SEATTLE, WA--(Marketwired - Jun 3, 2014) - Atossa Genetics Inc., (NASDAQ: ATOS) today announced it has hired John E. Sawyer as Senior Vice President of Global Regulatory Affairs and Quality Assurance effective June 1, 2014. For the past fifteen months, Mr. Sawyer has played a key advisory role as Atossa's Regulatory Affairs/Quality Assurance consultant, advising Atossa's Executive Management Team on Atossa's quality management systems and regulatory affairs activities with the U.S. Food and Drug Administration. Beginning now, Mr. Sawyer will be responsible for establishing and executing the regulatory strategy for Atossa for both the U.S. and international markets, ensuring that the quality management system appropriately addresses all U.S. and International quality standards while maintaining positive and pro-active interactions with U.S. and international regulatory authorities.
Mr. Sawyer brings 25 years of Regulatory Affairs and Quality Assurance experience in medical devices in both U.S. and international markets, including regulatory standards, product life-cycle management, risk management, R&D, clinical studies, post-market surveillance, supply chain management and acquisitions. In addition, Mr. Sawyer has established quality management systems based on the FDA Quality System Regulation, ISO-13485, Canadian Medical Device Conformity Assessment System and the European Medical Device Directive along with quality management system remediation activities to return organizations into compliance with these standards. Mr. Sawyer replaces Ben Chen, the former head of regulatory and quality assurance for Atossa.
"John has been instrumental in our ongoing efforts to create a world-class quality management system and obtain ISO and CE Mark certifications" said Dr. Steven Quay, Chairman, CEO and President of Atossa. "John's extensive and in-depth working knowledge of domestic and international regulatory affairs and quality assurance as well as his detailed understanding of Atossa's regulatory needs, gained over the last 15 months advising us, will be critical to our success for growth and development of our product portfolio and ensuring that we obtain our regulatory licenses and clearances as we commercialize our products in U.S. and foreign markets."
Prior to joining Atossa Genetics, Mr. Sawyer owned his own consulting firm, Realistic Quality Solutions LLC, located in Snohomish, Washington from June 2010 until present. From April 2009 to June 2010, he was the Vice-President of Quality Assurance & Regulatory Affairs for Cardiac Science. He also served as the Vice-President, Quality Assurance & Regulatory Affairs for Welch-Allyn from May 2003 to April 2009. He has served in other leadership positions with Fujifilm Medical Systems and GE OEC Medical Systems. He is also affiliated with the Association of the Advancement of Medical Instrumentation (AAMI) where he teaches various quality management training courses, published articles and participated in various quality management webinar's. Mr. Sawyer holds an MBA and a B.S. in Business Administration from Tampa College in Tampa, Florida.
On June 2, 2014, and as an inducement to cause Mr. Sawyer to join the Company, he was awarded an option to purchase a total of 200,000 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 but are subject to the terms of that plan. The stock option has an exercise price equal to $1.41 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. Sawyer'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 LDTs 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 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 accept-able 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 in the United States and foreign markets 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.