Have You read “Let’s Dance?” Vista Partners Weekly Market Update 3-24-18

Vista Partners has published “Let’s Dance?” Vista Partners Weekly Market Update 3-24-18   and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies.

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Atossa Genetics Expands Breast Health Program With Mens’ Initiative

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.

Seattle based Atossa Genetics Inc. (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, recently announced that it has expanded its breast health program by launching a mens’ breast health initiative with enrollment opening in a Phase 1 study of its proprietary topical Endoxifen in men. Tamoxifen is an active metabolite of tamoxifen, an FDA approved drug for breast cancer in women. The objectives of the placebo-controlled, repeat dose study of 24 healthy male volunteers are to assess the pharmacokinetics of proprietary topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability.

Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa, commented that “Initiating a program for mens’ breast health is a natural extension for our proprietary Endoxifen, which has focused on women to date. This Phase 1 study of topical Endoxifen in men should serve as a foundation for future development into mens’ breast health, including male breast cancer and gynecomastia. Men being treated for prostate cancer currently have limited options to address the gynecomastia that is associated with their cancer treatment, such as breast-bud irradiation, estrogen suppression therapy and surgery.”

After reviewing the data obtained from our recently-completed Phase 1 study in women, expanding our program to include the men, whose breast health is often underserved, was a logical next step. We have progressed rapidly in this endeavor having engaged the necessary contract research organizations and having submitted and received approval to open the study for enrollment. This will be the first of other studies targeting mens’ breast health. We look forward to reporting progress on this study as well as the other anticipated studies we are commencing in 2018.”

The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.  CPR Pharma recently completed the successful Phase 1 study of Atossa’s oral and topical Endoxifen in women.

The American Cancer Society (ACS) estimates that approximately 266,000 women will be diagnosed with breast cancer in the United States this year and that approximately 41,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,550 new cases of invasive breast cancer will be diagnosed; and 480 men will die from breast cancer in 2018.

Similar to women, the treatment for male breast cancer is typically surgery (with or without radiation) and chemotherapy. Breast cancer in men is deadlier than breast cancer in women: men with early-stage breast cancer have a lower five-year survival rate than women and breast cancer in men tends to be detected at a later stage of development than women (Jon M. Greif, DO, FACS, et al., May 2012, American Society of Breast Surgeons). Although tamoxifen is the standard of care for women to prevent new and recurrent breast cancer, there is no FDA-approved treatment for male breast cancer.

Endoxifen Background

Oral tamoxifen has been widely used for over 40 years to both treat and prevent breast cancer. Tamoxifen, however, has significant drawbacks: First, it can cause side effects including headaches, nausea and early menopausal symptoms as well as rare but serious side effects such as cataracts, stokes and cancer of the uterus. Second, tamoxifen is a “pro-drug,” meaning that it must be processed by the liver in order to produce therapeutic (“active”) metabolites. The metabolite in tamoxifen that accounts for most of its therapeutic activity is called Endoxifen. Unfortunately, up to 50% of breast cancer survivors who are taking tamoxifen do not produce therapeutic levels of Endoxifen (meaning they are “refractory”) for a number of reasons, including that they, due to their genotype, do not have the requisite liver enzymes. Additionally, it can take from 50-200 days for tamoxifen to reach “steady-state” meaning that the drug may be providing little or no benefit for up to several months after starting treatment.

Atossa is developing topical Endoxifen for women with mammographic breast density, or MBD, and for men with gynecomastia or breast cancer. There is no FDA-approved therapeutic for gynecomastia and male breast cancer. They estimate that approximately ten million women in the United States have MBD, for which there is no FDA-approved treatment. Although oral tamoxifen is approved to prevent breast cancer in “high-risk” women, it is used by less than 5% of women with an increased risk of developing breast cancer because of the actual or perceived side effects and risks of tamoxifen. They believe their topical Endoxifen may provide an effective treatment for MBD because, unlike an oral medication, it is applied directly to the breast and penetrates the skin; it does not require metabolism by the liver; and it may produce fewer side effects than tamoxifen. Moreover, their topical Endoxifen may improve mammography accuracy and patient care by unmasking cancerous tumors that are otherwise hidden by breast density, and reduce the risks of over diagnosing potential tumors when more highly sensitive imaging methods are used.

