As we age, hormone production begins to decrease. For men, this means producing lower levels of testosterone which, if left untreated, can cause an array of unpleasant symptoms. Need to know if youre experiencing symptoms of Low T? Take this quiz below and find out.

Low testosterone can manifest itself in a number of ways. Some of the most common symptoms experienced are weight gain, weakness, fatigue, loss of libido, mood disturbances, and hair loss.

Testosterone has a widespread impact on the way the body works and affects nearly every organ system. T plays a key role in metabolism, by affecting how the body uses its caloric intake and encouraging muscle protein synthesis. Excess abdominal fat can decrease the bodys levels of testosterone and boost estrogen production in males.

The most common reason for lowered T production is simply aging. Research has shown that testosterone levels in aging males fall 1-2% each year after age thirty.

Scientists have also found a link between low T and chemical imbalances in the brain, which may be why men with low T frequently report symptoms such as low libido, fatigue, and mood disturbances.

In recent years two different studies one done by researchers at Saint Louis University and the other by the Kobe University Graduate School of Medicine in Japan found that testosterone replacement therapy was an effective treatment for mild depression.

Men who have low T frequently report muscle weakness this is sometimes due to a decrease in muscle mass caused by low T levels.

Evidence has shown that both high and low levels of T can cause mood disturbances and emotional side effects.

Low libido is a common side effect of low T and is one of the main reasons men with low T pursue hormone replacement therapy,

As testosterone levels decrease men usually begin to see an increase in weight gain. Stomach fat, in particular, can increase estrogen levels in men, which can make T levels drop even further.

Often, low T goes hand-in-hand with low bone density (osteoporosis). The Endocrine Society lists TRT as an effective treatment option for men with low bone density and hypogonadism.

Testosterone plays a vital role in muscle building and maintenance. When T levels drop, men frequently report a decrease in muscle mass and strength.

Testosterone levels spiking during puberty leads to hair growth and other primary and secondary sex traits in young men. But as those levels diminish in older men, testosterone loss can often bring about thinner hair and male pattern baldness.

While low T isnt a direct cause of ED in aging men, its frequently seen as a contributor to sexual dysfunction because it decreases libido and can cause a lack of enjoyment of intimacy.

Testicular shrinkage and a decrease in sperm output is a common symptom of men with hypogonadism.

Though typically thought of as a menopause symptom, andropause can cause this uncomfortable side effect as well.

To find out if you have Low T, click the button below to take the quiz.

Link:
Low T Symptoms Quiz: Do I Have Low Testosterone Quiz ...

The physicians at Mantality accept insurance for the treatment of testosterone deficiency, or Low T, in order to make it the most affordable option for any man seeking treatment.

According to Mantality founder Kevin J. Meuret,my desire was to help get this type of care within the reach of any man who needed treatment. Many patients who could benefit from treatment dont seek it out because of the fear of cost. We have eliminated that concern by developing a program that is covered by insurance along with Board Certified physicians guiding care.

Mantality is staffed with Board Certified medical physicians, nurse practitioners, and nurses specializing in low testosterone treatment.

Putting care within reachof every man who needs treatment is at the heart of this clinic. Testosterone treatment used to be considered elective or optional. Today we know it is essential. Men suffering with Low T are no different than men suffering with diabetes. A medical condition that is treatable needs proper diagnosis, appropriate medication, and monitoring by specialists. This is exactly what we provide.

We believe men should have access to care, and our accepting insurance gives more people that convenience.

The treatments offered by the physicians at Mantalityare customized to fit individual testosterone needs with prescription medications that can only be prescribed by licensed practitioners. The treatment is simple, covered by insurance carriers, and can be available for less than $100 a month!

We acceptallmajor insurance providers so, if you dont see yours listed, give us a call.

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Does Insurance Cover Low T Treatment - Mantality Health

Company has Partnered with Sterling Medical to Finalize the Development of Cedars-Sinai-Developed 'Healight' Medical Device for Use in Patients with Coronavirus

ENGLEWOOD, CO / ACCESSWIRE / April 27, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

"Sterling has been working with the Cedars-Sinai team for the past several weeks on a very accelerated schedule to develop this much needed device," said Dan Sterling, President of Sterling Medical Devices. "We are happy to now be partnering with Aytu to further advance this critical project as fast as we possibly can for the many patients in need."

"The Aytu team is very pleased to be working with Sterling Medical on this important development program and in the fight against coronavirus," stated Josh Disbrow, Chairman and CEO of Aytu BioScience. Disbrow further commented, "Sterling has a stellar reputation as a best-in-class medical device product firm with more than 21 years of experience, over 1,100 projects engineered, with none failing to receive FDA regulatory approval upon submission. Our team is actively engaged with our colleagues at Sterling in an effort to finalize the device development, with hope of enabling human use in the very near future."

The company believes the Healight platform technology has the potential to positively impact outcomes for critically ill patients infected with coronavirus and other infections. Aytu, with support of the team at Cedars-Sinai, is working with the FDA to determine an expedited regulatory process to potentially enable near-term use of the technology initially as a coronavirus intervention for critically ill intubated patients.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial in China and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

About Sterling Medical Devices

Founded in 1998, Sterling Medical Devices (SMD), specializes in the product design and engineering of medical devices for the healthcare industry. Dedicated to resolving their clients' medical device design and engineering challenges, SMD addresses the whole development process, including, product design and human factors, systems, software, electronics, mechanical, quality, and compliance. The company utilizes the latest tools and technology to streamline the engineering process to speed regulatory approval of Class I, II and III devices. To date, the company has spearheaded the production of over 1,100 projects for more than 300 clients. SMD is internationally recognized and is FDA QSR 21, CFR 820, and 21 CFR Part 11 compliant, ISO 13485 registered, and IEC 62304, ISO 14971, IEC 60601, and IEC 62366 compliant. For more information, please visit http://www.sterlingmedicaldevices.com or call 201.227.7569 x2.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, our ability to enforce the exclusivity provisions of the distribution agreement, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, the manufacturer of the COVID-19 Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, our ability to obtain additional COVID-19 Rapid Tests to meet demand, our ability to secure additional tests if the manufacture of the COVID-19 Rapid Tests is unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization.

