SOURCE: Atossa Genetics Inc

Atossa Genetics Inc

March 04, 2015 08:00 ET

Atossa Genetics Launches the ForeCYTE Breast Aspirator Within the European Union

SEATTLE, WA--(Marketwired - Mar 4, 2015) - Atossa Genetics Inc. (NASDAQ: ATOS), announced today that it has begun to launch the ForeCYTE Breast Aspirator and Collection Kit within the European Union, focusing initially on The Netherlands, Germany, Switzerland, and the United Kingdom.

Dr. Steven Quay, Chairman, CEO & President of Atossa Genetics, commented, "Launching and commercializing the ForeCYTE device in the EU is one of our key objectives for 2015 and we are pleased to announce that we have taken a significant step forward in achieving this goal. We have accepted an initial order for ForeCYTE Breast Aspirators and Collection Kits from the University Medical Center Utrecht, The Netherlands, which will be fulfilled by our logistics provider, Rhenus Logistics, located in The Netherlands." 

The University Medical Center Utrecht, The Netherlands, is a leading university and medical school in the region and a center that performs seminal research on nipple aspirate fluid. UMC Utrecht plans to use the ForeCYTE device to expand their ability to provide community outreach of their breast care capabilities. The university has been Europe's leading institution for nipple aspirate fluid research for over a decade. "We anticipate that our ForeCYTE Breast Aspirator and Collection Kit will provide a broad platform of research possibilities," continued Dr. Quay.

Professor Paul van Diest, M.D., Ph.D., of the university stated: "We are now seeing the opportunity to use nipple aspirate fluid in the routine surveillance of potential abnormalities in the breast. NAF carries a range of possible markers, including DNA, microRNA, proteins, molecules and cells."

In addition, various studies using Atossa's ForeCYTE device are planned in each of these mentioned geographic areas.

Dr. Quay continued: "Atossa is very proud of the lineup of European opinion leaders who are interested in using our technology. Atossa is focused on four objectives in 2015 for the benefit of all of our stakeholders, especially women with serious breast disease:

  • Launching and commercializing the FullCYTE Breast Aspirator in the U.S. market;

  • Launching and commercializing the CE-marked ForeCYTE Breast Aspirator in the EU, and other non-U.S. markets;

  • Achieving top-line combined gross revenue of $8.0 million from medical device sales and laboratory services, including our pharmacogenomics test offering, and;

  • Initiating pharmaceutical clinical trials in women for the treatment of serious breast diseases via local delivery of pharmaceuticals, potentially reducing systemic adverse events.

Launching the ForeCYTE device in the EU significantly advances our key objectives. We look forward to announcing additional progress in each of these important objectives over the coming weeks and months."

About Atossa Genetics

Atossa Genetics Inc. is focused on improving breast health through the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health, Inc. The laboratory services 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 more information, please visit www.atossagenetics.com.

About University Medical Center Utrecht

UMC Utrecht was created in the year 2000 by merging the Academic Hospital Utrecht (founded 1875), Wilhelmina Children's Hospital (founded 1888) and the Medical Faculty of Utrecht University (founded 1636). With over 11,000 employees, 1,042 beds, UMC Utrecht offers basic-specialist care as well as advanced care requiring extraordinary knowledge or expertise, it performs leading scientific research, and offers excellent education to its 3,500 students, as well as its researchers, physicians and other healthcare providers. UMCU undertakes six strategic research programs, among them in Personalized Breast Cancer Care. For more information, please visit www.umcutrecht.nl/pers.

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, the outcome or timing of regulatory approvals needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to achieve its objectives, continue to manufacture and sell its products, recalls of products, the safety and efficacy of Atossa's products and services, performance of distributors, 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.