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

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Presentation on theme: "1 Preventing Breast Cancer by Measuring & Eliminating Risk The Breast Health Company™ NASDAQ: ATOS."— Presentation transcript:

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

2 Forward Looking Statement This presentation has been prepared by Atossa Genetics, Inc. (the “Company”) as of December 5, 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 1.Find high-risk women who have “sick lobes” 2.Find the sole “sick lobe” 3.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 AcellularCategory 0Category ICategory IICategory IIICategory IV Microscopic Results Family history of Breast cancer Personal Reproductive History Developed from a registry of 158,041 women in whom 3,257 breast cancers occurred IBIS Risk Algorithm

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

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 Acueity HC Ductoscope Acquired Q Breast endoscope Biopsy tools and accessories – Six FDA-cleared medical devices – 35 issued and 41 pending patents Launch 2H 2013

13 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

14 Atossa Devices & Tests FDA-cleared, patented medical devices CLIA-certified, patented Laboratory Developed Tests Service Revenue Product Revenue

15 Atossa Devices & Laboratory Tests

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

17 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 distributors with >5,000 ISR Goal: 33,000 Ob-Gyn customers

18 ForeCYTE Launch Team: 5,000 Strong

19 Atossa Revenue Model Sampling Kit Sales to Doctors Laboratory Analysis with Report Generation Reimbursement  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

20 Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Care Path Business Model The Atossa Cancer Prevention Plan US women age 18 to 73 at risk of breast cancer Normal Risk 0 to 15% Intermediate Risk 15 to 20% High Risk >20% Intraductal Treatment to prevent cancer Microcatheter System

21 Care Path Business Model Intellectual Property FDA Medical Device Market Authorizations – (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

22 Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Care Path Business Model The Atossa Breast Health Care Path 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

23 Two Diagnostics for Cancer Local disease Systemic disease

24 Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Care Path Business Model The Atossa Breast Health Care Path US women age 18 to 73 at risk of breast cancer Stratify 110 MM Normal Risk 0 to 15% Intermediate Risk 15 to 20% High Risk >20% Assess 10 MM Newly Diagnosed Breast Cancer Survivors ProfileMonitor 0.2 MM 2.9 MM

25 Management Team Family History: No Cancer Family history: Cancer Low Risk CytopathologyExpected resultsBiopsy-based Reassurance High Risk CytopathologyBiopsy-based ConcernExpected Results 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

26 Management Team Family History: No Cancer Family history: Cancer Low Risk CytopathologyExpected resultsBiopsy-based Reassurance High Risk CytopathologyBiopsy-based ConcernExpected Results 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)

27 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, ) Accumulated Deficit (04.09 – 06.12): $6.9M Shares Outstanding: 12.1M common; no preferred; 7.2M warrants at $1.56 per share

28 Management Team Family History: No Cancer Family history: Cancer Low Risk CytopathologyExpected resultsBiopsy-based Reassurance High Risk CytopathologyBiopsy-based ConcernExpected Results Care Path Business Model 2013 Milestones  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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