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/587152/Aytu-BioScience-Signs-Development-Agreement-with-Sterling-Medical-Devices-to-Advance-the-Development-of-Healight-as-a-Potential-Coronavirus-Treatment

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Aytu BioScience Signs Development Agreement with Sterling Medical Devices to Advance the Development of Healight as a Potential Coronavirus Treatment...

The Low T Therapy Market (2020) research report explores the market in terms of Revenu, Emerging Market Trends and Driver includes up to date analysis and forecasts for various market segments, major players, and all geographical regions till 2027.

The coronavirus epidemic (COVID-19) has affected all aspects of life around the world. This has changed some of the market situation. The main purpose of the research report is to provide users with a broad view of the market. Initial and future assessments of rapidly changing market scenarios and their impact are covered in the report. The report will account for Covid19 as a key market contributor.

The top players covered in Low T Therapy Market are: AbbVie, Endo International, Eli Lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

Download Sample PDF PagesClick Here!

This report sample includes: Brief Introduction to the research report, Table of Contents (Scope covered as a part of the study), Top players in the market, Research framework (presentation), Research methodology adopted by Worldwide Market Reports

Low T Therapy Market Outlook:

Global Low T Therapy market report provides exclusive coverage that has been provided for market drivers and challenges & opportunities for a country-level market in the respective regional segments. The report comprises a competitive analysis of the key players functioning in the market and covers in-depth data related to the competitive landscape of the market and the recent strategies & products that will assist or affect the market in the coming years.

Market Drivers and the Risks Associated with the Low T Therapy Market:

The international Low T Therapy market has been characterized by several primary factors, with each factor tends of playing a crucial role in the boom of the market. The growth in the products has doubled with the smoother availability of the customer base that has been helping the company of flourishing globally. On the other hand, the presence of a dynamic supply chain has helped the company to grow exponentially. Therefore, regarding the increase in the opportunities of the market Low T Therapy faces severe complaints from all the aspects.

Enumerating some of the fundamental parameters encompassed in the report:

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When a better look taken at the areas, the market has concentrated, and the file interior the important makes a strong point of Europe, Middle East & Africa, Asia Pacific, Latin America, and North America. These areas have studied regarding the hooked-up traits and the diverse possibilities in addition to the outlook that allows inside the benefitting of the market ultimately.

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Worldwide Market Reports provides customization of reports as per your request. This report can be personalized to meet your requirements. Get in touch with our research team, who will make sure you get a report that suits your necessities.

Continued here:
Peek on Low T Therapy Market Future, Extensive Studies and Prediction of Top Manufacturers Condition: AbbVie, Endo International, Eli Lilly -...

Commercial Distribution of First 100,000 Tests to Commence Upon Receipt of Inbound Product Shipment

ENGLEWOOD, CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the company may begin distribution of its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test throughout the United States. The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers results between 2 and 10 minutes at the point-of-care.

Aytu expects delivery of its first shipment of 100,000 tests this week. The Company has been in discussions with healthcare distributors, healthcare institutions, medical practices, and government agencies and is working quickly to begin distribution into the U.S. healthcare supply chain.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we're optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we're now just days away from placing these COVID-19 test kits into the hands of healthcare professionals."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 126 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test-Related Inquiries:COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/582030/Aytu-BioScience-Submits-Notice-of-Commercialization-to-the-FDA-Allowing-for-Companys-Distribution-of-its-2-10-Minute-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

Original post:
Aytu BioScience Submits Notice of Commercialization to the FDA, Allowing for Company's Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care...

ENGLEWOOD, CO / ACCESSWIRE / April 23, 2020 / Aytu BioScience, Inc. (AYTU) (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, announced the signing of a definitive agreement (the "Agreement") with Singapore-based Biolidics, Limited (SGX: 8YY; "Biolidics") to exclusively distribute Biolidics' COVID-19 IgG/IgM Rapid Test in the United States.

Under the terms of the Agreement, Aytu will exclusively distribute Biolidics' COVID-19 IgG/IgM rapid antibody test in the United States. Aytu has committed to purchase 500,000 tests within one business day from the date of signing of the Agreement. As an additional component of Aytu's exclusivity, the Company has committed to purchase a minimum of 1,250,000 tests within the first three months of the Agreement.

Biolidics' COVID-19 IgG/IgM Rapid Test has been issued Provisional Authorization for distribution by Singapore's Health Science's Authority (HSA), and the product has been authorized for export from Singapore. Biolidics' COVID-19 IgG/IgM Rapid Test will be supplied from Biolidics' facility in Singapore.

Aytu will collaborate with Biolidics and lead the U.S. clinical trials processes and plans to complete and obtain U.S. Food and Drug Administration ("FDA") 510k regulatory filing clearance of the COVID-19 IgG/IgM rapid test kits.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We are pleased to be partnering with Biolidics in distributing this COVID-19 rapid test in the U.S. With the continued call in the United States for increased COVID-19 testing, we are entering this distribution Agreement at an excellent time. We have experienced significant demand for our current COVID-19 rapid test, so adding this test to our product offering will enable us to better meet the high demand in the U.S. We look forward to a productive working relationship with Biolidics and thank them for their confidence in allowing Aytu to take this product to market in the United States."

Incorporated in 2009 and listed on the Singapore Stock Exchange, Biolidics Limited is a Singapore-based precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.

About Aytu BioScience, Inc.

