SOURCE: Atossa Genetics Inc.

Atossa Genetics Inc.

April 02, 2014 08:30 ET

Ben R. Chen Joins Atossa Genetics as Senior Vice President of Global Regulatory Affairs and Quality Assurance

SEATTLE, WA--(Marketwired - Apr 2, 2014) - Atossa Genetics, Inc. (NASDAQ: ATOS) announced today that Ben R. Chen has joined the Company as Senior Vice President of Global Regulatory Affairs and Quality Assurance, a newly created position. Mr. Chen will oversee all facets of Atossa's regulatory affairs, providing oversight for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities, and all quality assurance matters.

Mr. Chen brings 20 years' experience in Quality Systems for biologics, drugs, and medical devices in compliance with domestic and international regulations and guidelines for product lifecycle; R&D, pre-clinical studies, clinical trials, commercial operations, and post-market surveillance programs. In addition, Mr. Chen has implemented and managed robust quality risk programs through supplier and material qualification control, clean room qualification, equipment qualification, computer system validation, process validation, analytical method validation, cleaning validation, sterilization validation, and shipping and packaging validation.

"Ben Chen brings tremendous experience in regulatory affairs and we are excited to have him join the team at this important juncture as we continue to advance our pipeline of products and services directed toward breast health," said Dr. Quay. "Ben's extensive industry experience and in-depth knowledge of regulatory affairs and quality assurance will be invaluable as we complete development of products and services in our pipeline, obtain the necessary regulatory clearances, and initiate commercialization."

Prior to joining Atossa Genetics, Mr. Chen served as Vice President, Global Quality Assurance and Regulatory Affairs at WuXi AppTec Biopharmaceutical Company, located in Shanghai, China, from December 2012 to the present. From October 2011 to November 2012, he served as Vice President, Quality Assurance and Regulatory Affairs at Formosa Laboratories, Inc., in Taoyuan, Taiwan. Earlier, he served in increasingly responsible positions at Sandoz International GmbH, ZymoGenetics, Inc., Genentech, Inc., Baxter BioScience, Inc., Eli Lilly and Company, and Cargill, Inc. Mr. Chen holds a M.S. in Biotechnology from Johns Hopkins University and a B.S. in Chemical Engineering from Purdue University.

On April 1, 2014, and as an inducement to cause Mr. Chen to join the Company, he was awarded an option to purchase a total of 300,000 shares of common stock of the Company, par value $0.001 per share, which are outside the Company's 2010 Stock Option and Incentive Plan. The stock option has an exercise price equal to $1.69 per share, the fair market value on the grant date and vests over a four-year period from his commencement of service. This stock option was granted as an inducement material to Mr. Chen's entering into employment with the Company and is being reported in accordance with NASDAQ Listing Rule 5635(c)(4).

About Atossa Genetics

Atossa Genetics Inc. is focused on improving breast health through the development of laboratory developed tests (LDTs), medical devices and therapeutics. The Company's LDTs are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The LDT's and the Company's medical devices are being developed so they can be used as companions to therapeutics to treat various breast health conditions. For additional information, please visit www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, including timing of review by the FDA of 510(k) submissions, and actions related thereto, whether Atossa can submit additional information to the FDA in a timely fashion and whether the FDA will find that information acceptable and/or request additional information, the outcome of the FDA re-inspection completed on March 14, 2014, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa's products and services, performance of distributors, estimated future expenses and cash needs, whether Atossa can launch the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

Contact Information

  • Contact:

    Atossa Genetics, Inc.
    Kyle Guse
    CFO and General Counsel
    (O) 800-351-3902
    Email Contact

    Matthew D. Haines (Investors)
    Managing Director
    MBS Value Partners
    (O) 212-750-5800
    Email Contact