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MDx Firm Atossa Files for IPO

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Molecular diagnostics firm Atossa Genetics today filed a preliminary prospectus with the US Securities and Exchange Commission to raise up to $17.6 million from an initial public offering.

Proceeds from the offering will be used to create a cytology and molecular diagnostics laboratory focused on breast cancer, and to manufacture and launch its FDA-cleared Mammary Aspirate Specimen Cytology Test System in the Northwestern US, the Seattle-based company said.

Proceeds will also be used to develop a second generation of its MASCT System, to nationally launch the system, and to develop additional laboratory biomarker-based tests.

The company plans to offer up to 3 million units, each unit consisting of one share of common stock, two Class A warrants and one Class B warrant.

Each unit is expected to be priced at between $5 and $7 for the IPO, which will be listed on the New York Stock Exchange Amex under ticker symbol "ATOSU," Atossa said. The securities underlying the units will separate from the units on the 90th day after the date of the prospectus.

After separation, the units will automatically cease trading and be cancelled, and the common stock and Class B warrants will be traded on NYSE Amex under ticker symbols "ATOS" and "ATOSW" respectively. The Class A warrants will not be listed for trading.

Dawson James Securities is the sole book-running agent on the offering.

In its preliminary prospectus, Atossa calls itself a development-stage healthcare firm focused on commercializing cellular and molecular diagnostic risk assessment products and services for the detection of precancerous conditions that may lead to breast cancer.

Its lead product is the MASCT System, a device and method for collecting, shipping, and clinical analysis of nipple aspirate fluid, which contains cells and biomarkers "useful in detecting breast cancer and cellular changes that may be precursors to breast cancer," the company said.

The system was invented by Steven C. Quay, who founded Atossa in April 2009. He also currently serves as its CEO. Quay previously served as chairman and CSO of MDRNA; chairman, president, and CEO of Nastech Pharmaceutical; and chairman, president, and CEO of Sonus Pharmaceuticals.

Atossa said that it has engaged a contract manufacturer to produce 20 MASCT Systems and 10,000 test kits, "which we intend to field test for purposes of confirming the proper operation of the device and its ability to collect adequate NAF samples in the fourth quarter of 2010." It expects to launch the system in Q1 2011 following the completion of the IPO.

The NAF sample collection device will be priced at about $200 per device, the patient kits at $50 per kit, and cytology and molecular diagnostics testing and analysis service at between $106 and $1,202 per patient depending on the complexity of the analysis.

Atossa has recorded no revenues since its inception and a net loss of $384,778, or $0.08 per share, it said in its S-1. R&D costs total $21,250 since its founding. As of June 30, it had $40,098 in cash and cash equivalents, it said.

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