Aytu BioScience, Inc. is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired U.S. distribution rights to two COVID-19 IgG/IgM rapid tests. These coronavirus tests are solid phase immunochromatographic assays used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our ability to successfully commercialize Healight Platform Technology, our ability to obtain FDA approval for the Healight Platform Technology, the effectiveness of the Healight Platform Technology in treating patients with COVID-19 or other illnesses, our ability to adequately protect the intellectual property associated with the Healight Platform Technology, regulatory delays, the reliability of the Healight Platform Technology in killing viruses and bacteria, market acceptance of UV based medical devices, risks associated with the our COVID-19 rapid tests including our ability to enforce the exclusivity provisions of the distribution agreements, the reliability of serological testing in detecting COVID-19, shipping delays and their impact on our ability to introduce the COVID-19 rapid tests, the ability of the COVID-19 rapid tests to accurately and reliably test for COVID-19, the manufacturers of the COVID-19 rapid tests' ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 rapid test kits, the demand or lack thereof for the COVID-19 rapid test kits, our ability to obtain additional COVID-19 rapid tests to meet demand, our ability to secure additional tests if the manufactures of the COVID-19 rapid tests are unable to meet demand, the effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the Company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

Contact for COVID-19 IgG/IgM Rapid Test and Healight-Related Inquiries:

COVID-19@aytubio.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/586556/Aytu-BioScience-Announces-Exclusive-Distribution-Agreement-for-COVID-19-IgGIgM-Rapid-Test-with-Singapore-Based-Biolidics-Limited

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Aytu BioScience Announces Exclusive Distribution Agreement for COVID-19 IgG/IgM Rapid Test with Singapore-Based Biolidics Limited - Yahoo Finance

Company Expects to Seek Regulatory Clearance Under Health Canada and COFEPRIS Expedited Clearance Procedures

ENGLEWOOD, CO / ACCESSWIRE / March 19, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it extended its distribution right to commercialize the clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This amendment expands Aytu's commercial rights and grants Aytu the right to distribute and commercialize the COVID-19 test in North America, specifically including the United States, Canada and Mexico.

The Company expects to pursue expedited regulatory clearance of the product with Health Canada and COFEPRIS (Comisin Federal para la Proteccin contra Riesgos Sanitarios), the regulatory agencies in Canada and Mexico, respectively.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "We have to be progressive in doing our part in combatting the spread of the COVID-19 virus. We need to ensure that screening is available across North America and providing broad access to screening tests has to be among our highest priorities as we collectively fight the coronavirus outbreak. With COVID-19 now designated as a global pandemic, we believe we should expand our efforts to assist healthcare providers with faster point-of-care detection."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Story continues

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Contact for Media and Investors:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/581543/Aytu-BioScience-Expands-Its-Distribution-Rights-for-Coronavirus-2019-COVID-19-Point-of-Care-Rapid-Test-to-Canada-and-Mexico

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Aytu BioScience Expands Its Distribution Rights for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test to Canada and Mexico - Yahoo Finance

We place unreasonable trust in biological explanations of male behaviour. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men presumably those with more T have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientific study to date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognised, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined 1% annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: the science doesnt support this conclusion either. Some of the famous early studies linking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men read: darker-skinned men which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorous research showing little relation between T and aggression, except at very high or very low levels, is just now reaching the general public.

Whats more, it turns out that T is not just one thing a sex hormone with one purpose male reproduction. T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California, compiled a table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were new findings in this period showing the importance of T in promoting ovulation. There is also a difference between correlation and cause. T levels and aggression, for example, provide a classic chicken-egg challenge. As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man or woman, for that matter you cant predict their T level.

Testosterone is a molecule that was mislabelled almost 100 years ago as a sex hormone, because scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything: sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is even evidence that men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a United States Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh. One commentator in Forbes wrote about testosterone-induced gang rapes. Another interviewed on CNN asked, But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school? Yet another column in The New York Times read, Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain, and sometimes excuse, male behaviour in articles and speeches every day. Poetic licence, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behaviour, we can inadvertently excuse male behaviour as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalise the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defence not guilty, by reason of hormones.

Invoking mens biology to explain their behaviour too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about the research showing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in their book Testosterone a social molecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

This article first appeared on Aeon.

Read the original here:
No, not everything about mens sexual behaviour can be explained by testosterone - Scroll.in

ENGLEWOOD, CO / ACCESSWIRE / March 16, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today it was featured on a FOX segment titled: "Englewood company says it can get COVID-19 test results in 2-10 minutes," reported on by affiliated television station in Denver, Colorado, KDVR; and on an NBC segment titled "2-minute COVID-19 test results? Denver-area company wants to deliver that promise," reported on by affiliated television station in Denver, Colorado, KUSA.

To view the video segments in their entirety and to read the articles, please visit the links below:

FOX (VIDEO & Article)

https://kdvr.com/news/coronavirus/englewood-company-says-it-can-get-covid-19-test-results-in-2-10-minutes/

NBC (VIDEO & Article)

https://www.9news.com/article/news/investigations/2-minute-coronavirus-test/73-dca03a0e-0452-42ba-8fe4-2fe8d8e0ffbe

The video segments and articles note:

Statements from the video segments and articles:

Inquiries from healthcare professionals and healthcare institutions should be directed via email to COVID-19@aytubio.com.

Media inquiries should be directed via email to james@haydenir.com.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has been validated in a 113 patient clinical trial and has received CE marking.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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More here:
Aytu BioScience's Coronavirus Rapid Test Featured on NBC and Fox News (VIDEOS): ''Englewood Company Says It Can Get COVID-19 Test Results in 2-10...

Updated FDA Policy Likely Enables Near-Term Availability of COVID-19 Test in the U.S.

ENGLEWOOD, CO / ACCESSWIRE / March 17, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that the company intends to expedite the U.S. launch of its recently licensed COVID-19 IgG/IgM Point-of-Care Rapid Test in light of yesterday's updated FDA policy on coronavirus diagnostic testing.

On March 16, 2020 the FDA announced, "as part of our ongoing and aggressive commitment to address the coronavirus outbreak, the FDA updated a policy originally issued on Feb. 29 on diagnostic testing for coronavirus (COVID-19) in order to achieve more rapid testing capacity in the U.S. We believe the unprecedented policy set forth in today's updated guidance, which addresses laboratories and commercial manufacturers, will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests..." Further, the agency made recommendations specifically for test developers stating that "the FDA does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated" and other labeling conditions are satisfied.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "While we are still working with FDA on making the COVID-19 Rapid Test available, we believe that this updated policy may enable near-term availability of our recently-licensed point-of-care test. During this public health emergency, we are working tirelessly to satisfy all requirements in order to make the test available to the professional medical community as soon as possible." Disbrow also commented that, "We have already gotten confirmation from the manufacturer that our initial supply is being shipped and is expected to arrive in the U.S. very soon."