Second, Atossa is developing oral Endoxifen for breast cancer patients who are refractory to tamoxifen. Approximately one million breast cancer patients take tamoxifen to prevent recurrent and new breast cancer; however, up to 50% of those patients are refractory to tamoxifen. They believe their Endoxifen may provide an effective treatment supplement or option for these refractory patients because Endoxifen, unlike tamoxifen, does not require liver metabolism.

Atossa  recently completed a comprehensive Phase 1 study in 48 healthy women in Australia using both the topical and oral forms of their proprietary Endoxifen. They concluded that all objectives were successfully met in both arms of the study: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, there were low but measurable Endoxifen levels detected in the blood in a dose-dependent fashion and in the oral arm of the study participants exhibited dose-dependent Endoxifen levels in published reports of the therapeutic range. The median time for patients in the study to reach the steady-state serum levels of Endoxifen while taking daily doses of oral Endoxifen was 7 days. Published literature indicates that it takes approximately 50-200 days for patients to reach steady-state Endoxifen levels when taking daily doses of oral tamoxifen. Finally, the median time for patients in the study to reach the maximum serum level of Endoxifen after taking Atossa’s oral Endoxifen ranged from 4 to 8 hours (depending on dose). The 4 mg dose of Endoxifen produced a maximum serum level of Endoxifen in 4 to 8 hours at levels above the generally accepted threshold for a therapeutic effect on estrogen-dependent breast cancer.

In September 2017, Atossa contracted Stockholm South General Hospital in Sweden to conduct a Phase 2 study of their topical Endoxifen. The primary endpoint is MBD reduction, as well as safety and tolerability. Atossa is planning to open this study in the first half of 2018 and to complete it in the second half of 2018. Atossa plans to commence a Phase 2 clinical study using their oral Endoxifen for patients who are refractory to tamoxifen. Atossa has retained a clinical research organization to manage the study and they plan to open the study in the first half of 2018 and to complete it in the second half of 2018.  Atossa has now opened enrollment in our Phase 1 study of topical Endoxifen in men.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Launches Mens’ Breast Health Program

SEATTLE, March 22, 2018– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announced …..

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Happy St. Patty’s Day Weekend! “Lucky Charms For You?” Vista Partners Weekly Market Update 3-17-18 Now Available!

Vista Partners has published “Lucky Charms For You?” Vista Partners Weekly Market Update 3-17-18   and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30, International and Select Emerging Growth Companies.

Each weekly update issue is sent out via email directly to the thousands of investors around the world that have elected to be updated each week. Please “Join us” Today!

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Have You Read “In The Green, Again?” Vista Partners Weekly Market Update 3-10-18

Vista Partners has published “In The Green, Again?” Vista Partners Weekly Market Update 3-10-18  and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30 and Select Emerging Growth Companies.

Each weekly update issue is sent out via email directly to the thousands of investors around the world that have elected to be updated each week. Please “Join us” Today!

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Breast Cancer Therapeutics Innovator Atossa Genetics 2017 Results & Recent Developments Highlighted

Seattle based Atossa Genetics Inc. is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.

Today Atossa announced the following recent developments:

Successful Phase 1 Study

All objectives of Atossa’s recent Phase 1 study of its proprietary oral and topical formulations of Endoxifen were successfully met: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level. The median time for patients in the study to reach the steady-state serum levels of Endoxifen while taking daily doses of Atossa’s oral Endoxifen was 7 days. Published literature indicates that it takes approximately 50-200 days for patients to reach steady-state Endoxifen levels when taking daily doses of oral tamoxifen.

TRAP CAR-T Program

In October 2017, they announced that they are developing a novel method to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer. This approach uses their proprietary intraductal microcatheter technology for the potential transpapillary, or “TRAP,” delivery of either T-cells that have been genetically modified to attack breast cancer cells or various immunotherapies.

They believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells or immunotherapy; improved efficacy by placing the T-cells or immunotherapy in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells or immunotherapy potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. Their approach is in the R&D stage and is currently not FDA approved.

