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The Breast Health Company™

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Presentation on theme: "The Breast Health Company™"— Presentation transcript:

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

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
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 Personal Reproductive History
How ForeCYTE Works Acellular Category 0 Category I Category II Category III Category IV 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 Atossa Revenue Model 10-year March to Cancer Laboratory Analysis with
Report Generation Sampling Kit Sales to Doctors Normal Reversible Hyperplasia Cancer 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 Acueity HC Ductoscope Acquired Q3 2012 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 1 4 CLIA-certified, patented Laboratory
Developed Tests FDA-cleared, patented medical devices Service Revenue Product Revenue 3 2

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 Rudov: In every slide, I, the investor, have one question: How will this make me money? The most important point you must make is that 5,000 salesreps will call on 30,000 doctors (what kind of doctors?), who will buy the Atossa NAFerator instantly because…..(tell us why). This will lead to $M in revenues by 2013.

18 ForeCYTE Launch Team: 5,000 Strong

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

20 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% Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Microcatheter System Intraductal Treatment to prevent cancer

21 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

22 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% Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Newly Diagnosed Breast Cancer Breast Cancer Survivors

23 Two Diagnostics for Cancer
Local disease Systemic disease

24 The Atossa Breast Health Care Path
Care Path Business Model 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% 10 MM Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results Assess Newly Diagnosed Breast Cancer Breast Cancer Survivors Profile Monitor 0.2 MM 2.9 MM

25 Care Path Business Model
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 Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results

26 Care Path Business Model
Management Team Care Path Business Model Board of Directors Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results 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 Care Path Business Model
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 Family History: No Cancer Family history: Cancer Low Risk Cytopathology Expected results Biopsy-based Reassurance High Risk Cytopathology Biopsy-based Concern Expected Results

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