The company will continue to provide updates about the near-term availability of the COVID-19 test.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

Story continues

Originally posted here:
Aytu BioScience Announces Acceleration of U.S. Availability of COVID-19 IgG/IgM Rapid Test Based on Updated FDA Policy - Yahoo Finance

Low testosterone levels, or "low T," can affect men and women alike.

Testosterone, the primary sex hormone in men, is produced mainly in the testicles, and causes men to develop a deep voice, large muscles, and body hair.

Testosterone is also essential for the production of sperm.

When levels of testosterone fall known as low testosterone or "low T" it can have a profound effect on men, both physically and psychologically.

Normal levels of testosterone in healthy men range from about 300 nanograms per deciliter (ng/dL) up to 1,000 ng/dL, according to Medline Plus.

The normal range is broad and varies by age. In older men, the lower end of "normal" may be lower than in younger men.

Levels of testosterone in the male body rise during and after puberty, then gradually decrease after age 30.

This gradual lowering of testosterone is sometimes referred to as andropause or male menopause.

Testosterone levels may also be lower in men with hypogonadism, a condition in which the body is unable to produce normal amounts of testosterone.

Hypogonadism can occur because of a problem with the testicles or with the pituitary gland, which controls the testicles.

Obesity, having medical conditions such as autoimmune diseases or type 2 diabetes, or using drugs including alcohol or opioids, can also contribute to low levels of testosterone.

Women also produce testosterone, although much less than men: A normal testosterone level in women is 15 to 70 ng/dL according to Medline Plus.

In women, testosterone is produced in the ovaries and the adrenal glands.

Similar to men, low T in women can be caused by a variety of medical conditions as well as by advancing age.

In the years leading up to menopause, women normally experience a drop in testosterone levels.

Low levels in women may be associated with decreased libido, low energy, and depressed mood.

There is some evidence that testosterone replacement therapy can increase sex drive and help with other sexual problems in some women.

But the long-term safety of this treatment is unknown, and some experts say it may raise the risk of breast cancer, though there has yet to be conclusive evidence.

Currently, testosterone preparations are not approved for use in women by the Food and Drug Administration (FDA).

Male hypogonadism may be present from birth or may develop later in life as a consequence of injury or infection.

In infants, symptoms of hypogonadism include:

In boys around the age of puberty, symptoms include:

In men, symptoms of hypogonadism include:

As the level of testosterone in the body decreases with age, men may also experience:

However, these symptoms are nonspecific, meaning they can be caused by many factors, not just low testosterone.

Male hypogonadism is diagnosed based on symptoms, blood tests of testosterone level, and other lab tests, as needed.

It's typicallytreated with testosterone replacement therapy and other therapies, depending on what's causing low T.

In men who are obese, or who have an underlying medical condition such as diabetes that can contribute to low T, losing weight or managing the underlying condition often causes testosterone levels to normalize.

In recent years, many advertising dollars have been spent on promoting testosterone replacement therapy to middle-aged men experiencing such symptoms as fatigue and low libido.

Whether treating such men with testosterone is safe or appropriate, however, is a matter of some controversy. Some doctors are strongly in favor of it, while others are much more cautious.

Learn More About Low Testosterone Causes

Learn More About Low Testosterone Symptoms

Learn More About Low Testosterone Treatment

Learn More About Low Testosterone In Women

Continued here:
Low Testosterone - Symptoms & Treatment | Everyday Health

We place unreasonable trust in biological explanations of male behaviour. Nowhere is this truer than with testosterone. Contemporary pundits invoke the hormone nicknamed T to prove points about maleness and masculinity, to show how different men and women are, and to explain why some men (presumably those with more T) have greater libidos. Yet, despite the mythic properties popularly associated with T, in every rigorous scientific study to date there is no significant correlation in healthy men between levels of T and sexual desire.

Beginning in the 1990s and really picking up steam in the 2000s, sales of testosterone replacement therapies (TRTs) went from practically zero to over $5 billion annually in 2018. This was either because there was a sudden outbreak of Low T when a major medical epidemic was finally recognised, or because T became marketed as a wonder drug for men thrown into a panic when they learned that their T levels declined 1 per cent annually after they hit 30.

The answer is not that mens bodies changed or that Low T was horribly underdiagnosed before but that, in the minds of many, T became nothing short of a magic male molecule that could cure men of declining energy and sexual desire as they aged.

Whats more, many have been taught that, if you want to know what causes some men to be aggressive, you just test their T levels, right? Actually, wrong: the science doesnt support this conclusion either. Some of the famous early studies linking T and aggression were conducted on prison populations and were used effectively to prove that higher levels of T were found in some men (read: darker-skinned men), which explained why they were more violent, which explained why they had to be imprisoned in disproportionate numbers. The methodological flaws in these studies took decades to unravel, and new rigorous research showing little relation between T and aggression (except at very high or very low levels) is just now reaching the general public.

Whats more, it turns out that T is not just one thing (a sex hormone) with one purpose (male reproduction). T is also essential in the development of embryos, muscles, female as well as male brains, and red blood cells. Depending on a range of biological, environmental and social factors, its influence is varied or negligible.

Robert Sapolsky, a neuroscientist at Stanford University in California, compiled a table showing that there were only 24 scientific articles on T and aggression 1970-80, but there were more than 1,000 in the decade of the 2010s. New discoveries about aggression and T? No, actually, although there were new findings in this period showing the importance of T in promoting ovulation. There is also a difference between correlation and cause (T levels and aggression, for example, provide a classic chicken-egg challenge). As leading experts on hormones have shown us for years, for the vast majority of men, its impossible to predict who will be aggressive based on their T level, just as if you find an aggressive man (or woman, for that matter), you cant predict their T level.

Testosterone is a molecule that was mislabelled almost 100 years ago as a sex hormone, because (some things never change) scientists were looking for definitive biological differences between men and women, and T was supposed to unlock the mysteries of innate masculinity. T is important for mens brains, biceps and that other word for testicles, and it is essential to female bodies. And, for the record, (T level) size doesnt necessarily mean anything: sometimes, the mere presence of T is more important than the quantity of the hormone. Sort of like starting a car, you just need fuel, whether its two gallons or 200. T doesnt always create differences between men and women, or between men. To top it all off, there is even evidence that men who report changes after taking T supplements are just as likely reporting placebo effects as anything else.