Expansion of Scientific Advisory Board

At the end of 2017, they added Dr. Carl Novina to our Scientific Advisory Board. Together with Dr. Jack Cuzick, they now have a world-renowned group advising on the scientific and medical aspects of their programs.

Capital Raising Activity

In 2017, they made significant improvements to their balance sheet by raising approximately $12 million in capital, which strengthened their balance sheet and improved their stockholder base with the addition of institutional biotech-focused investors.

Atossa also provided the following 2018 potential milestones:

First half of 2018 – opening the Phase 2 Study of topical Endoxifen to treat MBD at Stockholm South General Hospital in Sweden (which they plan to complete in 2018)

First half of 2018 – opening the Phase 2 Study of oral Endoxifen to treat patients who are not responding to Tamoxifen (which they plan to complete in 2018).

Second half of 2018 – commencing one or more studies to demonstrate safety and efficacy of administering TRAP CAR-T or another immunotherapy with their microcatheters.

Throughout 2018 – Identifying additional opportunities for their Endoxifen formulations; and Continuing our Phase 2 study administering Fulvestrant with their microcatheters.

Dr. Steve Quay, President and CEO, commented, “In the later part of 2017, we completed a Phase 1 Study of our proprietary oral and topical Endoxifen formulations, and we were pleased to report that all study objectives were met. We are now looking forward to opening enrollment in two Phase 2 studies.  One will use our oral Endoxifen to treat breast cancer patients who are not responding to tamoxifen.  Tamoxifen is the current FDA-approved standard of care for the approximately one million breast cancer survivors to prevent a recurrence and new cancer.  The second study will use our topical Endoxifen to determine if it can reduce a condition called mammographic breast density, or MBD.  Mammographic Breast Density is an independent risk factor for developing breast cancer.  It affects approximately 10 million women in the U.S.  We are also planning to commence an additional study with topical Endoxifen as well as a study using our intraductal microcatheters to deliver CAR-T or other immunotherapy.”

Atossa provided the following 2017 Financial Results:

Revenue and Cost of Revenue: For the years ended December 31, 2017 and 2016, they have no source of sustainable revenue and no associated cost of revenue.

Operating Expenses: Total operating expenses were $7,649,171 for the year ended December 31, 2017, which is a decrease of $319,419 or 4.0%, from the year ended December 31, 2016.  Operating expenses for 2017 consisted of general and administrative (G&A) expenses of $4,859,369, R&D expenses of $2,328,087, and impairment of their Acueity intangible assets of $461,715.

General and Administrative Expenses: G&A expenses were $4,859,369 for the year ended December 31, 2017, a decrease of $1,619,824, or 25.0% from the total G&A expenses for the year ended December 31, 2016, of $6,479,193.  G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses.  The 2017 decrease in G&A expense was primarily attributable to a reduction in payroll expenses resulting from decreased headcount, rent and exit costs incurred in 2016.  At the beginning of 2016, their strategy shifted away from the commercialization of medical devices towards focusing exclusively on the development of their pharmaceutical and microcatheter candidates.

Research and Development Expenses: R&D expenses for the year ended December 31, 2017, were $2,328,087, an increase of $1,557,660, or 202% from R&D expenses in 2016 of $770,427.  The increase in R&D expenses is attributed to salaries, manufacturing, and clinical trial expenses associated with their Endoxifen program for which manufacturing commenced at the beginning of 2017 and the clinical studies commenced in mid-2017.  They expect their R&D expenses to increase throughout 2018 as they commence Phase 2 clinical studies of Endoxifen, continue the clinical trial of fulvestrant administered via their microcatheters and as they continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via their intraductal microcatheters.

Cash and Cash Equivalents: As of December 31, 2017, the Company had approximately $7.2 million in cash and cash equivalents and working capital of approximately $6.7 million.

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Announces 2017 Financial Results and Provides Company Update

SEATTLE, March 08, 2018– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announces …..

finance.yahoo.com

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New Fed Chair Jerome Powell Cools Overheating Talk & Confirms Gradual Approach

Jerome Hayden Powell is an American former investment banker, who is the current Chair of the Federal Reserve. He was nominated to the position by President Donald Trump and confirmed by the United States Senate. Based on public filings, Powell’s net worth is estimated to be as much as $112 million making him the richest member of the Federal Reserve Board of Governors.

