Investors: Atossa Genetics at a Glance

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Business Description: “The Pap Smear for Breast Cancer”

Atossa Genetics, Inc. (“Atossa”) is engaged in the commercialization of an FDA-cleared screening test for breast cancer. The FDA has indicated that the device can be used with cytology to “differentiate normal versus premalignant versus malignant” changes. Atossa intends to launch the product in 2011.

Company Background

The company was founded in 2009 by Steven Quay, MD, PhD, who holds 75 US patents, has invented five FDA-approved drugs, and has started and/or managed five companies. He was formerly on the faculty of the Stanford University School of Medicine and received training at the University of Michigan, MIT, and Harvard Medical School.

Products

Atossa has received FDA clearance to market the Mammary Aspirate Specimen Cytology Test System (MASCT System™), a medical device (below, left) which is designed to collect a small amount Nipple Aspirate Fluid (NAF) (below, right) for diagnostic purposes. The test takes ten minutes, uses no radiation, and is painless.

Services

Atossa will perform all testing of NAF samples in a CLIA-certified clinical laboratory to be established by the company.

Technologies / Special Know-how

The device is protected by 14 issued patents worldwide covering the US, Europe, Japan, Australia, Canada, and Hong Kong. Additional applications, including China, India, and Taiwan are pending. Patents protect both the device and the laboratory services.

Second generation diagnostic products and services derive from additional patented technologies in which samples of breast fluid, containing cancer biomarkers and abnormal and malignant cells, are obtained from the breast following administration of oxytocin, a brain hormone involved in lactation that increases NAF production.

Markets

All women undergoing mammography, having a cervical Pap Smear, or a general physician visit should receive the test. The potential market is over 35 million women per year in the US and over 100 million worldwide. Outside the US, where mammography is less available, the test may become the primary screening modality.

Distribution Channels

Product will be initially distributed by a regional direct sales force calling on mammography clinics and Ob/GYN practices. The adoption goal is to have this procedure performed during routine mammography and/or Pap smear tests.

Bank

JP Morgan Chase Bank NA

Auditor

KCCW Accountancy Corp

Law Firms

Corporate: Ropes & Gray LLP
Intellectual Property: Wilson, Sonsini, Goodrich & Rosati LLP