Still, we continue to imbue T with supernatural powers. In 2018, a US Supreme Court seat hung in the balance. The issues at the confirmation hearings came to focus on male sexual violence against women. Thorough description and analysis were needed. Writers pro and con casually dropped in the T-word to describe, denounce or defend the past behaviour of Justice Brett Kavanaugh: one commentator in Forbes wrote about testosterone-induced gang rapes; another, interviewed on CNN, asked: But were talking about a 17-year-old boy in high school with testosterone running high. Tell me, what boy hasnt done this in high school?; and a third, in a column in The New York Times, wrote: Thats him riding a wave of testosterone and booze

And it is unlikely that many readers questioned the hormonal logic of Christine Lagarde, then chair of the International Monetary Fund, when she asserted that the economic collapse in 2008 was due in part to too many males in charge of the financial sector: I honestly think that there should never be too much testosterone in one room.

You can find T employed as a biomarker to explain (and sometimes excuse) male behaviour in articles and speeches every day. Poetic licence, one might say. Just a punchy way to talk about leaving males in charge. Yet when we raise T as significant in any way to explain male behaviour, we can inadvertently excuse male behaviour as somehow beyond the ability of actual men to control. Casual appeals to biological masculinity imply that patriarchal relationships are rooted in nature.

When we normalise the idea that T runs through all high-school boys, and that this explains why rape occurs, we have crossed from euphemism to offering men impunity to sexually assault women by offering them the defence not guilty, by reason of hormones.

Invoking mens biology to explain their behaviour too often ends up absolving their actions. When we bandy about terms such as T or Y chromosomes, it helps to spread the idea that men are controlled by their bodies. Thinking that hormones and genes can explain why boys will be boys lets men off the hook for all manner of sins. If you believe that T says something meaningful about how men act and think, youre fooling yourself. Men behave the way they do because culture allows it, not because biology requires it.

No one could seriously argue that biology is solely responsible for determining what it means to be a man. But words such as testosterone and Y chromosomes slip into our descriptions of mens activities, as if they explain more than they actually do. T doesnt govern mens aggression and sexuality. And its a shame we dont hear as much about the research showing that higher levels of T in men just as easily correlate with generosity as with aggression. But generosity is less a stereotypically male virtue, and this would spoil the story about mens inherent aggressiveness, especially manly mens aggressiveness. And this has a profound impact on what men and women think about mens natural inclinations.

We need to keep talking about toxic masculinity and the patriarchy. Theyre real and theyre pernicious. And we also need new ways of talking about men, maleness and masculinity that get us out of the trap of thinking that mens biology is their destiny. As it turns out, when we sift through the placebo effects and biobabble, T is not a magic male molecule at all but rather as the researchers Rebecca Jordan-Young and Katrina Karkazis argue in their book Testosterone (2019) a social molecule.

Regardless of what you call it, testosterone is too often used as an excuse for letting men off the hook and justifying male privilege.

Matthew Gutmann

This article was originally published at Aeon and has been republished under Creative Commons.

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Getting Testosterone Down To The 'T' - Qrius

For those questioning how free for all policies espoused by progressive leaders on and off the presidential campaign trail would work in the real world, look no further than our own MBTA.

As the Boston Herald reported, the Ts Fiscal and Management Control Board met in December, and among the items on its agenda (besides the transit agencys expanding budget deficit) was discussion of means-tested fares, as in discounts for low-income riders.

We cant keep talking about this for years and years, board Vice Chairwoman Monica Tibbits-Nutt said. The community has been patient.

For those struggling to get by, T fares can take a big chunk out of the day-to-day budget, and the call for relief is understandable.

The Ts been studying the logistics, and this week revealed that an income-based MBTA fares option could boost ridership substantially. The bad news: It would cost the agency tens of millions of dollars in revenue.

Much depends on who would qualify for the lower fares, depending on where the income threshold would be set. Letting those who earn twice the federal poverty level ($26,200 for a family of four) qualify would bring in roughly 50,000 to 90,000 new commuters to the bus and subway every year, MBTA Deputy Director of Policy and Strategic Planning Lynsey Heffernan told the FMCB.

And those riders would cause the T to forgo between $23.3 million and $42.3 million in revenue each year.

The MBTA is spending on a lot of things, such as increased inspections and quality-control measures, in the wake of last years devastating report by a safety review panel. At the December meeting, the T said its budget was likely to run a $42.2 million deficit. Thats with riders paying their regular fares.

Gov. Charlie Bakers $18 billion transportation bond bill, meanwhile, has moved before the House Ways and Means Committee. Among the features: money for MBTA improvements, regional transit authority electrification and additional funding for the South Coast Rail and Green Line Extension projects, already underway.

The MBTA needs to make safety improvements, finish rail and subway projects and advance transportation options for Bay Staters outside of the Greater Boston area. That takes money, and Baker has put together a plan for borrowing it.

The House is rolling out its own transportation plan, one that may include a gas tax.

Inevitably, the proposal to institute an income-based MBTA fare system and lose revenue collides with efforts to borrow or raise revenue to maintain and bolster safety and advance capital improvements.

Which brings us to a key flaw in so many free for all proposals: There are many needs to be met, all of them come with costs, and revenue is not in inexhaustible supply.

Does one halt plans for regional transit authorities to pay for low-income fares in Greater Boston? Or put new buses and trains on hold, despite the rise in ridership such a fare program would initiate?And as many of the capital improvements are under the aegis of helping the environment by getting public transportation to more people, does one dial back the green agenda to assist low-income residents?

Or will someone hit the default switch and call for a tax hike to cover the tab? It takes little imagination to envision the reaction to that.

In the real world, even reducing costs can come at a high price, and when resources have to stretch to cover many needs, triage is a crucial part of the decision-making process.

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Lost revenue from low T fares must be recouped - Boston Herald

ENGLEWOOD, CO / ACCESSWIRE / February 6, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that the company will present its operational results for the quarter ended December 31, 2019 on February 13, 2020, at 4:30 p.m. ET. The company will review accomplishments from the quarter and provide an overview of its business and growth strategy.

