1

Preventing Breast Cancer by Measuring & Eliminating Risk

The Breast Health Company™

NASDAQ: ATOS

Forward Looking StatementThis 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.

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)

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

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

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

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

How ForeCYTE Works

           

Acellular Category 0 Category I Category II Category III Category IV

Microscopic Results

Family history ofBreast cancer

Personal Reproductive

HistoryDeveloped from a registry of 158,041 women in

whom 3,257 breast cancers occurred

IBIS Risk Algorithm

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

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

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

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

Atossa Devices & Tests

FDA-cleared, patented medical

devices

CLIA-certified, patented Laboratory

Developed Tests

ServiceRevenue

ProductRevenue

1

2

3

4

Early ForeCYTE Adoption:> $20K Revenue/MD/year

Revenue X 1000

Q4 11 Q1 12 Q2 120

50

100

150

200

250

GrossProfit92%

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 ISRGoal: 33,000 Ob-Gyn customers

ForeCYTE Launch Team:5,000 Strong

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

Family History: No

CancerFamily 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 73at risk of breast cancer

Normal Risk0 to 15%

Intermediate Risk15 to 20%

High Risk>20%

Intraductal Treatmentto prevent cancer

MicrocatheterSystem

Care Path Business Model Intellectual Property

• 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

Family History: No

CancerFamily 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 73at risk of breast cancer

Normal Risk0 to 15%

Intermediate Risk15 to 20%

High Risk>20%

Newly DiagnosedBreast Cancer Breast Cancer Survivors

Two Diagnostics for Cancer

Local disease

Systemic disease

Family History: No

CancerFamily 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 PathUS women age 18 to 73at risk of breast cancerStratify 110 MM

Normal Risk0 to 15%

Intermediate Risk15 to 20%

High Risk>20%

Assess

10 MM

Newly DiagnosedBreast Cancer

Breast Cancer Survivors

Profile Monitor0.2 MM 2.9 MM

Management Team

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 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

Management Team

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 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)

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

Management Team

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 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