Powell, during a Senate Banking Committee hearing in Washington, D.C., U.S., on Thursday, March 1, 2018, stated the following:

“By continuing to gradually raise interest rates over time we are trying to … achieve inflation moving up to target, but also make sure that the economy doesn’t overheat.”

“There is no evidence that the economy is currently overheating.”

“I will be honest. I would have thought you would have seen more wage increases by this point.”

“We’ve got an economy with strong momentum. … I do think you will begin to see wages coming up.”

These statements seemed to catch the market off-guard today as the Dow 30 sold off 420.22 points into the close off -1.68% for the day as it closed at 24,608.98.

Recently, Vista Partners (“Vista”) published February’s FREE Macroeconomic & Investment Monthly Newsletter, “Clear Skies Ahead?” Vista’s monthly newsletter contains investment considerations for Banks,Biotech, Cloud Services, Energy, Fintech, Healthcare, Manufacturing, Materials, Real Estate, SaaS, and Technology. Vista Partners centers its Coverage on the Dow 30 Components, Select Emerging Growth Companies & Vista’s Featured Companies, with exclusive, broad-based commentary from Managing Director, John F. Heerdink, Jr.

In February’s edition of the Macroeconomic & Investment Newsletter, Mr. Heerdink states, “For anyone holding long-term Treasuries, this could be a nightmare. If we see a move….” Read full newsletter.

Companies Featured in February’s Newsletter: Apple (AAPL), Atossa Genetics, Inc. (NASDAQ: ATOS) | Caterpillar (CAT) | Disney (DIS) | Fusion, Inc. (NASDAQ: FSNN) | & General Mills (GIS).

Vista Partners publishes 100% of its content free. Vista Partners offers a wealth of mixed-media resources on the Dow 30 & Select Emerging Growth Companies. To receive FREE email updates from Vista’s select & extensive coverage universe, please sign up at VistaPGlobal.com/signup.

 

Powell Plays Down Overheating Risk While Asserting Gradual Path

Federal Reserve Chairman Jerome Powell pushed back against the notion that the U.S. economy is close to overheating, as he fine-tuned the message on his outlook while reinforcing his commitment to a gradual …..

finance.yahoo.com

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House Bill 258 Seeks To Force Health Care Providers to Tell Patients If They Have Dense Breast Tissue

Approximately 10 million women have high breast density in the United States and there is currently no FDA-approved treatment for this condition. For more information about breast density please visit www.areyoudense.org

Recently, House Bill 258 advanced to the senate and proposes that health care providers would be required to tell patients if they have dense breast tissue and to consider further cancer screenings.

The proposed notice reads:

“Your mammogram indicates that you have dense breast tissue. Dense breast tissue is common and is found in as many as half of all women.

However, dense breast tissue can make it more difficult to fully and accurately evaluate your mammogram and detect early signs of possible cancer in the breast.

You might benefit from additional professionally recognized forms of cancer screening examinations, depending on your personal risk factors and family history.

This information is being provided to inform and encourage you to discuss your dense breast tissue and other breast cancer risk factors with your physician or health care provider.

Together, you can decide which screening options are best and most effective for you. A copy of your mammography report has been sent to your physician and health care provider.

Please contact them if you have any questions or concerns about this notice.”

 

President and CEO of Seattle, WA based Atossa Genetics (NasdaqCM: ATOS), Dr. Steven Quay, commented on this subject recently, “The presence of dense breast tissue can make it more difficult to evaluate the results of a mammogram because dense breast tissue is comprised of less fat and more stromal tissue which appears white on a mammogram. Cancer also appears white and tumors are therefore often hidden or masked by the dense tissue. Breast density is also associated with an increased risk of breast cancer. Although numerous states have recently enacted laws requiring that patients be notified of breast density, there is no federal standard and approximately 20 states still do not require that information about density be conveyed to the patient. We believe woman have the right to receive this important health information and we applaud the pending federal legislation. In addition, the provisions in the legislation that require expansion of programs and research activities related to breast density should improve diagnosis capabilities and accelerate treatments for this major breast cancer risk factor; which is one of only a few risk factors that can actually be modified.” Atossa is developing the drug Endoxifen for tamoxifen-refractory breast cancer patients, the treatment of mammographic breast density and other breast conditions. Atossa’s proprietary Endoxifen is being developed as an oral form as well as a topical solution, like a lotion, that can be applied directly to the breast. Atossa recently completed a Phase 1 study of its oral and topical Endoxifen and reported that all objectives of that study were successfully met. A Phase 2 study will be conducted at Stockholm South General Hospital in Sweden and will be led by principal investigator Dr. Per Hall, M.D., Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet.