Conference Call Information

1- 844-602-0380 (toll-free)

1- 862-298-0970 (international)

The webcast will be accessible live and archived on Aytu BioScience's website, within the Investors section under Events & Presentations, at aytubio.com, for 90 days.

A replay of the call will be available for fourteen days. Access the replay by calling 1-877-481-4010 (toll-free) and using the replay access code 57940.

About Aytu BioScience, Inc.

Aytu BioScience is a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the effects of the business combination of Aytu and the Commercial Portfolio and the previously announced, but not yet consummated, merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, the failure to obtain the required votes of Innovus' shareholders or Aytu's shareholders to approve the Merger and related matters, the risk that a condition to closing of the Merger may not be satisfied, that either party may terminate the merger agreement or that the closing of the Merger might be delayed or not occur at all, the price per share utilized in the formula for the initial $8 million merger consideration in the Merger may not be reflective of the current market price of Aytu's common stock on the closing date, potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the Merger, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience to Report Fiscal Q2 FY 2020 Results and Business Update - Yahoo Finance

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Low T Therapy Market 2020-2027 Worldwide Analysis and Prediction by Leading Players: AbbVie, Endo International, Eli Lilly, Pfizer - News Parents

The Great Debate at the 2019 ACR/ARP Annual Meeting addressed the issue of whether anabolic therapies are appropriate as first-line treatment for glucocorticoid-induced osteoporosis (GIO). The risk is usually defined based on previous fracture history, low T-score, and the presence of multiple risk factors for fracture including smoking, alcohol, or low body weight. Kenneth Saag, MD, presented the pro side while Mary Beth Humphrey, MD, PhD, presented the con side of using anabolic agents for GIO.

Audience members were surveyed on their opinion, with 60% of participants indicating their preference for using anabolic agents including teriparatide as first-line therapy for GIO. It was interesting to see this audience response, as certainly those advocating the use of teriparatide won. I was actually surprised the margin wasnt even greater for the pro side, because clearly anabolic drugs are superior to any antiresorptive agents for fracture protection in high-risk patients, with better bone efficacy data.

The main problem is that there have been no head-to-head trials conducted with fracture reduction as a primary end point for GIO. Several trials have shown bone mineral density (BMD) differences between drugs. Dr Saag noted in his presentation that research has found statistically significantly fewer fractures in patients taking teriparatide, but again, the fracture rate was not indicated as a primary end point in the design of the clinical trial. There also may never be a head-to-head trial for various drugs in GIO, the main reason being obviously the cost of conducting such trials.

Dr Humphrey indicated that patient preference, satisfaction, and adherence should also be taken into account when debating whether anabolic agents should be given to a patient at high risk for GIO, suggesting that some patients will not elect to receive medication delivered by injection. In general, patients dont want an injection when they can be prescribed a pill. From my point of view, the conversation should then shift to which is the best and most effective drug given your risk factors. From there we usually can come to a consensus that may include an anabolic agent. As for medication adherence, a patient who has a history of vertebral fracture and back pain may be more likely to be adherent than someone who is asymptomatic.

What I have found to be the larger issue, not only for payers but also patients, is the cost of the anabolic agents, especially for patients with Medicare who are dealing with the donut hole: those who are unable to use copay cards available to other patients with commercial insurance.

From a pathophysiologic perspective, I like to refer back to studies referenced in the past that point to the foundational effect of an anabolic. Researchers studied the effects of alendronate vs romosozumab in postmenopausal women with osteoporosis in the ARCH trial (Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis, ClinicalTrials.gov Identifier: NCT01631214). This trial found that patients who were treated with romosozumab for 1 year followed by alendronate had a significantly lower risk of fracture compared with patients treated with alendronate alone. The fracture rate in people who had taken romosozumab in the first year was significantly less because of the foundational effect of the drug. The process consists of laying down new bone and then consolidating that new bone formation. That is what we have always had to consider, and this speaks to Dr Humphreys point that you do need to continue on an oral bisphosphonate after romosozumab to consolidate the bone after treatment with an anabolic. I like to tell my patients that this process of building bone is like a spring: first you expand the spring, then you have to prevent bounce back to the set point.

Dr Saag mentioned that he was not advocating anabolic agents as first-line treatment for every patient; these agents should be reserved for high-risk patients. I absolutely agree with him. We do not want to give teriparatide, abaloparatide, or romosozumab to everyone. In some patients, oral bisphosphonates are perfectly appropriate, such as those patients taking steroids.

Another point that was mentioned during the Great Debate was the risk for osteosarcoma, which was mainly derived from rat toxicology data using Fischer rats with open epiphyses their entire lives. The incidence of osteosarcoma was found to be markedly higher at baseline compared with humans. However, this osteosarcoma risk was noted by researchers; a registry was started to examine this link, and a drug length use limitation is imposed with some drugs. The registry is still insufficiently powered, so we are not yet certain that there is no relationship between the drugs and the risk for osteosarcoma. Thus far, various tumor registries in the United States have looked at the incidence of osteosarcoma with teriparatide use and no increased signal has been found.

Currently use of romosozumab is limited to 1 year because the effect tends to wane after 12 months. This is probably because the effect on osteoblasts is so potent that it depletes the osteoblast, and after a year there is nothing left to do. After 1 year, romosozumab becomes an expensive antiresorptive drug. What is further notable is the lack of information on the label about retreatment, as well as the lack of further guidelines about retreatment.

The current gaps in preventing glucocorticoid-induced osteoporosis are similar to those present in preventing postmenopausal osteoporosis. The number of people in whom bone density is being measured and who are being diagnosed with osteoporosis is decreasing. I think some patients may be risk averse because of the issues related to atypical femur fractures and osteonecrosis of the jaw. I think physicians may also be too busy to elevate this issue, even though mortality after hip fracture in women is 20% after one year and in men its 40%.

More broadly speaking apart from GIO, I believe the biggest game changer in osteoporosis research being presented is romosozumab. We now have a new anabolic agent that works differently than teriparatide as a signaling pathway drug. STUCTURE (An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women; ClinicalTrials.gov Identifier: NCT01796301) studied the effect of 1 year of treatment with romosozumab compared with teriparatide on total hip BMD in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy. The investigators found a dramatic increase in BMD with romosozumab therapy compared with teriparatide. Importantly, they also conducted finite element analysis at the hip that showed increased hip strength with romosozumab. Given these data, I believe this is the biggest story right now in osteoporosis.

