Chairman, President and CEO
      Princess Atossa
      25
    • 26. The Next Generation in Women’s Health Solutions
      Advancing Women’s Breast Health
      Steven C. Quay, MD, PhDChairman, CEO, And President
      4105 E Madison St, Suite 320 Seattle, WA 98112
      T: 206.325.6086 STEVEN.QUAY@ATOSSAGENETICS.COM
      26

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