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Preventing Breast Cancer by Measuring & Eliminating Risk

The Breast Health Company™. Preventing Breast Cancer by Measuring & Eliminating Risk. NASDAQ: ATOS. 1. Forward Looking Statement.

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Preventing Breast Cancer by Measuring & Eliminating Risk

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  1. The Breast Health Company™ Preventing Breast Cancer by Measuring & Eliminating Risk NASDAQ: ATOS 1

  2. Forward Looking Statement This presentation has been prepared by Atossa Genetics, Inc. (the “Company”) as of December 5, 2012. It should not be considered as an offer or invitation to subscribe for or purchase any securities in the Company or as an inducement to make an offer or invitation with respect to those securities. It has been prepared for information purposes only. This presentation contains general summary information and does not take into account the investment objectives, financial situation and particular needs of any individual investor. It is not investment advice and prospective investors should obtain their own independent advice from qualified financial advisors having regard to their objectives, financial situation and needs. Certain statements contained herein, including, without limitation, statements containing the words “believes,” “intends” and other words of similar import, constitute “forward-looking statements” within the meaning of section 7a of the Securities Act of 1933, as amended, and section 21e of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual results to differ materially from projected results. Accordingly, investors should not place undue reliance on forward-looking statements as a prediction of actual results. The forward-looking statements may include projections and estimates, the timing and success of specific projects and our future operating results and financial condition. When we use the words "will," "believe," "intend," "expect," "may," "should," "anticipate," "could," "estimate," "plan," "predict," "project," or their negatives, or other similar expressions, the statements which include those words are usually forward-looking statements. When we describe strategy that involves risks or uncertainties, we are making forward-looking statements. The forward-looking statements in this presentation, if any, speak only as of the date of this presentation; we disclaim any obligation to update these statements. We have based these forward-looking statements on our current expectations and assumptions about future events. While our management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory and other risks, contingencies and uncertainties, most of which are difficult to predict and many of which are beyond our control. Neither the delivery of this presentation nor any further discussions by the Company or its representatives with any of the recipients shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since such date. This document contains confidential and proprietary information. Unauthorized possession, use or disclosure of the enclosed information is strictly prohibited and will be prosecuted under all applicable state and federal laws.

  3. The Breast Cancer Epidemic • Most-feared disease among women • In US, 235,000 new cases per year • 30 new cases every hour, 24/7 • Treatment >$13 billion per year • Doesn’t happen overnight • 10-year reversible process, if identified early (earlier than mammography)

  4. Breast Cancer and the Sick Lobe • Two breasts: 14 lobe-duct units • Hyperplasia in one lobe-duct starts 10-year march to cancer • Even if remaining 13 ducts are completely normal! • Hyperplasia is fully reversible until the final stage

  5. How Atossa Prevents Breast Cancer • Find high-risk women who have “sick lobes” • Find the sole “sick lobe” • Treat only the “sick lobe” (not entire patient) with intraductal therapy to eliminate hyperplasia

  6. Finding the “Sick Lobe" • Patented, FDA-cleared medical device and laboratory test developed over 14 years • Atossa can test 110M women, 18 to 73, to find high-risk women with “sick lobes” (reversible hyperplasia) • Launched 1H 2012 at $500 per patient $55 billion TPM

  7. ForeCYTE Breast Health Test • FDA-cleared, non-invasive biopsy device • Made in the USA • CLIA-certified test • Launched Dec 2011 • 17 patents • Device revenue: • $30/patient • Test revenue: • $500/patient

  8. How ForeCYTE Works Microscopic Results IBIS Risk Algorithm Personal Reproductive History Family history of Breast cancer Developed from a registry of 158,041 women in whom 3,257 breast cancers occurred

  9. 10-year March to Cancer Atossa Revenue Model Laboratory Analysis with Report Generation Sampling Kit Sales to Doctors Normal Cancer Reversible Hyperplasia Breast Pump and Kit Sales to Doctors

  10. 2. Finding the Sole “Sick Lobe” • Patented, FDA-cleared device and test, developed over 14 years; $50M+ R&D • Find “sick lobes” in 10M high-risk women • 1H 2013 launch at $3500/patient $35 billion TPM

