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
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
Notas del editor
$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