Disclosure: Dr Deal is a speaker and consultant for Radius and Amgen.

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Expert Insights on Osteoporosis From the ACR/ARP 2019 Annual Meeting - Rheumatology Advisor

The American College of Physicians (ACP) has released new clinical guidelines providing practical recommendations for testosterone therapy in adult men with age-related low testosterone.

The evidence-based recommendations target all clinicians and werepublished online January 6 in Annals of Internal Medicine, highlighting data from a systematic review of evidence on the efficacy and safety of testosterone treatment in adult men with age-related low testosterone.

Serum testosterone levels drop as men age, starting in their mid-30s, and approximately 20% of American men older than 60 years have low testosterone.

However, no widely accepted testosterone threshold level exists that represents a measure below which symptoms of androgen deficiency and adverse health outcomes occur.

In addition, the role of testosterone therapy in managing this patient population is controversial.

"The purpose of this American College of Physicians (ACP) guideline is to present recommendations based on the best available evidence on the benefits, harms, and costs of testosterone treatment in adult men with age-related low testosterone," write Amir Qaseem, MD, PhD, MHA, from the American College of Physicians, Philadelphia, Pennsylvania, and colleagues.

"This guideline does not address screening or diagnosis of hypogonadism or monitoring of testosterone levels," the authors note.

In particular, the recommendations suggest that clinicians should initiate testosterone treatment in these patients only to help them improve their sexual function.

According to the authors, moderate-certainty evidence from seven trials involving testosterone treatment in adult men with age-related low testosterone showed a small improvement in global sexual function, whereas low-certainty evidence from seven trials showed a small improvement in erectile function.

By contrast, the guideline emphasizes that clinicians should avoid prescribing testosterone treatment for any other concern in this population. Available evidence demonstrates little to no improvement in physical function, depressive symptoms, energy and vitality, or cognition among these men after receiving testosterone treatment, the authors stress.

ACP recommends that clinicians should reassess men's symptoms within 12 months of testosterone treatment initiation, with regular re-evaluations during subsequent follow up. Clinicians should discontinue treatment in men if sexual function fails to improve.

The guideline also recommends using intramuscular formulations of testosterone treatment for this patient population instead of transdermal ones, because intramuscular formulations cost less and have similar clinical effectiveness and harms.

"The annual cost in 2016 per beneficiary for TRT [testosterone replacement therapy] was $2135.32 for the transdermal and $156.24 for the intramuscular formulation, according to paid pharmaceutical claims provided in the 2016 Medicare Part D Drug Claims data," the authors write.

In an accompanying editorial, E. Victor Adlin, MD, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, notes that these new ACP guidelines mostly mirror those recently proposed by both the Endocrine Society and the American Urological Association.

However, he predicts that many clinicians will question the ACP's recommendation to favor use of intramuscular over transdermal formulations of testosterone.

Although Adlin acknowledges the lower cost of intramuscular preparations as a major consideration, he explains that "the need for an intramuscular injection every 1 to 4 weeks is a potential barrier to adherence, and some patients require visits to a health care facility for the injections, which may add to the expense."

Fluctuating blood testosterone levels after each injection may also result in irregular symptom relief and difficulty achieving the desired blood level, he adds. "Individual preference may vary widely in the choice of testosterone therapy."

Overall, Adlin stresses that a patientclinician discussion should serve as the foundation for starting testosterone therapy in men with age-related low testosterone, with the patient playing a central role in treatment decision making.

This guideline was developed with financial support from the American College of Physicians' operating budget. Study author Carrie Horwitch reports serving as a fiduciary officer for the Washington State Medical Association. Jennifer S. Lin, a member of the ACP Clinical Guidelines Committee, reports being an employee of Kaiser Permanente. Robert McLean, another member of the committee, reports being an employee of Northeast Medical Group. The remaining authors and the editorialist have disclosed no relevant financial relationships.

Ann Intern Med. Published online January 6, 2020. Full text, Editorial

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New Guideline for Testosterone Treatment in Men With 'Low T' - Medscape

Staff ReporterJan 22, 2020 07:57 PM EST

As people age, their bodies start to change. This includes issues related to hormones. One of the most common hormonal issues that men face has to do with low testosterone, also called low T. As a common male health issue, there are many people who would like help addressing this issue. For those who would like to learn more, read more about testo boosters and some of the signs of low T.

One of the most common signs that someone has low levels of testosterone is sexual dysfunction. Testosterone is the main male sex hormone and controls factors such as libido and the ability to both achieve and sustain an erection that is suitable for intercourse. When someone has low levels of testosterone, they are going to notice issues with their reproductive system. Men will notice that they just don't "feel" like having sex. Their libido has dropped due to a lack of testosterone. They will also notice that they don't have spontaneous erections like they used to. This can be incredibly frustrating and can lead to serious mental health issues. Therefore, the issues of low testosterone need to be addressed.

Next, men with low testosterone are going to notice that they don't have as much lean muscle mass as they used to. Testosterone plays a key role in someone's ability to put on lean muscle by working out. Even though someone puts in the hours at the gym and eats a healthy, well-balanced diet, they just can't seem to put on the same amount of lean muscle they used to. One of the possible reasons why is that someone has low testosterone. Testosterone is required for the body to respond to the stimulus produced by working out regularly. Without testosterone, lean muscle is not going to stick.

In addition, another common sign of low testosterone is hair loss. Testosterone is responsible for keeping hair follicles healthy and full. If someone has low levels of testosterone, people may notice bald spots starting to appear on the scalp. Hair may also fall out when someone uses a comb or brush. Finally, men may also notice more hair on the floor of the shower. Addressing low testosterone can help someone prevent hair loss.

Finally, one of the most important signs of low testosterone is reduced bone mass. Bones are made up of a calcium network that gives bones their strength and durability. Without testosterone, the bones are going to start to weaken. While this might lead to pain and discomfort, it may also cause someone to be more susceptible to bone fractures. This presents a serious health complication that might land someone in the hospital. In order to avoid this, those who have low testosterone need to make sure this problem is treated.

