ATOS Atossa Therapeutics Inc

Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that it has provided suggested changes to the draft recommendation of the United States Preventative Services Task Force (USPSTF) concerning “Breast Cancer: Medications for Risk Reduction.” The public comment period ends February 11, 2019 and the finalized USPSTF recommendations will become available in July 2019.

Atossa Genetics has proposed that the USPSTF recommendations include the following additional guidance:

• Mammographic breast density (MBD) provides the only patient level, biology-based assessment that is predictive of future breast cancer and it is modifiable. All women undergoing mammography should be informed of their breast density and its relationship to breast cancer incidence, risk and mammographic sensitivity. 
• Tamoxifen, but not raloxifene or aromatase inhibitors, is effective in reducing MBD and this reduction is associated with a reduced risk of estrogen-receptor positive breast cancer.

“Atossa is dedicated to the prevention of breast cancer through the use of mammography to identify women with MBD,” stated Dr. Steven Quay, Chairman and CEO of Atossa Genetics. “There are over 3,400 peer-reviewed articles on the relationship between mammographic breast density and the risk of future breast cancer. Many states have laws that require that women be told their breast density at the time they have a mammogram, as well as the impact a high density has on both reducing the sensitivity of cancer detection and increasing cancer incidence. Our recommended changes are based on a substantial, peer-reviewed foundation of research and, if accepted, should improve the utility of this widely used guidance.”

Dr. Quay added, “It is our hope that when this recommendation is updated in the future, Atossa’s proprietary Endoxifen, the active metabolite of tamoxifen, will be the leading approach to reduce breast density.”

You can leave your own comments for the USPSTF here: URL for comment. The comment period ends February 11, 2019.

About United States Preventative Services Task Force

Created in 1984, the USPSTF is an independent, volunteer panel of national experts in prevention and evidence-based medicine. The Task Force works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services such as screenings, counseling services, and preventive medications. All USPSTF recommendations are published on the Task Force’s Web site and/or in a peer-reviewed journal.

Forward-Looking Statements

Forward-looking statements in this press release, which Atossa undertakes no obligation to update, 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 and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, higher than anticipated drop-outs by study participants including because of skin irritations in our Phase 2 MBD study, results of clinical studies, the safety and efficacy of Atossa’s products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others, such as patent rights, 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.

Atossa Genetics Company Contact:

Kyle Guse CFO and General Counsel (O) 866 893-4927 kyle.guse@atossagenetics.com

Investor Relations ContactScott Gordon CorProminence LLC 377 Oak Street Concourse 2 Garden City, NY 11530 Office: 516.222.2560 scottg@coreir.com

Source: Atossa Genetics Inc