 

To learn about the interesting work that Seattle, WA based biotech firm Atossa Genetics (NasdaqGM: ATOS) is doing in breast cancer treatment please visit the Vista Partners ATOS Company Dedicated Page.

Bill warning women of dense breast tissue advances to Senate

SALT LAKE CITY, Utah (News4Utah) A house bill advanced to the senate Friday that would require doctors to notify women if a mammogram discovers dense breast tissue…

www.good4utah.com

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Vista Partners Publishes The February 2018 FREE Macroeconomic & Investment Monthly Newsletter

Vista Partners (“Vista”) has published February’s FREE Macroeconomic & Investment Monthly Newsletter, “Clear Skies Ahead?”.

Vista’s monthly newsletter contains investment considerations for Banks, Biotech, Cloud Services, Energy, Fintech, Healthcare, Manufacturing, Materials, Real Estate, SaaS, and Technology.

Vista Partners centers its Coverage on the Dow 30 Components, Select Emerging Growth Companies & Vista’s Featured Companies, with exclusive, broad-based commentary from Managing Director, John F. Heerdink, Jr.

In February’s edition of the Macroeconomic & Investment Newsletter, Mr. Heerdink states, “For anyone holding long-term Treasuries, this could be a nightmare. If we see a move….” Read full newsletter.

Companies Featured in February’s Newsletter: Apple (AAPL), Atossa Genetics, Inc. (NASDAQ: ATOS) | Caterpillar (CAT) | Disney (DIS) | Fusion, Inc. (NASDAQ: FSNN) | & General Mills (GIS).

Vista Partners publishes 100% of its content free. Vista Partners offers a wealth of mixed-media resources on the Dow 30 & Select Emerging Growth Companies. To receive FREE email updates from Vista’s select & extensive coverage universe, please sign up at VistaPGlobal.com/signup.

About Vista Partners LLC:

Founded in 2005, Vista Partners LLC (“Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, and Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

We encourage readers to view a complete list of disclaimers and disclosures on the Vista Partners website at VistaPGlobal.com/disclaimer.

Please follow Vista Partners on Twitter @VistaPResearch to receive updates, thoughts, and ideas on Dow 30 Components, Select Emerging Growth Companies & Vista’s Featured Companies.

Contact:

inquiries@VistaPGlobal.com




“Steady Volatility” Vista Partners Weekly Market Update 2-24-18

Vista Partners has published “Steady Volatility” Vista Partners Weekly Market Update 2-24-18 and is accessible on our Newsletters Page. Each issue is written by Managing Director, John Heerdink and speaks to the activities of the market, influencers and specific featured stories from Vista’s Coverage Universe that spans the Dow 30 and Select Emerging Growth Companies.

Each weekly update issue is sent out via email directly to the thousands of investors around the world that have elected to be updated each week. Please “Join us” Today!

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Study Shows Aerobic & Resistance Exercise Serves Breast Cancer Survivors

Researchers from USC recently reported their study of breast cancer survivors showed that aerobic and resistance exercise produced significant improvements in cardiovascular disease, type 2 diabetes & possibly breast cancer recurrence.

Atossa Genetics (NasdaqCM: ATOS) is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions. Recently, Vista Partners Published a FREE Research Report on Atossa Genetics (ATOS). DOWNLOAD the Vista Partners FREE Report at http://www.vistapglobal.com/vp-coverage/atossa-genetics-inc-atos/.

 

Breast Cancer Survivors Improve Health Through Aerobic, Resistance Exercise, USC Study Suggests

Researchers at the University of Southern California (USC) show that patients who underwent aerobic and resistance training three times a week had a significant improvement in factors associated with cardiovascular disease, type 2 diabetes, and possibly breast cancer recurrence…

breastcancer-news.com

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