Anyone who thinks they might have low testosterone should know that there are treatment options available. This comes in the form of testosterone boosters. This is a great way for someone to restore their testosterone levels back to normal. Then, they can enjoy life just as they did during their younger years.

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The Signs a Testosterone Booster is Needed - Science Times

The physicians at Low T 99 understand that one of the primary symptoms of low testosterone is Erectile Dysfunction. For many patients, one of the goals of testosterone therapy is to regain full sexual capabilities. With the intent of maximizing the patient experience, Low T 99 physicians have formulated some of the most powerful and efficient oral ED medications available. If your Low T 99 physician concludes that these medications might be beneficial to your overall therapy they will be made available as a supplementary option.

Many studies have shown that testosterone levels begin to decline by about 1% per year after the age of 30. Low Testosterone levels can lead to: lack of energy, decrease in muscle, fatigue, bad mood, irritability, an increase in body fat, weak erections, low libido, poor sleep, decreased urge to exercise and more. Start treating these symptoms as soon as possible. First, with a diagnosis from a LowT99 doctor find out once and for all if you do, in fact, suffer from low testosterone. If that is the case, let LowT99 doctors get you on a personalized testosterone therapy immediately and start turning things around.

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Low T 99 - Testosterone Therapy: Bellevue, Seattle, Tacoma ...

A lot of things in life get better after you turn 30. Unfortunately, your testosterone level isnt one of them. Testosterone peaks during adolescence and young adulthood, but as men age, this manliest of hormones begins to drop by one percent each year beginning at age 30, and the decline affects your body and brain in myriad ways. Were going to unpack the eight unfortunate effects of low T, but just because biology has it in for you and your masculinity doesnt mean you have to take these changes lying down. (In fact, lying down may be one of the worst things you could do.) There are strategies to combat plummeting T levels, and were going to help you figure out which ones might work for you.

To be blunt, testosterone is what makes you want to fuck. As T decreases in your system, you may find the urge to mate is less intense. Suddenly, you can take sex or leave it. Youd rather binge watch a good show, eat a bucket of fried chicken, and fall asleep in your recliner than swipe through Tindr looking for your next one-night stand.

What you can do: Get moving! Exercise pumps blood throughout your body, cock and balls included. Indulge your fantasy life (yes, this means all the porn, but it could also include erotic reading and role-playing with your partner). Build anticipation by planning a date night and getting excited about the sex it will inevitably involve; make a playlist, set the scene, take a long shower and primp beforehand.

The most disturbing side effect of low T is the inability to get (or keep) it up. Suddenly, your once rock-hard, go-all-night member is acting like a lazy stoner. While the occasional dick disappointment is nothing to be concerned about, if your cock is failing to crow on a regular basis, its time to call in the professionals.

What you can do: They make drugs for this, and for good reason. Viagra is just one of the options for medically-induced erections you can discuss with your doctor. If boner pills dont work, testosterone replacement therapy may also be necessary.

Testosterone is what gives muscles that pumped-up look. As your T dips, your muscles deflate, and what was once high and tight is now soft and saggy.

What you can do: Make sure your exercise routine incorporates cardio and strength training. Either of those alone wont be enough. You need them both. Get more sleep so that when its time to hit the gym, youre raring to go. Recover with high-protein foods to give your muscles a boost. You can also talk to your doctor about whether testosterone supplementation is right for you.

Its so unfair. Youre not even a dad but youve been cursed with dad bod. Blame low T. Beyond the aesthetic of a fuller shape, though, the real danger in weight gain (no matter what the cause) is that it increases your risk of Type 2 diabetes, heart disease, and some cancers.

What you can do: Theres no shortcut here. You have to lose weight. And to do that, youll have to burn more calories than you consume. This means cutting out any empty calories and replacing them with healthy foods in addition to exercising. If youre already athletic, now is the time to step up your exertion and work out harder. Seek out a trainer if you need some ideas on how to make that happen.

Low T can mess with your sleep at night, leaving you drowsy and unmotivated by day. You might feel like youre dragging a giant sandbag previously known as your body around. Your usual get-up-and-go is more like crawl-into-a-hole-and-sleep-until-spring.

What you can do: Were going to sound like a broken record, but here goes: exercise! It seems counterintuitive, but by expending energy, youll gain more oomph. Low energy also means its time to tweak your diet and make sure that youre fueling your body with high-quality calories from whole, healthy foods, not processed ones purchased at the gas station or drive-thru window.

Feeling anywhere from mildly blue to downright depressed is common when testosterone levels start to dwindle. You may also feel irritable or experience mood swings.

What you can do: Youve heard it before, but it bears repeating: exercise and diet are crucial in mediating your mood. Yoga and meditation can help you find your Zen. Therapy can be a beneficial way to unload your feelings without taking them out on your loved ones. Antidepressants may also be warranted if your depression is severe and/or persistent.

If only this meant we forgot all our former fuckups, that ex we cant stop obsessing about, and how little our boss appreciates us! Unfortunately, low T means your brain is like Teflon: new information slides right off and doesnt get stored as reliably as it used to. You forget what room the morning meeting is in, what the new guys name is, or the cross streets of that restaurant you wanted to check out at lunch.

What you can do: A daily meditation practice can help the brain maximize its memory storage space. If meditation puts you to sleep, no worries; naps are good for your brain, too. Some studies show that caffeine, berries, and chewing gum may improve memory functioning. Play brain games like sudoku and crosswords to keep your grey matter in tip-top shape. Finally, be proactive: if you're likely to forget something, write it down or set an alert on your phone.

Low T levels means your hair on your head and your face falls out easier. It sucks, though the one upside is if you have a hairy back (or other unflattering hairy areas), they, too, might just resolve themselves. Hello, dolphin bod!

What you can do: Try Rogaine. Look into laser treatments. Spring for a surgical follicle hair transplant. Or say fuck it and shave your head. (Its badass and plenty of ladies love the look.)

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8 Awful Things That Happen to You After You Turn 30 (And What You Can Do to Stop Them) - Mandatory