  11. FullCYTE Microcatheter System • FDA-cleared microcatheter finds the sole “sick lobe” and the six normal ducts • 19 issued US patents • Microcatheter revenue: $700/patient • Laboratory Revenue: $3500/patient

  12. Treatment 3. Treat only the “Sick Lobe” (not the entire patient) to Eliminate Hyperplasia • Patented intraductal treatment with positive clinical data published Oct 2012 • Initial market: adjunct to Ductal Carcinoma in Situ surgery • 66,000 per year • 2H 2013 clinical trials begin

  13. Atossa Devices & Tests 1 4 CLIA-certified, patented Laboratory Developed Tests FDA-cleared, patented medical devices Product Revenue Service Revenue 3 2

  14. Early ForeCYTE Adoption:> $20K Revenue/MD/year Revenue X 1000 Gross Profit 92%

  15. Co-Marketing & Sales Plan • Diagnostic Testing Group • 50+ years experience laboratory diagnostics • Branded Clarity Diagnostics provides immediate office and clinic recognition • Co-marketing • 24 direct national sales reps • Extensive GPO contracts • Contract with national distributorswith >5,000 ISR Goal: 33,000 Ob-Gyn customers

  16. ForeCYTE Launch Team: 5,000 Strong

  17. Reimbursement Atossa Revenue Model • In general, currently out-of-network • Multiplan Contract speeds revenue • Atossa’s first payer contract • 20% of Americans covered by plan • Reimbursement at 90+% of list price; payment within 30 days • A steppingstone to in-network contracts over next 24 months Laboratory Analysis with Report Generation Sampling Kit Sales to Doctors

  18. The Atossa Cancer Prevention Plan Care Path Business Model US women age 18 to 73 at risk of breast cancer Normal Risk 0 to 15% Intermediate Risk 15 to 20% High Risk >20% Microcatheter System Intraductal Treatment to prevent cancer

  19. Intellectual Property Care Path Business Model • FDA Medical Device Market Authorizations • 11 510(k)-cleared and two 510-exempt medical devices • CLIA-certified Laboratory Developed Tests • Four validated tests • Patents • >179 issued patents (56 in US & 123 foreign) • 50 pending applications • Trademarks • One registered and seven pending

  20. The Atossa Breast Health Care Path Care Path Business Model US women age 18 to 73 at risk of breast cancer Normal Risk 0 to 15% Intermediate Risk 15 to 20% High Risk >20% Newly Diagnosed Breast Cancer Breast Cancer Survivors

  21. Two Diagnostics for Cancer Local disease Systemic disease

  22. The Atossa Breast Health Care Path Care Path Business Model US women age 18 to 73 at risk of breast cancer Stratify 110 MM High Risk >20% Intermediate Risk 15 to 20% Normal Risk 0 to 15% 10 MM Assess Breast Cancer Survivors Newly Diagnosed Breast Cancer Profile Monitor 2.9 MM 0.2 MM

  23. Management Team Care Path Business Model Management Team • CEO • Steven C Quay, MD, PhD, FCAP • CFO • Christopher Benjamin • CSO • Shu-Chih Chen, PhD • VP Marketing & Sales • TBD in December 2012 • Operations • Michael Malafronte

  24. Management Team Care Path Business Model Board of Directors • Steven Quay, Chairman • John Barnhart: Former Disney Executive • Shu-Chih Chen, PhD • Alexander Cross, PhD: Former Syntex Executive • Stephen Galli, MD: Chairman, Stanford Pathology Department • Lawrence Remmel, Esq: Securities Atty (early-stage healthcare company financing expertise)

  25. Key Financial Metrics • Revenue: $273K (1H 2012) • Gross Profit: $233K (1H 2012) • Gross profit margin of 92%! • Total Op Expenses: $2.5M (1H 2012) • Monthly burn rate (1H 2012) ~ $370K • Shareholder Equity: $3.9M (adjusted, 06.30.12 ) • Accumulated Deficit (04.09 – 06.12): $6.9M • Shares Outstanding: 12.1M common; no preferred; 7.2M warrants at $1.56 per share

  26. 2013 Milestones Management Team Care Path Business Model • Q1 • ForeCYTE National launch • NextCYTE development advancement • Q2 • ArgusCYTE national launch • FullCYTE national launch • Q3 • Intraductal treatment program initiates pre-clinical toxicology work • Q4 • Intraductal treatment program initiates clinical trials

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